VOL 5, NO 7
CANCER CENTER PROFILE
Secondary Neoplasms in Childhood Cancer Survivors
Columbia University Medical Center
By Louise Leuthner, RN, BSN Next Steps Clinic, Children’s Hospital of Wisconsin, HOT Services
Center for Lymphoid Malignancies
Lynnette Anderson, RN, MS, APNP Blood and Marrow Transplant Clinic, Next Steps Clinic, Children’s Hospital of Wisconsin Debra Schmidt, RN, MS, APNP Oncology Clinic, Next Steps Clinic, Children’s Hospital of Wisconsin Milwaukee, Wisconsin
here are a growing number of adults worldwide who are childhood cancer survivors. It is estimated that 80% of children diagnosed with cancer will be childhood cancer survivors and, as of 2005, there were 328,000
survivors of childhood cancer in the United States.1 As this population continues to grow in number and age, new challenges for these survivors emerge. Approximately two-thirds of childhood Continued on page 18
Ellen A. Neylon, MSN, FNP-BC, CCRP, OCN, is an oncology nurse practitioner at the Center for Lymphoid Malignancies, Columbia University Medical Center.
RENAL CELL CARCINOMA n March 2012, Columbia University announced the opening of the Center for Lymphoid Malignancies in New York City. The center’s focus is on the care of patients with the various forms of nonHodgkin lymphoma, chronic lymphocytic leukemia, acute lymphoblastic leukemia, and Hodgkin disease. The highly skilled and experienced staff at the center comprises more than 25 personnel, including physicians, nurses, clinical trial coordinators, regulatory specialists, laboratory scientists, and other support staff under the directorship of Owen A. O’Connor, MD, PhD. Although the healthcare professionals at the center are focused on lymphoid malignancies, they also have expertise in most hematologic cancers, including multiple myeloma, myelodysplastic syndrome, and acute myeloid leukemia. At the center, the emphasis is on research that translates the latest
Continued on page 17
Quality of Life Drives Patient Preference for Metastatic Renal Cell Carcinoma Drug By Wayne Kuznar
he surprising results of a randomized trial on patient preference for one cancer therapy over another show that patient-reported quality-of-life (QOL) differences influence treatment preference far more than physicians had imagined, suggested researchers at the
2012 Annual Meeting of the American Society of Clinical Oncology, held in Chicago, Illinois. In a double-blind, crossover trial, 169 patients with metastatic renal cell carcinoma (mRCC) were randomized 1:1 to 10 weeks of 800 mg of pazopanib or 50 Continued on page 22
CONFERENCE NEWS: MASCC
Advances in Supportive Care By Alice Goodman
t the recent 2012 symposium of the Multinational Association of Supportive Care in Cancer (MASCC), held in New York City, experts discussed a wide range of topics related to management of treatmentinduced side effects. Below are some highlights from the MASCC annual symposium.
INSIDE The PaTienT’s Voice . . . . . . . . . .
Broken-Down Me suPPorTiVe care
Management of Febrile Neutropenia Advances over the past few decades have led to reduced morbidity and mortality from chemotherapy-induced febrile neutropenia (FN). FN was once considered fatal, but in the modern era, mortality is about 5% and FN-related
Breathing Life Into Dyspnea Relief . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Nurse Practitioner–Delivered Automated Telephone Remote Monitoring System . . . . . 22
healTh insurance coVerage . . . . . . . . . . . . . . . . . . . . .
Provisions and Status of the Affordable Care Act BesT PracTices . . . . . . . . . . . . . .
Patient-Friendly Educational Book Enhances Transplant Process
You voted for the
Continued on page 8
FIND ©2012 Green Hill Healthcare Communications, LLC
OUT WHO WON ON PAGE
FOR APPROPRIATE PATIENTS WITH BONE METASTASES FROM SOLID TUMORS
XGEVA® acts precisely to inhibit RANK Ligand, a key mediator of bone resorption, and inhibit osteoclast formation, function, and survival.1
INDICATION XGEVA is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors. ®
XGEVA® is not indicated for the prevention of skeletalrelated events in patients with multiple myeloma.
IMPORTANT SAFETY INFORMATION
• Based on clinical trials using a lower dose of denosumab,
patients with a creatinine clearance less than 30 mL/min or receiving dialysis are at greater risk of severe hypocalcemia compared to patients with normal renal function. The risk of hypocalcemia at the recommended dosing schedule of 120 mg every 4 weeks has not been evaluated in patients with a creatinine clearance less than 30 mL/min or receiving dialysis.
Hypocalcemia ® • XGEVA can cause severe hypocalcemia. Correct pre- Osteonecrosis of the Jaw (ONJ) existing hypocalcemia prior to XGEVA® treatment. Monitor • Osteonecrosis of the jaw (ONJ) can occur in patients calcium levels and administer calcium, magnesium, receiving XGEVA®, manifesting as jaw pain, osteomyelitis, and vitamin D as necessary. Monitor levels more osteitis, bone erosion, tooth or periodontal infection, frequently when XGEVA® is administered with other drugs toothache, gingival ulceration, or gingival erosion. that can also lower calcium levels. In the postmarketing Persistent pain or slow healing of the mouth or jaw after setting, severe symptomatic hypocalcemia has been dental surgery may also be manifestations of ONJ. reported. Advise patients to contact a healthcare professional for symptoms of hypocalcemia. ® REFERENCES: 1. XGEVA 2. Data on file, Amgen.
(denosumab) prescribing information, Amgen.
SUPERIOR EFFICACY XGEVA® delivered 8.2 more months without a skeletal-related event (SRE) in a prespecified integrated analysis of 3 head-to-head studies vs zoledronic acid2
DELAY IN MEDIAN TIME TO FIRST SRE
8.2 month delay2 (HR = 0.83, P < 0.0001*)
N/A1† (HR = 0.82, P = 0.010*)
OTHER SOLID TUMORS‡ OR MULTIPLE MYELOMA
4.2 month delay1 3.6 month delay1 (HR = 0.84, P < 0.001, (HR = 0.82, noninferiority; P = 0.060, P = 0.008*) NS for superiority)
The integrated analysis included three international, phase 3, randomized, double-blind, double-dummy, activecontrolled studies comparing XGEVA® with zoledronic acid for the prevention of SREs in patients with bone metastases from advanced breast cancer (N = 2,046), castration-resistant prostate cancer (N = 1,901), and solid tumors (other than breast or prostate) or multiple myeloma (N = 1,776). Zoledronic acid 4 mg was administered as an IV infusion over a minimum of 15 minutes, once every 4 weeks, in accordance with prescribing information. XGEVA® was administered subcutaneously 120 mg, once every 4 weeks. The primary endpoint was time to first SRE (noninferiority), and the secondary endpoints were time to first SRE (superiority) and time to first and subsequent SREs (superiority). SREs are defined as: radiation to bone, pathologic fracture, surgery to bone, and spinal cord compression. Select exclusion criteria: patients receiving current or prior IV bisphosphonate therapy were excluded from the studies. Patients receiving oral bisphosphonates for the treatment of osteoporosis were not excluded. Daily supplementation of calcium ≥ 500 mg and vitamin D ≥ 400 IU was recommended.1,2 *P value for superiority. † Median time to first SRE: not yet reached for XGEVA®; 26.4 months for zoledronic acid. ‡ Excluding breast and prostate cancer.
ACCESS FOR PATIENTS
Approximately 70% of patients are expected to have $0 out-of-pocket cost for XGEVA ®2§
XGEVA® patients who need help may be eligible for financial assistance2 Based on XGEVA payor mix and coverage for similar products.
an oral examination and appropriate preventive Adverse Reactions dentistry prior to the initiation of XGEVA® and periodically • The most common adverse reactions in patients receiving during XGEVA® therapy. Advise patients regarding oral XGEVA® were fatigue/asthenia, hypophosphatemia, and hygiene practices. Avoid invasive dental procedures nausea. The most common serious adverse reaction was during treatment with XGEVA®. dyspnea. The most common adverse reactions resulting in discontinuation were osteonecrosis and hypocalcemia. • Patients who are suspected of having or who develop ® ONJ while on XGEVA should receive care by a dentist During post approval use, severe symptomatic or an oral surgeon. In these patients, extensive dental hypocalcemia, including fatal cases has been identified. surgery to treat ONJ may exacerbate the condition. Pregnancy Please see brief summary of Prescribing Information • Women should be advised not to become pregnant on the following page. when taking XGEVA®. If the patient is pregnant or becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
©2012 Amgen Inc. All rights reserved. 07/12 68020-R1-V2 G68979-R1-V2
Brief Summary: Consult package insert for complete Prescribing Information INDICATIONS AND USAGE: Bone Metastasis from Solid Tumors. Xgeva is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors. Important Limitation of Use. Xgeva is not indicated for the prevention of skeletal-related events in patients with multiple myeloma (see Clinical Trials  in full Prescribing Information). DOSAGE AND ADMINISTRATION: Recommended Dosage. The recommended dose of Xgeva is 120 mg administered as a subcutaneous injection every 4 weeks in the upper arm, upper thigh, or abdomen. Administer calcium and vitamin D as necessary to treat or prevent hypocalcemia (see Warnings and Precautions). Preparation and Administration. Visually inspect Xgeva for particulate matter and discoloration prior to administration. Xgeva is a clear, colorless to pale yellow solution that may contain trace amounts of translucent to white proteinaceous particles. Do not use if the solution is discolored or cloudy or if the solution contains many particles or foreign particulate matter. Prior to administration, Xgeva may be removed from the refrigerator and brought to room temperature (up to 25Â°C/77Â°F) by standing in the original container. This generally takes 15 to 30 minutes. Do not warm Xgeva in any other way (see How Supplied/Storage and Handling). Use a 27-gauge needle to withdraw and inject the entire contents of the vial. Do not re-enter the vial. Discard vial after single-use or entry. CONTRAINDICATIONS: None. WARNINGS AND PRECAUTIONS: Hypocalcemia. Xgeva can cause severe hypocalcemia. Correct pre-existing hypocalcemia prior to Xgeva treatment. Monitor calcium levels and administer calcium, magnesium, and vitamin D as necessary. Monitor levels more frequently when Xgeva is administered with other drugs that can also lower calcium levels. In the postmarketing setting, severe symptomatic hypocalcemia has been reported (see Adverse Reactions). Advise patients to contact a healthcare professional for symptoms of hypocalcemia (see Adverse Reactions and Patient Counseling Information  in full Prescribing Information). Based on clinical trials using a lower dose of denosumab, patients with a creatinine clearance less than 30 mL/min or receiving dialysis are at greater risk of severe hypocalcemia compared to patients with normal renal function. In a trial of 55 patients, without cancer and with varying degrees of renal impairment, who received a single dose of 60 mg denosumab, 8 of 17 patients with a creatinine clearance less than 30 mL/min or receiving dialysis experienced corrected serum calcium levels less than 8.0 mg/dL as compared to 0 of 12 patients with normal renal function. The risk of hypocalcemia at the recommended dosing schedule of 120 mg every 4 weeks has not been evaluated in patients with a creatinine clearance less than 30 mL/min or receiving dialysis.
Osteonecrosis of the Jaw (ONJ). Osteonecrosis of the jaw (ONJ) can occur in patients receiving Xgeva, manifesting as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration, or gingival erosion. Persistent pain or slow healing of the mouth or jaw after dental surgery may also be manifestations of ONJ. In clinical trials, in patients with osseous metastasis, 2.2% of patients receiving Xgeva developed ONJ after a median exposure of 13 doses; of these patients, 79% had a history of tooth extraction, poor oral hygiene, or use of a dental appliance (see Adverse Reactions). In a clinical trial conducted in patients with prostate cancer at high risk for osseous metastasis, a condition for which denosumab is not approved, 5.4% of patients developed ONJ after a median exposure of 20 doses. Perform an oral examination and appropriate preventive dentistry prior to the initiation of Xgeva and periodically during Xgeva therapy. Advise patients regarding oral hygiene practices. Avoid invasive dental procedures during treatment with Xgeva. Patients who are suspected of having or who develop ONJ while on Xgeva should immunogenicity. Using an electrochemiluminescent bridging immunoassay, less receive care by a dentist or an oral surgeon. In these patients, extensive dental than 1% (7/2758) of patients with osseous metastases treated with denosumab surgery to treat ONJ may exacerbate the condition. doses ranging from 30 â€“ 180 mg every 4 weeks or every 12 weeks for up to PREGNANCY: Xgeva can cause fetal harm when administered to a pregnant 3 years tested positive for binding antibodies. No patient with positive binding woman. Based on ďŹ ndings in animals, Xgeva is expected to result in adverse antibodies tested positive for neutralizing antibodies as assessed using a reproductive effects. In utero denosumab exposure in cynomolgus monkeys chemiluminescent cell-based in vitro biological assay. There was no evidence resulted in increased fetal loss, stillbirths, and postnatal mortality, along with of altered pharmacokinetic proďŹ le, toxicity proďŹ le, or clinical response associated evidence of absent peripheral lymph nodes, abnormal bone growth and with binding antibody development. The incidence of antibody formation is decreased neonatal growth (see Use in Specific Populations) . There are no highly dependent on the sensitivity and speciďŹ city of the assay. Additionally, adequate and well controlled studies with Xgeva in pregnant women. Women the observed incidence of a positive antibody (including neutralizing antibody) should be advised not to become pregnant when taking Xgeva. If this drug is test result may be inďŹ‚uenced by several factors, including assay methodology, used during pregnancy, or if the patient becomes pregnant while taking this drug, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of antibodies to denosumab the patient should be apprised of the potential hazard to the fetus. with the incidence of antibodies to other products may be misleading. ADVERSE REACTIONS: The following adverse reactions are discussed below DRUG INTERACTIONS: No formal drug-drug interaction trials have been conducted and elsewhere in the labeling: with Xgeva. In clinical trials in patients with breast cancer metastatic to bone, Xgeva t)ZQPDBMDFNJB TFF8BSOJOHTBOE1SFDBVUJPOT
was administered in combination with standard anticancer treatment. Serum t0TUFPOFDSPTJTPGUIF+BX TFF8BSOJOHTBOE1SFDBVUJPOT) denosumab concentrations at 1 and 3 months and reductions in the bone turnover The most common adverse reactions in patients receiving Xgeva (per-patient marker uNTx/Cr (urinary N-terminal telopeptide corrected for creatinine) at 3 months incidence greater than or equal to 25%) were fatigue/asthenia, hypophosphatemia, were similar in patients with and without prior intravenous bisphosphonate therapy. and nausea (see Table 1). The most common serious adverse reaction in patients There was no evidence that various anticancer treatments affected denosumab receiving Xgeva was dyspnea. The most common adverse reactions resulting in systemic exposure and pharmacodynamic effect. Serum denosumab concentrations discontinuation of Xgeva were osteonecrosis and hypocalcemia. at 1 and 3 months were not altered by concomitant chemotherapy and/or hormone Clinical Trials Experience. Because clinical trials are conducted under widely therapy. The median reduction in uNTx/Cr from baseline to month 3 was similar varying conditions, adverse reaction rates observed in the clinical trials of a drug between patients receiving concomitant chemotherapy and/or hormone cannot be directly compared to rates in other clinical trials and may not reďŹ‚ect the therapy (see Clinical Pharmacology [12.2] in full Prescribing Information). rates observed in practice. The safety of Xgeva was evaluated in three randomized, USE IN SPECIFIC POPULATIONS: double-blind, double-dummy trials (see Clinical Trials  in full Prescribing Pregnancy: Category D [see Warnings and Precautions]. Risk Summary: Information) in which a total of 2841 patients with bone metastasis from prostate Xgeva can cause fetal harm when administered to a pregnant woman based cancer, breast cancer, or other solid tumors, or lytic bony lesions from multiple on ďŹ ndings in animals. In utero denosumab exposure in cynomolgus monkeys myeloma received at least one dose of Xgeva. In Trials 1, 2, and 3, patients were resulted in increased fetal loss, stillbirths, and postnatal mortality, along with randomized to receive either 120 mg of Xgeva every 4 weeks as a subcutaneous injection or 4 mg (dose adjusted for reduced renal function) of zoledronic acid evidence of absent lymph nodes, abnormal bone growth and decreased every 4 weeks by intravenous (IV) infusion. Entry criteria included serum calcium neonatal growth. There are no adequate and well-controlled studies with Xgeva (corrected) from 8 to 11.5 mg/dL (2 to 2.9 mmol/L) and creatinine clearance in pregnant women. Women should be advised not to become pregnant when 30 mL/min or greater. Patients who had received IV bisphosphonates were taking Xgeva. If this drug is used during pregnancy, or if the patient becomes excluded, as were patients with prior history of ONJ or osteomyelitis of the jaw, an pregnant while taking this drug, the patient should be apprised of the potential active dental or jaw condition requiring oral surgery, non-healed dental/oral surgery, hazard to the fetus. Women who become pregnant during Xgeva treatment are or any planned invasive dental procedure. During the study, serum chemistries encouraged to enroll in Amgenâ€™s Pregnancy Surveillance Program. Patients or including calcium and phosphorus were monitored every 4 weeks. Calcium and their physicians should call 1-800-77-AMGEN (1-800-772-6436) to enroll. vitamin D supplementation was recommended but not required. The median duration of exposure to Xgeva was 12 months (range: 0.1 â€“ 41) and median duration on-study was 13 months (range: 0.1 â€“ 41). Of patients who received 9HFWB XFSFGFNBMF&JHIUZmWFQFSDFOUXFSF8IJUF )JTQBOJD-BUJOP Asian, and 3% Black. The median age was 63 years (range: 18 â€“ 93). SeventyďŹ ve percent of patients who received Xgeva received concomitant chemotherapy.
Clinical Considerations: The effects of Xgeva are likely to be greater during the second and third trimesters of pregnancy. Monoclonal antibodies are transported across the placenta in a linear fashion as pregnancy progresses, with the largest amount transferred during the third trimester. If the patient becomes pregnant during Xgeva therapy, consider the risks and beneďŹ ts in continuing or discontinuing treatment with Xgeva.
Renal Impairment. In a trial of 55 patients without cancer and with varying degrees of renal function who received a single dose of 60 mg denosumab, patients with a creatinine clearance of less than 30 mL/min or receiving dialysis were at greater risk of severe hypocalcemia with denosumab compared to patients with normal renal function. The risk of hypocalcemia at the recommended dosing schedule of 120 mg every 4 weeks has not been evaluated in patients with a creatinine clearance of less than 30 mL/min or receiving dialysis (see Warnings and Precautions, Adverse Reactions, and Clinical Pharmacology [12.3] in full Prescribing Information). OVERDOSAGE: There is no experience with overdosage of Xgeva. HOW SUPPLIED/STORAGE AND HANDLING: Xgeva is supplied in a single-use vial. Store Xgeva in a refrigerator at 2Â°C to 8Â°C (36Â°F to 46Â°F) in the original carton. Do not freeze. Once removed from the refrigerator, Xgeva must not be exposed to temperatures above 25Â°C/77Â°F or direct light and must be used within 14 days. Discard Xgeva if not used within the 14 days. Do not use Xgeva after the expiry date printed on the label. Protect Xgeva from direct light and heat. Avoid vigorous shaking of Xgeva. PATIENT COUNSELING INFORMATION: Advise patients to contact a healthcare professional for any of the following: t4ZNQUPNTPGIZQPDBMDFNJB JODMVEJOHQBSFTUIFTJBTPSNVTDMFTUJGGOFTT twitching, spasms, or cramps (see Warnings and Precautions and Adverse Reactions) t4ZNQUPNTPG0/+ JODMVEJOHQBJO OVNCOFTT TXFMMJOHPGPSESBJOBHFGSPNUIF jaw, mouth, or teeth (see Warnings and Precautions and Adverse Reactions) t1FSTJTUFOUQBJOPSTMPXIFBMJOHPGUIFNPVUIPSKBXBGUFSEFOUBMTVSHFSZ (see Warnings and Precautions) t1SFHOBODZPSOVSTJOH(see Warnings and Precautions and Use in Specific Populations) Advise patients of the need for: t1SPQFSPSBMIZHJFOFBOESPVUJOFEFOUBMDBSF t*OGPSNJOHUIFJSEFOUJTUUIBUUIFZBSFSFDFJWJOH9HFWB t"WPJEJOHJOWBTJWFEFOUBMQSPDFEVSFTEVSJOHUSFBUNFOUXJUI9HFWB Advise patients that denosumab is also marketed as ProliaÂŽ. Patients should inform their healthcare provider if they are taking Prolia. Amgen Manufacturing Limited, a subsidiary of Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 ÂŠ2012 Amgen Inc. All rights reserved. Printed in USA.
8/8/12 11:14 AM
Table 1. Per-patient Incidence of Selecteda Adverse Reactions of Any Animal Data: The effects of denosumab on prenatal development have been studied Severity (Trials 1, 2, and 3) in both cynomolgus monkeys and genetically engineered mice in which RANK ligand (RANKL) expression was turned off by gene removal (a â€œknockout mouseâ€?). Xgeva Zoledronic Acid In cynomolgus monkeys dosed subcutaneously with denosumab throughout Body System n = 2841 n = 2836 pregnancy at a pharmacologically active dose, there was increased fetal loss during % % gestation, stillbirths, and postnatal mortality. Other ďŹ ndings in offspring included absence of axillary, inguinal, mandibular, and mesenteric lymph nodes; abnormal GASTROINTESTINAL bone growth, reduced bone strength, reduced hematopoiesis, dental dysplasia and Nausea 31 32 tooth malalignment; and decreased neonatal growth. At birth out to one month of Diarrhea 20 19 age, infants had measurable blood levels of denosumab (22-621% of maternal levels). Following a recovery period from birth out to 6 months of age, the effects GENERAL on bone quality and strength returned to normal; there were no adverse effects Fatigue/ Asthenia 45 46 on tooth eruption, though dental dysplasia was still apparent; axillary and inguinal lymph nodes remained absent, while mandibular and mesenteric lymph nodes INVESTIGATIONS were present, though small; and minimal to moderate mineralization in multiple )ZQPDBMDFNJBb 18 9 tissues was seen in one recovery animal. There was no evidence of maternal )ZQPQIPTQIBUFNJBb 32 20 harm prior to labor; adverse maternal effects occurred infrequently during labor. NEUROLOGICAL Maternal mammary gland development was normal. There was no fetal NOAEL (no )FBEBDIF 13 14 observable adverse effect level) established for this study because only one dose of 50 mg/kg was evaluated. In RANKL knockout mice, absence of RANKL (the target of RESPIRATORY denosumab) also caused fetal lymph node agenesis and led to postnatal impairment Dyspnea 21 18 of dentition and bone growth. Pregnant RANKL knockout mice showed altered Cough 15 15 maturation of the maternal mammary gland, leading to impaired lactation (see Use in Nursing Mothers and Nonclinical Toxicology [13.2] in full Prescribing Information). a Adverse reactions reported in at least 10% of patients receiving Xgeva in Trials Nursing Mothers. It is not known whether Xgeva is excreted into human milk. 1, 2, and 3, and meeting one of the following criteria: Measurable concentrations of denosumab were present in the maternal milk t"UMFBTUHSFBUFSJODJEFODFJO9HFWBUSFBUFEQBUJFOUT PS of cynomolgus monkeys up to 1 month after the last dose of denosumab t#FUXFFOHSPVQEJGGFSFODF FJUIFSEJSFDUJPO PGMFTTUIBOBOENPSFUIBO (â‰¤ 0.5% milk:serum ratio). Because many drugs are excreted in human milk and 5% greater incidence in patients treated with zoledronic acid compared to because of the potential for serious adverse reactions in nursing infants from placebo (US Prescribing Information for zoledronic acid) Xgeva, a decision should be made whether to discontinue nursing or discontinue b Laboratory-derived and below the central laboratory lower limit of normal the drug, taking into account the importance of the drug to the mother. Maternal [8.3 â€“ 8.5 mg/dL (2.075 â€“ 2.125 mmol/L) for calcium and 2.2 â€“ 2.8 mg/dL exposure to Xgeva during pregnancy may impair mammary gland development and lactation based on animal studies in pregnant mice lacking the RANK/RANKL (0.71 â€“ 0.9 mmol/L) for phosphorus] signaling pathway that have shown altered maturation of the maternal mammary Severe Mineral/Electrolyte Abnormalities HMBOE MFBEJOH UP JNQBJSFE MBDUBUJPO QPTUQBSUVN )PXFWFS JO DZOPNPMHVT t4FWFSFIZQPDBMDFNJB DPSSFDUFETFSVNDBMDJVNMFTTUIBONHE-PSMFTT monkeys treated with denosumab throughout pregnancy, maternal mammary than 1.75 mmol/L) occurred in 3.1% of patients treated with Xgeva and 1.3% gland development was normal, with no impaired lactation. Mammary gland of patients treated with zoledronic acid. Of patients who experienced severe histopathology at 6 months of age was normal in female offspring exposed to hypocalcemia, 33% experienced 2 or more episodes of severe hypocalcemia denosumab in utero; however, development and lactation have not been fully and 16% experienced 3 or more episodes (see Warnings and Precautions and evaluated (see Nonclinical Toxicology [13.2] in Full Prescribing Information). Use in Specific Populations). Pediatric Use. Xgeva is not recommended in pediatric patients. The safety and t4FWFSFIZQPQIPTQIBUFNJB TFSVNQIPTQIPSVTMFTTUIBONHE-PSMFTTUIBO effectiveness of Xgeva in pediatric patients have not been established. Treatment 0.6 mmol/L) occurred in 15.4% of patients treated with Xgeva and 7.4% of with Xgeva may impair bone growth in children with open growth plates and patients treated with zoledronic acid. may inhibit eruption of dentition. In neonatal rats, inhibition of RANKL (the target Osteonecrosis of the Jaw of Xgeva therapy) with a construct of osteoprotegerin bound to Fc (OPG-Fc) In the primary treatment phases of Trials 1, 2, and 3, ONJ was conďŹ rmed in at doses â‰¤ 10 mg/kg was associated with inhibition of bone growth and tooth 1.8% of patients in the Xgeva group and 1.3% of patients in the zoledronic eruption. Adolescent primates treated with denosumab at doses 5 and 25 times acid group (see Warnings and Precautions). When events occurring during an (10 and 50 mg/kg dose) higher than the recommended human dose of extended treatment phase of approximately 4 months in each trial are included, 120 mg administered once every 4 weeks, based on body weight (mg/kg), had the incidence of conďŹ rmed ONJ was 2.2% in patients who received Xgeva. The abnormal growth plates, considered to be consistent with the pharmacological activity of denosumab. Cynomolgus monkeys exposed in utero to denosumab median time to ONJ was 14 months (range: 4 â€“ 25). exhibited bone abnormalities, reduced hematopoiesis, tooth malalignment, Postmarketing Experience. Because postmarketing reactions are reported decreased neonatal growth, and an absence of axillary, inguinal, mandibular, and voluntarily from a population of uncertain size, it is not always possible to reliably mesenteric lymph nodes. Some bone abnormalities recovered once exposure estimate their frequency or establish a causal relationship to drug exposure. was ceased following birth; however, axillary and inguinal lymph nodes remained The following adverse reactions have been identiďŹ ed during post approval absent 6 months post-birth (see Use in Pregnancy). use of Xgeva: Geriatric Use. Of patients who received Xgeva in Trials 1, 2, and 3, 1260 (44%) t)ZQPDBMDFNJB Severe symptomatic hypocalcemia, including fatal cases. were 65 years of age or older. No overall differences in safety or efďŹ cacy were Immunogenicity. As with all therapeutic proteins, there is potential for observed between these patients and younger patients.
Editorial Board EDITOR-IN-CHIEF
Cassandra J. Hammond, RN,
Dolores “Jeff” Nordquist, RN, MS,
Avid Education Partners, LLC Sharpsburg, MD
Mayo Clinic Rochester, MN
Northern Michigan University Independent Oncology & Palliative Care Consultant Marquette, MI
RN, MSN, APRN, BC, OCN
RN, BSN, OCN
Melinda Oberleitner, RN,
Karla Wilson, RN, MSN, FNP-C, CPON
DNS, APRN, CNS
City of Hope National Medical Center Duarte, CA
Beth Faiman, PhD(c), MSN, APRNBC, AOCN Cleveland Clinic Taussig Cancer Institute Cleveland, OH
John Theurer Cancer Center Hackensack University Medical Center Hackensack, NJ
Catherine Bishop, DNP, NP, AOCNP
Novant Health Presbyterian Cancer Center Charlotte, NC
Patricia Irouer Hughes, RN, MSN,
College of Nursing and Allied Health Professions University of Louisiana Lafayette, LA
Jayshree Shah, NP
Piedmont Healthcare Rex, GA
John Theurer Cancer Center Hackensack University Medical Center Hackensack, NJ
Deena Damsky Dell, MSN, RN-BC,
NP, MSN, ACNP-C
University of Southern California Norris Cancer Center & Hospital Los Angeles, CA
MSN, NP, ANP-BC, AOCNP
Sibley Memorial Hospital Johns Hopkins Medicine Washington, DC
Fox Chase Cancer Center Philadelphia, PA
PhD, RN, AOCN
Pharmacy John F. Aforismo, BSc Pharm, RPh, FASCP RJ Health Systems International, LLC Wethersfield, CT
Nutrition Karen Connelly, RD, CSO
NYU Clinical Cancer Center New York, NY
Somerset Medical Center Somerville, NJ
Sandra E. Kurtin,
Lori Stover, RN,
DNP, APRN, AOCN
RN, MS, AOCN, ANP-C
Patient Advocate Peg Ford
Western Pennsylvania Cancer Institute Pittsburgh, PA
Ovarian Cancer Advocacy Alliance Coronado, CA
Joseph D. Tariman, PhD,
Social Work Carolyn Messner,
DSW, MSW, LCSW-R, BCD
Genentech New London, NH
Denice Economou, RN, MN, CNS, AOCN
Arizona Cancer Center Tucson, AZ
Ann McNeill, MSN, RN, NP-C, OCN
City of Hope National Medical Center Duarte, CA
John Theurer Cancer Center Hackensack University Medical Center Hackensack, NJ
Northwestern University Myeloma Program Chicago, IL
Constance Engelking, RN,
Kena C. Miller, RN, MSN, FNP
Jacqueline Marie Toia, RN, MS, DNP
MS, CNS, OCN
Roswell Park Cancer Institute Buffalo, NY
Northwestern University Myeloma Program Chicago, IL
The CHE Consulting Group, Inc. Mt. Kisco, NY
CancerCare New York, NY
Managed Care and Pharmaceutical Management Burt Zweigenhaft, BS BioPharma Partners LLC New York, NY
Amy Ford, RN,
MS, RN, APN-C, AOCNS
Quintiles Dallas, TX
Pamela Hallquist Viale, RN, MS, CS, ANP, AOCN
Isabell Castellano, RN
Somerset Medical Center Somerville, NJ
Bristol-Myers Squibb Children’s Hospital Robert Wood Johnson University Hospital New Brunswick, NJ
Sharon S. Gentry,
Ellen A. Neylon,
Jeanne Westphal, RN
RN, MSN, AOCN
MSN, FNP-BC, CCRP, OCN
RN, PhD, APRN
Meeker County Memorial Hospital Litchfield, MN
Derrick L. Davis Forsyth Regional Cancer Center Winston-Salem, NC
Columbia University Medical Center Center for Lymphoid Malignancies New York, NY
University of South Florida College of Nursing Tampa, FL
AuguST 2012 I VOL 5, NO 7
From the Editor
n this month’s issue of The Oncology Nurse-APN/PA (TON), we continue our coverage of the news from the 37th Annual Congress of the Oncology Nursing Society (ONS) and the 2012 Annual Meeting of the American Society of Clinical Oncology. The news from ONS continues to demonstrate the important role nurses play in symptom management and in helping Beth Faiman, PhD(c), MSN, APRN-BC, AOCN patients prepare for and understand Editor-in-Chief their treatments. Staff at the CedarsSinai Blood and Marrow Transplant Program are using educational materials, prepared by one of their own, to educate and empower patients undergoing blood and marrow transplant. As reported at ONS, these new patient-friendly notebooks have received very positive responses from patients, caregivers, and members of the oncology team. These materials can be
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AuguST 2012 I VOL 5, NO 7
downloaded from the Cedars-Sinai Web site and customized for use by other institutions. This issue starts our coverage of the Multinational Association of Supportive Care in Cancer symposium, held in July in New York City. Our coverage includes results of a pilot study that “may offer a glimmer of hope” for patients dealing with chemotherapy-induced peripheral neuropathy as well as acknowledgment that diarrhea is a problematic side effect for patients even in the era of molecularly targeted treatments. In The Patient’s Voice article, MMA tells us how her hospital stay for a stem cell transplant included some harrowing incidents that brought about an emotional breakdown that still lingers. She asks, “Will I ever recover from the emotional scars left from that hospital stay?” As oncology nurses, this is something we have to acknowledge and figure out how to handle so we can best help our patients get through these overwhelming situations. Please let us know your reactions to what you see in TON. Contact us at firstname.lastname@example.org. l
Approval of Ziv-aflibercept for Metastatic Colorectal Cancer On August 3, 2012, the US Food and Drug Administration (FDA) approved ziv-aflibercept (Zaltrap, Sanofi US Inc) for use in combination with FOLFIRI (5-fluorouracil, leucovorin, and irinotecan) for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing chemotherapy regimen. Ziv-aflibercept, which was previously known as aflibercept, is an angiogenesis inhibitor that inhibits the blood supply to tumors. The FDA approval was based on the results of a phase 3 trial of 1226 patients with mCRC whose cancer had progressed during or within 6 months of having received oxaliplatin-based combination chemotherapy, with or without prior bevacizumab. Patients were randomized to receive FOLFIRI with either ziv-aflibercept or placebo. Patients in the trial received treatment until their cancer progressed or side effects became unacceptable. The primary efficacy end point was overall survival. Patients who received FOLFIRI with ziv-aflibercept had a median overall survival of 13.5 months compared with 12.06 months for patients who received FOLFIRI with placebo. Median progression-free survival for patients in the FOLFIRI with ziv-aflibercept arm was 6.9 months compared with 4.7 months for patients in the FOLFIRI with placebo arm. A reduction in tumor size occurred in 20% of patients who received the FOLFIRI with ziv-aflibercept combination versus 11% for those who received FOLFIRI with placebo. Ziv-aflibercept was approved with a Boxed Warning alerting patients and healthcare professionals that the drug can cause severe and sometimes fatal bleeding, including gastrointestinal bleeding, and the development of holes in the gastrointestinal tract. Ziv-aflibercept can also make it more difficult for wounds to heal. The most common side effects observed in patients receiving FOLFIRI with ziv-aflibercept were decreased white blood cell count, diarrhea, mouth ulcers, fatigue, high blood pressure, increased amount of protein in the urine, weight loss, decreased appetite, abdominal pain, and headache. Everolimus Approval for Advanced Breast Cancer The FDA approved everolimus (Afinitor; Novartis Pharmaceuticals Corporation) for use in combination with exemestane to treat postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer
who experienced treatment failure with letrozole or anastrozole. The approval was granted on July 20, 2012. Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, commented that everolimus “is another example of the value of continuing to study drugs in additional types of cancer after their initial approval.” Everolimus had previously received approval to treat patients with advanced renal cell carcinoma that had progressed after treatment with other cancer therapies, in adult patients with progressive advanced neuroendocrine tumors of pancreatic origin, for patients with renal angiomyolipoma and tuberous sclerosis complex (TSC) not requiring immediate surgery, and for adults and children with subependymal giant cell astrocytoma associated with TSC who were not candidates for curative surgery but who required treatment. FDA approval was based on the results of a randomized, double-blind, multicenter trial involving 724 patients who had experienced menopause, had estrogen receptor–positive, HER2-negative breast cancer that had spread, and had previously received treatment with letrozole or anastrozole. Patients received either everolimus plus exemestane or placebo plus exemestane. Median progression-free survival was 7.8 months for patients in the everolimus plus exemestane arm and 3.2 months in the placebo plus exemestane arm. An interim analysis of overall survival was not statistically significant; a final analysis is expected in June 2014. Mouth ulcers, infections, rash, fatigue, diarrhea, and decreased appetite were the most common side effects observed in patients in the trial who received everolimus. Patients aged 65 years and older experienced a higher rate of serious side effects than did younger patients. l
For the Record In the June issue of The Oncology Nurse-APN/PA, the improvement in overall survival (OS) and radiographic progression-free survival (PFS) data presented in the Androgen Blockers Score Big in Prostate Cancer news brief was incorrect. With respect to enzalutamide, the improvement in OS is 4.8 and the improvement in PFS is 5.4 compared with placebo. We apologize for the error.
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Conference News: MASCC Advances in Supportive Care Continued from cover morbidity is about 20% to 30%. Complications can include hypotension, respiratory failure, intensive care unit admission, and confusion. The MASCC scoring system for FN and the use of granulocyte colony-stimulating factor (G-CSF) for prevention of FN in high-risk patients are the most important advances over the past 2 or 3 decades, explained Jean Klastersky, MD, Institut Jules Bordet, Université Libre de Bruxelles, Belgium. “Mortality and morbidity are greatly reduced, and therapies are simpler, less toxic, and appropriately delineated according to patients’ risk status,” Klastersky told the audience. “Despite this progress, numerous challenges remain in patients at high risk, and further study is needed to define the optimal use of G-CSF.” “Even a 5% mortality rate is too high,” he continued. “Some of the patients who die are young and treated with curative therapy.” Treating an episode of FN is expensive, with much of the direct treatment costs driven by G-CSF. The mean cost of treating 1 episode of FN is $7700 for outpatients, and $15,231 for inpatients. “The cost is reduced by 50% if you can treat on an outpatient basis,” he said. The MASCC scoring index, developed in 2000, enables risk stratification of patients who develop FN. A score >21 predicts a low risk of complications (ie, <5%). These patients can be treated with oral antibiotics as outpatients. Prerequisites for oral antibiotic therapy include: (1) low risk on MASCC scoring index, (2) feasibility of oral antibiotics, and (3) 24-hour hospitalization period for observation. The rates of mortality and complications are higher in patients with a MASCC index score <15 versus >21. Mortality from gram-negative bacteremia is 43% in patients with a MASCC score <15, Klastersky noted. “A low MASCC score predicts for severe sepsis. We need protocolized approaches for patients with FN and poor MASCC score. Some of these patients are kept too long in the emergency department—for several hours— without antibiotics. We should be more aggressive in selecting patients at high risk,” he continued. The possibility of preventing FN with G-CSF has moved the field forward. Prophylactic use of G-CSF can decrease the incidence by about 50% and reduce mortality as well. The management algorithm for G-CSF is based on economic considerations, Klastersky noted, and now it is given when the risk of FN is >20%.
“I take issue with the fact that if the risk is >10%, G-CSF is not advised. This is not based on clinical science.” Low-risk patients who develop FN
have similar rates of complications and mortality as high-risk patients, and studies show that low-risk patients derive a similar benefit from G-CSF. Klastersky
suggested expanding criteria for use of G-CSF as primary prophylaxis and exploring the possibility of shorter schedules for this expensive therapy.
TREANDA® (bendamustine HCI) for Injection is his chemo.
This is his therapy.
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Conference News: MASCC Scrambler Therapy for Chemotherapy-Induced Peripheral Neuropathy Current treatments for chemotherapy-induced peripheral neuropathy (CIPN) are suboptimal, according to Charles Loprinzi, MD, Mayo Clinic,
Rochester, Minnesota. Drugs such as duloxetine, venlafaxine, and gabapentin are sometimes used off label and are not universally effective. A recent study presented at the 2012 Annual Meeting of the American Society of Clinical Oncology showed
that duloxetine reduced pain associated with CIPN by 30% in about onethird of patients. Although this reduction was clinically meaningful according to the authors, about two-thirds of patients did not get better. Venlafaxine and gabapentin are used off label
based on anecdotal evidence. Loprinzi said that scrambler therapy “may offer a glimmer of hope” in this setting. A previous pilot study found that scrambler therapy reduced pain scores by 59% in 52 patients with neuContinued on page 10
Single-agent TREANDA tripled median PFS* TREANDA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL). Efficacy relative to first-line therapies other than chlorambucil has not been established. PROGRESSION-FREE SURVIVAL (PFS): CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) Survival distribution function
1.0 0.9 0.8 0.7 0.6 0.5 0.4 0.3 0.2 0.1
18 months median PFS
6 months median PFS
P<.0001 HR†=0.27 (95% CI‡: 0.17, 0.43)
Months *TREANDA (95% CI: 11.7, 23.5) vs chlorambucil (95% CI: 5.6, 8.6). † HR=hazard ratio. ‡ CI=confidence interval.
• TREANDA was compared with chlorambucil in a randomized, open-label, phase 3 trial in treatment-naïve patients with Binet stage B or C (Rai stages I-IV) CLL who required treatment (N=301) • TREANDA is administered with a convenient dosing schedule – The recommended dose for TREANDA is 100 mg/m2 administered intravenously over 30 minutes on Days 1 and 2 of a 28-day treatment cycle, up to 6 cycles – In the phase 3 trial, patients received chlorambucil at a dose of 0.8 mg/kg orally on Days 1 and 15 (n=148) of a 28-day treatment cycle, up to 6 cycles • In the pivotal phase 3 trial, the most common non-hematologic adverse reactions (frequency ≥15%) were pyrexia (24%), nausea (20%), and vomiting (16%) (n=153). The most common hematologic abnormalities (frequency ≥15%) were anemia (89%), thrombocytopenia (77%), neutropenia (75%), lymphopenia (68%), and leukopenia (61%) (n=150) Important Safety Information • Serious adverse reactions, including myelosuppression, infections, infusion reactions and anaphylaxis, tumor lysis syndrome, skin reactions including SJS/TEN, other malignancies, and extravasation, have been associated with TREANDA. Some reactions, such as myelosuppression, infections, and SJS/TEN (when TREANDA was administered concomitantly with allopurinol and other medications known to cause SJS/TEN), have been fatal. Patients should be monitored closely for these reactions and treated promptly if any occur • Adverse reactions may require interventions such as decreasing the dose of TREANDA, or withholding or delaying treatment • TREANDA is contraindicated in patients with a known hypersensitivity to bendamustine or mannitol. Women should be advised to avoid becoming pregnant while using TREANDA
Discover the elements of efficacy and safety LEARN MORE AT WWW.TREANDA.COM Please see accompanying brief summary of full Prescribing Information.
©2012 Cephalon, Inc., a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd.
All rights reserved. TRE-2460 March 2012
AuguST 2012 I VOL 5, NO 7
Conference News: MASCC Advances in Supportive Care Continued from page 9 ropathic pain (Smith TJ, et al. J Pain Symptom Manage. 2010;40(6):883-891). â€œAt first I was skeptical about using scrambler therapy for CIPN, but I am encouraged by results of a pilot study at our institution,â€? he told listeners. Scrambler therapy uses a device to
treat pain via noninvasive cutaneous electrostimulation, substituting â€œpainâ€? messages with â€œnonpainâ€? messages; the device generates 16 different current patterns to stimulate nerve action potentials. At MASCC, Deirdre R. Pachman, MD, Mayo Clinic, reported experience
with scrambler therapy in the first 11 patients with CIPN-related pain: 8 were women, and 3 were men; mean age was 57 years; patients had been exposed to various chemotherapy regimens; and the majority of patients had symptoms for more than 2 years.
The Grade 3 and 4 hematology laboratory test values by treatment group in the randomized CLL clinical study are described in Table 2. These findings confirm the myelosuppressive effects seen in patients treated with TREANDA. Red blood cell transfusions were administered to 20% of patients receiving TREANDA compared with 6% of patients receiving chlorambucil. Brief Summary of Prescribing Information for Chronic Lymphocytic Leukemia INDICATIONS AND USAGE: TREANDA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. CONTRAINDICATIONS: TREANDA is contraindicated in patients with a known hypersensitivity (eg, anaphylactic and anaphylactoid reactions) to bendamustine or mannitol. [See Warnings and Precautions] WARNINGS AND PRECAUTIONS: Myelosuppression. Patients treated with TREANDA are likely to experience myelosuppression. In the two NHL studies, 98% of patients had Grade 3-4 myelosuppression. Three patients (2%) died from myelosuppression-related adverse reactions; one each from neutropenic sepsis, diffuse alveolar hemorrhage with Grade 3 thrombocytopenia, and pneumonia from an opportunistic infection (CMV). In the event of treatment-related myelosuppression, monitor leukocytes, platelets, hemoglobin (Hgb), and neutrophils closely. In the clinical trials, blood counts were monitored every week initially. Hematologic nadirs were observed predominantly in the third week of therapy. Hematologic nadirs may require dose delays if recovery to the recommended values have not occurred by the first day of the next scheduled cycle. Prior to the initiation of the next cycle of therapy, the ANC should be â‰Ľ 1 x 109/L and the platelet count should be â‰Ľ 75 x 109/L. [See Dosage and Administration]. Infections. Infection, including pneumonia and sepsis, has been reported in patients in clinical trials and in post-marketing reports. Infection has been associated with hospitalization, septic shock and death. Patients with myelosuppression following treatment with TREANDA are more susceptible to infections. Patients with myelosuppression following TREANDA treatment should be advised to contact a physician if they have symptoms or signs of infection. Infusion Reactions and Anaphylaxis. Infusion reactions to TREANDA have occurred commonly in clinical trials. Symptoms include fever, chills, pruritus and rash. In rare instances severe anaphylactic and anaphylactoid reactions have occurred, particularly in the second and subsequent cycles of therapy. Monitor clinically and discontinue drug for severe reactions. Patients should be asked about symptoms suggestive of infusion reactions after their first cycle of therapy. Patients who experienced Grade 3 or worse allergic-type reactions were not typically rechallenged. Measures to prevent severe reactions, including antihistamines, antipyretics and corticosteroids should be considered in subsequent cycles in patients who have previously experienced Grade 1 or 2 infusion reactions. Discontinuation should be considered in patients with Grade 3 or 4 infusion reactions. Tumor Lysis Syndrome. Tumor lysis syndrome associated with TREANDA treatment has been reported in patients in clinical trials and in post-marketing reports. The onset tends to be within the first treatment cycle of TREANDA and, without intervention, may lead to acute renal failure and death. Preventive measures include maintaining adequate volume status, and close monitoring of blood chemistry, particularly potassium and uric acid levels. Allopurinol has also been used during the beginning of TREANDA therapy. However, there may be an increased risk of severe skin toxicity when TREANDA and allopurinol are administered concomitantly. Skin Reactions. A number of skin reactions have been reported in clinical trials and post-marketing safety reports. These events have included rash, toxic skin reactions and bullous exanthema. Some events occurred when TREANDA was given in combination with other anticancer agents, so the precise relationship to TREANDA is uncertain. In a study of TREANDA (90 mg/m2) in combination with rituximab, one case of toxic epidermal necrolysis (TEN) occurred. TEN has been reported for rituximab (see rituximab package insert). Cases of Stevens-Johnson syndrome (SJS) and TEN, some fatal, have been reported when TREANDA was administered concomitantly with allopurinol and other medications known to cause these syndromes. The relationship to TREANDA cannot be determined. Where skin reactions occur, they may be progressive and increase in severity with further treatment. Therefore, patients with skin reactions should be monitored closely. If skin reactions are severe or progressive, TREANDA should be withheld or discontinued. Other Malignancies. There are reports of pre-malignant and malignant diseases that have developed in patients who have been treated with TREANDA, including myelodysplastic syndrome, myeloproliferative disorders, acute myeloid leukemia and bronchial carcinoma. The association with TREANDA therapy has not been determined. Extravasation. There are postmarketing reports of bendamustine extravasations resulting in hospitalizations from erythema, marked swelling, and pain. Precautions should be taken to avoid extravasations, including monitoring of the intravenous infusion site for redness, swelling, pain, infection, and necrosis during and after administration of TREANDA. Use in Pregnancy. TREANDA can cause fetal harm when administered to a pregnant woman. Single intraperitoneal doses of bendamustine in mice and rats administered during organogenesis caused an increase in resorptions, skeletal and visceral malformations, and decreased fetal body weights. ADVERSE REACTIONS: The data described below reflect exposure to TREANDA in 153 patients who participated in an actively-controlled trial for the treatment of CLL. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following serious adverse reactions have been associated with TREANDA in clinical trials and are discussed in greater detail in other sections [See Warnings and Precautions] of the label: Myelosuppression; Infections; Infusion Reactions and Anaphylaxis; Tumor Lysis Syndrome; Skin Reactions; Other Malignancies. Clinical Trials Experience in CLL. The data described below reflect exposure to TREANDA in 153 patients. TREANDA was studied in an active-controlled trial. The population was 45-77 years of age, 63% male, 100% white, and had treatment naĂŻve CLL. All patients started the study at a dose of 100 mg/m2 intravenously over 30 minutes on days 1 and 2 every 28 days. Adverse reactions were reported according to NCI CTC v.2.0. In the randomized CLL clinical study, non-hematologic adverse reactions (any grade) in the TREANDA group that occurred with a frequency greater than 15% were pyrexia (24%), nausea (20%), and vomiting (16%). Other adverse reactions seen frequently in one or more studies included asthenia, fatigue, malaise, and weakness; dry mouth; somnolence; cough; constipation; headache; mucosal inflammation; and stomatitis. Worsening hypertension was reported in 4 patients treated with TREANDA in the randomized CLL clinical study and none treated with chlorambucil. Three of these 4 adverse reactions were described as a hypertensive crisis and were managed with oral medications and resolved. The most frequent adverse reactions leading to study withdrawal for patients receiving TREANDA were hypersensitivity (2%) and pyrexia (1%). Table 1 contains the treatment emergent adverse reactions, regardless of attribution, that were reported in â‰Ľ 5% of patients in either treatment group in the randomized CLL clinical study. Table 1: Non-Hematologic Adverse Reactions Occurring in Randomized CLL Clinical Study in at Least 5% of Patients Number (%) of patients TREANDA Chlorambucil (N=153) (N=143) System organ class Preferred term All Grades Grade 3/4 All Grades Grade 3/4 Total number of patients with at least 1 adverse reaction 121 (79) 52 (34) 96 (67) 25 (17) Gastrointestinal disorders Nausea 31 (20) 1 (<1) 21 (15) 1 (<1) Vomiting 24 (16) 1 (<1) 9 (6) 0 Diarrhea 14 (9) 2 (1) 5 (3) General disorders and administration site conditions Pyrexia 36 (24) 6 (4) 8 (6) 2 (1) Fatigue 14 (9) 2 (1) 8 (6) 0 Asthenia 13 (8) 0 6 (4) 0 Chills 9 (6) 0 1 (<1) 0 Immune system disorders Hypersensitivity 7 (5) 2 (1) 3 (2) 0 Infections and infestations Nasopharyngitis 10 (7) 0 12 (8) 0 Infection 9 (6) 3 (2) 1 (<1) 1 (<1) Herpes simplex 5 (3) 0 7 (5) 0 Investigations Weight decreased 11 (7) 0 5 (3) 0 Metabolism and nutrition disorders Hyperuricemia 11 (7) 3 (2) 2 (1) 0 Respiratory, thoracic and mediastinal disorders Cough 6 (4) 1 (<1) 7 (5) 1 (<1) Skin and subcutaneous tissue disorders Rash 12 (8) 4 (3) 7 (5) 3 (2) Pruritus 8 (5) 0 2 (1) 0
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Table 2: Incidence of Hematology Laboratory Abnormalities in Patients Who Received TREANDA or Chlorambucil in the Randomized CLL Clinical Study Chlorambucil TREANDA (N=141) (N=150) Grade 3/4 All Grades Grade 3/4 All Grades Laboratory Abnormality n (%) n (%) n (%) n (%) Hemoglobin Decreased 134 (89) 20 (13) 115 (82) 12 (9) Platelets Decreased 116 (77) 16 (11) 110 (78) 14 (10) Leukocytes Decreased 92 (61) 42 (28) 26 (18) 4 (3) Lymphocytes Decreased 102 (68) 70 (47) 27 (19) 6 (4) Neutrophils Decreased 113 (75) 65 (43) 86 (61) 30 (21) In the randomized CLL clinical study, 34% of patients had bilirubin elevations, some without associated significant elevations in AST and ALT. Grade 3 or 4 increased bilirubin occurred in 3% of patients. Increases in AST and ALT of Grade 3 or 4 were limited to 1% and 3% of patients, respectively. Patients treated with TREANDA may also have changes in their creatinine levels. If abnormalities are detected, monitoring of these parameters should be continued to ensure that significant deterioration does not occur. Post-Marketing Experience. The following adverse reactions have been identified during post-approval use of TREANDA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: anaphylaxis; and injection or infusion site reactions including phlebitis, pruritus, irritation, pain, and swelling. Skin reactions including SJS and TEN have occurred when TREANDA was administered concomitantly with allopurinol and other medications known to cause these syndromes. [See Warnings and Precautions] OVERDOSAGE: The intravenous LD of bendamustine HCl is 240 mg/m2 in the mouse and rat. Toxicities included sedation, tremor, ataxia, convulsions and respiratory distress. Across all clinical experience, the reported maximum single dose received was 280 mg/m2. Three of four patients treated at this dose showed ECG changes considered dose-limiting at 7 and 21 days post-dosing. These changes included QT prolongation (one patient), sinus tachycardia (one patient), ST and T wave deviations (two patients), and left anterior fascicular block (one patient). Cardiac enzymes and ejection fractions remained normal in all patients. No specific antidote for TREANDA overdose is known. Management of overdosage should include general supportive measures, including monitoring of hematologic parameters and ECGs. DOSAGE AND ADMINISTRATION: Dosing Instructions for CLL. Recommended Dosage: The recommended dose is 100 mg/m2 administered intravenously over 30 minutes on Days 1 and 2 of a 28-day cycle, up to 6 cycles. Dose Delays, Dose Modifications and Reinitiation of Therapy for CLL: TREANDA administration should be delayed in the event of Grade 4 hematologic toxicity or clinically significant â‰ĽÂ Grade 2 non-hematologic toxicity. Once non-hematologic toxicity has recovered to â‰¤Â Grade 1 and/or the blood counts have improved [Absolute Neutrophil Count (ANC) â‰ĽÂ 1 x 109/L, platelets â‰ĽÂ 75 x 109/L], TREANDA can be reinitiated at the discretion of the treating physician. In addition, dose reduction may be warranted. [See Warnings and Precautions] Dose modifications for hematologic toxicity: for Grade 3 or greater toxicity, reduce the dose to 50 mg/m2 on Days 1 and 2 of each cycle; if Grade 3 or greater toxicity recurs, reduce the dose to 25 mg/m2 on Days 1 and 2 of each cycle. Dose modifications for non-hematologic toxicity: for clinically significant Grade 3 or greater toxicity, reduce the dose to 50 mg/m2 on Days 1 and 2 of each cycle. Dose re-escalation in subsequent cycles may be considered at the discretion of the treating physician. Reconstitution/Preparation for Intravenous Administration. t Aseptically SFDPOTUJUVUFFBDI53&"/%"WJBMBTGPMMPXTtNH53&"/%"WJBM"EEN-PGPOMZSterile Water for Injection, USPtNH53&"/%"WJBM"EEN-PGPOMZSterile Water for Injection, USP. Shake well to yield a clear, colorless to a pale yellow solution with a bendamustine HCl concentration of 5 mg/mL. The lyophilized powder should completely dissolve in 5 minutes. If particulate matter is observed, the reconstituted product should not be VTFEt"TFQUJDBMMZXJUIESBXUIFWPMVNFOFFEFEGPSUIFSFRVJSFEEPTF CBTFEPONHN-DPODFOUSBUJPO BOE immediately transfer to a 500 mL infusion bag of 0.9% Sodium Chloride Injection, USP (normal saline). As an alternative to 0.9% Sodium Chloride Injection, USP (normal saline), a 500 mL infusion bag of 2.5% Dextrose/0.45% Sodium Chloride Injection, USP, may be considered. The resulting final concentration of bendamustine HCl in the infusion bag should be within 0.2â€“0.6 mg/mL. The reconstituted solution must be transferred to the infusion bag within 30 minutes of reconstitution. After transferring, thoroughly mix the contents of the infusion bag. The BENJYUVSFTIPVMECFBDMFBSBOEDPMPSMFTTUPTMJHIUMZZFMMPXTPMVUJPOt6TF4UFSJMF8BUFSGPS*OKFDUJPO 641 GPS reconstitution and then either 0.9% Sodium Chloride Injection, USP, or 2.5% Dextrose/0.45% Sodium Chloride *OKFDUJPO 641 GPSEJMVUJPO BTPVUMJOFEBCPWF/PPUIFSEJMVFOUTIBWFCFFOTIPXOUPCFDPNQBUJCMFt1BSFOUFSBM drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Any unused solution should be discarded according to institutional procedures for antineoplastics. Admixture Stability. TREANDA contains no antimicrobial preservative. The admixture should be prepared as close as possible to the time of patient administration. Once diluted with either 0.9% Sodium Chloride Injection, USP, or 2.5% Dextrose/0.45% Sodium Chloride Injection, USP, the final admixture is stable for 24 hours when stored refrigerated (2-8Â°C or 36-47Â°F) or for 3 hours when stored at room temperature (15-30Â°C or 59-86Â°F) and room light. Administration of TREANDA must be completed within this period. DOSAGE FORMS AND STRENGTHS: TREANDA for Injection single-use vial containing either 25 mg or 100 mg of bendamustine HCl as white to off-white lyophilized powder. HOW SUPPLIED/STORAGE AND HANDLING: Safe Handling and Disposal. As with other potentially toxic anticancer agents, care should be exercised in the handling and preparation of solutions prepared from TREANDA. The use of gloves and safety glasses is recommended to avoid exposure in case of breakage of the vial or other accidental spillage. If a solution of TREANDA contacts the skin, wash the skin immediately and thoroughly with soap and water. If TREANDA contacts the mucous membranes, flush thoroughly with water. Procedures for the proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published. There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate. How Supplied. TREANDA (bendamustine hydrochloride) for Injection is supplied in individual cartons as follows: NDC 63459-390-08 TREANDA (bendamustine hydrochloride) for Injection, 25 mg in 8 mL amber singleuse vial and NDC 63459-391-20 TREANDA (bendamustine hydrochloride) for Injection, 100 mg in 20 mL amber single-use vial. Storage. TREANDA may be stored up to 25Â°C (77Â°F) with excursions permitted up to 30Â°C (86Â°F) (see USP Controlled Room Temperature). Retain in original package until time of use to protect from light. 50
Distributed by: Cephalon, Inc. Frazer, PA 19355 TREANDA is a trademark of Cephalon, Inc., or its affiliates. All rights reserved. ÂŠ2008-2012 Cephalon, Inc., or its affiliates. TRE-2500 (Label Code: 00016287.06) This brief summary is based on TRE-006 TREANDA full Prescribing Information.
After 10 days of treatment, scrambler therapy decreased the average daily CIPN score (measuring pain, numbness, and tingling) as well as the worst daily CIPN score for these symptoms. Numbness was decreased by about 30% over 10 days, and pain and tingling were reduced by about 40%. Loprinzi and colleagues plan to conduct a prospective, placebo-controlled trial to confirm these findings. Control of Grade 1 Diarrhea Important In the molecularly targeted therapy era, severe diarrhea continues to be a problematic side effect and accounts for increased resource utilization if not controlled. â€œIf grade 1 diarrhea is not appropriately treated, diarrhea can quickly spiral down to grades 2, 3, and 4 and risk of hospitalization and death,â€? Lowell Anthony, MD, Louisiana State University School of Medicine, New Orleans, told supportive care experts at MASCC. â€œOnly you can really prevent the spiral of diarrhea.â€? Conventional chemotherapy agents, such as fluorouracil (5-FU), irinotecan, paclitaxel, and epirubicin, cause diarrhea. With good supportive care, these drugs can be used in clinical practice. â€œEven giving 5-FU via different routes is still associated with 10% to 20% severe diarrhea. An incidence of >20% is not acceptable,â€? he said. Targeted agents, including bevacizumab, epidermal growth factor receptor inhibitors, sunitinib, and sorafenib, have an additive risk of diarrhea when combined with chemotherapy. â€œThe only good news is that the rate of grades 3 and 4 diarrhea [with these agents] is under 10%, but they increase the rates of grades 1 and 2 diarrhea,â€? Anthony stated. â€œIn general we donâ€™t stop treatment with targeted therapy for grades 1 and 2 diarrhea. These rates are much lower than what we see with irinotecan.â€? Bortezomib causes diarrhea (all grades) in about 45% of patients. Lapatinib causes grades 1 to 3 diarrhea in up to 64% of patients. Vandetanib causes grades 1 to 4 diarrhea in 56% of patients with thyroid cancer. Cabozantinib, used to treat solid tumors, causes grades 1 to 4 diarrhea in 57% of patients. Regorafenib, an investigational oral multikinase inhibitor, caused grades 1 to 4 diarrhea in 32% of patients with colorectal cancer, but more data are needed to establish risk. â€œWe are dealing with diarrhea in the context of other side effects caused by small molecule inhibitors; for example, peripheral neuropathy with bortezomib; QTc prolongation with dasatinib; rash, diarrhea, fatigue, conjunctivitis with erlotinib; rash, loss of appetite, intersti-
5/15/12 1:54 PM
Conference News: MASCC tial lung disease with gefitinib; rash, weight gain, edema with imatinib; hypertension, heart failure syndrome with sorafenib and sunitinib,” Anthony explained. In clinical practice, diarrhea and its sequelae involve increased resource utilization, he continued. It is important to establish the diagnosis and etiology of diarrhea in cancer patients. Factors to consider in assessing risk of diarrhea include prior chemotherapy and prior pelvic radiation, performance status, response to prior cycle of chemotherapy, increased age, and female gender. Guidelines suggest 3 drugs: loperamide, opium derivatives, and octreotide. Grades 1 and 2 uncomplicated diarrhea should be managed with adequate fluids, and the BRAT (bananas, rice, applesauce, and toast) diet. Grades 3 and 4 diarrhea may require hospitalization, antibiotics, octreotide, and fluids. With tyrosine kinase inhibitor (TKI)induced diarrhea, dosing adjustment is not usually needed for grades 1 and 2 diarrhea; dose reduction and intravenous fluids should be used to treat grades 3 and 4. “We will never see a clinical trial of treating TKI-induced diarrhea. Treatment will be based on expert opinion,” Anthony said. Studies are now evaluating probiotics and aluminum silicates for treatment of diarrhea. In Europe, glucagon-like peptide-2 is being studied in this setting, but these drugs cannot be used for chronic diarrhea, Anthony reported. Impact of a Specialized Nursing Intervention on Newly Diagnosed Breast and Colorectal Cancer Patients Results of a randomized trial failed to demonstrate a benefit for specialized oncology nursing intervention compared with usual care 8 weeks following surgery in newly diagnosed patients with breast cancer and colorectal cancer. “Based on this finding, the care trajectory may be less problematic from a supportive care point of view than was assumed. We found that patients’ needs are low following surgery, which means we are already doing a good job,” stated Darryl Bainbridge, PhD, McMaster University in Hamilton, Ontario, Canada. The early cancer care trajectory is a difficult time for patients, with many transitions and much uncertainty, he said. Patients often experience anxiety about their diagnosis and the next steps of care, which can lead to psychological problems. The investigators sought to determine whether a community-based specialty nursing intervention early in the care trajectory could improve patient continuity of care. The study was a cluster randomized trial, meaning that practices—not indi-
vidual patients—were randomized to usual care or the specialized nursing intervention. The study was conducted at 8 surgical practices in the greater Toronto area. The control arm was usual care (104 patients), and the intervention arm was usual care plus referral after surgery to a specialized oncology program (80 patients) that provides direct care to address patients’ needs and provides links to services. The
intervention could be delivered over the telephone or during home visits. Patients had 2 phone interviews 1 week following surgery, an interview 1 week later, and again 8 to 10 weeks after baseline. The median number of nursing contacts was 6, and the median number of at-home visits was 2. At baseline, patients’ demographic and clinical characteristics were well
balanced. At the end of the study, 179 patients were evaluable. At baseline, patients in both groups had low supportive care needs (score of 1 to 5, with 5 denoting higher level of needs). Patients had low needs according to 5 subdomains assessed. At the end of the study, weeks 8 to 10, no significant differences in supportive care needs were observed between the 2 treatment arms. Continued on page 12
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Conference News: MASCC Advances in Supportive Care Continued from page 11 The intervention arm showed improved continuity of care, but no significant differences were seen in any subdomain of continuity of care. No significant differences were found between the 2 groups on the EORTC quality-of-life scale or on any of the subdomains of quality of life measured. The groups did not differ in levels of
uncertainty about their illness or about healthcare utilization. The intervention group used more social workers and fewer personal support workers than usual care. “There were 2 key observations. First, patients’ supportive care needs were fulfilled at baseline to a greater degree than is reported in the litera-
ture, which creates a potential for a ceiling effect prior to this study. Second, all patients in both groups improved over time,” Bainbridge said. Education Intervention Helps Patients With Fatigue A randomized trial found that patient participation in the FIBS education pro-
“Quality care is everyone’s business.” Beth Faiman, PhD(c), MSN, APRN-BC, AOCN Nurse Practitioner, Multiple Myeloma Program Cleveland Clinic Taussig Cancer Institute Cleveland, OH
Value-Based Care in Myeloma !&%0!,- !2 &/-%0! %(.!,0%!1( *!,-*! .%0!- ,!& .! .) )-. +/ &%.3 ( !-- %--/!*! % & -! .%)(- "), -! &%(% % (0 ( ! *, .% ! (/,-!- ( *$ ,' %-.- 1%&& &-) ") /- )( .$! /(%+/! $ &&!(#!%( .$! ' ( #!'!(. )" '/&.%*&! '3!&)'
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AuguST 2012 I VOL 5, NO 7
gram (“Coping with fatigue individually: a self-management program for cancer patients”) improved patients’ understanding of cancer-related fatigue (CRF) as well as several aspects of quality of life when compared with a control group wait-listed for the FIBS intervention. The study was conducted in Germany, where there is no other available treatment, explained lead author Karl Reif, MD, University of Bremen, Germany. “FIBS is designed as a complementary intervention to individual counseling for fatigue and should be translated and evaluated in other countries than Germany. The control group should include patients receiving the same time and attention as the intervention group,” he stated. FIBS consisted of 6 weekly structured sessions of 90 minutes taught by nurses and psychologists; each session was designed for 8 patients at a time. During these sessions, patients learned to differentiate between physical, cognitive, and emotional dimensions of fatigue; the etiology and treatment of fatigue; and the benefits of exercise. They learned to review their daily routine and structure activities according to individual energy levels using a patient diary. Sleep hygiene and positive self-reinforcement for enjoyment of life were also part of the education process. Patients learned strategies to overcome periods of depression by accessing positive emotions, and they learned to use resources to overcome barriers that may impede incorporating these new strategies into everyday life. Between sessions, patients were encouraged to keep diaries, perform exercise, and implement lifestyle changes, Reif explained. All 261 patients enrolled in the trial had moderate to severe CRF; 129 were randomized to the intervention group (IG) and 132 to the wait-list control group (CG). Of these, 120 and 114 patients, respectively, were evaluable at the end of the study. About 80% were female, mean age was about 57 years, and 64% in the IG and 54% in the CG had breast cancer. The intervention reduced the incidence of CRF (the primary end point) from 42% to 22% as measured by the Fatigue Assessment Questionnaire; improved participation in physical activity per week to 57% in the IG versus 32% in the CG; and improved knowledge of fatigue by about 10%. Patients in the IG had less depression and anxiety as assessed by the Hospital Anxiety and Depression Scale, and improved quality of life and improved general feelings of self-efficacy on the EORTC-QLQ-C30 instrument compared with the CG. l
The Patient’s Voice
Broken-Down Me By MMA
hate to criticize oncology nurses. I honestly appreciate the care they have given me and the difficulty of dealing constantly with seriously ill patients. Yet, on a recent hospital stay, my oncology nurses failed me. They treated my physical symptoms but completely left me hanging emotionally. I entered the hospital for a stem cell transplant. Though informed by my medical team—including my nurses— that the stay would be “tough,” I never imagined the sea of human suffering I would enter, and the trauma it would leave on my very soul. On one particularly bleak day, I was sent to get a chest x-ray under suspicion of pneumonia. I chose to go in a wheelchair instead of a gurney, having been told that sitting was better for my lungs than lying down. My 15-year-old daughter accompanied me, a fact that probably averted my total breakdown. Once in the x-ray waiting room, seated in my wheelchair, separated on 3 sides by curtains yet able to see the other patients across the aisle in front of me, the screaming started. It came from behind me, on the other side of one of the curtains. “Nooooo!” I heard the woman screech. “Owwww! There is no blood! Stop!” Then the spine-tingling sobbing started. I heard the nurses’ voices trying to soothe her. “We need to take blood to be able to know what is going on,” I heard one say. “It’s all right,” another stated. “We are right here with you.” Clearly in distress, the woman continued to scream and sob. I could not see her, but I could feel her misery. Tears welled in my eyes and streamed down my cheeks. I took my daughter’s advice and covered my ears, uselessly trying to block out the sounds of suffering that now, 5 weeks later, continue to be indelibly imprinted on my psyche. Even as I write this, I cannot help but sob at the vivid memory of so much horror. I wanted to jump out of my wheelchair and tell the nurses to leave that woman alone! I wanted to scream myself, scream about the injustice of normal people suffering indescribable pain. I wanted to shout about the fear all cancer patients face every second of every day! But instead, I muffled the sounds, my hands on my ears, tears streaming down my face, and my sweet daughter patting my leg, trying to calm me. After my x-ray, when I got back to my room on the stem cell transplant floor, I continued to sob. I could not shake the sounds of the woman’s screams. Of course, this one event did not cause my
complete breakdown. Instead, it was just one more event added to a string of experiences during my hospital stay—the crying of a grown man I heard on my hall begging for more painkillers, the unknown patient in the room next to me who I could hear gasping for air between strangling coughing fits during the night, and my own vomiting, diarrhea, and disorientation caused by my treatment— that broke me. “It’s all right, Mommy,” my daughter told me. Yet, even with the gnawing knowledge that I should probably not cry so desperately in front of my child, I could not stop.
Will I ever recover from the emotional scars left from that hospital stay?
About 15 minutes after returning from my x-ray, I heard a knock on the door. A nurse entered my room. My eyes, puffy and bloodshot from crying, my cheeks covered with streams of tears, could not have gone unperceived by her or anyone else. Yet, she greeted me with a smile and
cheerily told me, “Time for your medicine. Here it is,” she chimed as she placed 2 little pills in a tiny cup, filled a plastic cup with water, and handed the pills and the water to me. “Glad you got back from your x-ray.” What? Didn’t you see me? Am I invisible except as a vessel in which to pump medicines supposedly going to help me? Do you have any idea what I have been through, what my colleagues in suffering have been through? Do you have any concept of what it means to see fellow human beings reduced to their most desperate states—to witness grown men and women beg for relief from excruciating pain, to listen to the unparalleled anguish of adults gasping for breath, to be immersed in a sea of distress you can do nothing to mitigate? Even soldiers in the midst of war have orders, weapons, and comrades to help them through the atrocities; I and all patients have none. Certainly many of us have family and friends who serve as caregivers. But do you really think that they have the training to guide us through the landmines that dot the hospital landscape? Have you, dear nurse, become blinded to your own workplace reality? Have you seen so much suffering that you no longer recognize it? At the very least, could you or any of your colleagues have asked me during my 4-week stay if I was all right, why I was crying, or taken 5 minutes to comfort me emotionally? All I needed was a few simple sentences: “I know you have seen a lot of suffering, but I want to let you know that most of those patients
will be all right.” “Are you all right? This can be really difficult on your emotions, I know. Do you want to tell me what is bothering you?” “Why are you so sad? Tell me what is making you so sad. Sometimes it helps just to talk about it for a minute.” As I said at the beginning of this article, I hate to criticize my nurses. However, I hate even more my sporadic crying sprees nearly 3 weeks after being released from the hospital, the guilt of my children having to see me reduced to a babbling baby, my inability to erase the pain of other human beings from my memory, and the profound sadness that grips me when I think of all those patients in the hospital right now who need just a comforting word from a nurse but who will not get it. Am I angry? Yes! Is it all the nurses’ fault? Not all, but they are the frontline, and they could have helped. Will I ever recover from the emotional scars left from that hospital stay? Eventually I will learn to live better with them, perhaps, but like all scars, they will stay. For now, my immediate task is to try to rebuild—perhaps by trying to smile one time more per day, by visualizing that most of the patients I heard suffering are now at home like me, or by making an effort to understand why my nurses never comforted me—the broken-down me. l MMA is undergoing treatment for cancer. She wishes to use her initials.
Are you confident that the FDA actions and the recent congressional legislation will resolve the drug shortage issue? In the July issue, we published an article exploring the efforts to deal with the drug shortage issue. We asked our online reading community if they thought these regulatory and legislative actions would be effective. • 38% said they thought the recent actions would help resolve the issue • 62% indicated they were not confident that recent actions would be effective Here’s a sample of the comments: • Cautiously optimistic, but such large changes usually progress slowly. • Congress has resolved very few issues in our country. Why would this be any different?
Our sincere thanks to all who participated in this survey. If you want to participate in this month’s survey, see page 20 for details.
www.TheOncologyNurse.com AuguST 2012 I VOL 5, NO 7
The median age of patients in the VISTAâ€Ą trial was 71 years (range: 48-91).
S AT ONFERENCE VVISIT I SI T U US AT A AONN ONN 33rd rd A ANNUAL NNUAL C CONFERENCE BOOTH MORE B OOTH 102 102 TTO O LLEARN E A RN M ORE
Survival never gets old VELCADE® (bortezomib) delivered >13-month overall survival advantage in combination with MP* vs MP alone for previously untreated multiple myeloma (median 56.4 vs 43.1 months†; 60.1-month median follow-up‡)
Approved for subcutaneous and IV administration§ VELCADE (bortezomib) Indication and Important Safety Information INDICATION
CONTRAINDICATIONS ADVERSE REACTIONS WARNINGS, PRECAUTIONS, AND DRUG INTERACTIONS ▼
▼ ▼ ▼
Noteworthy Numbers Each year, a significant number of adolescents and young adults (AYAs), aged 15 to 39 years, are faced with a cancer diagnosis—that’s more than 70,000 in the United States. Although cancer prognosis for AYAs has improved over recent decades, survival rates have not advanced at the same rate as other age groups. To better understand the facts and figures associated with these patients, let’s take a closer look at AYA oncology statistics.
Between the ages of 15 and 29, cancer occurrence is 2.7 times more likely than during the first 15 years of life.
Cancer is the number one cause of diseaserelated death in the AYA population.
Brief Summary INDICATIONS: VELCADE® (bortezomib) for Injection is indicated for the treatment of patients with multiple myeloma. VELCADE is indicated for the treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy. CONTRAINDICATIONS: VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol. VELCADE is contraindicated for intrathecal administration. WARNINGS AND PRECAUTIONS: VELCADE should be administered under the supervision of a physician experienced in the use of antineoplastic therapy. Complete blood counts (CBC) should be monitored frequently during treatment with VELCADE. Peripheral Neuropathy: VELCADE treatment causes a peripheral neuropathy that is predominantly sensory. However, cases of severe sensory and motor peripheral neuropathy have been reported. Patients with pre-existing symptoms (numbness, pain or a burning feeling in the feet or hands) and/or signs of peripheral neuropathy may experience worsening peripheral neuropathy (including ≥ Grade 3) during treatment with VELCADE. Patients should be monitored for symptoms of neuropathy, such as a burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, neuropathic pain or weakness. In the Phase 3 relapsed multiple myeloma trial comparing VELCADE subcutaneous vs. intravenous the incidence of Grade ≥ 2 peripheral neuropathy events was 24% for subcutaneous and 41% for intravenous. Grade ≥ 3 peripheral neuropathy occurred in 6% of patients in the subcutaneous treatment group, compared with 16% in the intravenous treatment group. Starting VELCADE subcutaneously may be considered for patients with pre-existing or at high risk of peripheral neuropathy. Patients experiencing new or worsening peripheral neuropathy during VELCADE therapy may benefit from a decrease in the dose and/or a less dose-intense schedule. In the single agent phase 3 relapsed multiple myeloma study of VELCADE vs. Dexamethasone following dose adjustments, improvement in or resolution of peripheral neuropathy was reported in 51% of patients with ≥ Grade 2 peripheral neuropathy in the relapsed multiple myeloma study. Improvement in or resolution of peripheral neuropathy was reported in 73% of patients who discontinued due to Grade 2 neuropathy or who had ≥ Grade 3 peripheral neuropathy in the phase 2 multiple myeloma studies. The long-term outcome of peripheral neuropathy has not been studied in mantle cell lymphoma. Hypotension: The incidence of hypotension (postural, orthostatic, and hypotension NOS) was 13%. These events are observed throughout therapy. Caution should be used when treating patients with a history of syncope, patients receiving medications known to be associated with hypotension, and patients who are dehydrated. Management of orthostatic/postural hypotension may include adjustment of antihypertensive medications, hydration, and administration of mineralocorticoids and/or sympathomimetics. Cardiac Disorders: Acute development or exacerbation of congestive heart failure and new onset of decreased left ventricular ejection fraction have been reported, including reports in patients with no risk factors for decreased left ventricular ejection fraction. Patients with risk factors for, or existing heart disease should be closely monitored. In the relapsed multiple myeloma study of VELCADE vs. dexamethasone, the incidence of any treatment-emergent cardiac disorder was 15% and 13% in the VELCADE and dexamethasone groups, respectively. The incidence of heart failure events (acute pulmonary edema, cardiac failure, congestive cardiac failure, cardiogenic shock, pulmonary edema) was similar in the VELCADE and dexamethasone groups, 5% and 4%, respectively. There have been isolated cases of QT-interval prolongation in clinical studies; causality has not been established. Pulmonary Disorders: There have been reports of acute diffuse infiltrative pulmonary disease of unknown etiology such as pneumonitis, interstitial pneumonia, lung infiltration and Acute Respiratory Distress Syndrome (ARDS) in patients receiving VELCADE. Some of these events have been fatal. In a clinical trial, the first two patients given high-dose cytarabine (2 g/m2 per day) by continuous infusion with daunorubicin and VELCADE for relapsed acute myelogenous leukemia died of ARDS early in the course of therapy. There have been reports of pulmonary hypertension associated with VELCADE administration in the absence of left heart failure or significant pulmonary disease. In the event of new or worsening cardiopulmonary symptoms, a prompt comprehensive diagnostic evaluation should be conducted. Reversible Posterior Leukoencephalopathy Syndrome (RPLS): There have been reports of RPLS in patients receiving VELCADE. RPLS is a rare, reversible, neurological disorder which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances. Brain imaging, preferably MRI (Magnetic Resonance Imaging), is used to confirm the diagnosis. In patients developing RPLS, discontinue VELCADE. The safety of reinitiating VELCADE therapy in patients previously experiencing RPLS is not known. Gastrointestinal Adverse Events: VELCADE treatment can cause nausea, diarrhea, constipation, and vomiting sometimes requiring use of antiemetic and antidiarrheal medications. Ileus can occur. Fluid and electrolyte replacement should be administered to prevent dehydration. Thrombocytopenia/Neutropenia: VELCADE is associated with thrombocytopenia and neutropenia that follow a cyclical pattern with nadirs occurring following the last dose of each cycle and typically recovering prior to initiation of the subsequent cycle. The cyclical pattern of platelet and neutrophil decreases and recovery remained consistent over the 8 cycles of twice weekly dosing, and there was no evidence of cumulative thrombocytopenia or neutropenia. The mean platelet count nadir measured was approximately 40% of baseline. The severity of thrombocytopenia was related to pretreatment platelet count. In the relapsed multiple myeloma study of VELCADE vs. dexamethasone, the incidence of significant bleeding events (≥Grade 3) was similar on both the VELCADE (4%) and dexamethasone (5%) arms. Platelet counts should be monitored prior to each dose of VELCADE. Patients experiencing thrombocytopenia may require change in the dose and schedule of VELCADE. There have been reports of gastrointestinal and intracerebral hemorrhage in association with VELCADE. Transfusions may be considered. The incidence of febrile neutropenia was <1%. Tumor Lysis Syndrome: Because VELCADE is a cytotoxic agent and can rapidly kill malignant cells, the complications of tumor lysis syndrome may occur. Patients at risk of tumor lysis syndrome are those with high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken. Hepatic Events: Cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions. Other reported hepatic events include increases in liver enzymes, hyperbilirubinemia, and hepatitis. Such changes may be reversible upon discontinuation of VELCADE. There is limited re-challenge information in these patients. Hepatic Impairment: Bortezomib is metabolized by liver enzymes. Bortezomib exposure is increased in patients with moderate or severe hepatic impairment; these patients should be treated with VELCADE at reduced starting doses and closely monitored for toxicities. Use in Pregnancy: Pregnancy Category D. Women of childbearing potential should avoid becoming pregnant while being treated with VELCADE. Bortezomib administered to rabbits during organogenesis at a dose approximately 0.5 times the clinical dose of 1.3 mg/m2 based on body surface area caused post-implantation loss and a decreased number of live fetuses.
AuguST 2012 I VOL 5, NO 7
Overall relative risk of developing a second malignancy for patients aged 0 to 39 ranges from 2.37 to 6.13.
ADVERSE EVENT DATA: Safety data from phase 2 and 3 studies of single-agent VELCADE (bortezomib) 1.3 mg/m2/dose administered intravenously twice weekly for 2 weeks followed by a 10-day rest period in 1163 patients with previously treated multiple myeloma (N=1008, not including the phase 3, VELCADE plus DOXIL® [doxorubicin HCI liposome injection] study) and previously treated mantle cell lymphoma (N=155) were integrated and tabulated. In these studies, the safety profile of VELCADE was similar in patients with multiple myeloma and mantle cell lymphoma. In the integrated analysis, the most commonly reported adverse events were asthenic conditions (including fatigue, malaise, and weakness); (64%), nausea (55%), diarrhea (52%), constipation (41%), peripheral neuropathy NEC (including peripheral sensory neuropathy and peripheral neuropathy aggravated); (39%), thrombocytopenia and appetite decreased (including anorexia); (each 36%), pyrexia (34%), vomiting (33%), anemia (29%), edema (23%), headache, paresthesia and dysesthesia (each 22%), dyspnea (21%), cough and insomnia (each 20%), rash (18%), arthralgia (17%), neutropenia and dizziness (excluding vertigo); (each 17%), pain in limb and abdominal pain (each 15%), bone pain (14%), back pain and hypotension (each 13%), herpes zoster, nasopharyngitis, upper respiratory tract infection, myalgia and pneumonia (each 12%), muscle cramps (11%), and dehydration and anxiety (each 10%). Twenty percent (20%) of patients experienced at least 1 episode of ≥Grade 4 toxicity, most commonly thrombocytopenia (5%) and neutropenia (3%). A total of 50% of patients experienced serious adverse events (SAEs) during the studies. The most commonly reported SAEs included pneumonia (7%), pyrexia (6%), diarrhea (5%), vomiting (4%), and nausea, dehydration, dyspnea and thrombocytopenia (each 3%). In the phase 3 VELCADE + melphalan and prednisone study in previously untreated multiple myeloma, the safety profile of VELCADE administered intravenously in combination with melphalan/prednisone is consistent with the known safety profiles of both VELCADE and melphalan/prednisone. The most commonly reported adverse events in this study (VELCADE+melphalan/prednisone vs melphalan/prednisone) were thrombocytopenia (52% vs 47%), neutropenia (49% vs 46%), nausea (48% vs 28%), peripheral neuropathy (47% vs 5%), diarrhea (46% vs 17%), anemia (43% vs 55%), constipation (37% vs 16%), neuralgia (36% vs 1%), leukopenia (33% vs 30%), vomiting (33% vs 16%), pyrexia (29% vs 19%), fatigue (29% vs 26%), lymphopenia (24% vs 17%), anorexia (23% vs 10%), asthenia (21% vs 18%), cough (21% vs 13%), insomnia (20% vs 13%), edema peripheral (20% vs 10%), rash (19% vs 7%), back pain (17% vs 18%), pneumonia (16% vs 11%), dizziness (16% vs 11%), dyspnea (15% vs 13%), headache (14% vs 10%), pain in extremity (14% vs 9%), abdominal pain (14% vs 7%), paresthesia (13% vs 4%), herpes zoster (13% vs 4%), bronchitis (13% vs 8%), hypokalemia (13% vs 7%), hypertension (13% vs 7%), abdominal pain upper (12% vs 9%), hypotension (12% vs 3%), dyspepsia (11% vs 7%), nasopharyngitis (11% vs 8%), bone pain (11% vs 10%), arthralgia (11% vs 15%) and pruritus (10% vs 5%). In the phase 3 VELCADE subcutaneous vs. intravenous study in relapsed multiple myeloma, safety data were similar between the two treatment groups. The most commonly reported adverse events in this study were peripheral neuropathy NEC (38% vs 53%), anemia (36% vs 35%), thrombocytopenia (35% vs 36%), neutropenia (29% vs 27%), diarrhea (24% vs 36%), neuralgia (24% vs 23%), leukopenia (20% vs 22%), pyrexia (19% vs 16%), nausea (18% vs 19%), asthenia (16% vs 19%), weight decreased (15% vs 3%), constipation (14% vs 15%), back pain (14% vs 11%), fatigue (12% vs 20%), vomiting (12% vs 16%), insomnia (12% vs 11%), herpes zoster (11% vs 9%), decreased appetite (10% vs 9%), hypertension (10% vs 4%), dyspnea (7% vs 12%), pain in extremities (5% vs 11%), abdominal pain and headache (each 3% vs 11%), abdominal pain upper (2% vs 11%). The incidence of serious adverse events was similar for the subcutaneous treatment group (36%) and the intravenous treatment group (35%). The most commonly reported SAEs were pneumonia (6%) and pyrexia (3%) in the subcutaneous treatment group and pneumonia (7%), diarrhea (4%), peripheral sensory neuropathy (3%) and renal failure (3%) in the intravenous treatment group. DRUG INTERACTIONS: Bortezomib is a substrate of cytochrome P450 enzyme 3A4, 2C19 and 1A2. Co-administration of ketoconazole, a strong CYP3A4 inhibitor, increased the exposure of bortezomib by 35% in 12 patients. Therefore, patients should be closely monitored when given bortezomib in combination with strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir). Co-administration of omeprazole, a strong inhibitor of CYP2C19, had no effect on the exposure of bortezomib in 17 patients. Co-administration of rifampin, a strong CYP3A4 inducer, is expected to decrease the exposure of bortezomib by at least 45%. Because the drug interaction study (n=6) was not designed to exert the maximum effect of rifampin on bortezomib PK, decreases greater than 45% may occur. Efficacy may be reduced when VELCADE is used in combination with strong CYP3A4 inducers; therefore, concomitant use of strong CYP3A4 inducers is not recommended in patients receiving VELCADE. St. John’s Wort (Hypericum perforatum) may decrease bortezomib exposure unpredictably and should be avoided. Co-administration of dexamethasone, a weak CYP3A4 inducer, had no effect on the exposure of bortezomib in 7 patients. Co-administration of melphalan-prednisone increased the exposure of bortezomib by 17% in 21 patients. However, this increase is unlikely to be clinically relevant. USE IN SPECIFIC POPULATIONS: Nursing Mothers: It is not known whether bortezomib is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from VELCADE, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use: The safety and effectiveness of VELCADE in children has not been established. Geriatric Use: No overall differences in safety or effectiveness were observed between patients ≥age 65 and younger patients receiving VELCADE; but greater sensitivity of some older individuals cannot be ruled out. Patients with Renal Impairment: The pharmacokinetics of VELCADE are not influenced by the degree of renal impairment. Therefore, dosing adjustments of VELCADE are not necessary for patients with renal insufficiency. Since dialysis may reduce VELCADE concentrations, VELCADE should be administered after the dialysis procedure. For information concerning dosing of melphalan in patients with renal impairment, see manufacturer’s prescribing information. Patients with Hepatic Impairment: The exposure of bortezomib is increased in patients with moderate and severe hepatic impairment. Starting dose should be reduced in those patients. Patients with Diabetes: During clinical trials, hypoglycemia and hyperglycemia were reported in diabetic patients receiving oral hypoglycemics. Patients on oral antidiabetic agents receiving VELCADE treatment may require close monitoring of their blood glucose levels and adjustment of the dose of their antidiabetic medication. Please see full Prescribing Information for VELCADE at VELCADEHCP.com.
VELCADE, MILLENNIUM and are registered trademarks of Millennium Pharmaceuticals, Inc. Other trademarks are property of their respective owners. Millennium Pharmaceuticals, Inc., Cambridge, MA 02139 Copyright © 2012, Millennium Pharmaceuticals, Inc. All rights reserved. Printed in USA
AYA cancer survivors often face infertility. Following cancer treatments, a man’s semen analysis will usually improve within 1 to 3 years after he completes cancer treatment, if sperm production recovery is possible. For a female survivor who completed puberty before starting treatment, her period should return within 6 months of finishing treatment. If it does not return within a year, there may be infertility issues. Many AYA survivors experience increased risk of suicidal thoughts and a higher risk of depression related to chronic health conditions that affect quality of life. Approximately 16% of young adult survivors suffer posttraumatic stress disorder. In order of frequency, the 10 most common types of cancer are breast cancer, lymphoma (non-Hodgkin and Hodgkin), melanoma, sarcoma, gynecologic cancers of the ovary and cervix, thyroid cancer, testicular cancer, colorectal cancer, leukemia, and brain tumors. These types account for 90% of the cancers in the AYA age group. Sources http://stupidcancer.com/about/stats.sht ml; www.aamhf.com/CCJRoot/v15n1/pdf/55. pdf; http://www.cancer.gov/cancertopics/ aya/reports; http://www.fhcrc.org/en/treat ment/survivorship/survival-strategies/ young-adult-survivors.htm; http://www.live strong.org/Get-Help/Learn-About-Cancer/ Cancer-Support-Topics/Physical-Effectsof-Cancer/Male-Infertility; http://www.live strong.org/Get-Help/Learn-About-Cancer/ Cancer-Support-Topics/Physical-Effects-ofCancer/Female-Infertility; http://www.can cer.net/patient/All+About+Cancer/Can cer.Net+Feature+Articles/Expert+Informatio n+from+ASCO/ASCO+Expert+Corner%3A+ Young+Adults+With+Cancer.
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Cancer Center Profile Columbia University Medical Center Continued from cover scientific discoveries into promising and innovative treatments for these complex malignancies. The center has a portfolio of nearly 20 clinical trials in various phases, some of which have led to the development of several pioneering treatments for various forms of lymphoma and lymphoid leukemia. The center offers a multidisciplinary approach with experts from various fields related to hematologic malignancies, collaborating on the management of patients and their cancers, including treatment-related side effects. Care of individual patients is coordinated by experts in drug development, pharmacology, radiation oncology, and bone marrow transplantation. These experts are working on novel approaches that will change the paradigms for how patients with these diseases are managed. The center also offers highly skilled nursing care, as well as skilled psychiatric and social support. The Oncology Nurse-APN/PA spoke with Ellen A. Neylon, MSN, FNP-BC, CCRP, OCN, about the trajectory of her own career path as an oncology nurse practitioner and also about her experience at the Center for Lymphoid Malignancies.
What are you excited about right now in the cancer field? Ellen A. Neylon (EAN): I am excited about the number of new and effective treatments becoming available. In this specialized practice where we primarily see patients with lymphoid malignancies, a significant portion of our practice involves working with an extensive portfolio of clinical trials. I have been fortunate to be involved in clinical trials of 3 medications that have shown efficacy and have been approved by the FDA. With these treatments, I was able to witness firsthand the positive benefits that patients experienced when receiving the drugs. The continual growth and development of new treatments, specifically the molecules targeted to specific parts of the cancer cell, make it an exciting time to be involved in oncology. What approach does the Center for Lymphoid Malignancies take to treating people with cancer?
EAN: At our center, each patient has a treatment plan that is tailored to his or her individual diagnosis and needs. As part of a large academic medical center, we have access to specialists in every aspect of medicine, as well as some highly sophisticated resources, including innovative imaging technologies. Our patients are treated with the specialized oncologic care that they require but also have access to outstanding physicians in other fields, as needed. Throughout the patient’s treatment course, a comorbid condition or severe side effect can require the skills beyond those of the oncology team. As an oncology nurse, I know that it is essential to have a strong hospital support system to care for my patients as they undergo treatment.
clearly shows that maintaining the administration of treatment with the fewest interruptions is associated with a superior outcome.
How has the role of the oncology nurse changed over the past 5 years? EAN: As nurses, we have made great strides to improve the management of side effects induced by chemotherapy and radiation. These advances have helped our patients to maintain more independence and improved quality of life by receiving treatments in an outpatient setting. I believe that this independence helps patients remain engaged in their daily lives, interacting with friends and family, and ultimately maintaining their strength to fight
“While you will have difficult days, the numerous smiles, hugs, and kind words you will receive from your patients and their families are affirmations that you have chosen a rewarding and life-changing career.” —Ellen A. Neylon, MSN, FNP-BC, CCRP, OCN
How does that translate to better outcomes for your patients? EAN: The benefit of having access to premier physicians in cardiology, pulmonology, neurology, dermatology, and surgery while undergoing specialized oncologic treatment is that this allows for comprehensive patient care. As new health concerns arise, the patient can be seen promptly by an appropriate specialist, often allowing an earlier diagnosis of the problem. Through receiving an early and accurate diagnosis, a treatment plan can be implemented with the hope of alleviating long-term side effects for the patient. By having this multidisciplinary approach available while undergoing chemotherapy, patients are able to continue with their regimen without lengthy interruptions or delays. The literature
their disease. With the increased number of patients receiving treatment outside of the hospital setting, nurses must educate patients about potential side effects that can occur. Making sure that each patient and their respective caregivers are familiar with possible side effects, including when to alert the clinician, is critical information to be communicated clearly and routinely throughout treatment.
What inspired you to enter the field of oncology nursing? EAN: I became interested in nursing in my first postbaccalaureate job when I had the opportunity to work directly with several nurse practitioners. These professionals were not only educated in their specific fields but were knowledgeable about emerging treatments. Ad-
ditionally, their caring and compassion as medical providers inspired me as I sought my career path. As I prepared for medical school, I found myself drawn to the nursing profession, a path similar to that of mentors I had worked with in the past. It became clear that I was better suited to being a nurse practitioner than a physician, caring for the patient from a holistic view. I was inspired to work in oncology because of the challenge and complexity involved in managing cancer patients. I know that I must continue to enhance my skills in physical examination and symptom management, as well as be able to identify abnormal findings. The complexity in oncology—in particular, how treatments are increasingly tailored to the biological context—keeps me intrigued for the next challenging case.
Do you have any advice for nurses just entering the field? EAN: The best advice I can give to a nurse entering oncology is to listen to your patients. Most patients know their bodies well and may have experienced a similar pain or symptom previously. By carefully listening to the patient, you can often identify the underlying cause of their problem. My colleague, Kathleen Maignan, RN, and I often talk about the physical and emotional demands associated with advanced cancer patients. We would tell new nurses that it is important to be aware that this profession can be emotionally taxing, both at work and in your personal life. Establish time for yourself by finding activities outside of work that you enjoy; this will clear your mind and be rejuvenating. While you will have difficult days, the numerous smiles, hugs, and kind words you will receive from your patients and their families are affirmations that you have chosen a rewarding and life-changing career. If you weren’t working in this field, what would you be doing? EAN: How funny you should ask! I love animals almost as much as I love and enjoy helping people. If I weren’t doing what I do now for my 2-legged patients, I would be doing something similar for all of our 4-legged furry friends. l
Take action: get YOUR cancer center profiled! We are looking to interview oncology nurses from cancer centers around the country. It’s an easy process—a short phone interview and you need to submit some photos.
Contact email@example.com for more information. www.TheOncologyNurse.com
AuguST 2012 I VOL 5, NO 7
Childhood Cancer Secondary Neoplasms in Childhood Cancer Survivors Continued from cover cancer survivors will have at least 1 Table 1 Host and Treatment Factors Increasing Risk of Selected Subsequent Neoplasms After Childhood Cancer17 chronic health condition as a conseHost Factor Treatment Factor quence of their treatment, and one-third Subsequent Cancer of those survivors will have multiple or Any subsequent Female sex, young age at diagnosis; Alkylating agents; epipodophyllotoxins; severe long-term health conditions.2 As malignancy histology13 primary diagnosis of Hodgkin’s disease anthracyclines a healthcare community, it is our or soft tissue sarcoma responsibility to care for these survivors Breast18 Female sex; primary diagnosis of bone Chest radiation now and in the future. tumor or soft tissue sarcoma One of the consequences of treatment with chemotherapy and radiation theraThyroid19,20 Younger age at diagnosis Thyroid radiation (20 to 40 Gy) py for childhood cancer is the develop21 Young age at initial therapy (glioma); CNS radiation ment of secondary neoplasms, which CNS ≥ age 5 at initial therapy (meningioma) can have a direct impact on the survivors’ morbidity and mortality and Sarcoma22 Primary diagnosis of soft tissue sarcoma; Radiation therapy; higher anthracycline quality of life. In this article we will history of other subsequent neoplasm; dose (>100 mg/m2); higher alkylating agent describe the incidence of secondary neodose (alkylators score ≥2) family history of cancer plasms in this population, the common 23 White race; older attained age; primary Radiation therapy secondary neoplasms that can occur, the Nonmelanoma skin cancer diagnosis of HD; family history of skin risk factors that influence the developcancer ment of secondary neoplasms, and current screening recommendations. Journal of Clinical Oncology 2009. License number 2758520908356 granted the authors permission to use the above table in this Much of what is known today comes article. Abbreviations: CNS, central nervous system; HD, Hodgkin’s disease. from data obtained by the Childhood Cancer Survivor Study The most common secondary neofollow-up, other concerns treatments received for the primary (CCSS). The CCSS is a begin to emerge. One of cancer diagnosis may prohibit or limit plasms include breast cancer, skin canmulti-institutional (from both these concerns is that the treatment modalities available for cer, thyroid cancer, treatment-related the United States and patients who have devel- survivors who develop multiple subse- myelodysplasia or leukemia, lung cancer, Canada), retrospective cohort oped an initial secondary quent neoplasms. Survivors may not be central nervous system (CNS) tumors study funded by a National neoplasm are at greater risk able to receive optimal treatment for (including meningiomas), and bone Cancer Institute grant. The for developing subsequent subsequent neoplasms, which may ulti- cancers and soft tissue cancers. It study population comprises appears that there are certain diagnoses, neoplasms. Armstrong and mately affect their mortality. childhood cancer survivors colleagues, in a study Primary cancer therapy is a contribut- therapeutic exposures, and other characwho have survived 5 or more recently published by the ing factor in the risk of secondary neo- teristics that may increase the risk of years from the time of their Louise Leuthner, CCSS, reported that plasm occurrence. The survivor’s initial secondary neoplasms in this population. original diagnosis. The enrollRN, BSN among survivors with an diagnosis, the specific treatment re- Table 1 identifies host and treatment ment population includes initial subsequent neo- ceived, and the time from last treatment factors increasing the survivor’s risk of 20,346 survivors diagnosed between 1970 and 1996 and approxi- plasm, the cumulative incidence of are all risk factors. The CCSS and other subsequent neoplasms.17-23 Survivors mately 4000 siblings who serve as a com- developing a second subsequent neo- studies have attempted to identify with genetic predispositions, including parison group.3 All participants have plasm, either malignant or benign, is which patients are at highest risk for the those with a family history of early-onset completed a baseline questionnaire, 33.4% at 10 years, 38.8% at 15 years, development of secondary neoplasms. cancers, are more at risk than the generwith information collected on demoal population. Survivors exposed to radigraphics, medical history, family history, ation to the head and neck are at medical late effects, and diagnosis of increased risk for secondary malignant One of the consequences of treatment new neoplasms. Therapeutic exposures neoplasms. There is an increased risk of are abstracted from a medical chart breast and lung cancer, particularly in with chemotherapy and radiation therapy for review.4 Other sources of data from this female survivors who received mantle or childhood cancer is the development of population come from international surchest radiation. Secondary skin cancer is vivorship studies and single institutional commonly a basal cell carcinoma. The secondary neoplasms. studies.5-12 risk of thyroid cancer is greater in In recent studies published by the females and in those whose time from CCSS, the 20-year cumulative inciinitial cancer therapy is greater than 10 dence for developing a secondary malig- and 46.9% at 20 years. At 15 years post- For example, survivors with a history of years. Radiation-associated risks remain nant neoplasm (SMN) is 3.2%,13 and treatment, survivors exposed to radia- Hodgkin lymphoma, hereditary retino- elevated for at least 20 years postradiathe 30-year cumulative incidence is tion for their original cancer diagnosis blastoma, the genetic form of Wilms’ tion exposure and in doses ≥25 Gy.17 7.9%.14 In 14,359 CCSS survivors, a had a cumulative incidence of 41.3% of tumor, von Recklinghausen neurofibro- Secondary lung cancer occurs more total of 2703 subsequent neoplasms developing 2 second subsematosis, xeroderma pig- often in survivors exposed to prior chest have been reported. Of those, there quent neoplasms compared mentosum, and Klinefelter radiation. CNS tumors can also include syndrome, as well as those relapsed CNS leukemia. Bone and soft were 802 malignant neoplasms, 159 with those not exposed who have immunodefi- tissue cancers occur more often in surnonmalignant meningiomas, 168 other to radiation, whose cumulaciency, are at the highest vivors of primary sarcomas. Survivors benign or in situ neoplasms, and 1574 tive incidence was 25.7%. risk of secondary neo- exposed to radiation and higher cumulanonmelanoma skin cancers. The medi- Radiation-exposed survivors plasms.15,16 Age at time of tive doses of anthracyclines and/or alkylan time to first occurrence was 17.8 whose first secondary neo14 initial diagnosis is also an ating agents also appear to be at higher years (range 5-35.2 years). Among plasm was a nonmelanoma important factor to consid- risk for the development of a secondary childhood cancer survivors, SMNs are skin cancer were at higher er: the younger the age at neoplasm. Prior exposure to alkylating the most common cause of treatment- risk for developing subsetime of diagnosis, the agents (cyclophosphamide, ifosfamide, related death.4 quent malignant neoplasms.4 As this population of survivors ages Another concern that arises Lynnette Anderson, greater the risk for second- cisplatin, carboplatin, busulfan, melphaRN, MS, APNP ary neoplasms. lan, nitrogen mustard, and procarand there is a longer time interval for for this population is that
AuguST 2012 I VOL 5, NO 7
Childhood Cancer bazine), epipodophyllotoxins (etoposide), and anthracyclines (doxorubicin) increases the risk of secondary leukemia. The speculated latency period for secondary leukemia onset for alkylating agents is 4 to 7 years, whereas the latency period is much shorter for epipodophyllotoxins, at 1 to 3 years.15 In addition to primary cancer diagnosis and treatment, lifestyle and environmental factors may impact the development of secondary neoplasms in this population. These risk factors include exposure to smoking and chewing tobacco, alcohol consumption, lack of exercise, diet, and the use of reproductive hormones. For most childhood cancer survivors, the thought of developing a second cancer can be discouraging and stressful. Anxiety may be reduced if the survivors understand their individual risk, recommended medical follow-up, and the importance of leading a healthy lifestyle. Childhood cancer survivors, who are aware of their bodies, may be able to detect problems early on. In 2006, the Children’s Oncology Group (COG) developed Long-Term Follow-Up Guidelines for Survivors of Childhood, Adolescent, and Young Adult Cancers (available at www.survivorshipguide lines.org).24 These guidelines are riskbased, exposure-related clinical practice guidelines for screening and management of late effects. The goal is to increase the quality of life for pediatric cancer survivors and to provide ongoing monitoring of health status.
Nurses play a critical role in encouraging healthy lifestyles to lower a survivor’s risk of developing a secondary neoplasm.
The most important screening for childhood cancer survivors is to have a yearly comprehensive exam, either at the hospital or clinic where treated or with a primary care provider who knows the cancer treatment history and recommended follow-up. Many adult childhood cancer survivors were very young during their treatment and may not know the specifics of their therapy. Therefore, it is vital that survivors understand their cancer history, including surgeries, chemotherapies, and radiation exposure, in order to be aware of their individual risks and recommended screening. Late-effect clinics provide survivors with a cancer summary, or a survivor passport, which provides the details of individual treatment, includ-
ing the protocol and total dosages of chemotherapy and radiation and follow-up recommendations. This summary can be a useful tool for the pediatric cancer survivor who transitions to adult care. There are specific guidelines for recommended screening to detect secondary malignancies in this population based on treatment
Debra Schmidt, RN, MS, APNP
exposures. If a hereditary predisposition for a secondary cancer is suspected (eg, genetic form of retinoblastoma, embryonal tumors, Wilms’ tumor, neuroblastoma), genetic counseling and testing may lead to interventions that could prevent future cancers.25 Table 2 provides a summary of a childhood cancer sur-
vivor’s potential exposure, risk of potential secondary neoplasms, and the current screening guidelines as recommended by the COG guidelines.24 Adherence to screening guidelines directed at the general population is of particular importance among averagerisk survivors.26 These screening guidelines are published by the US Preventive Services Task Force27 and the American Cancer Society.28 Continued on page 20
Individualizing Treatment for DCIS of the Breast: New Molecular Approaches LOG ON TODAY TO PARTICIPATE
www.coexm.com/ace09 TARGET AUDIENCE This initiative will target medical oncologists, hematologists, breast surgeons, radiation oncologists, oncology nurses, advanced practice nurses, nurse practitioners, physician assistants, oncology pharmacists, managed care professionals, and others with clinical research and management interest in treatment of ductal carcinoma in situ (DCIS) and early-stage breast cancer.
STATEMENT OF NEED Ability to detect DCIS has dramatically improved in recent decades, and the current incidence of DCIS is several-fold higher than in the 1970s and 1980s, largely due to increased use of mammography screening.1,2 However, attempts to identify subsets of DCIS women who may be spared radiotherapy and perhaps treated with surgery alone have heretofore been unsuccessful. This inability to predict which patients will develop recurrent DCIS or invasive disease has complicated DCIS management. Many clinicians and other healthcare professionals dealing with patients diagnosed with DCIS are unaware or incompletely knowledgeable about the most recent results from a clinical trial examining the ability of the 12-gene assay, using a prespecified DCIS algorithm, to predict recurrence risk, and the implications these findings may have for management of their patients with DCIS. 1. Kerlikowske K. Epidemiology of ductal carcinoma in situ. J Natl Cancer Inst Monogr. 2010;2010:139-141. 2. Virnig BA, Tuttle TM, Shamliyan T, Kane RL. Ductal carcinoma in situ of the breast: a systematic review of incidence, treatment, and outcomes. J Natl Cancer Inst. 2010;102:170-178.
EDUCATIONAL OBJECTIVES After completion of this activity, participants will be better able to: • Identify approaches currently available or in development to predict recurrence risk in DCIS patients • Explain how the 12-gene expression assay for DCIS was developed and how it compares with the 21-gene assay for early invasive breast cancer • Describe the design and findings of the ECOG 5194 validation study • Apply the 12-gene assay for DCIS into clinical decision-making • Explain relevant information about the 12-gene DCIS assay and DCIS score to patients
Release Date: May 8, 2012 Expiration Date: May 7, 2013
FACULTY Chair: Lawrence J. Solin, MD, FACR, FASTRO Chairman Department of Radiation Oncology Albert Einstein Medical Center Philadelphia, PA
E. Shelley Hwang, MD, MPH Professor and Chief, Breast Surgery Duke University Medical Center Durham, NC
Kathy D. Miller, MD Associate Professor Department of Medicine IU School of Medicine Indianapolis, IN This activity is supported by an educational grant from Genomic Health, Inc.
ACCREDITATION Physicians: Creative Educational Concepts, Inc. (CEC) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. CEC designates this enduring educational activity for a maximum of 1.0 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity. Nurses: CEC is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s (ANCC) Commission on Accreditation. CEC provides this activity for 1.0 contact hour. Learners are advised that accredited status does not imply endorsement by the provider or ANCC of any commercial products displayed in conjunction with an activity. Case Managers: This activity has been approved for 1.0 clock hour through 12/31/12 by the Commission for Case Manager Certification. Case Managers number 790005057.
AuguST 2012 I VOL 5, NO 7
Childhood Cancer Secondary Neoplasms in Childhood Cancer Survivors Continued from page 19 Nurses play a critical role in encouraging healthy lifestyles to lower a survivor’s risk of developing a secondary neoplasm. Survivors can take control of their health and reduce their cancer risks by avoiding tobacco; limiting alcohol consumption; protecting skin from sun exposure; maintaining a healthy weight; participating in regular physical activity; eating a healthy diet, including a minimum of 5 servings of fruits and vegetables per day; knowing their family history; knowing their personal risk factors; and, most importantly, having having regular checkups with the recommended cancer screening. In addition, education regarding symptoms to be aware of and to report is important in early detection of potential secondary neoplasms. Education and communicating the risks to this population of survivors is crucial. Increasing compliance with medical follow-up and recommended medical surveillance may increase the longevity and enhance the quality of life for childhood cancer survivors. En-
couraging these survivors to be advocates for their long-term healthcare is a vital role for oncology and cancer survivorship nurses worldwide. l References 1. Mariotto AB, Rowland JH, Yabroff KR, et al. Longterm survivors of childhood cancers in the United States. Cancer Epidemiol Biomarkers Prev. 2009; 18(4):1033-1040. 2. Oeffinger KC, Mertens AC, Sklar CA, et al; Childhood Cancer Survivor Study. Chronic health conditions in adult survivors of childhood cancer. N Engl J Med. 2006;355(15):1572-1582. 3. Robison LL, Mertens AC, Boice JD, et al. Study design and cohort characteristics of the Childhood Cancer Survivor Study: a multi-institutional collaborative project. Med Pediatr Oncol. 2002;38(4):229-239. 4. Armstrong GT, Liu W, Leisenring W, et al. Occurrence of multiple subsequent neoplasms in longterm survivors of childhood cancer: a report from the Childhood Cancer Survivor Study. J Clin Oncol. 2011; 29(22):3056-3064. 5. Borgmann A, Zinn C, Hartmann R, et al. Secondary malignant neoplasms after intensive treatment of relapsed acute lymphoblastic leukaemia in childhood. Eur J Cancer. 2008;44(2):257-268. 6. Cohen A, Rovelli A, Merlo DF, et al. Risk for secondary thyroid carcinoma after hematopoietic stem-cell transplantation: an EBMT Late Effects Working Party Study. J Clin Oncol. 2007;25(17):2449-2454. 7. Jenkinson HC, Hawkins MM, Stiller CA, et al. Long-term population-based risks of second malignant neoplasms after childhood cancer in Britain. Br J Cancer. 2004;91(11):1905-1910.
8. Kaatsch P, Reinisch I, Spix C, et al. Case-control study on the therapy of childhood cancer and the occurrence of second malignant neoplasms in Germany. Cancer Causes Control. 2009;20(6):965-980. 9. Kersun LS, Wimmer RS, Hoot AC, et al. Secondary malignant neoplasms of the bladder after cyclophosphamide treatment for childhood acute lymphocytic leukemia. Pediatr Blood Cancer. 2004;42(3):289-291. 10. O’Brien MM, Donaldson SS, Balise RR, et al. Second malignant neoplasms in survivors of pediatric Hodgkin’s lymphoma treated with low-dose radiation and chemotherapy. J Clin Oncol. 2010;28(7):1232-1239. 11. Peterson KM, Shao C, McCarter R, et al. An analysis of SEER data of increasing risk of secondary malignant neoplasms among long-term survivors of childhood brain tumors. Pediatr Blood Cancer. 2006; 47(1):83-88. 12. Tukenova M, Guibout C, Hawkins M, et al. Radiation therapy and late mortality from second sarcoma, carcinoma, and hematological malignancies after a solid cancer in childhood. Int J Radiat Oncol Biol Phys. 2011;80(2):339-346. 13. Neglia JP, Friedman DL, Yasui Y, et al. Second malignant neoplasms in five-year survivors of childhood cancer: Childhood Cancer Survivor Study. J Natl Cancer Inst. 2001;93(8):618-629. 14. Friedman DL, Whitton J, Leisenring W, et al. Subsequent neoplasms in 5-year survivors of childhood cancer: the Childhood Cancer Survivor Study. J Natl Cancer Inst. 2010;102(14):1083-1095. 15. Rheingold SR, Neugut AI, Meadows AT, et al. Secondary cancers: incidence, risk factors and management. In: Bast RC Jr, Kufe DW, Pollock RE, et al, eds. Holland-Frei Cancer Medicine. 5th ed. Hamilton, Ontario: BC Decker; 2000:chapter 156. 16. Bhatia S, Blatt J, Meadows AT. Late effects of childhood cancer and its treatment. In: Pizzo PA, Poplack DG, eds. Principles and Practice of Pediatric Oncology. 5th
Table 2 Children’s Oncology Group Cancer Screening Guidelines for Survivors at Highest Risk for Secondary Cancers24 Exposure Chemotherapy Alkylating agents, anthracyclines, epipodophyllotoxins Radiation Any
Potential Secondary Cancer Myelodysplasia Acute myeloid leukemia Skin cancer Bone/soft tissue cancers
Recommended Screening • CBC with differential yearly up until 10 years after exposure • Education in assessing skin lesions/ mole changes • Yearly dermatologic exam • Education in monitoring for bone/soft tissue changes
Cranial, orbital/eye, ear, nasopharyngeal, Waldeyer’s ring, or TBI
• Yearly neurologic exam
Cranial, nasopharyngeal, oropharyngeal, Waldeyer’s ring, spine, cervical, supraclavicular, chest, whole lung, mediastinum, mantle, TLI, STLI, TBI
• Yearly thyroid exam • Counseling on symptoms of poor thyroid control
Pelvic with alkylating agents
• Annual urinalysis • Counseling to report dysuria or gross hematuria
>20 Gy to chest, lung, mediastinum, axilla, mantle, TLI, STLI, TBI
>30 Gy to spine, extended mantle, Colorectal cancer hepatic, renal, upper quad, spleen, paraaortic, flank/hemiabdomen, whole abdomen, inverted Y, pelvic, vaginal, prostate, bladder, iliac, inguinal, femoral, TLI, STLI, TBI
• Mammogram/MRI beginning 8 years after radiation or at age 25 years, whichever is last • Education on monthly SBE starting in early 20s • Clinical breast exam beginning at puberty until age 25 years, then every 6 months • Colonoscopy every 5 years (minimum) beginning 10 years after radiation or at age 35 years, whichever occurs last
Long-Term Follow-Up Guidelines for Survivors of Childhood, Adolescent, and Young Adult Cancers, Version 3.0–October 2008. Abbreviations: CBC, complete blood cell count; SBE, self breast exam; STLI, short course total lymphoid irradiation; TBI, total body irradiation; TLI, total lymphoid irradiation.
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ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2006:1490-1514 (chapter 49). 17. Hudson MM, Mulrooney DA, Bowers DC, et al. High-risk populations identified in Childhood Cancer Survivor Study investigations: implications for riskbased surveillance. J Clin Oncol. 2009;27(14):24052414. 18. Kenney LB, Yasui Y, Inskip PD, et al. Breast cancer after childhood cancer: a report from the Childhood Cancer Survivor Study. Ann Intern Med. 2004;141:590597. 19. Sklar C, Whitton J, Mertens A, et al. Abnormalities of the thyroid in survivors of Hodgkin’s disease: data from the Childhood Cancer Survivor Study. J Clin Endocrinol Metab. 2000;85:3227-3232. 20. Sigurdson AJ, Ronckers CM, Mertens AC, et al. Primary thyroid cancer after a first tumour in childhood (the Childhood Cancer Survivor Study): a nested casecontrol study. Lancet. 2005;365:2014-2023. 21. Neglia JP, Robison LL, Stovall M, et al. New primary neoplasms of the central nervous system in survivors of childhood cancer: a report from the Childhood Cancer Survivor Study. J Natl Cancer Inst. 2006; 98:1528-1537. 22. Henderson TO, Whitton J, Stovall M, et al. Secondary sarcomas in childhood cancer survivors: a report from the Childhood Cancer Survivor Study. J Natl Cancer Inst. 2007;99:300-308. 23. Perkins JL, Liu Y, Mitby PA, et al. Nonmelanoma skin cancer in survivors of childhood and adolescent cancer: a report from the Childhood Cancer Survivor Study. J Clin Oncol. 2005;23:3733-3741. 24. Children’s Oncology Group. Long-Term Follow-Up Guidelines for Survivors of Childhood, Adolescent, and Young Adult Cancers. Version 3.0 – October 2008. Arcadia, CA: Children’s Oncology Group; 2008. http://www.survivorshipguidelines.org. Accessed October 18, 2011. 25. Bhatia S, Meadows AT. Long-term follow-up of childhood cancer survivors: future directions for clinical care and research. Pediatr Blood Cancer. 2005; 46(2):143-148. 26. Nathan PC, Ness KK, Mahoney MC, et al. Screening and surveillance for second malignant neoplasms in adult survivors of childhood cancer: a report from the Childhood Cancer Survivor Study. Ann Intern Med. 2010;153(7):442-451. 27. Agency for Healthcare Research and Quality, US Department of Health and Human Services. US Preventive Services Task Force. http://www.ahrq. gov/CLINIC/uspstfix.htm. Accessed October 18, 2011. 28. American Cancer Society. Cancer Facts & Figures 2011. Atlanta, GA; American Cancer Society; 2011. http://www.cancer.org/Healthy/FindCancerEarly/Cance rScreeningGuidelines/american-cancer-society-guide lines-for-the-early-detection-of-cancer. Updated June 23, 2011. Accessed October 18, 2011.
Reader Poll Have you treated adult patients who are survivors of childhood cancer? r Yes r No
Go to www.TheOncologyNurse.com to answer the question and add your comments. Please tell us about your experiences.
Breathing Life Into Dyspnea Relief By Caroline Helwick
program conducted at CedarsSinai Medical Center, Los Angeles, California, improved oncology nurses’ awareness of dyspnea in patients with advanced cancer. Sarah Kang, RN, MSN, described the program at the 37th Annual Congress of the Oncology Nursing Society. “Refractory dyspnea is especially frequent and distressing to terminally ill adults with advanced cancer at the end of life, and it is estimated that 60% to 70% of patients experience this,” Kang said. “Because of the great suffering it inflicts, dyspnea is consistently the primary or secondary indication for palliative consultations.” The program aimed to educate nurses on the pervasive and distressing nature of dyspnea, the recommended assessment, evidence-based interventions, and current research, measured through a pretest and posteducation questionnaire. The program included a brief in-service session on managing dyspnea in patients with advanced cancer without chronic obstructive pulmonary disease. It also included an educational flier and a large poster placed in the floor hallway. The program components covered the following areas: (1) What is dyspnea? (2) How common is dyspnea? (3) How can you assess for dyspnea? and (4) How can you alleviate dyspnea? While nurses tend to be able to identify when dyspnea occurs, prior to the program few could name 5 evidencebased interventions and few knew how to properly assess for it. “Studies show that healthcare professionals often fail to correctly identify and assess for the severity of dyspnea,” with “a huge disparity between what nurses see and what patients report,” she added. “So part of the educational program was to enhance assessment.” The program instructed nurses to assess for dyspnea at the end of life as often as they assess for pain or nausea. They should ask the patient, “Are you having any difficulty breathing?” and “Did you feel breathless or feel as if you are not getting enough air?” The program, attended by 15 nurses, was effective at raising awareness of the incidence of dyspnea at the end of life and in increasing knowledge of evidencebased interventions, Kang reported. In particular, nurses better understood the potential effect of providing increasingly high doses of opioids at the end of life—an area where there has been confusion, she noted. Prior to the program, 9 of 15 nurses suggested higher doses of opioids decrease respirations, 2 of 15 said they hasten death, 1 believed they increase agitation,
and 1 suggested they are overly sedating. After the program, 11 believed that increasingly high doses of opioids alleviate dyspnea or provide comfort, and only 3 still believed this approach produces respiratory depression. “For the typical cancer patient at the end of "life, high doses of! opioids do
decrease respiratory rate, but when done appropriately there is no change in oxygen saturation, carbon dioxide retention, or survival time. In fact, sometimes they prolong life, because they decrease the work of breathing. This is a surprise to some nurses,” she explained. In addition, in the pretest only 5 of 15
nurses listed interventions that reduce anxiety as a way to manage dyspnea, while this increased to 11 in the posttest. “These responses demonstrate that education had a positive impact on the nurses’ knowledge of dyspnea in cancer patients during end of life, and therefore on their practices,” she said. “In addition, nurse feedback and anecdotal responses suggested that the educational project has also positively impacted patients who experience dyspnea.” l
YOUR QUESTIONS ANSWERED
Editor in Chief
Editor in Chief
Sagar Lonial, MD
Stephanie A. Gregory, MD
Professor Vice Chair of Clinical Affairs Department of Hematology and Medical Oncology Winship Cancer Institute Emory University School of Medicine
Topics include: • Newly Diagnosed Patients • Maintenance Settings • Transplant-Eligible and -Ineligible Patients • Retreatment Settings • Bone Health
The Elodia Kehm Chair of Hematology Professor of Medicine Director, Lymphoma Program Rush University Medical Center/Rush University
Topics include: • Mantle Cell Lymphoma • Follicular Lymphoma
These activities are supported by educational grants from Millennium: The Takeda Oncology Company and Celgene Corporation.
These activities are supported by educational grants from Millennium: The Takeda Oncology Company and Spectrum Pharmaceuticals.
ALL NEW CONTENT FOR 2012 Accreditation These activities will be accredited for physicians, nurses, and pharmacists. For complete accreditation information, please refer to each activity. This activity is jointly sponsored by Medical Learning Institute, Inc. and Center of Excellence Media, LLC.
AuguST 2012 I VOL 5, NO 7
Nurse Practitioner–Delivered Automated Telephone Remote Monitoring System Provides Good Control of Unrelieved Chemotherapy-Induced Symptoms By Alice Goodman
n automated computer-based telephone remote monitoring system with a built-in follow-up component involving nurse practitioners (NPs) appears to be feasible and effective for managing cancer patients’ unrelieved symptoms following chemotherapy. A study presented at the 2012 Annual Meeting of the American Society of Clinical Oncology showed that use of this system during chemotherapy cut the number of days with severe symptoms by two-thirds and the number of moderate symptom days by half, at the same time increasing the number of asymptomatic days and mild symptom days. “This is a case management system in which we monitor symptoms with our automated system and then automatically triage unrelieved symptoms to the nurse practitioner for follow-up. With the case management component, the nurse practitioner is able to see the data on symptom severity and distress and symptom trends over time, and then use the national symptom guidelines for further assessment and intervention,” explained Kathi Mooney, PhD, RN, College of
Nursing and Huntsman Cancer Institute, University of Utah, Salt Lake City. Prior to initiating chemotherapy, 335 patients were randomized to telephone care (TC; n = 173) or usual care (UC; n = 162). Regardless of randomization assignment, all patients called in to a
“We monitor symptoms with our automated system and then automatically triage unrelieved symptoms to the nurse practitioner for follow-up." —Kathi Mooney, PhD, RN
remote system daily and reported the presence, severity, and distress (on a scale from 0 to 10) for 11 common chemotherapy-associated symptoms (ie, fatigue, pain, insomnia, nausea, depression, anx-
iety, impaired thinking, numbness, diarrhea, mucositis, and appearance). Patients assigned to TC also received automated tailored symptom self-care messages and telephone calls from NPs for further treatment of their symptoms. The NP’s intervention was triggered by automated alerts about any unrelieved symptoms at moderate to severe levels. Participants’ median age was around 56 years, and about 77% were female. About 45% had breast cancer, 16% had lung cancer, and 10% had ovarian cancer; 45% of participants had stage IV cancer. Patients in the TC group experienced a significantly lower number of severe symptom days (mean, 3.16 vs 10.24, respectively; P <.001) and moderate symptom days (mean, 8.91 vs 19.06, respectively; P <.001) versus the UC group. The TC group also experienced significantly more asymptomatic days (mean, 66.06 vs 52.02, respectively; P = .015) and a somewhat higher number of mild symptom days (mean, 19.85 vs 13.75, respectively; P = .06) versus the UC group.
The incidence of each of the 11 common symptoms was significantly lower in the TC group (P <.001), with the exception of diarrhea. The study found that TC intervention significantly reduced alerting symptoms within 4 days of the NP telephone calls (P <.001). Mooney and colleagues hope to present further information about the system and both patient and NP satisfaction with using it at an Oncology Nursing Society meeting in the fall of 2012. In a separate interview, she explained that the system was first tested with symptom alerts sent to oncologists and nurses, and that the study showed no difference between UC and TC, because the providers did not follow up. Results of this new study, however, suggest that if there is follow-up, patients experience fewer days of unrelieved symptoms. l Reference Mooney KH, Beck SL, Wong B, Dunson WA Jr, Wujcik D. Outpatient chemotherapy supportive care: trial of an IT integrated, NP delivered system for unrelieved symptoms. Poster presented at: 48th Annual Meeting of the American Society of Clinical Oncology; June 1-5, 2012; Chicago, IL. Abstract 9137.
Renal Cell Carcinoma Quality of Life Drives Patient Preference... Continued from cover
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The researchers expected Photo by © ASCO/Scott Morgan 2012.
mg of sunitinib as first-line cancer treatment; after a 2-week washout period, patients received 10 weeks of the alternate treatment. The primary end point was patient preference, measured at 22 weeks. Because patients with mRCC receive therapies for many months or even years, the team assessed whether the drug toxicity would be significant enough to make patients want to continue treatment with either drug or to switch therapy. A total of 126 patients completed a preference questionnaire. In the primary analysis, 70% of the patients preferred pazopanib, 22% preferred sunitinib, and 8% cited no preference. After adjustments for a modest sequence effect, the difference in preference was 49% in favor of pazopanib. All other analyses showed a significant preference for pazopanib. The most common reasons given for pazopanib preference were better QOL and less fatigue. Patients taking pazo-
patients to prefer one drug over the other because of adverse effects, but “we didn’t ever expect such a big difference between the 2 drugs.” —Bernard J. Escudier, MD
panib had fewer dose reductions than those taking sunitinib (13% vs 20%, respectively) and fewer treatment interruptions (6% vs 12%). Adverse events were compatible with known profiles for both drugs. The researchers, led by Bernard J. Escudier, MD, from the Institut Gustave Roussy, Villejuif, France, said
that they expected patients to prefer one drug over the other because of adverse effects, but “we didn’t ever expect such a big difference between the 2 drugs.” Physicians may perceive toxicity differences between 2 different therapies as relatively minor, but to patients, even low-grade toxicities over a long period
have a significant effect on QOL, according to Escudier and colleagues. How patients feel when they take a drug over many months is not reflected in traditional reporting of adverse events. A survey on physician therapy preferences, which was a secondary end point in this study, showed some difference in physicians’ drug preferences: 61% preferred pazopanib, 22% preferred sunitinib, and 17% had no preference. Patient-reported outcomes are increasingly being added to traditional efficacy outcomes to better understand the clinical relevance of differences in drug toxicities, Escudier and colleagues noted. l Reference Escudier BJ, Porta C, Bono P, et al. Patient preference between pazopanib (Paz) and sunitinib (Sun): results of a randomized double-blind, placebo-controlled, crossover study in patients with metastatic renal cell carcinoma (mRCC)—PISCES study, NCT 01064310. Presented at: 2012 Annual Meeting of the American Society of Clinical Oncology; June 2012; Chicago, IL. Abstract CRA4502.
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Oncology Nurse Excellence Award Winner Atlanta Nurse Deborah Thompson Wins the Oncology Nurse Excellence Award By Lynne Lederman, PhD
program. I can’t wait to see who wins this award in 2013 and in the years to come.” Thompson was nominated by Rita Walker, RN, BSN, MS, the Assistant Nurse Manager of Medical Specialty and Oncology Clinics at the Atlanta VA Medical Center. She said, “Ms Thompson is an exemplary nurse who gives her all toward her patients during their treatment in the hospital setting as well as the community at large. Her commitment to extending healthcare beyond the confinements of the hospital setting and contributions to alternative measures of making the veteran feel loved is what inspired me to nominate this nurse for this prestigious award. Ms Thompson initiated hugs for those veterans receiving chemotherapy in the outpatient hematology/oncology clinic. The hugs contribute to a special bond between the nurse and those we serve.” Thompson said she initiated the hugs because she knew that when patients first come to her treatment area they are afraid and don’t know what to expect. She wanted to alleviate their anxiety and their fears. “The first thing that I do when they come in this treatment area is I give them a hug, but I get permission to do that, because not everybody likes touching or hugging. Then we give the patients a hug, and once the patients have finished their treatment we give them a hug when they leave. This helps the patients with their anxiety and to feel more comfortable in this environment.”
They are very special because they served our country, and I’m especially honored and humbled to serve our American heroes, our veterans, for all these years. The patients are so appreciative of everything you —Deborah Thompson, RN, OCN do for them.”
he Oncology Nurse-APN/PA congratulates Deborah Austin Thompson, RN, OCN, on being chosen by more than 650 of her peers to be this year’s winner of the Oncology Nurse Excellence (ONE) award, sponsored by Teva Oncology. Thompson is an oncology staff nurse at the Atlanta Veterans Administration (VA) Medical Center, and is the charge nurse in the hematology/oncology outpatient infusion
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center. Upon being notified about receiving the ONE award, Thompson said, “I accept this award in memory of my father and mother who are no longer in their earthly vessels. I am eternally grateful to each person who sacrificed their time to cast their vote for me. I applaud Teva Oncology for sponsoring such a noble award and the forward thinking of The Oncology Nurse-APN/PA for facilitating such a great
Choosing Veterans and Oncology When Thompson was preparing to graduate from high school in Greenwood, Mississippi, she chose nursing from the different career paths her high school counselor showed her. She earned her BS in nursing from Dillard University in New Orleans, Louisiana, where she credits her instructors with giving her a strong foundation and shaping her into the nurse she is today. She notes that her instructors demanded professionalism in the patient care setting from the beginning, and instilled the students with a strong work ethic. As a nursing student, Thompson did some of her clinical training at the New Orleans VA hospital, and also at Charity Hospital and Children’s Hospital, and realized she wanted to do adult nursing. She loved the veterans and when she graduated she went to the VA. She has been with the VA her entire 34-year nursing career. “I tell the patients, this is not just a job for me, this is my ministry, I love what I do, I love veterans, I enjoy taking care of them, and I let them know that they are not patients, they are family members,” she says.
the Thompson started out in neurology and neurosurgery for 2 years, then went to a medical oncology floor at the New Orleans VA. An oncology nurse specialist had been observing her taking care of patients in the unit, and suggested she apply for an open position as an oncology staff nurse. Despite her young age and 20 other applicants, some with decades of experience, she got the job. She trained for a year, administering inpatient chemotherapy in the morning and outpatient chemotherapy in the afternoon. After 5 years there, in 1987, her husband, who was in the military, was transferred to Atlanta, and she started her career path over at the Atlanta VA. She worked in the inpatient unit until 1995, then became an oncology care manager until 2003, helped the VA organize satellite clinics for about 2 years, then returned to the main hospital and the outpatient infusion treatment center. The center is staffed with an interdisciplinary team of oncology staff doctors, nurse practitioners, physician assistants, an assistant nurse manager, staff nurses, and a pharmacist. The center treats 35 to 50 patients, whose treatments range from 30 minutes to 6 hours, and include intravenous chemotherapy, immunotherapy, blood products, bisphosphonates, fluids, pain medicines, and bone marrow procedures. Thompson notes that veterans have unique needs because they may have served in wartime, and may suffer from posttraumatic stress disorder. Some cancers may be related to exposure to Agent Orange or to other chemicals while in the military. Although in the past the veteran population was primarily male, now about 30% of patients who come through the treatment area are female. “They are very special because they served our country, and I’m especially honored and humbled to serve our American heroes, our veterans, for all these years. The patients are so appreciative of everything you do for them,” Thompson says. “If you come across a veteran who has been exposed to Agent Orange they need to enroll at the VA,” she observes. Patients may have had an exposure related to their cancer and may be eligible to receive benefits. Challenges and Advice A major challenge for Thompson as an oncology nurse is dealing with the psychological consequences of watching the condition of patients she is close to deteriorate, or hearing of their death. There are programs for patients and their families, including the hospital palliative care service that prepares patients and teaches them how to live with their diagnosis and to manage their pain. There is a living with cancer support group that Thompson participates in. There is also a chaplain service and a social work service. However, there is no formal program to help the staff deal with losing patients, and Thompson has brought this up with her nurse manager and their associate nurse executive. “We don’t have that and it is really needed,” she observes. “Oftentimes we are with these patients through the whole journey and sometimes we don’t find out until days after they have died.” The nurses and doctors try to call the family members when the patient is placed on home hospice, and try to visit when the patient is placed on inpatient hospice. They do come together and talk informally about patients who have died, cry together, and try
to go to patients’ funerals. “We do try to communicate with the family members and work with each other and help each other through it. Everyone deals with it in their own individual way, everyone deals with death differently. I personally try to talk with the family, when I hear a patient is taken off treatment and is put on hospice. There are patients you connect to and want to keep in touch with. We try to let them know we are here for them, and we give our patients a direct phone number to our treatment area so they can call without going through the main number and let us know what’s going on,” she says. Thompson says that to care for patients with cancer who are on a journey from the time they are diagnosed to the time they expire, nurses have to have a passion to care for these patients, a positive attitude, and positive energy, and it has to be something they really want to do and enjoy doing. Other desirable traits include being dedicated and dependable, and having integrity, loyalty, and trust. Those are key elements for the nurse–patient relation-
Ms Thompson is an exemplary nurse who gives her all toward her patients during their treatment in the hospital setting as well as the community at large.”
—Rita Walker, RN, BSN, MS, in her nomination of Thompson
ship, she believes. She tells new nurses coming into oncology that they can learn something new every day. She also advises keeping up to date, networking with other nurses, being actively involved in national and local chapters of the Oncology Nursing Society and other organizations, and in the community. She recommends they attend conferences and in-services to increase their knowledge in oncology. However, the most important thing is for nurses to take care of themselves first. “Once you have taken care of yourself, you can take care of others,” Thompson believes. Another challenge is not having enough time for all the creative activities she would like. She is on several hospital committees, is involved with hospital and community support groups and community health fairs, is one of the instructors for a biotherapy and chemotherapy class, and is an officer for the National Nurses United local chapter of the VA union for nurses. “There’s not enough time, but I enjoy it so it’s OK,” she says. One thing Thompson does every day at work is to put a positive affirmation on the board. Her favorites include, “One step at a time, one day at a time,” and “Do not go where the path may lead, go instead where there is no path, and leave a trail.” l
A Commitment to Helping Those With Cancer
s the Oncology Nurse Excellence award winner, Deborah Austin Thompson, RN, OCN, chose 2 local charities to receive donations: the Southside Atlanta Multiple Myeloma Support Group, and the VA Volunteer Service Department at the Atlanta VA Medical Center.
The Southside Atlanta Multiple Myeloma Support Group Deborah and others at the Atlanta VA Medical Center volunteer at this support group for patients with multiple myeloma. The goal of this group of myeloma survivors is to provide hope and encouragement to others, and to help patients with myeloma become better educated about the disease and its treatment. According to their website, “Our belief that the greatest fear is the fear of the unknown drives our desire to help others to become better informed, while helping to spread the word that ‘Knowledge is Power!’” Although the International Myeloma Foundation (IMF) does not sponsor this group, the IMF supports their efforts and conducts annual summits for myeloma support group leaders. The Southside Atlanta Multiple Myeloma Support Group is one of over 150 myeloma support groups worldwide that holds regular meetings for members of the myeloma community. The Southside Atlanta Multiple Myeloma Support Group meets on the 4th Saturday of each month. If you wish to help the group’s efforts, please make checks payable to the IMF. Include a note or write on the memo line “Southside MM Support Group Fund” and mail donations to: International Myeloma Foundation 12650 Riverside Drive, Suite 206 North Hollywood, CA 91607
VA Volunteer Service Department, Atlanta VA Medical Center, Decatur, Georgia Deborah’s passion is for veterans and she would also like to see money donated to veterans. The Atlanta VA Medical Center volunteer service department helps patients coming for treatment with gas cards and transportation to and from treatment. Deborah notes that they have had patients who did not have food, and who are given grocery cards by the department. Young veterans in particular often have financial needs and find it difficult and time-consuming to get benefits. The volunteer service department helps both patients and their families, including those with young, dependent children. If you would like to help, donations can be made to the Atlanta VA Medical Center Voluntary Service Office, with a note to earmark the funds for aid to patients treated in the Hematology/Oncology OutPatient Infusion Center. Checks may be sent to: Mary Lou Pittman Atlanta VA Medical Center 1670 Clairmont Road (135) Decatur, GA 30333
AuguST 2012 I VOL 5, NO 7
Third Annual Navigation and Survivorship Conference PRELIMINARY AGENDA*
Friday, September 14 12:45 – 1:00pm
1:00 – 2:00pm & 2:15 – 3:15pm
3:15 – 3:30pm 3:30 – 5:00pm
5:00 – 6:00pm 6:00 – 8:00pm
Welcome Conference Co-Chairs: Sharon Gentry, RN, MSN, AOCN, CBCN Lillie D. Shockney, RN, BS, MAS Pre-Conference Workshops Beginners Track • Core Principles of Navigation Nicole Messier, RN, BSN Pamela J. Vlahakis, RN, MSN, CBCN Members • Getting Excited about Research – Case Examples Linda Fleisher, PhD, MPH Elaine Sein, RN, BSN, OCN, CBCN • Panel Discussion: Building Optimal Community Outreach – Lay and Community Jean B. Sellers, RN, MSN (Moderator) Leah Leilani Beck, BS Jessica Denton, MSW • Implementing a Survivorship Program/Clinic Cynthia Waddington, RN, MSN, AOCN Break Administrators Track • Administering a Navigation Program Bonnie J. Miller, RN, BSN, OCN, FAAMA Elizabeth Whitley, PhD, RN Navigators Track • How Do Case Managers and Navigators Interface? Nancy Skinner, RN-BC, CCM FREE TIME Welcome Reception/Posters in the Exhibit Hall
Saturday, September 15 7:30 – 8:30am
Breakfast/Product Theater: New Route of Administration for Velcade supported by Millennium Pharmaceuticals, Inc. 8:30 – 8:45am Welcome & Introductions Conference Co-Chairs 8:45 – 9:45am General Session 1: Navigation Update: 2012 Current Regulations – Navigation & Survivorship Care Plan Linda Ferris, PhD 9:45 – 10:00am Break 10:00 – 11:30am Disease-Site–Specific Breakouts Stand-Alone Sessions • Breast Cancer Navigation Mary Rooney, RN, BSN, OCN • Thoracic Oncology Navigation Pamela Matten, RN, BSN, OCN • GI & Colorectal Cancer Navigation Maura Kadan, RN, MSN, OCN Coralyn Martinez, MSN, RN, OCN • GYN Cancer Navigation Robin A. Atkinson, RN, BSN, OCN ®
Prostate Cancer Navigation Juli Aistars, RN, MS, APN, AOCN Rapid Fire Sessions with Panel • Head, Neck, & Neuro Navigation Heather Stern, RN, BSN, CNOR, OCN And • Hematology/Oncology Tina Scherer, RN, MSN, OCN Administrators Session • The Role of the Administrator Barbara Francks, RN, BSN, CBCN Lisa Shalkowski, RN, BSN, MSM 11:45 – 1:00pm Lunch in the Exhibit Hall 1:15 – 2:15pm Keynote Session: Beginning the Breast Reconstructive Journey: Importance of Reconstructive Surgery Referrals and Stateof-the-Art Oncoplastic Breast Reconstruction Steven Kronowitz, MD, FACS 2:15 – 3:15pm General Session 2: Best Practices in Survivorship Care Rehabilitation Julie Silver, MD 3:15 – 4:15pm General Session 3: Plenary Session Financial and Legal Issues for Our Cancer Patients David S. Landay, JD 4:15 – 5:00pm The Art of Exceptional Professional Performance – Making a Difference in Your Patients’ Lives Selinza Mitchell, RN 5:00 – 7:00pm Poster Award Reception in the Exhibit Hall Pamela Matten, RN, BSN, OCN 7:00pm Conclusion of Day – Networking FREE TIME
Sunday, September 16 7:30 – 8:30am 8:30 – 9:30am
Breakfast Symposium/Product Theater General Session 4: Navigation in the Age of Personalized Cancer Care Sharon Gentry, RN, MSN, AOCN, CBCN Lillie D. Shockney, RN, BS, MAS 9:30 – 10:30am General Session 5: Best Practices in Addressing Health Inequities Lauren Kelley, MSW, MPA Adrienne Lofton, RN, MSN 10:30 – 10:45am Break 10:45 – 12:15pm Practice Setting – Panel Discussion with Moderator • Office-Based Roxanne Parker, RN, MSN, CPN (Moderator) • Academic Jessie Schol, RN, BSN, OCN • Community Hospital–Based Karyl Blaseg, RN, MSN, OCN 12:15 – 1:15pm Lunch in the Exhibit Hall 1:30 – 2:30pm Clinical Survivorship Guidance Mandi Pratt-Chapman, MA Katherine Sharpe, MTS 2:30 – 2:45pm Conclusion/Final Remarks Conference Co-Chairs *Preliminary agenda, subject to change.
September 14-16, 2012 Phoenix, Arizona Arizona Grand CONFERENCE CO-CHAIRS Sharon Gentry, RN, MSN, AOCN, CBCN
CONFERENCE REGISTRATION Register online: www.regonline.com/aonn2012 Conference Registration: $345 Includes Membership through September 30, 2013.
Breast Health Navigator Derrick L. Davis Forsyth Regional Cancer Center Winston-Salem, NC
AONN’s Third Annual Conference is the only meeting that gives you access to decision-makers and key practitioners involved in oncology navigation and survivorship. If your company provides any of the following services/products for the oncology healthcare community, this is the meeting for you.
Lillie D. Shockney, RN, BS, MAS
This educational initiative is directed toward oncology nurse navigators, patient navigators, and social workers.
University Distinguished Associate Professor of Breast Cancer Adm Director, Johns Hopkins Clinical Breast Programs Adm Director, Johns Hopkins Cancer Survivorship Programs Depts of Surgery and Oncology Associate Professor, JHU School of Medicine, Depts of Surgery, Oncology and Gynecology Associate Professor, JHU School of Nursing Johns Hopkins Avon Foundation Breast Center Baltimore, MD
FACULTY* Juli Aistars, RN, MS, APN, AOCN
Bonnie J. Miller, RN, BSN, OCN, FAAMA
Robin A. Atkinson, RN, BSN, OCN
Roxanne Parker, RN, MSN, CPN
Leah Leilani Beck, BS
Mandi Pratt-Chapman, MA
Karyl Blaseg, RN, MSN, OCN
Mary Rooney, RN, BSN, OCN
Jessica Denton, MSW
Tina Scherer, RN, MSN, OCN
Linda Ferris, PhD
Jessie Schol, RN, BSN, OCN
Linda Fleisher, PhD, MPH
Elaine Sein, RN, BSN, OCN, CBCN
Barbara Francks, RN, BSN, CBCN
Jean B. Sellers, RN, MSN
Maura Kadan, RN, MSN, OCN
Lisa Shalkowski, RN, BSN, MSM
Lauren Kelley, MSW, MPA
Katherine Sharpe, MTS
Steven Kronowitz, MD, FACS
Julie Silver, MD
David S. Landay, JD
Nancy Skinner, RN-BC, CCM
Adrienne Lofton, RN, MSN
Heather Stern, RN, BSN, CNOR, OCN
Coralyn Martinez, MSN, RN, OCN
Pamela J. Vlahakis, RN, MSN, CBCN
Pamela Matten, RN, BSN, OCN
Cynthia Waddington, RN, MSN, AOCN
Nicole Messier, RN, BSN
Elizabeth Whitley, PhD, RN
• • • • •
Pharmaceutical/Biotech Genetic Laboratory Services Navigation Software Patient Advocacy Training
• • • • •
Patient Access Reimbursement Publishers Education Certification
CONTINUING EDUCATION INFORMATION Goal AONN’s Third Annual Navigation and Survivorship Conference will advance the role of navigation and survivorship in cancer care to ultimately improve the quality of patient care. Objectives • Discuss the evolution of the role of navigation in healthcare • Assess strategies for navigating diverse patient populations by cancer type and environmental factors • Define methods for providing patient support and guidance in the age of personalized cancer care • Evaluate best practices regarding survivorship and psychosocial care
SPONSORS This activity is jointly sponsored by AONN Foundation for Learning, Inc., Center of Excellence Media, LLC, and Medical Learning Institute, Inc.
COMMERCIAL SUPPORT ACKNOWLEDGMENT This activity is supported by educational grants from Celgene Corporation and Eisai Pharmaceuticals.
*For full information visit www.aonnonline.org
CONFERENCE OVERVIEW AONN’s Third Annual Conference will continue to advance the navigation profession by expanding the scope of educational sessions, networking opportunities, and poster presentations. In addition, this year’s conference will address the evolving challenges of program improvement, the role of personalized medicine, and implementing best practices in navigation, survivorship, and psychosocial care.
REGISTERED NURSE DESIGNATION Medical Learning Institute, Inc. Provider approved by the California Board of Registered Nursing, Provider Number 15106, for up to 12.25 contact hours.
SOCIAL WORK DESIGNATION This activity is pending approval from the National Association of Social Workers. Contact hours for this continuing social worker education activity have been submitted to the National Association of Social Workers. "
Health Insurance Coverage
Provisions and Status of the Affordable Care Act By Shawn Kravich, Esq Cancer Legal Resource Center, Los Angeles, California
he Affordable Care Figure Affordable Care Act 2010-2014 Timeline their options. Second, insurance Act (ACA) has been companies will no longer be the subject of some of allowed to place annual or lifewww.cancerlegalresourcecenter.org © Disability Rights Legal Center the most contentious public time limits on policyholders for The Patient Protection & Affordable Care Act debate in recent years, but essential health benefits, mean(“ACA”) was signed into law. (3/23/2010) many Americans are still mising that people won’t be cut off informed about all or part of from services because their treatChildren 19 Supreme Court & under can’t be what the legislation entails. ment costs reach a certain dollar holds most of the denied insurance Though no law is perfect, the amount. As some health plans ACA to be for preexisting constitutional ACA has the potential to had policy limits of $50,000, canconditions (6/25/2012) (9/23/2010) expand coverage opportunities cer patients could reach—and and make access to healthcare surpass—total plan allowances in 2011 2012 2013 2014 2010 more effective, particularly for a single day, having to pay out-ofpeople with cancer. pocket for all future costs. Third, Seniors enrolled Health insurance coverage in 2014 many states will expand in Medicare get and access to screenings are Medicaid to include new populaInsurance companies will not be allowed to: 1) discriminate access to free fundamental in the fight tions, although this component against people with preexisting conditions or 2) set lifetime preventive or annual limits on essential health benefits. services against cancer, and treatment of the ACA was somewhat limit(1/01/2011) and prognosis can vary drastied by the US Supreme Court. As Individuals will be required to have insurance or pay a cally, largely depending on the it currently stands, Medicaid is a penalty. Healthcare.gov stage at diagnosis. Regular national program that provides goes live: giving States who choose to expand Medicaid to cover all residents access to health screening for cancer can result medical care to low-income indiwith incomes at or below 138% of the Federal Poverty Line information to in early detection and manageviduals who are blind, who are must do so by 2014. consumers (1/01/2014) ment of the disease at a time age 65 or older, or who have a (7/01/2010) when treatment is most effecdisability through the Aged, tive (and most affordable for Blind, and Disabled program. the patient and the healthcare system as Starting January 1, 2014, PCIPs will coverage solely because of this provision. Earlier this summer, the Supreme a whole). Unfortunately, many people be phased out of existence because the Other important consumer protec- Court heard 4 challenges to the ACA. are uninsured or underinsured when ACA requires insurance companies to tions of the ACA include a mandate First, the Court determined that the they learn that they have cancer. begin covering all adults regardless of that insurance companies provide cer- individual mandate was constitutionAccording to the 2010 Census, over 50 preexisting conditions. Congress envi- tain preventive services at no cost, the al, meaning that Congress can require million people in the United States sioned gaining insurance companies’ sup- right of patients to have external that all people have healthcare coverhave no form of medical coverage—and port for this component of the law by health insurance appeals, and the age or pay a penalty. Second and third, according to the American Cancer creating the “individual mandate,” a elimination of rescissions of insurance the Court looked to 2 largely technical Society, half of all men and one-third of requirement that all Americans have policies when there is no fraud. This issues, whether the Anti-Injunction all women in the US will develop can- healthcare coverage of some kind or pay means that patients won’t have to pay Act precluded the Court from hearing cer during their lifetime. a penalty. While it remains to be seen copays or deductibles for certain pre- the case at all and whether “severabilMany patients diagnosed with canity” would have made the rest of the cer while uninsured were denied ACA unconstitutional if the individhealth insurance options due to their ual mandate component were struck preexisting condition, an exclusion down. Fourth, the Court looked at put in place by private health insurwhether Congress could force states to Health insurance coverage and access to screenings ance providers. The US Department expand Medicaid to include all loware fundamental in the fight against cancer, and of Health and Human Services estiincome individuals (below 138% of mates that up to 129 million nonelderthe federal poverty line) by 2014, or treatment and prognosis can vary drastically, largely ly Americans have preexisting condilose all federal Medicaid funding. tions, making it difficult or impossible While this expansion will be fully depending on the stage at diagnosis. to get insurance. Indeed, up to onefunded by the federal government fifth of Americans with preexisting between 2014 and 2017 and will be conditions are uninsured. The ACA funded at 90% for the years to follow, sought to increase coverage options for the Court held that instead of forcing people with preexisting conditions. To how affordable many of these plans will ventive services, they will have an states to expand coverage, Congress address coverage gaps, the ACA creat- be and what the benefits will include, option to appeal insurance decisions had to let states choose expansion. ed a temporary program known as the there will now be government oversight to an independent medical review Though many of the major changes Pre-Existing Condition Insurance in an area where there was none. board, and they will no longer experi- have yet to occur, the Affordable Care Plan (PCIP). PCIPs are available to Some of the ACA’s other protections ence retroactive cancellation of cover- Act has already begun to significantly those who have been uninsured for 6 for people with preexisting conditions age because of mistakes or honest increase access to early and more months or more, who are residing are already in effect. As of September 23, omissions on insurance applications. comprehensive care for people with legally in the US, and who have a pre- 2010, children 19 years and younger canThough many of the ACA’s reforms cancer. l existing condition, such as cancer. not be denied insurance due to a preex- have already gone into effect, 3 other Some states administer their own isting condition. In addition, young big changes will come in 2014. First, For information about the Cancer PCIP programs, while others use the adults up to 26 years old are now eligible every person will be able to participate Legal Resource Center, please visit federal government to administer the for coverage under their parents’ insur- in health insurance exchanges—tools www.cancerlegalresourcecenter.org. program. More information about ance. In 2011 alone, an estimated 6.6 for comparing insurance choices so that PCIPs can be found at www.pcip.gov. million young adults retained access to consumers are better informed about
AuguST 2012 I VOL 5, NO 7
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At Genentech BioOncology, not only are we leading the fight against cancer with innovative science, but we’re also dedicated to supporting patients and others within the oncology community. A commitment to patients — We created Genentech BioOncology™ Access Solutions®, a single source for all access and reimbursement issues, so healthcare providers can remain focused on patient care. Reducing barriers to treatment — We help make treatment possible for patients in financial need through our BioOncology Co-pay Card and ongoing charitable donations to various co-pay assistance foundations. A commitment to care — Since 1985, when our first product was approved, we have donated $2.85* billion in free medicine through the Genentech® Access to Care Foundation (GATCF) and other product donation programs. Our goal is to fundamentally change the way that cancer is treated by personalizing solutions to patient care. *GATCF donation value is based on the most current forecast.
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Patient-Friendly Educational Book Enhances Transplant Process Most Materials Are Too Complex for Patients, Nurses Maintained By Caroline Helwick
ducational materials for transplant patients are often too complex for patients to fully comprehend. That’s why oncology nurses at CedarsSinai Medical Center, Los Angeles, California, decided to produce 2 patient-friendly books that have gotten rave reviews from cancer patients and the whole oncology team. At the 37th Annual Congress of the Oncology Nursing Society (ONS) held in New Orleans, Louisiana, the author of the Patient Education Notebooks, Laura Snoussi, RN, BSN, OCN, described the books, which can be downloaded and customized from the Cedars-Sinai Blood and Marrow Transplant Program Web site (http://www. cedars-sinai.edu/Patients/Programsand-Services/Blood-and-Marrow-Trans plant-Program/For-Patients/PatientEducation.aspx). “The aim of developing these books was to provide a user-friendly and effective tool to educate and empower our patients undergoing blood and marrow transplant,” Snoussi said. “The existing books were from 2005, and the content did not reflect our current
standards of practice. They were written in textbook style, were too complex and verbose for the average adult learner (a patient or the caregiver), and had too many contributors, so the style was disjointed.” In addition, she said nurse coordinators determined patients were not reading the material, and were leaving the books at home; nurses, therefore, could
the information on a 7th grade level [using an educational software application],” she said. “We used pictures and colors. The format was more like ‘Bone Marrow Transplant for Dummies.’ ” New, Improved Version Snoussi, the clinical program coordinator for the Blood and Marrow Transplant Program, authored the 2 books, one with
“The new books have made a big difference in how we talk to patients. The patients actually read them and like them, and they free up time for floor nurses.” —Anne Rosenblatt, RN, MSN
not review the material with them. Compliance with important instructions related to patient care before and after transplant was suboptimal, and patients were being readmitted for preventable problems. “We were using a textbook geared to nurses. I tried to dial it down and keep
comprehensive pretransplant content and the other a detailed review of the transplant, discharge, and self-care. She incorporated feedback from the coordinator team, transplant physicians, and other staff. The books were written in English and Spanish. In the new books, pictures and images
Sample pages from the Patient Education Notebooks. These pages are excerpts from internal patient education materials and do not constitute medical advice or endorsement of any particular treatment or product.
AuguST 2012 I VOL 5, NO 7
are interspersed with text that addresses different learning styles. Important safety information is contained within key points boxes and highlighted. There are quizzes at the end of each chapter to test the patient’s knowledge and improve the patient’s confidence in the material. The nursing coordinator reviews the quizzes with the patient or caregiver to reinforce the teaching, evaluate the patient’s mastery of content, and identify needs for further teaching or clarification. Anne Rosenblatt, RN, MSN, lead clinical program coordinator of the Blood and Marrow Transplant Program, commented on the value of the new educational books. “I had noticed that the original books were not so good. The new books have made a big difference in how we talk to patients. The patients actually read them and like them, and they free up time for floor nurses.” Snoussi agreed that the impact has been very favorable, “as evidenced by nursing coordinators engaging in comprehensive, interactive discussions earlier in the pretransplant process, and patients stating they feel prepared by the level of education they have received,” she said. “Patients are utilizing the books in a meaningful way,” she continued, “asking more specific questions, demonstrating a higher level of understanding, and successfully completing quizzes with fewer errors. Caregivers are also included in the discussions, because their purpose is detailed in the books. Some patients arrive at their consults having already read the books, since they are available on the Web site. It has clearly met a need for patients, caregivers, and staff.” “Other healthcare providers involved in teaching this complex patient population can adapt our process to their setting and likely achieve similar positive outcomes,” she added. The presentation at ONS was entitled Empowering Blood and Marrow Transplant Patients Through a Com prehensive, Manageable Education Book. In addition to Rosenblatt and Snoussi, contributors to the abstract (1342733) included Carolina Caso, RN, CPON; Sandra Rome, RN, MN, AOCN; Margarita Guerrero, RN, OCN; Patricia Van Strien, RN, OCN, CHTC; and Seda Gharapetian, RN, MSN, NP, AOCN, all members of the team at the Cedars-Sinai Medical Center Blood and Marrow Transplant Program. l
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MULTIPLE MYELOMA NEVER GIVES UP.
BUT NEITHER DO WE.
For 15 years, Celgene has been working to develop innovative therapies and has partnered with the multiple myeloma community to advance patient care. We’re relentless. We’re persistent. We’re progressive. And we’re not done yet.
© 2012 Celgene Corporation
August 2012 issue of The Oncology Nurse