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Journal of Oncology ®

NAVIGATION & SURVIVORSHIP APRIL 2011 • VOL. 2, NO. 2

The Official Journal of the Academy of Oncology Nurse Navigators ®

NEEDS OF OLDER AND ELDERLY CANCER SURVIVORS Commentary: Implications for Navigation

HAND-OFF COMMUNICATION AMONG NAVIGATORS PATIENT NAVIGATION BECOMES NEW STANDARD FOR CANCER PROGRAM ACCREDITATION

© 2011 Green Hill Healthcare Communications, LLC


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The first and only monoclonal antibody indicated for use in HER2+ metastatic gastric and gastroesophageal junction (GEJ) cancer Indication Herceptin is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease.

to drive outcomes in HER2+ metastatic gastric/GEJ cancer

Boxed WARNINGS Herceptin administration can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving Herceptin with anthracycline-containing chemotherapy regimens. In a pivotal adjuvant breast cancer trial, one patient who developed CHF died of cardiomyopathy Evaluate cardiac function prior to and during treatment. Discontinue Herceptin for cardiomyopathy Herceptin can result in serious and fatal infusion reactions and pulmonary toxicity. Discontinue Herceptin for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome Exposure to Herceptin during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death

6391080 Gastric Launch Ad Jrl Onco Nav Surv MAY M01 indd 1


S

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Herceptin plus chemotherapy* extended median overall survival (OS) in HER2+ metastatic gastric and GEJ cancer1 In the ToGA† trial: • The final overall survival analysis demonstrated a 13.5-month median OS with Herceptin + chemotherapy (cisplatin and either capecitabine or 5-fluorouracil) vs an 11.0-month median OS with chemotherapy alone1 • The updated overall survival analysis demonstrated a 13.1-month median OS with Herceptin + chemotherapy (cisplatin and either capecitabine or 5-fluorouracil) vs an 11.7-month median OS with chemotherapy alone1 • Herceptin should be administered until disease progression or unacceptable toxicity in HER2+ metastatic gastric and GEJ cancer1 †

Trastuzumab for gastric cancer.

Final Median Overall Survival Analysis1

13.5

Hazard Ratio = 0.73 95% CI: 0.60-0.91 P=0.0038

11.0 Updated Median Overall Survival Analysis1‡

13.1 S:10.375

Hazard Ratio = 0.80 95% CI: 0.67-0.97

11.7 0

3

6

9

12

15

Months Herceptin plus chemotherapy* (n=298) Chemotherapy alone* (n=296)

er

*Chemotherapy was cisplatin and either capecitabine or 5-FU. ‡ The updated analysis was conducted one year after the final analysis. No P value was associated with the updated analysis in the Herceptin Prescribing Information because there was no preplanned statistical testing for OS after the final analysis.

Additional Important Safety Information Exacerbation of chemotherapy-induced neutropenia has also occurred Detection of HER2 protein overexpression is necessary for selection of patients appropriate for Herceptin therapy The most common adverse reactions associated with Herceptin were neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia Please see brief summary of full Prescribing Information, including Boxed WARNINGS and additional important safety information, on the following pages. Reference: 1. Herceptin Prescribing Information. Genentech, Inc. October 29, 2010.

©2011 Genentech USA, Inc.

So. San Francisco, CA

All rights reserved.

HER0000330201

3/11

4/8/11 11:07 AM


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HERCEPTIN® (trastuzumab) Brief Summary For full Prescribing Information, see package insert. WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY Cardiomyopathy Herceptin administration can result in sub clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving Herceptin with anthracycline containing chemotherapy regimens. Evaluate left ventricular function in all patients prior to and during treatment with Herceptin. Discontinue Herceptin treatment in patients receiving adjuvant therapy and withhold Herceptin in patients with metastatic disease for clinically significant decrease in left ventricular function. [see Warnings and Precautions and Dosage and Administration] Infusion Reactions; Pulmonary Toxicity Herceptin administration can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of Herceptin administration. Interrupt Herceptin infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue Herceptin for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. [see Warnings and Precautions] Embryo-Fetal Toxicity Exposure to Herceptin during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. [see Warnings and Precautions, Use in Specific Populations] INDICATIONS AND USAGE Adjuvant Breast Cancer Herceptin is indicated for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Studies] breast cancer • as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel • with docetaxel and carboplatin • as a single agent following multi-modality anthracycline based therapy. Metastatic Breast Cancer Herceptin is indicated: • In combination with paclitaxel for firstline treatment of HER2-overexpressing metastatic breast cancer • As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease. Metastatic Gastric Cancer Herceptin is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease. CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Cardiomyopathy Herceptin can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death [see Boxed Warning: Cardiomyopathy]. Herceptin can also cause asymptomatic decline in left ventricular ejection fraction (LVEF). There is a 4−6 fold increase in the incidence of symptomatic myocardial dysfunction among patients receiving Herceptin as a single agent or in combination therapy compared with those not receiving Herceptin. The highest absolute incidence occurs when Herceptin is administered with an anthracycline. Withhold Herceptin for * 16% absolute decrease in LVEF from pre-treatment values or an LVEF value below institutional limits of normal and * 10% absolute decrease in LVEF from pretreatment values [see Dosage and Administration]. The safety of continuation or resumption of Herceptin in patients with Herceptininduced left ventricular cardiac dysfunction has not been studied. Cardiac Monitoring Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan. The following schedule is recommended: • Baseline LVEF measurement immediately prior to initiation of Herceptin • LVEF measurements every 3 months during and upon completion of Herceptin • Repeat LVEF measurement at

4 week intervals if Herceptin is withheld for significant left ventricular cardiac dysfunction [see Dosage and Administration] • LVEF measurements every 6 months for at least 2 years following completion of Herceptin as a component of adjuvant therapy. In Study 1, 16% (136/844) of patients discontinued Herceptin due to clinical evidence of myocardial dysfunction or significant decline in LVEF. In Study 3, the number of patients who discontinued Herceptin due to cardiac toxicity was 2.6% (44/1678). In Study 4, a total of 2.9% (31/1056) patients in the TCH arm (1.5% during the chemotherapy phase and 1.4% during the monotherapy phase) and 5.7% (61/1068) patients in the AC-TH arm (1.5% during the chemotherapy phase and 4.2% during the monotherapy phase) discontinued Herceptin due to cardiac toxicity. Among 32 patients receiving adjuvant chemotherapy (Studies 1 and 2) who developed congestive heart failure, one patient died of cardiomyopathy and all other patients were receiving cardiac medication at last follow-up. Approximately half of the surviving patients had recovery to a normal LVEF (defined as * 50%) on continuing medical management at the time of last follow-up. Incidence of congestive heart failure is presented in Table 1. The safety of continuation or resumption of Herceptin in patients with Herceptininduced left ventricular cardiac dysfunction has not been studied. Table 1 Incidence of Congestive Heart Failure in Adjuvant Breast Cancer Studies Study Regimen 1 & 2a ACbAPaclitaxel+ Herceptin 3 ChemoAHerceptin 4 ACbADocetaxel+ Herceptin 4 Docetaxel+Carbo+ Herceptin

Incidence of CHF Herceptin Control 2% (32/1677) 0.4% (7/1600) 2% (30/1678) 0.3% (5/1708) 2% (20/1068) 0.3% (3/1050) 0.4% (4/1056) 0.3% (3/1050)

a

Includes 1 patient with fatal cardiomyopathy. Anthracycline (doxorubicin) and cyclophosphamide Table 2 Incidence of Cardiac Dysfunctiona in Metastatic Breast Cancer Studies b

Study 5 (AC)b 5 (paclitaxel) 6

Incidence NYHA I−IV NYHA III−IV Herceptin Control Herceptin Control

Event Cardiac Dysfunction 28% 7% 19% 3% Cardiac Dysfunction 11% 1% 4% 1% Cardiac Dysfunctionc 7% N/A 5% N/A a Congestive heart failure or significant asymptomatic decrease in LVEF. b Anthracycline (doxorubicin or epirubicin) and cyclophosphamide. c Includes 1 patient with fatal cardiomyopathy. In Study 4, the incidence of NCI-CTC Grade 3/4 cardiac ischemia/infarction was higher in the Herceptin containing regimens: (AC-TH: 0.3% (3/1068) and TCH 0.2% (2/1056)) as compared to none in AC-T. Infusion Reactions Infusion reactions consist of a symptom complex characterized by fever and chills, and on occasion included nausea, vomiting, pain (in some cases at tumor sites), headache, dizziness, dyspnea, hypotension, rash, and asthenia. [see Adverse Reactions] In postmarketing reports, serious and fatal infusion reactions have been reported. Severe reactions which include bronchospasm, anaphylaxis, angioedema, hypoxia, and severe hypotension, were usually reported during or immediately following the initial infusion. However, the onset and clinical course were variable including progressive worsening, initial improvement followed by clinical deterioration, or delayed postinfusion events with rapid clinical deterioration. For fatal events, death occurred within hours to days following a serious infusion reaction. Interrupt Herceptin infusion in all patients experiencing dyspnea, clinically significant hypotension, and intervention of medical

therapy administered, which may include: epinephrine, corticosteroids, diphenhydramine, bronchodilators, and oxygen. Patients should be evaluated and carefully monitored until complete resolution of signs and symptoms. Permanent discontinuation should be strongly considered in all patients with severe infusion reactions. There are no data regarding the most appropriate method of identification of patients who may safely be retreated with Herceptin after experiencing a severe infusion reaction. Prior to resumption of Herceptin infusion, the majority of patients who experienced a severe infusion reaction were pre-medicated with antihistamines and/ or corticosteroids. While some patients tolerated Herceptin infusions, others had recurrent severe infusion reactions despite pre-medications. EmbryoFetal Toxicity Herceptin can cause fetal harm when administered to a pregnant woman. In post-marketing reports, use of Herceptin during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise women of the potential hazard to the fetus resulting from Herceptin exposure during pregnancy and provide contraception counseling to women of childbearing potential. [see Use in Specific Populations, Patient Counseling Information]. Pulmonary Toxicity Herceptin use can result in serious and fatal pulmonary toxicity. Pulmonary toxicity includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, non-cardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis. Such events can occur as sequelae of infusion reactions [see Warnings and Precautions]. Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity. Exacerbation of ChemotherapyInduced Neutropenia In randomized, controlled clinical trials the per-patient incidences of NCI CTC Grade 3−4 neutropenia and of febrile neutropenia were higher in patients receiving Herceptin in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received Herceptin and those who did not. [see Adverse Reactions] HER2 Testing Detection of HER2 protein overexpression is necessary for selection of patients appropriate for Herceptin therapy because these are the only patients studied and for whom benefit has been shown. Due to differences in tumor histopathology, use FDA-approved tests for the specific tumor type (breast or gastric/gastroesophageal adenocarcinoma) to assess HER2 protein overexpression and HER2 gene amplification. Tests should be performed by laboratories with demonstrated proficiency in the specific technology being utilized. Improper assay performance, including use of suboptimally fixed tissue, failure to utilize specified reagents, deviation from specific assay instructions, and failure to include appropriate controls for assay validation, can lead to unreliable results. Several FDA-approved commercial assays are available to aid in the selection of breast cancer and metastatic gastric cancer patients for Herceptin therapy. Users should refer to the package inserts of specific assay kits for information on the Intended Use, and the validation and performance of each assay. Limitations in assay precision make it inadvisable to rely on a single method to rule out potential Herceptin benefit. Treatment outcomes for adjuvant breast cancer (Studies 2 and 3) and for metastatic breast cancer (Study 5) as a function of IHC and FISH testing are provided in Tables 8 and 10. Assessment of HER2 protein overexpression and HER2 gene amplification in metastatic gastric cancer should be performed using FDA-approved tests specifically for gastric cancers due to differences in gastric vs. breast histopathology, including incomplete membrane staining and more frequent heterogeneous expression of HER2 seen in gastric cancers. Study 7 demonstrated that gene amplification and protein overexpression were not as well correlated as with breast cancer. Treatment outcomes for metastatic gastric cancer (Study 7), based on HER2 gene amplification (FISH) and HER2 protein overexpression (IHC) test results are provided in Table 12.


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ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: • Cardiomyopathy [see Warnings and Precautions] • Infusion reactions [see Warnings and Precautions] • Embryo-fetal Toxicity [see Warnings and Precautions] • Pulmonary toxicity [see Warnings and Precautions] • Exacerbation of chemotherapyinduced neutropenia [see Warnings and Precautions] The most common adverse reactions in patients receiving Herceptin in the adjuvant and metastatic breast cancer setting are fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia. Adverse reactions requiring interruption or discontinuation of Herceptin treatment include CHF, significant decline in left ventricular cardiac function, severe infusion reactions, and pulmonary toxicity [see Dosage and Administration]. In the metastatic gastric cancer setting, the most common adverse reactions (* 10%) that were increased (* 5% difference) in the Herceptin arm as compared to the chemotherapy alone arm were neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia. The most common adverse reactions which resulted in discontinuation of treatment on the Herceptincontaining arm in the absence of disease progression were infection, diarrhea, and febrile neutropenia. Clinical Trials Experience 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. Adjuvant Breast Cancer Studies The data below reflect exposure to Herceptin across three randomized, open-label studies, Studies 1, 2, and 3, with (n= 3355) or without (n= 3308) trastuzumab in the adjuvant treatment of breast cancer. The data summarized in Table 3 below, from Study 3, reflect exposure to Herceptin in 1678 patients; the median treatment duration was 51 weeks and median number of infusions was 18. Among the 3386 patients enrolled in Study 3, the median age was 49 years (range: 21 to 80 years), 83% of patients were Caucasian, and 13% were Asian. Table 3 Adverse Reactions for Study 3, All Gradesa : 1 Year Herceptin Observation Adverse Reaction (n= 1678) (n=1708) Cardiac Hypertension 64 (4%) 35 (2%) Dizziness 60 (4%) 29 (2%) Ejection Fraction Decreased 58 (3.5%) 11 (0.6%) Palpitations 48 (3%) 12 (0.7%) Cardiac Arrhythmiasb 40 (3%) 17 (1%) Cardiac Failure Congestive 30 (2%) 5 (0.3%) Cardiac Failure 9 (0.5%) 4 (0.2%) Cardiac Disorder 5 (0.3%) 0 (0%) Ventricular Dysfunction 4 (0.2%) 0 (0%) Respiratory Thoracic Mediastinal Disorders Cough 81 (5%) 34 (2%) Influenza 70 (4%) 9 (0.5%) Dyspnea 57 (3%) 26 (2%) URI 46 (3%) 20 (1%) Rhinitis 36 (2%) 6 (0.4%) Pharyngolaryngeal Pain 32 (2%) 8 (0.5%) Sinusitis 26 (2%) 5 (0.3%) Epistaxis 25 (2%) 1 (0.06%) Pulmonary Hypertension 4 (0.2%) 0 (0%) Interstitial Pneumonitis 4 (0.2%) 0 (0%) Gastrointestinal Disorders Diarrhea 123 (7%) 16 (1%) Nausea 108 (6%) 19 (1%) Vomiting 58 (3.5%) 10 (0.6%) Constipation 33 (2%) 17 (1%) Dyspepsia 30 (2%) 9 (0.5%) Upper Abdominal Pain 29 (2%) 15 (1%) Musculoskeletal & Connective Tissue Disorders Arthralgia 137 (8%) 98 (6%) Back Pain 91 (5%) 58 (3%) Myalgia 63 (4%) 17 (1%) Bone Pain 49 (3%) 26 (2%) Muscle Spasm 46 (3%) 3 (0.2%)

Table 3 (cont’d) Adverse Reactions for Study 3, All Gradesa: Adverse Reaction

1 Year Herceptin Observation (n= 1678) (n=1708)

Nervous System Disorders Headache 162 (10%) Paraesthesia 29 (2%) Skin & Subcutaneous Tissue Disorders Rash 70 (4%) Nail Disorders 43 (2%) Pruritis 40 (2%) General Disorders Pyrexia 100 (6%) Edema Peripheral 79 (5%) Chills 85 (5%) Aesthenia 75 (4.5%) Influenza-like Illness 40 (2%) Sudden Death 1 (0.06%) Infections Nasopharyngitis 135 (8%) UTI 39 (3%) Immune System Disorders Hypersensitivity 10 (0.6%) Autoimmune Thyroiditis 4 (0.3%) a b

49 (3%) 11 (0.6%) 10 (0.6%) 0 (0%) 10 (0.6%) 6 (0.4%) 37 (2%) 0 (0%) 30 (2%) 3 (0.2%) 0 (0%)

Black, 1% Asian and 5% other racial/ethnic groups. All patients received 4 mg/kg initial dose of Herceptin followed by 2 mg/kg weekly. The percentages of patients who received Herceptin treatment for * 6 months and * 12 months were 58% and 9%, respectively. Among the 352 patients treated in single agent studies (213 patients from Study 6), the median age was 50 years (range 28−86 years), 86% were White, 3% were Black, 3% were Asian, and 8% in other racial/ethnic groups. Most of the patients received 4 mg/kg initial dose of Herceptin followed by 2 mg/kg weekly. The percentages of patients who received Herceptin treatment for * 6 months and * 12 months were 31% and 16%, respectively. Table 4 Per-Patient Incidence of Adverse Reactions Occurring in * 5% of Patients in Uncontrolled Studies or at Increased Incidence in the Herceptin Arm (Studies 5 and 6) Herceptin Single + Paclitaxel Herceptin ACb a Agent Paclitaxel Alone + ACb Alone n = 352 n = 91 n = 95 n = 143 n = 135 Body as a Whole Pain 47% 61% 62% 57% 42% Asthenia 42% 62% 57% 54% 55% Fever 36% 49% 23% 56% 34% Chills 32% 41% 4% 35% 11% Headache 26% 36% 28% 44% 31% Abdominal pain 22% 34% 22% 23% 18% Back pain 22% 34% 30% 27% 15% Infection 20% 47% 27% 47% 31% Flu syndrome 10% 12% 5% 12% 6% Accidental injury 6% 13% 3% 9% 4% Allergic reaction 3% 8% 2% 4% 2% Cardiovascular Tachycardia 5% 12% 4% 10% 5% Congestive 7% 11% 1% 28% 7% heart failure Digestive Nausea 33% 51% 9% 76% 77% Diarrhea 25% 45% 29% 45% 26% Vomiting 23% 37% 28% 53% 49% Nausea and vomiting 8% 14% 11% 18% 9% Anorexia 14% 24% 16% 31% 26% Heme & Lymphatic Anemia 4% 14% 9% 36% 26% Leukopenia 3% 24% 17% 52% 34% Metabolic Peripheral edema 10% 22% 20% 20% 17% Edema 8% 10% 8% 11% 5% Musculoskeletal Bone pain 7% 24% 18% 7% 7% Arthralgia 6% 37% 21% 8% 9% Nervous Insomnia 14% 25% 13% 29% 15% Dizziness 13% 22% 24% 24% 18% Paresthesia 9% 48% 39% 17% 11% Depression 6% 12% 13% 20% 12% Peripheral neuritis 2% 23% 16% 2% 2% Neuropathy 1% 13% 5% 4% 4% Respiratory Cough increased 26% 41% 22% 43% 29% Dyspnea 22% 27% 26% 42% 25% Rhinitis 14% 22% 5% 22% 16% Pharyngitis 12% 22% 14% 30% 18% Sinusitis 9% 21% 7% 13% 6% Skin Rash 18% 38% 18% 27% 17% Herpes simplex 2% 12% 3% 7% 9% Acne 2% 11% 3% 3% < 1% Urogenital Urinary tract infection 5% 18% 14% 13% 7%

43 (3%) 13 (0.8%) 1 (0.06%) 0 (0%)

The incidence of Grade 3/4 adverse reactions was <1% in both arms for each listed term. Higher level grouping term.

The data from Studies 1 and 2 were obtained from 3206 patients, of whom 1635 received Herceptin; the median treatment duration was 50 weeks. The median age was 49 years (range: 24−80); 84% of patients were White, 7% Black, 4% Hispanic, and 4% Asian. In Study 1, only Grade 3−5 adverse events, treatment-related Grade 2 events, and Grade 2−5 dyspnea were collected during and for up to 3 months following protocol-specified treatment. The following non-cardiac adverse reactions of Grade 2−5 occurred at an incidence of at least 2% greater among patients randomized to Herceptin plus chemotherapy as compared to chemotherapy alone: arthralgia (31% vs. 28%), fatigue (28% vs. 22%), infection (22% vs. 14%), hot flashes (17% vs. 15%), anemia (13% vs. 7%), dyspnea (12% vs. 4%), rash/desquamation (11% vs. 7%), neutropenia (7% vs. 5%), headache (6% vs. 4%), and insomnia (3.7% vs. 1.5%). The majority of these events were Grade 2 in severity. In Study 2, data collection was limited to the following investigator-attributed treatment-related adverse reactions: NCI-CTC Grade 4 and 5 hematologic toxicities, Grade 3−5 non-hematologic toxicities, selected Grade 2−5 toxicities associated with taxanes (myalgia, arthralgias, nail changes, motor neuropathy, sensory neuropathy) and Grade 1−5 cardiac toxicities occurring during chemotherapy and/or Herceptin treatment. The following non-cardiac adverse reactions of Grade 2−5 occurred at an incidence of at least 2% greater among patients randomized to Herceptin plus chemotherapy as compared to chemotherapy alone: arthralgia (11% vs. 8.4%), myalgia (10% vs. 8%), nail changes (9% vs. 7%), and dyspnea (2.5% vs. 0.1%). The majority of these events were Grade 2 in severity. Safety data from Study 4 reflect exposure to Herceptin as part of an adjuvant treatment regimen from 2124 patients receiving at least one dose of study treatment [AC-TH: n = 1068; TCH: n = 1056]. The overall median treatment duration was 54 weeks in both the AC-TH and TCH arms. The median number of infusions was 26 in the AC-TH arm and 30 in the TCH arm, including weekly infusions during the chemotherapy phase and every three week dosing in the monotherapy period. Among these patients, the median age was 49 years (range 22 to 74 years). In Study 4, the toxicity profile was similar to that reported in Studies 1, 2, and 3 with the exception of a low incidence of CHF in the TCH arm. Metastatic Breast Cancer Studies The data below reflect exposure to Herceptin in one randomized, open-label study, Study 5, of chemotherapy with (n=235) or without (n=234) trastuzumab in patients with metastatic breast cancer, and one single-arm study (Study 6; n=222) in patients with metastatic breast cancer. Data in Table 4 are based on Studies 5 and 6. Among the 464 patients treated in Study 5, the median age was 52 years (range: 25−77 years). Eighty-nine percent were White, 5%

a b

Data for Herceptin single agent were from 4 studies, including 213 patients from Study 6. Anthracycline (doxorubicin or epirubicin) and cyclophosphamide.


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Metastatic Gastric Cancer The data below are based on the exposure of 294 patients to Herceptin in combination with a fluoropyrimidine (capecitabine or 5-FU) and cisplatin (Study 7). In the Herceptin plus chemotherapy arm, the initial dose of Herceptin 8 mg/kg was administered on Day 1 (prior to chemotherapy) followed by 6 mg/kg every 21 days until disease progression. Cisplatin was administered at 80 mg/m2 on Day 1 and the fluoropyrimidine was administered as either capecitabine 1000 mg/m2 orally twice a day on Days 1-14 or 5-fluorouracil 800 mg/m2/day as a continuous intravenous infusion Days 1 through 5. Chemotherapy was administered for six 21-day cycles. Median duration of Herceptin treatment was 21 weeks; median number of Herceptin infusions administered was eight.

Table 6a Per-patient Incidence of New Onset Myocardial Dysfunction (by LVEF) Studies 1, 2, 3 and 4 LVEF <50% and Absolute Decrease from Baseline

LVEF *10% *16% <20% and <50% decrease decrease *10% *20% Studies 1 & 2b ACATH 22.8% (n=1606) (366)

Table 5 Study 7: Per Patient Incidence of Adverse Reactions of All Grades (Incidence * 5% between Arms) or Grade 3 /4 (Incidence >1% between Arms) and Higher Incidence in Herceptin Arm

Body System/ Adverse Event

Herceptin +FC (N = 294) N (%)

FC (N = 290) N (%)

All Grades Grades 3 / 4

All Grades Grades 3/ 4

Investigations Neutropenia 230 (78) 101 (34) Hypokalemia 83 (28) 28 (10) Anemia 81 (28) 36 (12) Thrombocytopenia 47 (16) 14 (5) Blood And Lymphatic System Disorders Febrile Neutropenia _ 15 (5) Gastrointestinal Disorders Diarrhea 109 (37) 27 (9) Stomatitis 72 (24) 2 (1) Dysphagia 19 (6) 7 (2) Body as a Whole Fatigue 102 (35) 12 (4) Fever 54 (18) 3 (1) Mucosal Inflammation 37 (13) 6 (2) Chills 23 (8) 1 ()1) Metabolism And Nutrition Disorders Weight Decrease 69 (23) 6 (2) Infections And Infestations Upper Respiratory Tract Infections 56 (19) 0 (0) Nasopharyngitis 37 (13) 0 (0) Renal And Urinary Disorders Renal Failure and Impairment 53 (18) 8 (3) Nervous System Disorders Dysgeusia 28 (10) 0 (0)

212 (73) 83 (29) 69 (24) 16 (6) 61 (21) 30 (10) 33 (11) 8 (3)

a

b

_

8 (3) c

80 (28) 43 (15) 10 ( 3)

11 (4) 6 (2) 1 ()1)

82 (28) 36 (12)

7 (2) 0 (0)

18 (6) 0 (0)

2 (1) 0 (0)

40 (14)

7 (2)

29 (10) 17 (6)

0 (0) 0 (0)

42 (15)

5 (2)

14 (5)

0 (0)

The following subsections provide additional detail regarding adverse reactions observed in clinical trials of adjuvant breast, metastatic breast cancer, metastatic gastric cancer, or post-marketing experience. Cardiomyopathy Serial measurement of cardiac function (LVEF) was obtained in clinical trials in the adjuvant treatment of breast cancer. In Study 3, the median duration of follow-up was 12.6 months (12.4 months in the observation arm; 12.6 months in the 1-year Herceptin arm); and in Studies 1 and 2, 23 months in the AC-T arm, 24 months in the AC-TH arm. In Studies 1 and 2, 6% of patients were not permitted to initiate Herceptin following completion of AC chemotherapy due to cardiac dysfunction (LVEF < 50% or * 15 point decline in LVEF from baseline to end of AC). Following initiation of Herceptin therapy, the incidence of new-onset doselimiting myocardial dysfunction was higher among patients receiving Herceptin and paclitaxel as compared to those receiving paclitaxel alone in Studies 1 and 2, and in patients receiving Herceptin monotherapy compared to observation in Study 3 (see Table 6, Figures 1 and 2).

Absolute LVEF Decrease

18.3% (294)

11.7% (188)

33.4% (536)

9.2% (148)

ACAT (n=1488)

9.1% (136)

5.4% (81)

2.2% (33)

18.3% (272)

2.4% (36)

Study 3 Herceptin (n=1678)

8.6% (144)

7.0% (118)

3.8% (64)

22.4% (376)

3.5% (59)

Observation 2.7% (n=1708) (46)

2.0% (35)

1.2% (20)

11.9% (204)

1.2% (21)

Study 4c TCH (n=1056)

8.5% (90)

5.9% (62)

3.3% (35)

34.5% (364)

6.3% (67)

ACATH (n=1068)

17% (182)

13.3% (142)

9.8% (105)

44.3% (473)

13.2% (141)

ACAT (n=1050)

9.5% (100)

6.6% (69)

3.3% (35)

34% (357)

5.5% (58)

For Studies 1, 2 and 3, events are counted from the beginning of Herceptin treatment. For Study 4, events are counted from the date of randomization. Studies 1 and 2 regimens: doxorubicin and cyclophosphamide followed by paclitaxel (ACAT) or paclitaxel plus Herceptin (ACATH). Study 4 regimens: doxorubicin and cyclophosphamide followed by docetaxel (ACAT) or docetaxel plus Herceptin (ACATH); docetaxel and carboplatin plus Herceptin (TCH).

Figure 1 Studies 1 and 2: Cumulative Incidence of Time to First LVEF Decline of *10 Percentage Points from Baseline and to Below 50% with Death as a Competing Risk Event

Time 0 is initiation of paclitaxel or Herceptin + paclitaxel therapy. Figure 2 Study 3: Cumulative Incidence of Time to First LVEF Decline of * 10 Percentage Points from Baseline and to Below 50% with Death as a Competing Risk Event

Time 0 is the date of randomization. Figure 3 Study 4: Cumulative Incidence of Time to First LVEF Decline of * 10 Percentage Points from Baseline and to Below 50% with Death as a Competing Risk Event

Time 0 is the date of randomization.

The incidence of treatment emergent congestive heart failure among patients in the metastatic breast cancer trials was classified for severity using the New York Heart Association classification system (I−IV, where IV is the most severe level of cardiac failure) (see Table 2). In the metastatic breast cancer trials the probability of cardiac dysfunction was highest in patients who received Herceptin concurrently with anthracyclines. In Study 7, 5.0% of patients in the Herceptin plus chemotherapy arm compared to 1.1% of patients in the chemotherapy alone arm had LVEF value below 50% with a * 10% absolute decrease in LVEF from pretreatment values. Infusion Reactions During the first infusion with Herceptin, the symptoms most commonly reported were chills and fever, occurring in approximately 40% of patients in clinical trials. Symptoms were treated with acetaminophen, diphenhydramine, and meperidine (with or without reduction in the rate of Herceptin infusion); permanent discontinuation of Herceptin for infusional toxicity was required in <1% of patients. Other signs and/ or symptoms may include nausea, vomiting, pain (in some cases at tumor sites), rigors, headache, dizziness, dyspnea, hypotension, elevated blood pressure, rash, and asthenia. Infusional toxicity occurred in 21% and 35% of patients, and was severe in 1.4% and 9% of patients, on second or subsequent Herceptin infusions administered as monotherapy or in combination with chemotherapy, respectively. In the postmarketing setting, severe infusion reactions, including hypersensitivity, anaphylaxis, and angioedema have been reported. Anemia In randomized controlled clinical trials, the overall incidence of anemia (30% vs. 21% [Study 5]), of selected NCI-CTC Grade 2-5 anemia (12.5% vs. 6.6% [Study 1]), and of anemia requiring transfusions (0.1% vs. 0 patients [Study 2]) were increased in patients receiving Herceptin and chemotherapy compared with those receiving chemotherapy alone. Following the administration of Herceptin as a single agent (Study 6), the incidence of NCI-CTC Grade 3 anemia was < 1%. In Study 7 (metastatic gastric cancer) on the Herceptin containing arm as compared to the chemotherapy alone arm the overall incidence of anemia was 28% compared 21% and of NCI CTC Grade 3/4 anemia was 12.2% compared to 10.3%. Neutropenia In randomized controlled clinical trials in the adjuvant setting, the incidence of selected NCI-CTC Grade 4−5 neutropenia (2% vs. 0.7% [Study 2]) and of selected Grade 2−5 neutropenia (7.1% vs. 4.5% [Study 1]) were increased in patients receiving Herceptin and chemotherapy compared with those receiving chemotherapy alone. In a randomized, controlled trial in patients with metastatic breast cancer, the incidences of NCI-CTC Grade 3/4 neutropenia (32% vs. 22%) and of febrile neutropenia (23% vs. 17%) were also increased in patients randomized to Herceptin in combination with myelosuppressive chemotherapy as compared to chemotherapy alone. In Study 7 (metastatic gastric cancer) on the Herceptin containing arm as compared to the chemotherapy alone arm, the incidence of NCI CTC Grade 3/4 neutropenia was 36.8% compared to 28.9%; febrile neutropenia 5.1% compared to 2.8%. Infection The overall incidences of infection (46% vs. 30% [Study 5]), of selected NCI-CTC Grade 2−5 infection/ febrile neutropenia (22% vs. 14% [Study 1]) and of selected Grade 3−5 infection/febrile neutropenia (3.3% vs. 1.4%) [Study 2]), were higher in patients receiving Herceptin and chemotherapy compared with those receiving chemotherapy alone. The most common site of infections in the adjuvant setting involved the upper respiratory tract, skin, and urinary tract. In Study 4, the overall incidence of infection was higher with the addition of Herceptin to AC-T but not to TCH [44% (AC-TH), 37% (TCH), 38% (AC-T)]. The incidences of NCI-CTC Grade 3−4 infection were similar [25% (AC-TH), 21% (TCH), 23% (AC-T)] across the three arms. In a randomized, controlled trial in treatment of metastatic breast cancer, the reported incidence of febrile neutropenia was higher (23% vs. 17%) in patients receiving Herceptin in combination with myelosuppressive chemotherapy as compared to chemotherapy alone. Pulmonary Toxicity Adjuvant Breast Cancer Among women receiving adjuvant therapy for


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breast cancer, the incidence of selected NCI-CTC Grade 2−5 pulmonary toxicity (14% vs. 5% [Study 1]) and of selected NCI-CTC Grade 3−5 pulmonary toxicity and spontaneous reported Grade 2 dyspnea (3.4% vs. 1% [Study 2]) was higher in patients receiving Herceptin and chemotherapy compared with chemotherapy alone. The most common pulmonary toxicity was dyspnea (NCI-CTC Grade 2−5: 12% vs. 4% [Study 1]; NCI-CTC Grade 2−5: 2.5% vs. 0.1% [Study 2]). Pneumonitis/pulmonary infiltrates occurred in 0.7% of patients receiving Herceptin compared with 0.3% of those receiving chemotherapy alone. Fatal respiratory failure occurred in 3 patients receiving Herceptin, one as a component of multi-organ system failure, as compared to 1 patient receiving chemotherapy alone. In Study 3, there were 4 cases of interstitial pneumonitis in Herceptin-treated patients compared to none in the control arm. Metastatic Breast Cancer Among women receiving Herceptin for treatment of metastatic breast cancer, the incidence of pulmonary toxicity was also increased. Pulmonary adverse events have been reported in the post-marketing experience as part of the symptom complex of infusion reactions. Pulmonary events include bronchospasm, hypoxia, dyspnea, pulmonary infiltrates, pleural effusions, non-cardiogenic pulmonary edema, and acute respiratory distress syndrome. For a detailed description, see Warnings and Precautions. Thrombosis/Embolism In 4 randomized, controlled clinical trials, the incidence of thrombotic adverse events was higher in patients receiving Herceptin and chemotherapy compared to chemotherapy alone in three studies (3.0% vs. 1.3% [Study 1], 2.5% and 3.7% vs. 2.2% [Study 4] and 2.1% vs. 0% [Study 5]). Diarrhea Among women receiving adjuvant therapy for breast cancer, the incidence of NCI-CTC Grade 2−5 diarrhea (6.2% vs. 4.8% [Study 1]) and of NCI-CTC Grade 3−5 diarrhea (1.6% vs. 0% [Study 2]), and of Grade 1−4 diarrhea (7% vs. 1% [Study 3]) were higher in patients receiving Herceptin as compared to controls. In Study 4, the incidence of Grade 3−4 diarrhea was higher [5.7% AC-TH, 5.5% TCH vs. 3.0% AC-T] and of Grade 1−4 was higher [51% AC-TH, 63% TCH vs. 43% AC-T] among women receiving Herceptin. Of patients receiving Herceptin as a single agent for the treatment of metastatic breast cancer, 25% experienced diarrhea. An increased incidence of diarrhea was observed in patients receiving Herceptin in combination with chemotherapy for treatment of metastatic breast cancer. Renal Toxicity In Study 7 (metastatic gastric cancer) on the Herceptin-containing arm as compared to the chemotherapy alone arm the incidence of renal impairment was 18% compared to 14.5%. Severe (Grade 3/4) renal failure was 2.7% on the Herceptincontaining arm compared to 1.7% on the chemotherapy only arm. Treatment discontinuation for renal insufficiency/failure was 2% on the Herceptin-containing arm and 0.3% on the chemotherapy only arm. In the postmarketing setting, rare cases of nephrotic syndrome with pathologic evidence of glomerulopathy have been reported. The time to onset ranged from 4 months to approximately 18 months from initiation of Herceptin therapy. Pathologic findings included membranous glomerulonephritis, focal glomerulosclerosis, and fibrillary glomerulonephritis. Complications included volume overload and congestive heart failure. Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. Among 903 women with metastatic breast cancer, human anti-human antibody (HAHA) to Herceptin was detected in one patient using an enzyme-linked immunosorbent assay (ELISA). This patient did not experience an allergic reaction. Samples for assessment of HAHA were not collected in studies of adjuvant breast cancer. The incidence of antibody formation is highly dependent on the sensitivity and the specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Herceptin with the

incidence of antibodies to other products may be misleading. Post-Marketing Experience The following adverse reactions have been identified during post approval use of Herceptin. 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. • Infusion reaction [see Warnings and Precautions] • Oligohydramnios or oligohydramnios sequence, including pulmonary hypoplasia, skeletal abnormalities, and neonatal death [see Warnings and Precautions] • Glomerulopathy [see Adverse Reactions] DRUG INTERACTIONS In Study 5, the mean serum trough concentration of trastuzumab was consistently elevated approximately 1.5-fold, when administered in combination with paclitaxel as compared to trough concentrations of trastuzumab when administered in combination with an anthracycline and cyclophosphamide. In other pharmacokinetic studies, where Herceptin was administered in combination with paclitaxel, docetaxel or doxorubicin, Herceptin did not alter the plasma concentrations of these chemotherapeutic agents, or the metabolites that were analyzed. In a drug interaction substudy conducted in patients in Study 7, the pharmacokinetics of cisplatin, capecitabine and their metabolites were not altered when administered in combination with Herceptin. USE IN SPECIFIC POPULATIONS Pregnancy: Category D [see Warnings and Precautions, Nonclinical Toxicology] Herceptin can cause fetal harm when administered to a pregnant woman. In post-marketing reports use of Herceptin during pregnancy resulted in cases of oligohydramnios and of oligohydramnios sequence, manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. These case reports described oligohydramnios in pregnant women who received Herceptin either alone or in combination with chemotherapy. In some case reports, amniotic fluid index increased after Herceptin was stopped. In one case, Herceptin therapy resumed after the amniotic fluid index improved, and oligohydramnios recurred. Monitor women exposed to Herceptin during pregnancy for oligohydramnios. If oligohydramnios occurs, perform fetal testing that is appropriate for gestational age and consistent with community standards of care. The efficacy of IV hydration in management of oligohydramnios due to Herceptin exposure is not known. Advise women of the potential hazard to the fetus resulting from Herceptin exposure during pregnancy. Encourage pregnant women with breast cancer who are using Herceptin to enroll in MotHER-the Herceptin Pregnancy Registry: phone 1-800-690-6720. [see Patient Counseling Information]. No teratogenic effects were observed in offspring from reproduction studies in cynomolgus monkeys at doses up to 25 times the recommended weekly human dose of 2 mg/kg trastuzumab. In mutant mice lacking HER2, embryos died in early gestation. Trastuzumab exposure was reported at delivery in offspring of cynomolgus monkeys treated during the early (Days 20-50 of gestation) or late (Days 120-150 of gestation) fetal development periods, at levels of 15 to 28% of the maternal blood levels. Nursing Mothers It is not known whether Herceptin is excreted in human milk, but human IgG is excreted in human milk. Published data suggest that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts. Trastuzumab was present in the breast milk of lactating cynomolgus monkeys given 12.5 times the recommended weekly human dose of 2 mg/kg of Herceptin. Infant monkeys with detectable serum levels of trastuzumab did not have any adverse effects on growth or development from birth to 3 months of age; however, trastuzumab levels in animal breast milk may not accurately reflect human breast milk levels. Because many drugs are secreted in human milk and because of the potential for serious adverse reactions in nursing infants from Herceptin, a decision should be made whether to discontinue nursing, or discontinue drug, taking into account the elimination half-life of trastuzumab and the importance of the drug to the

mother. Pediatric Use The safety and effectiveness of Herceptin in pediatric patients has not been established. Geriatric Use Herceptin has been administered to 386 patients who were 65 years of age or over (253 in the adjuvant treatment and 133 in metastatic breast cancer treatment settings). The risk of cardiac dysfunction was increased in geriatric patients as compared to younger patients in both those receiving treatment for metastatic disease in Studies 5 and 6, or adjuvant therapy in Studies 1 and 2. Limitations in data collection and differences in study design of the 4 studies of Herceptin in adjuvant treatment of breast cancer preclude a determination of whether the toxicity profile of Herceptin in older patients is different from younger patients. The reported clinical experience is not adequate to determine whether the efficacy improvements (ORR, TTP, OS, DFS) of Herceptin treatment in older patients is different from that observed in patients <65 years of age for metastatic disease and adjuvant treatment. In Study 7 (metastatic gastric cancer), of the 294 patients treated with Herceptin 108 (37%) were 65 years of age or older, while 13 (4.4%) were 75 and over. No overall differences in safety or effectiveness were observed. OVERDOSAGE There is no experience with overdosage in human clinical trials. Single doses higher than 8 mg/kg have not been tested. PATIENT COUNSELING INFORMATION • Advise patients to contact a health care professional immediately for any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness [see Boxed Warning Cardiomyopathy]. • Advise pregnant women and women of childbearing potential that Herceptin exposure can result in fetal harm [see Warnings and Precautions and Use in Specific Populations]. • Advise women of childbearing potential to use effective contraceptive methods during treatment and for a minimum of six months following Herceptin [see Warnings and Precautions]. • Advise nursing mothers treated with Herceptin to discontinue nursing or discontinue Herceptin, taking into account the importance of the drug to the mother [see Use in Specific Populations]. • Encourage women who are exposed to Herceptin during pregnancy to enroll in MotHER- the Herceptin Pregnancy Registry (1-800-690-6720) [see Warnings and Precautions and Use in Specific Populations]. HERCEPTIN® [trastuzumab] Manufactured by: Genentech, Inc. A Member of the Roche Group 1 DNA Way South San Francisco, CA 94080-4990 Initial US Approval: September 1998 Revision Date: October 29, 2010 Herceptin® is a registered trademark of Genentech, Inc. HER0000097200 ©2010 Genentech, Inc.


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PUBLISHING STAFF s en io r v ic e pr es id en t , s a l es & m a r k et in g Philip Pawelko phil@greenhillhc.com pu bl is h er John W. Hennessy john@greenhillhc.com a s s o c iat e ed it o r Dawn Lagrosa dawn@greenhillhc.com

TABLE OF CONTENTS ORIGINAL RESEARCH

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pr o d u c t io n m a n a g er Michael J. Molfetto

c ir c u l at io n d epa r t m en t circulation@greenhillhc.com Journal of Oncology Navigation & Survivorship, ISSN applied for; (print, online) is published 6 times a year by Green Hill Healthcare Communications, LLC, 241 Forsgate Drive, Suite 205C, Monroe Twp, NJ 08831. Telephone: 732.656.7935. Fax: 732.656.7938. Copyright ©2011 by Green Hill Healthcare Communications, LLC. All rights reserved. Journal of Oncology Navigation & Survivorship logo is a registered trademark of Green Hill Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the publisher. Printed in the United States of America. EDITORIAL CORRESPONDENCE should be ad dressed to EDITORIAL DIRECTOR, Journal of Oncology Navigation & Survivorship (JONS), 241 Forsgate Drive, Suite 205C, Monroe Twp, NJ 08831. E-mail: dawn@greenhillhc.com. YEARLY SUBSCRIPTION RATES: United States and possessions: individuals, $50.00; institutions, $90.00; single issues, $5.00. Orders will be billed at individual rate until proof of status is confirmed. Prices are subject to change without notice. Correspondence regarding permission to reprint all or part of any article published in this journal should be addressed to REPRINT PERMISSIONS DEPARTMENT, Green Hill Healthcare Communications, LLC, 241 Forsgate Drive, Suite 205C, Monroe Twp, NJ 08831. The ideas and opinions expressed in JONS do not necessarily reflect those of the editorial board, the editorial director, or the publisher. Publication of an advertisement or other product mention in JONS should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturer with questions about the features or limitations of the products mentioned. Neither the editorial board nor the publisher assumes any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material contained in this periodical. The reader is advised to check the appropriate medical literature and the product information currently provided by the manufacturer of each drug to be administered to verify the dosage, the method and duration of administration, or contraindications. It is the responsibility of the treating physician or other healthcare professional, relying on independent experience and knowledge of the patient, to determine drug dosages and the best treatment for the patient. Every effort has been made to check generic and trade names, and to verify dosages. The ultimate responsibility, however, lies with the prescribing physician. Please convey any errors to the editorial director.

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APRIL 2011 • VOLUME 2, ISSUE 2

Needs of Older and Elderly Cancer Survivors By Marietta Stanton, PhD, RN, CMAC, NEA, BC, CCM; Gina Franco, MSN, NP-C; and Reggie Scoggins, RN

18 Commentary: Implications for Navigation

Qu a l it Y c o n t r o l d ir ec t o r Barbara M. Marino bu s in es s m a n a g er Blanche Marchitto

APRIL 2011 • VOL. 2, NO. 2

By Jennifer R. Powers, MS, BSN, CCRC, OCN

CLINICAL PRACTICE

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Hand-off Communication Among Navigators By Karyl Blaseg, RN, MSN, OCN

ACCREDITATION

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Patient Navigation Becomes New Standard for Cancer Program Accreditation By Elaine Sein, RN, BSN, OCN, CBCN

ABOUT THE COVER

Inspired by microscopic photos of cells, this depiction of Cancer Cell No. 1 combines acrylic paints with tissue paper, finalized with dry brushing to add color to the tissue. Artist Angela Canda Hopkins, after losing her father to cancer, embraced the bittersweet and therapeutic irony through her art. Canada Hopkins is a full-time artist and resides in Loveland, Colorado, with her husband, James.

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Editor-in-Chief Lillie D. Shockney, RN, BS, MAS Administrative Director University Distinguished Service Associate Professor of Breast Cancer Associate Professor, Johns Hopkins University School of Medicine Departments of Surgery & Gynecology and Obstetrics Associate Professor, John Hopkins University School of Nursing

Section Editors Breast Cancer Sharon Gentry, RN, MSN, AOCN, CBCN Breast Health Navigator Derrick L. Davis Forsyth Regional Cancer Center

AONN Research Committee Elaine Sein, RN, BSN, OCN, CBCN Senior Project Manager Fox Chase Cancer Center Partners Marcy Poletti, RN, MSN Program Administrator, Oncology Services Wake Forest University Baptist Medical Center Penny Widmaier, RN, MSN Nurse Navigator Botsford Cancer Center

Executive Director, AONN Sean T. Walsh sean@aonnonline.org

MISSION STATEMENT The Journal of Oncology Navigation & Survivorship (JONS) promotes reliance on evidence-based practices in navigating patients with cancer and their caregivers through diagnosis, treatment, and survivorship. JONS also seeks to strengthen the role of nurse and patient navigators in cancer care by serving as a platform for these professionals to disseminate original research findings, exchange best practices, and find support for their growing community.

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APRIL 2011 窶「 VOLUME 2, ISSUE 2

AN EXPANDED RESOURCE FOR NAVIGATING CANCER CARE

I

am thrilled to serve as Editor-in-Chief for the Journal of Oncology Navigation & Survivorship. I am confident that this peer-reviewed journal will provide a great deal of valuable content to benefit your patients. We will present opportunities to learn new models of patient navigation, patient education, psychosocial support, community outreach, and survivorship care. Evidence-based research studies will focus on your areas of expertise窶馬avigation and survivorship. We are striving to provide information that covers the full spectrum of navigator functions and possibilities. These include reaching patients in rural, suburban, and urban areas; describing navigation processes associated with specific tumor types (breast, lung, prostate, etc); successfully reaching underserved populations; transitioning patients from acute treatment to short-term follow-up; creating survivorship transitional programs for long-term follow-up; and the list of topics goes on and on. The many aspects to what we do provide fertile ground for educating one another. And our hope is that we provide a forum for nurses to illustrate their success with steps that will make it as easy as possible for you to replicate their results within your cancer program. Learning from others who are working with similar oncology patient populations and needing to address the same patient issues enables us to build a network of professional support as well as to reduce the risk of reinventing the wheel. As a nurse who has worked in oncology for quite some time, I can truly appreciate the strides that have been made in cancer care. In addition, as an 18-year cancer survivor who has traveled the cancer journey several times, I have a new perspective on oncology nursing and the need to be a strong patient advocate, always. We have a long way to go before our work is through. Growth of the population and better awareness and screening increase cancer incidence. Additionally, patients are dealing with a fragmented healthcare system that can place them at risk for not receiving the right care, or all the care they need to become a survivor. Combine these issues with the realization that we are embarking on a shortage of oncology specialists to take care of newly diagnosed patients, and you can clearly see the significant need for navigation programs and survivorship care. Your role for ensuring that patients destined to get cancer get diagnosed early, receive the appropriate treatment they need and in a timely manner, as well as ensure their longterm side effects of treatment are addressed is pivotal to the success of future cancer care for patients around the world. It is also important that leadership at your institution understand the value of your work as they begin to align their programs and services to address the needs of healthcare reform in the near future. We hope that as a reader you will join our forum and consider submitting your work for publication too. Lillie D. Shockney, RN, BS, MAS Editor-in-Chief

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Second Annual Navigation and Survivorship Conference

©iStockphoto.com/YinYang

September 16-18, 2011 - San Antonio, Texas

Register Online at

www.AONNonline.org/conference Conference Overview AONN’s second annual conference will further advance navigation and survivorship in cancer care through the addition of a variety of sessions, topics, and networking events. Attendees will receive a thorough understanding of the state of navigation and survivorship in today’s evolving healthcare system.

CURRENT MEMBERS - $295 NEW MEMBERS - $345 (Registration includes member dues)

NONMEMBERS - $425* Who Should Attend All clinical and nonclinical professionals involved or interested in patient navigation and survivorship. This conference will enhance the skills and knowledge of: • Oncology Nurse Navigators • Administrators • Oncology Social Workers • Patient Navigators • Case Managers • Oncology Nurses & Nurse Practitioners • Practice Managers

Topics Include • Navigation and Survivorship Program Planning and Implementation • Best Practices • Collaborative Navigation • Psychosocial Care and Distress Management • Compassion Fatigue • Tumor-site Focused Breakouts/Workshops

*Register by June 24 and save $100 off full registration of $525.

CONFERENCE LOCATION San Antonio Marriott Rivercenter Hotel 101 Bowie Street San Antonio, TX 78205-3901 Phone: 800.266.9432

TM

NAVIGATING PATIENTS ACROSS THE CONTINUUM OF CANCER CARE

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ORIGINAL RESEARCH

Needs of Older and Elderly Cancer Survivors By Marietta Stanton, PhD, RN, CMAC, NEA, BC, CCM Capstone College of Nursing, University of Alabama, Tuscaloosa

Gina Franco, MSN, NP-C Spartanburg Regional Gibbs Cancer Center, Spartanburg, South Carolina

Reggie Scoggins, RN Spartanburg Regional Gibbs Cancer Center, Spartanburg, South Carolina

J Oncol Navigat Surviv. 2011;2(2):12-17.

A self-administered questionnaire was distributed to a convenience sample of cancer survivors (N = 237) attending an annual cancer survivors’ day organized by a community cancer center. Responses were used to assess the prevailing physical, psychological, spiritual, and social needs of cancer survivors and to determine whether those needs varied according to age. Fear of recurrence was the greatest psychosocial concern across all age-groups. For the 89% of cancer survivors who were aged 51 years and older, fatigue was the predominant physical concern. Older survivors were less concerned with genetic counseling and finances than their younger counterparts. The findings suggest survivorship programs for older patients should place more emphasis on addressing physical and psychosocial needs. They also point to the importance of conducting additional research to differentiate between the needs of older and younger cancer survivors.

A

lmost 12 million people in the United States are cancer survivors, with more than 60% considered elderly (≥65 years).1 Survivorship is increasingly recognized as a distinct, important phase of cancer care, prompting interest in developing strategies to support and enhance the lives of cancer survivors.2 Economou says survivorship encompasses the physical, psychological, social, and spiritual issues associated with cancer from the moment of diagnosis to death. The purpose of survivorship care is to preserve or improve the health and quality of life of a person given a cancer diagnosis; family, friends, and caregivers are recognized as part of this experience.3 The survivorship program model implemented at a particular facility depends on its resources, geographic location, and type. A survivorship program initiated after the active phase of treatment might offer a one-time visit, consist of several visits, or assume the provision of oncologic care in lieu of the patient returning to their oncologist. Programs can be delineated further into disease-specific, multidisciplinary, or needsbased (ie, psychosocial or physical). Regardless of the model used, the Institute of Medicine states that the primary goals of survivorship care are to reduce the incidence of and ameliorate symptoms resulting from treatment; to surveil patients

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APRIL 2011 • VOLUME 2, ISSUE 2

for secondary cancers, recurrences, and the risks for late effects from cancer or treatment; to diagnose and treat late effects of cancer; to provide coordination between specialists and other providers to ensure that all the patient’s health needs are met following a cancer diagnosis; and to educate survivors on their risks and follow-up care needs.4 The National Action Plan for Cancer Survivorship focuses on preventing secondary cancers and recurrences, promoting appropriate management of symptoms following diagnosis and treatment, minimizing preventable pain, mitigating disability and psychosocial distress, and helping survivors and families access resources and community support to cope with their disease.5 Although information about survivorship programs continues to expand, limited information is available about specific survivorship needs for elderly Americans and whether they differ from the needs of younger or middle-aged cancer survivors. Sachs-Ericsson and colleagues found a predictive correlation between the perception among community-dwelling elders that their basic needs were not being met and the risk for decreased physical function.6 Ganz found that promoting health and aggressive management of comorbid conditions enhanced the health and quality of

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ORIGINAL RESEARCH

life for elderly cancer survivors.7 Bowman and colleagues found that older cancer survivors believed their physicians were too focused on their cancer care and treatment and failed to consider other physical concerns.8 Although these studies illustrate that paying attention to the special needs of elderly cancer survivors might have a profound effect on their general health, quality of life, and sense of well-being, they do little to identify those needs or assess how they compare with the needs of younger patients. Cancer and its treatment present many personal and physical challenges, some of which appear more prevalent among elderly patients. Elderly patients might also have vastly different recovery goals—physical, psychological, social, and spiritual—than their younger counterparts.9 People at an advanced age often have comorbidities that interfere with or complicate recovery. They sometimes lack financial stability or resources, which can contribute to increased levels of stress and a sense of hopelessness, complicate recovery, and/or substantially reduce their quality of life.9 The elderly typically have decreased physical stamina compared with younger cancer survivors, making them more susceptible to profound fatigue. In addition, elderly patients are often more dependent on others for assistance and might require help with activities of daily living. Health providers need to be cognizant of the special needs of elderly patients and learn how to identify members of this population who are especially vulnerable. Being aware of age-dependent differences is critical to optimizing outcomes for cancer survivors.

STUDY DESIGN Objective This study examined the special needs of cancer survivors, especially the needs of elderly survivors. By examining the data from the survey, we sought to identify information about the needs of this population. Methods A convenience sample of cancer survivors attending an annual cancer survivors’ day were asked to complete a survey. The survey targeted the physical, psychosocial, social, and spiritual needs of all cancer survivors in attendance, many of whom were aged 65 years and older. There

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were no exclusion criteria; anyone attending the meeting had the option of completing the survey. The discussion of this survey analysis for educational endeavors was requested and approved by the institutional review board for the regional medical center hosting the survivorship program. The survey instrument was constructed by a focus group comprised of oncology service staff and cancer survivors convened for the purpose of constructing the instrument for the community cancer center’s survivors’ day event. Several oncology service staff were also cancer survivors, although none of them completed the survey during the event. The oncology service staff conducted a literature review before convening the focus group and developing the instrument. The items on the survey were created after this literature review and then were examined by the focus group. The items contained in the instrument were not intended to be an exhaustive list of issues. The instrument incorporated the major survivorship issues highlighted by the literature review and later by the focus group. No reliability or validity information concerning the survey instrument was available because this was its original implementation. It was surmised that the survey had face validity based on the unique composition of the focus group and the congruence of the survey content with information found in the literature. The 1-page survey was distributed to attendees of the cancer survivors’ day at a booth offering a back massage tool as a gift for the completion of the survey. Completion and submission of the survey was voluntary. The completed surveys were deposited by the participants in a collection bin at the back of the meeting room at the close of activities. The survey consisted of a Likert-type scale, where survivors were asked to rate their level of concern about each item on a scale from 0 (no concern) to 5 (extreme concern). Items included on the Likerttype scale portion of the questionnaire were divided into 4 general categories: physical effects, social issues, psychosocial effects, and spiritual issues. The instrument used appears in the e-Appendix (see www.AONNonline.org/e-appendix). The items in each of the 4 categories were generated by the members of the focus group. Physical effects of cancer survivorship included fatigue, pain, sleep disturbances, body-image changes, and memory/concentration issues. Psychosocial issues dealt with psychological

Elderly patients might also have vastly different recovery goals— physical, psychological, social, and spiritual—than their younger counterparts.

JOURNAL OF ONCOLOGY NAVIGATION & SURVIVORSHIP

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ORIGINAL RESEARCH

Distribution of Respondents to Cancer Survivor Table 1 Age Survey (N = 237) Age, years

n (%)

<50

31 (13)

51-64

89 (38)

â&#x2030;Ľ65

117 (49)

sequelae associated with cancer survivorship, including living with uncertainty, fear of recurrence, and managing the stress associated with cancer survivorship. Psychosocial issues included statements regarding family and friends, and the impact of the diagnosis, treatment, and survivorship on those relationships. Support resources including survivorship support group availability was also included in the items for this category. Items for the spiritual and religious domain included statements about feeling alone, isolated, and helpless. The social issues category included items that seem to affect individuals as well as survivors as a group, that is, reimbursement, cost of treatment, advanced directives, and living wills. The survey also asked survivors if there were adequate education, support, and counseling services for family members and/or caregivers. Fertility was determined by the focus group to be an important social issue for younger age-groups, especially after certain types of treatment. The instrument was meant to capture the major issues for cancer survivors in the local community and compare them with national issues and trends. An open-ended question asked respondents to list needs not included in the survey, and an optional question inquired how they preferred to receive information. Data were collected and analyzed using standard descriptive statistical techniques, including frequency distributions. Items within each of the 4 categories were ranked according to frequency of selection by respondents. A few demographic items regarding age and gender also were included in the survey. Frequency distributions on these demographic variables were calculated. In addition, frequency distributions were determined on a question asking respondents how they wanted to receive future survivorship program information. An open-ended question also asked respondents to comment about the survivorship program or their cancer treatment and

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diagnosis. A content analysis of these responses was completed to determine other major topics of interest to survivors.

Results A total of 237 individuals completed the questionnaire. Demographic information indicated that the group was approximately 60% women (n = 148) and 40% men (n = 89). Approximately 89% were 51 years of age or older. Table 1 shows a frequency distribution by age-group. Based on the age distribution of respondents, it is apparent that a large portion of the group was aged 51 years and older, with almost one-half of the respondents 65 years of age and older. Respondents were asked to rate their level of concern to a series of items on a Likert-type scale from 0 (no concern) to 5 (extreme concern) in 4 domains categorized as physical, psychosocial, social, and spiritual. Individual items from the 4 categories were analyzed, and the frequency of response for each item compared with the frequency of response to all other items on the total scale. Items within each domain or category also were analyzed to compare the frequency of the response to an item with responses to the other items within the same domain. Respondents could indicate more than one response under each category. Respondents also could choose not to check any items in a category. The data have been divided into the 4 domains contained in the instrument for ease of review. For each of the 4 categories, the individual items were collapsed into 2 categories. Category 1 included all responses of 1, 2, or 3 (with 1 being 0 [no concern] on the Likert-type scale) and Category 2 included all responses of 4 (concerned) and 5 (extreme concern) on the Likert-type scale. Tables 2 through 5 show the frequency of 4 and 5 rankings for each item in the 4 categories. Respondents were asked to indicate their preferred methods of receiving survivorship information from a list. Most (54%) preferred receiving written information. About 12% indicated they preferred educational classes. The next most frequently chosen preferences were meeting with a healthcare specialist (7%) and receiving an educational video (6%). Approximately 21% of the respondents did not indicate a preference. Most respondents did not complete the openended question. A content analysis yielded only 7 additional responses:

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1. Educational issues are well met by the oncology learning center 2. Need help on obtaining health insurance 3. Survivorship program on an annual basis is good 4. Would like e-mail updates on cures and treatments 5. A structured physical exercise program for survivors would be helpful 6. Would like risk assessment for family members relating to cancer 7. Would like survivor conference with attendees from outside the local area.

DISCUSSION Psychosocial and physical issues for the group of respondents as a whole outweighed all other categories, with fear of recurrence and fatigue receiving

the highest rates of response (35% each). Additional concerns of similar importance, ranging from 23% to 29%, include sleep disturbances, memory issues, pain, managing stress, spirituality, financial concerns, and relationships. Preference for receiving information in written form was by far the most frequent response. The open-ended question indicated the desire for structured educational opportunities in the form of the learning center, survivorship meetings on an annual basis, and a conference for a broader audience beyond just local participants. In addition, survivors were interested in ongoing information on cures, cancer treatments, and negotiating healthcare insurance. Respondents aged 51 to 64 years as well as those aged 65 years and older ranked items somewhat differently than those aged 50 years and younger. In the physical category, the elderly (≥65 years)

Psychosocial and physical issues for the group of respondents as a whole outweighed all other categories, with fear of recurrence and fatigue receiving the highest rates of response.

Table 2 Frequency of Level 4 and 5 Concern with Physical Issuesa All ages (N = 237)

Age <50 (n = 31)

Age 51-64 (n = 89)

Age ≥65 (n = 117)

Fatigue, n (%)

83 (35)

11 (35)

37 (45)

35 (30)

Sleep disturbances, n (%)

71 (29)

14 (45)

28 (34)

29 (25)

Memory/concentration, n (%)

66 (28)

12 (39)

28 (34)

26 (22)

Pain, n (%)

65 (27)

11 (35)

28 (34)

26 (22)

Body image, n (%)

42 (17)

17 (12)

17 (21)

13 (11)

Physical issues

a

Respondents checked all those physical issues that applied to their personal experience, therefore, the N does not sum to 237 nor do the percentages total 100. Level 4 indicates concerned; level 5, extreme concern.

Table 3 Frequency of Level 4 and 5 Concern with Social Issuesa All ages (N = 237)

Age <50 (n = 31)

Age 51-64 (n = 89)

Age ≥65 (n = 117)

Financial concerns, n (%)

59 (25)

16 (52)

22 (27)

21 (18)

Legal concerns, n (%)

31 (29)

7 (23)

11 (13)

13 (11)

Genetic counseling, n (%)

19 (8)

9 (29)

6 (7)

4 (3)

Social issues

a

Respondents checked all those social issues that applied to their personal experience, therefore, the N does not sum to 237 nor do the percentages total 100. Level 4 indicates concerned; level 5, extreme concern.

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ORIGINAL RESEARCH

were most concerned with fatigue and sleep disturbances, as were those aged 51 to 64 years. Those aged 50 years and younger appear most concerned with sleep disturbances, memory, and body image. As a whole, items in the physical category were chosen more frequently by both older age-groups, that is, respondents aged 51 years and older. For older (51-64 years) and elderly (≥65 years) cancer survivors, fatigue was their top concern, making strategies to help these survivors cope and deal with fatigue a priority for those who work with them. Respondents aged 50 years and younger seemed very concerned with financial issues. Individuals aged between 51 and 64 as well as those aged 65 years and older, however, did not select the social issues as frequently as they chose the physical issues. Of note, those aged 50 years and younger indicated more or just as

much concern with financial issues as with physical side effects. The lower response rate to social issues for the older and elderly respondents indicates they have greater needs in other categories included in the survey. In addition, older and elderly respondents indicated minimal concern regarding genetic counseling. This difference in response rates between those aged 50 years and younger versus those aged 51 years and older on financial concerns and genetic counseling appears statistically significant. However, this association should be made with caution because of the small number of younger survivors taking part in this survey. For the psychosocial issues, all age-groups indicated fear of recurrence as their main concern. The other significant concern, as indicated by the high response rate, was the impact of their cancer on family relationships. Response rates to spiritual

Table 4 Frequency of Level 4 and 5 Concern with Psychosocial Issuesa All ages (N = 237)

Age <50 (n = 31)

Age 51-64 (n = 89)

Age ≥65 (n = 117)

Fear of recurrence, n (%)

83 (35)

14 (45)

29 (45)

40 (34)

Managing stress, n (%)

71 (63)

13 (42)

26 (32)

24 (21)

Relationships, family/friends, n (%)

55 (23)

9 (29)

17 (21)

29 (25)

Support resources, n (%)

39 (16)

8 (26)

11 (13)

20 (17)

Marriage and family counseling, n (%)

30 (13)

9 (29)

12 (15)

9 (8)

Psychosocial issues

a

Respondents checked all those psychosocial issues that applied to their personal experience, therefore, the N does not sum to 237 nor do the percentages total 100. Level 4 indicates concerned; level 5, extreme concern.

Table 5 Frequency of Level 4 and 5 Concern with Spiritual Issuesa All ages (N = 237)

Age <50 (n = 31)

Age 51-64 (n = 89)

Age ≥65 (n = 117)

Religious or spiritual issues, n (%)

65 (27)

10 (32)

23 (28)

32 (27)

Feeling alone/helpless, n (%)

37 (16)

9 (29)

14 (17)

14 (12)

Spiritual issues

a Respondents checked all those spiritual issues that applied to their personal experience, therefore, the N does not sum to 237 nor do the percentages total 100. Level 4 indicates concerned; level 5, extreme concern.

16

APRIL 2011 • VOLUME 2, ISSUE 2

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ORIGINAL RESEARCH

issues indicated the importance of this subject for individuals in all age-groups. Ranking the issues irrespective of category, we identified priority issues for survivors aged 51 years and older: 1. Fatigue 2. Fear of recurrence 3. Sleep disturbances 4. Memory and concentration 5. Pain 6. Family relationships 7. Religious and spiritual.

instrumentation. This information should be used to develop structured educational programs for survivors and their families on an ongoing basis. Efforts should focus on helping survivors deal with fatigue and fear of recurrence.

Based on the findings of this survey, the needs of survivors aged between 51 and 64 years as well as those 65 years and older are not significantly different. However, the survey demonstrates that there are some differences in needs indicated by survivors aged 50 years and younger. Therefore, awareness of these differences can assist providers in focusing on the concerns of older and elderly cancer survivors. Follow-up programs for cancer survivors should, perhaps, focus on helping older and elderly cancer survivors deal with fatigue, sleep disturbances, and pain, as well as memory and concentration. Providers should be aware of the high level of concern regarding cancer recurrence and provide frequent followup and counseling for both the survivors and their family. Providers also need to be cognizant of the strong spiritual needs of survivors of all ages and realize how important spirituality is to cancer survivors, especially for those aged 65 years and older. Analysis of the survivor survey provides insight into survivor needs and, because of the number of elderly survivors attending this event, we had an opportunity to examine their unique needs. The needs identified as a result of this survey provide some insight into the needs of older and elderly survivors. There seems to be a strong similarity in the needs of both of these agegroups. Although there is also some congruence with the need of survivors aged 50 years and younger, providers need to be aware of some significant differences when helping older and elderly survivors cope with the consequences of their cancer and treatment.

CONCLUSIONS Psychosocial and physical issues on a whole outweigh all other issues, with fear of recurrence and fatigue as the most pervasive issues for older (51-64 years) and elderly (≥65 years) survivors. Our finding on the fear of recurrence is consistent with findings from other needs assessments of cancer survivors. However, this survey provides further refinement to physical and psychosocial issues identified by older and elderly cancer survivors. g

RECOMMENDATIONS There is a need to assess the specific requirements of elderly cancer survivors using valid and reliable

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LIMITATIONS This study was spurred by access to a convenience sample of older and elderly cancer survivors. The instrumentation, methodology, and data analysis lack the precision a more controlled study design might yield.

Follow-up programs for cancer survivors should, perhaps, focus on helping older and elderly cancer survivors deal with fatigue, sleep disturbances, and pain, as well as memory and concentration.

References 1. Mosher CE, Sloane R, Morey MC, et al. Associations between lifestyle factors and quality of life among older longterm breast, prostate, and colorectal cancer survivors. Cancer. 2009;115:4001-4009. 2. Fairly TL, Pollack LA, Moore AR, Smith JL. Addressing cancer survivorship through public health: an update from the Centers for Disease Control and Prevention. J Womens Health (Larchmt). 2009;18:1525-1531. 3. Economou D. Cancer survivorship programs: return on investment. Presented at: Association of Community Cancer Centers’ 27th National Oncology Economics Conference; October 2, 2010; St. Louis, MO. 4. Hewitt M, Greenfield S, Stovall E, eds. From Cancer Patient to Cancer Survivor: Lost in Transition. Committee on Cancer Survivorship: Improving Care and Quality of Life, National Cancer Policy Board, Institute of Medicine and National Research Council of the National Academies. Washington, DC: National Academies Press; 2005. 5. A National Action Plan for Cancer Survivorship: Advancing Public Health Strategies. Centers for Disease Control and Prevention, Lance Armstrong Foundation. Atlanta, GA: Centers for Disease Control and Prevention; 2004. 6. Sachs-Ericsson N, Schatschneider C, Blazer DG. Perception of unmet basic needs as a predictor of physical functions among community-dwelling older adults. J Aging Health. 2006;18:852-868. 7. Ganz PA. Survivorship: adult cancer survivors. Prim Care. 2009;36:721-741. 8. Bowman KF, Rose JH, Deimling GT, et al. Primary care physicians’ involvement in the cancer care of older longterm survivors. J Aging Health. 2010;22:673-686. 9. Esbensen BA, Osterlind K, Hallberg IR. Quality of life of elderly persons with cancer: a 3-month follow-up. Cancer Nurs. 2006;29:214-224.

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Or IGINAL  r ESEAr CH

C o m m e n t a r y

Needs of Older and Elderly Cancer Survivors: Implications for Navigation By Jennifer R. Powers, MS, BSN, CCRC, OCN Maine Medical Center Cancer Institute, Scarborough

It is essential for navigators to be able to identify and delineate the patient/family needs based on age and prioritize survivorship care accordingly.

—Jennifer R. Powers, MS, BSN, CCRC, OCN

18

With 11.7 million cancer survivors in the United States, the role of navigation in survivorship is growing. As our population ages, navigators will need to focus on the specific needs of the older and elderly patients they navigate through survivorship care. Survivorship is an essential component of the cancer care continuum, in which navigation now plays a key role. The role of the navigator may differ from program to program and cancer site to cancer site. However, navigation continues to grow and become more integrated in every aspect of the cancer care continuum. This study confirms that navigation objectives similar to survivorship program goals need to be modified based on the populations we serve, whether they are young, middle-aged, or elderly. It is essential for navigators to be able to identify and delineate the patient/family needs based on age and prioritize survivorship care accordingly. There are several different survivorship models and navigation models. Regardless, the primary goals of survivorship remain constant. The relationship that is formed between the navigator and the patient and family is critical to the overall outcomes in survivorship.

APRIL 2011 • VOLUME 2, ISSUE 2

Communication is one of the key elements for a successful patient–navigator relationship throughout the cancer care continuum. Navigators will educate and assist survivors in understanding surveillance guidelines and schedules that are necessary to assess risks for late effects and secondary cancers. This is also true for understanding the importance of early detection for cancer recurrences. In addition, the navigator will serve as the survivors’ and their families’ resource and advocate for connecting them to other health professionals who play a big role in survivorship. Examples include mental health, allied health, and community outreach professionals. As Stanton and colleagues found, elderly survivors will have concerns regarding physical quality-of-life issues, fear of recurrence, and financial concerns, as well as others. The navigator will serve as the conduit for these survivors and their families to gain access to the other professionals to have their issues and concerns addressed. In doing so, navigators improve the ability to assist survivors and their families achieve overall satisfaction and positive outcomes throughout survivorship. g

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Billings Clinic Cancer Center Navigation Team

HAND-OFF COMMUNICATION AMONG NAVIGATORS By Karyl Blaseg, RN, MSN, OCN

Manager of Cancer Programs, Billings Clinic Cancer Center, Billings, Montana

P Karyl Blaseg, RN, MSN, OCN

atient care navigation at the Billings Clinic Cancer Center spans the continuum of care from outreach efforts targeted at early detection through survivorship care planning. Care navigation can be defined and implemented in many different ways. At Billings Clinic, navigation involves the provision of individualized care planning and education for patients and their families to minimize barriers to care and maximize patient outcomes. The Billings Clinic navigation model places patients at the center of decision-making as they move through the cancer care continuum, with navigators working to ensure the optimal cancer care experience through coordination of services.

The navigation team at the Billings Clinic Cancer Center consists of 9 registered nurses. Each navigator is assigned to a different type of cancer or point across the continuum of care (Sidebar). This structure evolved over 7 years through identification of gaps in service and a desire to ensure a seamless cancer care experience for our patients. Because coordination of care may be assumed by more than 1 navigator as patients transition through the continuum of

20

APRIL 2011 â&#x20AC;˘ VOLUME 2, ISSUE 2

care, it has been essential for the navigation team to develop and implement a solid hand-off communication mechanism to ensure appropriate identification and follow-through of all pertinent healthcare needs. TEAM COMMUNICATION Hand-off communication refers to the interactive sharing of pertinent information related to a patientâ&#x20AC;&#x2122;s care when transferring responsibility

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CLINICAL PRACTICE

The hand-off communication model adopted at Billings Clinic has facilitated a concise and standardized reporting mechanism that has proved valuable in transitioning care from one navigator to another across the continuum for cancer patients and families. from one provider or setting to another. Inadequate hand-off communication has been recognized by The Joint Commission as a major contributor to medical errors, treatment delays, and inappropriate care.1 The situation, background, assessment, recommendation (SBAR) model (Sidebar) was adopted by Billings Clinic as the standard hand-off communication model based on previously demonstrated success in other healthcare settings, the effectiveness across both inpatient and outpatient settings, and the ease of use for various disciplines. This model has since formed the basis for all healthcare communications (both verbal and written) by the Billings Clinic navigators. The SBAR model facilitates hand-off communication of the most pertinent pieces of information from one healthcare provider to the next. The SBAR model is not intended to be an exhaustive report that covers every element of a patient’s medical history and all potential barriers to care; rather it is a synopsis of key elements to which the oncoming navigator needs to be aware to continue to navigate the patient’s care in a seamless and efficient manner. Some key elements frequently used in hand-off communication between navigators include: • Diagnosis • Healthcare providers • Course of treatment • Pertinent complications of treatment • Barriers to care experienced • Referrals initiated. A sample SBAR report from our breast diagnostic navigator to our breast treatment navigator might be: SITUATION: Jane Doe, DOB 1/1/55, had a positive breast biopsy done by Dr Jones on Monday, which showed invasive ductal carcinoma. BACKGROUND: Her primary care provider, Dr Adams, is aware that I have set her up for a surgical consult tomorrow with Dr Smith at 2 PM. ASSESSMENT: She has some significant psychosocial and financial concerns as she is

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Structure of Patient Navigation at Billings Clinic Outreach/Early Detection Outreach/Early Detection: Breast,Cervical,Colorectal Diagnostic: Breast Treatment: Breast Gastrointestinal/Sarcoma Genitourinary/Head&Neck/Skin Gynecologic Hematologic Lung/UnknownPrimary/CentralNervous System Survivorship: Breast,Colorectal,Hematologic,Lung

a single mother of 2 young children and was recently laid off at her job. RECOMMENDATIONS: I have made a referral to the oncology social worker and patient financial services. Would you please be sure to follow up on these as you work with Jane on her plan of treatment? In summary, effective communication (whether this be verbal or written) is essential to the patient care navigator’s ability to coordinate seamless care for patients and families. SBAR,

SBAR Model SITUATION —Currenthappeningsandconcerns BACKGROUND —Synopsisofpertinenthistory ASSESSMENT —Evaluationoftheproblem/changesnoted RECOMMENDATION —Requestforaction

the hand-off communication model adopted at Billings Clinic, has facilitated a concise and standardized reporting mechanism that has proved valuable in transitioning care from one navigator to another across the continuum for cancer patients and families. g Reference 1. The Joint Commission for Transforming Healthcare. Facts about hand-off communications. www.centerfortransform inghealthcare.org/projects/about_handoff_communication. aspx. Accessed March 22, 2011.

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PATIENT NAVIGATION BECOMES NEW STANDARD FOR CANCER PROGRAM ACCREDITATION By Elaine Sein, RN, BSN, OCN, CBCN

Senior Project Manager, Fox Chase Cancer Center Partners Program, Fox Chase Cancer Center, Philadelphia, Pennsylvania

P

atient navigation and care coordination have been a focus in healthcare for several years because of the fragmentation that commonly occurs among access, diagnosis, and treatment. This strong national movement has evidence-based research to support the need, which has led cancer program–accrediting bodies to add patient navigation as a required standard. The National Accreditation Programs for Breast Centers has had a patient navigation standard in place since it was instituted in 2009, and the American College of Surgeons Commission on Cancer will be adding patient navigation as standard 3.1 in the revised standards that will go live January 1, 2012.

Elaine Sein, RN, BSN, OCN, CBCN

22

RATIONALE Evidence shows that in addition to unequal access to healthcare, racial and ethnic minorities as well as underserved populations do not always receive timely, appropriate advice and care when faced with a cancer diagnosis.1 Care coordination/patient-centered care takes patient navigation to a higher level, one that ensures not only guidance for access, screening, diagnosis, and treatment but also psychosocial care. The Institute of Medicine report entitled Cancer Care for the Whole Patient stresses the need that all cancer care should ensure the provision of appropriate psychosocial health services, facilitate effective communication, identify each patient’s psychosocial needs, design and implement a plan that links the patient with needed psychosocial care, coordinate biomedical and psychosocial care, engage and support patients in

APRIL 2011 • VOLUME 2, ISSUE 2

managing illness, and systematically follow up on evaluating and adjusting the plan.2 The National Quality Forum, through the National Priorities Partnership (NPP), developed a portfolio for care coordination, in which the members of NPP envision a healthcare system that guides patients and families through their healthcare experience, while respecting patient choice, offering physical and psychological supports, and encouraging strong relationships between patients and the healthcare professionals accountable for their care.3

THE NEW STANDARD The Commission on Cancer’s new standard 3.1 focuses on health disparities and finding a patient navigation process that addresses the needs of the community. This new standard requires each program or institution to be responsible for evaluat-

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ACCREDITATION

Each program will need to track areas for quality improvement and create action plans to enhance the navigation process.

care identified and reviewing populations served. The needs assessment will then be used to create or revise processes. This The cancer committee conducts an assessment of standard will require documentation of barriers to care for patients with cancer. A patient the needs assessment process as well as navigation process is established to address barriers to outcome metrics to prove the value of the care for patients with cancer and healthcare disparities program. Each program will need to track either onsite or by referral. The cancer committee areas for quality improvement and create evaluates and reports on the process annually. action plans to enhance the navigation process. A working draft of Cancer Program Standards 2012: This new standard will be phased in Ensuring Patient-Centered Care is available on the over a 3-year period by all accredited canAmerican College of Surgeons Commission on Cancer cer programs. To help programs meet the website: www.facs.org/cancer/coc/cps2011.html. new standard, the Commission on Cancer will be providing a webinar series ing the needs of its cancer patient population as this fall to provide a framework for compliance. well as those of the community it serves. Each Topics will include: program will need to establish a navigation • How to conduct a community needs assessment process that suits its needs and to determine • How to operationalize a plan and evaluate it appropriate staffing. • A best practice repository of tools to assist with To meet the standard, it is important to each aspect of program planning. g remember that patient navigation is a process, not a person. Many questions Voice Your Comments/Questions have arisen regarding what type of navigators will be acceptable to be in compliCancer Program Standards 2011 Wiki provides a vehicle ance with this standard. The Comfor comments to Standard 3.1: mission on Cancer is allowing each www.socialtext.net/cancer_standards/cancer_standards program to determine this depending on Deadline for comments is May 31, 2011. the gaps in care identified through its needs assessment. Some institutions will have non-clinical navigators, whereas Comments about the categories or standards should be submitted through the Wiki page to CPS2011@facs.org. others may need both nonclinical and Please include the category name, or standard number or clinical navigators to provide care description in the subject line. through the continuum. Another question relates to offering patient navigaQuestions about the standards should be submitted to the tion onsite versus by referral and how CAnswer Forum at cancerbulletin.facs.org/forums. that may be interpreted by the commission. As the final standards are dissemiReferences nated this summer, the rationale for this option 1. Freeman HP, Vydelingum NA. The role of the Special Popushould be clearly defined.

Draft Standard 3.1

WHAT THIS MEANS FOR NAVIGATION PROGRAMS Navigation programs currently in place as well as new programs will need to perform a full assessment reviewing health disparities and barriers to

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lations Networks program in eliminating cancer health disparities. Cancer. 2006;107(8 suppl):1933-1935. 2. Institute of Medicine. Cancer Care for the Whole Patient: Meeting Psychosocial Health Needs. Washington, DC: National Academies Press; 2007. 3. National Priorities Partnership. Vision. 2008. www.national prioritiespartnership.org/PriorityDetails.aspx?id=606. Accessed April 21, 2001.

This article was adapted with permission from the PA Patient Navigator Network.

Sein E. Patient Navigation as a New Standard for Cancer Program Accreditation. March 18, 2011. http://pubweb.fccc.edu/pan avnet/?p=443.

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April 2011 - Journal of Oncology Navigation & Survivorship  

The Official Journal of the Academy of Oncology Nurse Navigators

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