Florida Cancer Specialists Magazine Summer 2022

SUMMER 2022

Tarshia Rivera

Finds Remission Through FCS Care and Enduring Faith

Summer 2022

1

For adults with intermediate- or high-risk myelofibrosis (MF)

WHAT YOU DO TODAY CAN IMPACT THEIR TOMORROW

Indications and Usage Jakafi is indicated for treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults.

Important Safety Information • Treatment with Jakafi® (ruxolitinib) can cause thrombocytopenia, anemia and neutropenia, which are each dose-related effects. Perform a pre-treatment complete blood count (CBC) and monitor CBCs every 2 to 4 weeks until doses are stabilized, and then as clinically indicated • Manage thrombocytopenia by reducing the dose or temporarily interrupting Jakafi. Platelet transfusions may be necessary • Patients developing anemia may require blood transfusions and/or dose modifications of Jakafi • Severe neutropenia (ANC <0.5 × 109/L) was generally reversible by withholding Jakafi until recovery • Serious bacterial, mycobacterial, fungal and viral infections have occurred.

Delay starting Jakafi until active serious infections have resolved. Observe patients receiving Jakafi for signs and symptoms of infection and manage promptly. Use active surveillance and prophylactic antibiotics according to clinical guidelines • Tuberculosis (TB) infection has been reported. Observe patients taking Jakafi for signs and symptoms of active TB and manage promptly. Prior to initiating Jakafi, evaluate patients for TB risk factors and test those at higher risk for latent infection. Consult a physician with expertise in the treatment of TB before starting Jakafi in patients with evidence of active or latent TB. Continuation

of Jakafi during treatment of active TB should be based on the overall risk-benefit determination • Progressive multifocal leukoencephalopathy (PML) has occurred with Jakafi treatment. If PML is suspected, stop Jakafi and evaluate • Advise patients about early signs and symptoms of herpes zoster and to seek early treatment • Increases in hepatitis B viral load with or without associated elevations in alanine aminotransferase and aspartate aminotransferase have been reported in patients with chronic hepatitis B virus (HBV) infections. Monitor and treat patients with chronic HBV infection according to clinical guidelines • When discontinuing Jakafi, myeloproliferative neoplasm-related symptoms may return within one week. After discontinuation, some patients with myelofibrosis have experienced fever, respiratory distress, hypotension, DIC, or multi-organ failure. If any of these occur after discontinuation or while tapering Jakafi, evaluate and treat any intercurrent illness and consider restarting or increasing the dose of Jakafi. Instruct patients not to interrupt or discontinue Jakafi without consulting their physician. When discontinuing or interrupting Jakafi for reasons other than thrombocytopenia or neutropenia, consider gradual tapering rather than abrupt discontinuation • Non-melanoma skin cancers (NMSC) including basal cell, squamous cell, and Merkel cell carcinoma have occurred. Perform periodic skin examinations • Treatment with Jakafi has been associated with increases in total cholesterol, low-density lipoprotein cholesterol, and triglycerides. Assess lipid parameters 8-12 weeks after initiating Jakafi. Monitor and treat according to clinical guidelines for the management of hyperlipidemia

INTERVENE WITH JAKAFI AT DIAGNOSIS COMFORT-I Primary Endpoint*

42

COMFORT-I Secondary Endpoint‡

of patients receiving Jakafi achieved a ≥35% reduction in spleen volume at week 24 vs 0.7% of patients receiving placebo (P < 0.0001)1,2

%

46

4.4-year median duration of spleen response among primary responders (n = 65)3†

%

of patients receiving Jakafi achieved a ≥50% improvement in Total Symptom Score (TSS) at week 24 vs 5% of patients receiving placebo (P < 0.0001)1,2

Median time to symptom response was <4 weeks for patients receiving Jakafi1

COMFORT-I 5-year analysis: Jakafi and placebo Overall Survival Probability

Overall Survival Kaplan-Meier Curves by Treatment Group in COMFORT-I1,3,4,a,b At 3 years, survival probability was 70% for patients originally randomized to Jakafi and 61% for those originally randomized to placebo1

Jakafi Placebo

1.00 0.75

51%

0.50 0.25

Median crossover c to Jakafi: 9 months

0.00

0

% 1-year survival

Jakafi (n = 155) 91%

% 3-year survival

70%

61%

% 5-year survival

51%

40%

1

Placebo (n = 154) 84%

2

40% 4

3

Overall survival was a prespecified secondary endpoint in COMFORT-I1

5

Time, y Number of patients at risk Jakafi Placebo

155 154

148 144

137 119

124 105

112 95

108 85

100 78

86 72

80 59

75 51

69 46

57 38

Jakafi 5-year overall survival probability was 51%3

All patients in the placebo group either crossed over to Jakafi at a median of 9 months or discontinued1

Intervene with Jakafi at diagnosis in appropriate patients with MF STARTWITHJAKAFI.COM CT, computed tomography; MRI, magnetic resonance imaging.

*COMFORT-I (COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment-I) was a randomized, double-blind, placebo-controlled phase 3 study with 309 patients with intermediate-2–risk or high-risk MF. The primary endpoint was the proportion of patients achieving a ≥35% reduction in spleen volume from baseline to week 24 as measured by CT or MRI.1,2 † Duration of spleen response was defined as the interval between the first spleen response measurement that was a ≥35% reduction from baseline and the date of the first measurement that was no longer a ≥35% reduction from baseline that was also a >25% increase from nadir.3 ‡ A secondary endpoint was the proportion of patients with a ≥50% reduction in TSS from baseline to week 24 as measured by the daily patient diary, the modified Myelofibrosis Symptom Assessment Form. TSS encompasses core symptoms of MF: abdominal discomfort, early satiety, pain under left ribs, pruritus, night sweats, and bone/muscle pain. Symptom scores ranged from 0 to 10, with 0 representing symptoms “absent” and 10 representing symptoms “worst imaginable.” These scores were added to create the daily total score, which has a maximum of 60. At baseline, mean TSS was 18.0 in the group receiving Jakafi and 16.5 in the group receiving placebo.1,2 a The 5-year overall survival analysis is not included in the Full Prescribing Information for Jakafi. Although the 3-year overall survival analysis is presented in the Full Prescribing Information, P values and hazard ratios are omitted from the overall survival Kaplan-Meier curves.1,3 b COMFORT-I was not designed to compare survival probabilities between Jakafi and placebo at 3 or 5 years.3 c Patients randomized to placebo were eligible to crossover to receive Jakafi because of progression-driven events or at the physician’s discretion; however, these patients continued to be grouped within their original randomized assignment for analysis purposes.3

• Another JAK-inhibitor has increased the risk of major adverse cardiovascular events (MACE), including cardiovascular death, myocardial infarction, and stroke (compared to those treated with tumor TNF blockers) in patients with rheumatoid arthritis, a condition for which Jakafi is not indicated. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Jakafi particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur • Another JAK-inhibitor has increased the risk of thrombosis, including deep venous thrombosis (DVT), pulmonary embolism (PE), and arterial thrombosis (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which Jakafi is not indicated.

In patients with myelofibrosis (MF) and polycythemia vera (PV) treated with Jakafi in clinical trials, the rates of thromboembolic events were similar in Jakafi and control treated patients. Patients with symptoms of thrombosis should be promptly evaluated and treated appropriately • Another JAK-inhibitor has increased the risk of lymphoma and other malignancies excluding NMSC (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which Jakafi is not indicated. Patients who are current or past smokers are at additional increased risk. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Jakafi, particularly in patients with a known secondary malignancy (other than a successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers

• In myelofibrosis and polycythemia vera, the most common nonhematologic adverse reactions (incidence ≥15%) were bruising, dizziness, headache, and diarrhea. In acute graft-versus-host disease, the most common nonhematologic adverse reactions (incidence >50%) were infections (pathogen not specified) and edema. In chronic graft-versus-host disease, the most common nonhematologic adverse reactions (incidence ≥20%) were infections (pathogen not specified) and viral infections • Avoid concomitant use with fluconazole doses greater than 200 mg. Dose modifications may be required when administering Jakafi with fluconazole doses of 200 mg or less, or with strong CYP3A4 inhibitors, or in patients with renal or hepatic impairment. Patients should be closely monitored and the dose titrated based on safety and efficacy • Use of Jakafi during pregnancy is not recommended and should only be used if the potential benefit justifies the potential risk to the fetus. Women taking Jakafi should not breastfeed during treatment and for 2 weeks after the final dose Please see Brief Summary of Full Prescribing Information for Jakafi on the following pages. To learn more about Jakafi, visit HCP.Jakafi.com References: 1. Jakafi Prescribing Information. Wilmington, DE: Incyte Corporation. 2. Verstovsek S, et al. N Engl J Med. 2012;366(9):799-807. 3. Data on file. Incyte Corporation. Wilmington, DE. 4. Verstovsek S, et al. J Hematol Oncol. 2017;10(1):55.

Jakafi and the Jakafi logo are registered trademarks of Incyte. © 2022, Incyte Corporation. MAT-JAK-03732 01/22

The safetyThe of Jakafi safetywas of Jakafi assessed was in assessed 617 in 617 following adverse followingevents adverse after events discontinuing after discontinuing Jakafi: fever, Jakafi:Myelofibrosis fever, Myelofibrosis patients inpatients six clinical in six studies clinical with studies a median with duration a medianofduration of respiratoryrespiratory distress, hypotension, distress, hypotension, DIC, or multi-organ DIC, or multi-organ follow-up offollow-up 10.9 months, of 10.9 including months,301 including patients 301 with patients MF inwith MF in failure. If one failure. or more If oneoforthese moreoccur of these afteroccur discontinuation after discontinuation 3 studies.

Phase 3Instudies. these two In these Phasetwo 3 studies, Phase 3 studies, of, or whileof,tapering or whilethe tapering dose ofthe Jakafi, dose evaluate of Jakafi,for evaluate and fortwo andPhasetwo had patients a median had duration a medianofduration exposure of to exposure Jakafi ofto Jakafi of treat any intercurrent treat any intercurrent illness andillness consider andrestarting consider or restartingpatients or 9.5 months9.5 (range months 0.5(range to 17 months), 0.5 to 17with months), 89% with 89% the dose ofthe Jakafi. dose Instruct of Jakafi. patients Instructnot patients to not to BRIEF SUMMARY: BRIEF SUMMARY: For Full Prescribing For Full Prescribing Information, Information,increasingincreasing of patients of treated patients for treated more than for more 6 months thanand 6 months 25% treated and 25% treated interrupt orinterrupt discontinue or discontinue Jakafi therapy Jakafi without therapy consulting without consulting see package seeinsert. package insert. for more 12 months. than 12One months. hundred Oneand hundred elevenand (111) eleven (111) their physician.

When discontinuing When discontinuing or interrupting or interrupting for more than INDICATIONS INDICATIONS AND USAGE AND Myelofibrosis USAGE Myelofibrosis Jakafi is Jakafi is their physician. patients started patients treatment started treatment at 15 mg twice at 15 daily mg twice and 190 daily and 190 therapy Jakafiwith for reasons Jakafi forother reasons thanother than indicated for indicated treatment for of treatment intermediate of intermediate or high-riskor high-risk therapy with patients at 20 started mg twice at 20 daily. mg twice In patients daily. Instarting patients starting thrombocytopenia thrombocytopenia or neutropenia or neutropenia [see Dosage [see and Dosage and patients started myelofibrosis myelofibrosis (MF), including (MF),primary including MF,primary MF, with 15 mgwith twice 15 daily mg twice (pretreatment daily (pretreatment platelet platelet Administration Administration (2.7) in Full(2.7) Prescribing in Full Prescribing Information], Information],treatment treatment post-polycythemia post-polycythemia vera MF and vera post-essential MF and post-essential 209/L) mgand twice 20 daily mg twice daily counts counts to 200 of 100 × 10 to9/L) 200and × 10 consider tapering considerthe tapering dose ofthe Jakafi dosegradually of Jakafi rather gradually thanrather than of 100 thrombocythemia thrombocythemia MF in adults.

MFPolycythemia in adults. Polycythemia Vera JakafiVera Jakafi (pretreatment (pretreatment platelet counts platelet greater counts than greater 200 ×than 109/L), 200 × 109/L), discontinuing discontinuing abruptly.

Non-Melanoma abruptly.

Non-Melanoma Skin Cancer Skin Cancer is indicatedisfor indicated treatment for of treatment polycythemia of polycythemia vera (PV) invera (PV) in 65% and 25% 65%ofand patients, 25% ofrespectively, patients, respectively, required arequired dose a dose (NMSC) Non-melanoma (NMSC) Non-melanoma skin cancers skin including cancers basal including cell, basal cell, adults whoadults have had whoan have inadequate had an inadequate response toresponse or are to or are reduction below reduction the below startingthe dose starting withindose the within first 8 the weeks first 8 weeks cell, and Merkel cell, and cellMerkel carcinoma cell carcinoma have occurred have occurred intolerant of intolerant hydroxyurea. of hydroxyurea.

Acute Graft-Versus-Host Acute Graft-Versus-Hostsquamoussquamous of therapy.ofIntherapy. a double-blind, In a double-blind, randomized, randomized, placebo- placebopatients with treated Jakafi.with Perform Jakafi.periodic Performskin periodic skin Disease Jakafi Disease is indicated Jakafi isfor indicated treatment for of treatment steroid- of steroid- in patientsintreated controlled study of Jakafi, study among of Jakafi, theamong 155 patients the 155 patients Lipid Elevations Lipid Elevations Treatment Treatment with Jakafiwith hasJakafi has controlled refractory acute refractory graft-versus-host acute graft-versus-host disease (aGVHD) diseasein(aGVHD) adult inexaminations. adult examinations. treated with treated Jakafi,with theJakafi, most frequent the mostadverse frequentreactions adverse reactions been associated been associated with increases with in increases lipid parameters in lipid parameters and pediatric andpatients pediatric12patients years and 12 older. years Chronic and older.GraftChronic Graftwere thrombocytopenia were thrombocytopenia and anemia and [see anemia Table [see 2]. Table 2]. including total including cholesterol, total cholesterol, low-density low-density lipoproteinlipoprotein (LDL) (LDL) Versus-Host Versus-Host Disease Jakafi Disease is indicated Jakafi isfor indicated treatment for of treatment of cholesterol,cholesterol, and triglycerides and triglycerides [see Adverse [seeReactions Adverse Reactions (6.1) Thrombocytopenia, (6.1) Thrombocytopenia, anemia andanemia neutropenia and neutropenia are dose-related are dose-related chronic graft-versus-host chronic graft-versus-host disease (cGVHD) diseaseafter (cGVHD) failureafter of failure of in Full Prescribing in Full Prescribing Information].

Information].

The effect The of these effectlipid of these effects. lipid Theeffects. three most The three frequent most nonhematologic frequent nonhematologic adverse adverse one or twoone linesoroftwo systemic lines oftherapy systemic in therapy adult andinpediatric adult and pediatric parameterparameter elevations elevations on cardiovascular on cardiovascular morbidity and morbidity and reactions were reactions bruising, weredizziness bruising,and dizziness headache and[see headache [see patients 12patients years and 12 older. years and older. mortality has mortality not been hasdetermined not been determined in patientsintreated patients treated Table 1]. Discontinuation Table 1]. Discontinuation for adversefor events, adverse regardless events, regardless of of CONTRAINDICATIONS CONTRAINDICATIONS None.

None. with Jakafi.with Assess Jakafi. lipid Assess parameters lipid parameters approximately approximately 8-12 8-12 was causality, causality, observed wasinobserved 11% of patients in 11% of treated patients withtreated Jakafiwith Jakafi WARNINGS WARNINGS AND PRECAUTIONS AND PRECAUTIONS Thrombocytopenia, Thrombocytopenia, weeks following weeks initiation followingofinitiation Jakafi therapy. of JakafiMonitor therapy. and Monitorand and11% ofand patients 11% of treated patients withtreated placebo. with Table placebo.

1 presents Table 1 presents Anemia and Anemia Neutropenia and Neutropenia Treatment Treatment with Jakafiwith canJakafi can treat according treat according to clinical guidelines to clinical guidelines for the management for the management the most common the mostnonhematologic common nonhematologic adverse reactions adverse reactions cause thrombocytopenia, cause thrombocytopenia, anemia and anemia neutropenia. and neutropenia. [see [see of hyperlipidemia. of hyperlipidemia.

Major Adverse MajorCardiovascular Adverse Cardiovascularoccurring inoccurring patients who in patients received whoJakafi received in theJakafi double-blind, in the double-blind, Adverse Reactions Adverse Reactions (6.1) in Full(6.1) Prescribing in Full Prescribing Information].

Information].

Events (MACE) EventsAnother (MACE)JAK-inhibitor Another JAK-inhibitor has increased has increased the the placebo-controlled placebo-controlled study during study randomized during randomized treatment. treatment.

Manage thrombocytopenia Manage thrombocytopenia by reducing bythe reducing dose orthe dose orrisk of MACE, riskincluding of MACE,cardiovascular including cardiovascular death, myocardial death, myocardial Table 1: Myelofibrosis: Table 1: Myelofibrosis: Nonhematologic Nonhematologic Adverse Adverse temporarilytemporarily interruptinginterrupting Jakafi. Platelet Jakafi. transfusions Platelet transfusions may may infarction, infarction, and strokeand (compared stroke (compared to those treated to those with treated with ReactionsReactions OccurringOccurring in Patientsinon Patients Jakafi on in Jakafi in be necessary be necessary [see Dosage [see and Dosage Administration and Administration (2) in Full (2) inTNF Fullblockers) TNF inblockers) patientsinwith patients rheumatoid with rheumatoid arthritis, a arthritis, a the Double-blind, the Double-blind, Placebo-controlled Placebo-controlled Study Study PrescribingPrescribing Information].

Information].

Patients developing Patients developing anemia may anemia may for condition condition which Jakafi for which is not Jakafi indicated. is not indicated.

Consider the Consider the During Randomized During Randomized TreatmentTreatment require blood require transfusions blood transfusions and/or dose and/or modifications dose modifications of of benefits and benefits risks for and the risks individual for the patient individual prior patient to prior to 9 Jakafi Jakafi Placebo Placebo /L) Jakafi. Severe Jakafi. neutropenia Severe neutropenia (ANC less than (ANC0.5 less×than 109/L) 0.5 × 10initiating orinitiating continuing or continuing therapy with therapy Jakafiwith particularly Jakafi particularly in in (N=155) (N=155) (N=151) (N=151) was generally was reversible generally reversible by withholding by withholding Jakafi untilJakafi untilpatients who patients are current who are or current past smokers or pastand smokers patients and patients All GradeAll Grade GradeAllGrade GradeAll Grade Grade Grade recovery. Perform recovery.a Perform pre-treatment a pre-treatment complete blood complete count blood count with other with cardiovascular other cardiovascular risk factors. risk Patients factors.should Patients be should be 4 Adverse AdverseGradesa 3Grades4a 3Grades4 3Grades4 3 (CBC) and (CBC) monitor andCBCs monitor everyCBCs 2 to every 4 weeks 2 tountil 4 weeks dosesuntil doses informed about informed the symptoms about the symptoms of serious of cardiovascular serious cardiovascular Reactions Reactions(%) (%) (%)(%) (%)(%) (%)(%) (%)(%) (%) (%) are stabilized, are stabilized, and then as and clinically then asindicated clinically [see indicated [see events andevents the steps and to thetake steps if they to take occur. if they Thrombosis occur. Thrombosis b Bruising Bruisingb 23 < 1 23 0 < 1 15 0 0 15 0 0 0 Dosage and Dosage Administration and Administration (2) in Full Prescribing (2) in Full Prescribing Another JAK-inhibitor Another JAK-inhibitor has increased has increased the risk of the risk of 0 Dizzinessc Dizzinessc 18 < 1 18 0 < 1 7 0 0 7 0 0 Information].

Information].

Risk of Infection Risk of Serious Infection bacterial, Serious bacterial, thrombosis, thrombosis, including deep including venous deep thrombosis venous thrombosis (DVT), (DVT), mycobacterial, mycobacterial, fungal andfungal viral infections and viral infections have occurred have occurred 0 15 0 0 5 0 0 5 0 0 0 pulmonarypulmonary embolism embolism (PE), and arterial (PE), and thrombosis arterial thrombosis Headache Headache 15 [see Adverse [seeReactions Adverse Reactions (6.1) in Full(6.1) Prescribing in Full Prescribing (compared(compared Urinary TractUrinary Tract to those treated to those with treated TNF blockers) with TNF inblockers) patientsin patients 0 9 0 0 5 0 <1 5<1 <1 <1 d Infections Infectionsd 9 Information].

Information].

Delay starting Delay therapy starting with therapy Jakafiwith untilJakafi untilwith rheumatoid with rheumatoid arthritis, a arthritis, conditiona for condition which Jakafi for which is Jakafi is e e Weight Gain Weight Gain 7 < 1 7 0 <11 0 <1 1 0 <1 0 active serious active infections serious infections have resolved. haveObserve resolved.patients Observe patients not indicated. not indicated.

In patientsInwith patients MF and with PVMF treated and PV with treated with receiving Jakafi receiving for signs Jakafiand for signs symptoms and symptoms of infectionofand infection and in clinical 0 5 0 0 <1 0 0 <10 0 0 Jakafi Jakafi trials, in clinical the rates trials,ofthe thromboembolic rates of thromboembolicFlatulence Flatulence 5 f manage promptly. manage Use promptly. activeUse surveillance active surveillance and and Herpes Zoster Herpes Zoster 2f 0 2 0 0 <1 0 0 <10 0 0 events were events similar were in Jakafi similarand in Jakafi controland treated control patients. treated patients. prophylactic prophylactic antibioticsantibiotics according according to clinical guidelines. to clinical guidelines. a Patients with Patients symptoms with symptoms of thrombosis of thrombosis should be should be a National Cancer National Institute Cancer Common Institute Terminology CommonCriteria Terminology for Adverse CriteriaEvents for Adverse Events Tuberculosis Tuberculosis Tuberculosis Tuberculosis infection has infection been reported has beeninreported in (CTCAE), version (CTCAE), 3.0 version 3.0 promptly evaluated promptly evaluated and treatedand appropriately. treated appropriately.

SecondarySecondary b b includes contusion, includes ecchymosis, contusion,hematoma, ecchymosis,injection hematoma, site hematoma, injection site hematoma, patients receiving patients Jakafi. receiving Observe Jakafi.patients Observereceiving patients receiving Malignancies Malignancies Another JAK-inhibitor Another JAK-inhibitor has increased has increased the the periorbital hematoma, periorbital vessel hematoma, puncture vessel site puncture hematoma, siteincreased hematoma, tendency increased tendency Jakafi for signs Jakafiand for signs symptoms and symptoms of active tuberculosis of active tuberculosis and riskand of lymphoma risk of lymphoma and other malignancies and other malignancies excluding excluding to bruise, petechiae, to bruise, purpura petechiae, purpura manage promptly. manage Prior promptly. to initiating Prior toJakafi, initiating patients Jakafi, patientsNMSC (compared c c NMSC (compared to those treated to those with treated TNF blockers) with TNF inblockers) in dizziness, includes includes postural dizziness, dizziness, postural vertigo, dizziness, balance vertigo, disorder, balance Meniere’s disorder, Meniere’s should be should evaluated be evaluated for tuberculosis for tuberculosis risk factors, risk and factors, and Disease, labyrinthitis Disease, labyrinthitis patients with patients rheumatoid with rheumatoid arthritis, a arthritis, conditiona for condition which for which d d includes urinary includes tract infection, urinary tract cystitis, infection, urosepsis, cystitis, urinary urosepsis, tract infection urinary tract infection those at higher thoserisk at higher shouldrisk be should tested for be latent testedinfection. for latent infection.

Jakafi is not Jakafi indicated. is not indicated.

Patients who Patients are current who are or current past or past bacterial, kidney bacterial, infection, kidney pyuria, infection, bacteria pyuria, urine,bacteria bacteriaurine, urinebacteria identified, urine identified, Risk factors Risk include, factorsbutinclude, are notbut limited are not to, limited prior residence to, prior residence smokers are smokers at additional are at additional increased increased risk. Consider risk.the Consider the nitrite urine present nitrite urine present in or travelintoorcountries travel to with countries a highwith prevalence a high prevalence of of benefits and e benefits risks for andthe risks individual for the patient individual prior patient to prior to e includes weight includes increased, weight abnormal increased, weight abnormal gain weight gain f f tuberculosis, tuberculosis, close contact close with contact a person withwith a person activewith active includes herpes includes zoster herpes and post-herpetic zoster and post-herpetic neuralgia neuralgia initiating orinitiating continuing or continuing therapy with therapy Jakafi,with particularly Jakafi, particularly in in tuberculosis, tuberculosis, and a history andofa active historyoroflatent activetuberculosis or latent tuberculosis Description of Selected of Adverse SelectedReactions: Adverse Reactions: Anemia Anemia patients with patients a known withsecondary a known secondary malignancymalignancy (other than(otherDescription than where an adequate where an course adequate of treatment course of treatment cannot be cannot be a successfully Phase the two 3 clinical Phasestudies, 3 clinicalmedian studies, time median to time to a successfully treated NMSC), treated patients NMSC),who patients develop whoa developInathe two In confirmed.confirmed.

For patients Forwith patients evidence withofevidence active oroflatent active or latent onset CTCAE of first Grade CTCAE 2 orGrade higher2anemia or higher was anemia was malignancy, malignancy, and patients andwho patients are current who are or current past or past onset of first tuberculosis, tuberculosis, consult a physician consult a with physician expertise with inexpertise the in the approximately approximately 6 weeks. One 6 weeks. patientOne (< patient 1%) discontinued (< 1%) discontinued smokers. ADVERSE smokers. ADVERSE REACTIONS REACTIONS The following The clinically following clinically treatment treatment of tuberculosis of tuberculosis before starting before Jakafi. starting TheJakafi. Thesignificantsignificant treatment treatment because ofbecause anemia.ofInanemia. patientsInreceiving patients Jakafi, receiving Jakafi, adverse reactions adverse are reactions discussed are discussed in greater in greater decision todecision continuetoJakafi continue during Jakafi treatment during treatment of active of active mean decreases mean decreases in hemoglobin in hemoglobin reached a reached nadir of a nadir of detail in other detail sections in otherofsections the labeling: of the• labeling: Thrombocytopenia, • Thrombocytopenia, tuberculosis tuberculosis should be should based on be the based overall on the risk-benefit overall risk-benefit approximately approximately 1.5 to 2.0 g/dL 1.5 tobelow 2.0 g/dL baseline belowafter baseline 8 to 12 after 8 to 12 Anemia and Anemia Neutropenia and Neutropenia [see Warnings [seeand Warnings Precautions and Precautions determination. determination.

Progressive Progressive Multifocal Multifocal weeks of therapy weeks of and therapy then gradually and then recovered gradually recovered to reach a to reach a (5.1) in Full(5.1) Prescribing in Full Prescribing Information] Information] • Risk of Infection • Risk of Infection Leukoencephalopathy Leukoencephalopathy Progressive Progressive multifocal multifocal new steadynew state steady that was stateapproximately that was approximately 1.0 g/dL below 1.0 g/dL below [see Warnings [seeand Warnings Precautions and Precautions (5.2) in Full(5.2) Prescribing in Full Prescribing leukoencephalopathy leukoencephalopathy (PML) has (PML) occurred haswith occurred Jakafiwith Jakafi baseline. pattern This waspattern observed wasinobserved patientsinregardless patients regardless Information] Information] • Symptom• Exacerbation Symptom Exacerbation Following Following baseline. This treatment.treatment.

If PML is suspected, If PML is suspected, stop Jakafistop andJakafi evaluate. and evaluate. of whetherofthey whether had received they hadtransfusions received transfusions during therapy. during therapy.

InterruptionInterruption or Discontinuation or Discontinuation of Treatment of Treatment with Jakafiwith Jakafi Herpes Zoster Herpes Advise Zoster patients Adviseabout patients earlyabout signsearly and signs and[see Warnings In the randomized, In the randomized, placebo-controlled placebo-controlled study, 60%study, of 60% of [seeand Warnings Precautions and Precautions (5.3) in Full(5.3) Prescribing in Full Prescribing symptomssymptoms of herpes zoster of herpes andzoster to seek and treatment to seek treatment as as patients treated patients with treated Jakafiwith andJakafi 38% ofand patients 38% ofreceiving patients receiving InformationInformation ] • Non-Melanoma ] • Non-Melanoma Skin Cancer Skin [see Cancer Warnings [see Warnings early as possible early asif possible suspected. if suspected.

Hepatitis BHepatitis HepatitisBBHepatitis viral and B viral placebo received placebored received blood cell red transfusions blood cell transfusions during during Precautions and Precautions (5.4) in Full(5.4) Prescribing in Full Prescribing Information] Information] load (HBV-DNA load (HBV-DNA titer) increases, titer) increases, with or without with or associated without associated randomized randomized treatment.treatment.

Among transfused Among transfused patients, the patients, the • Lipid Elevations • Lipid Elevations [see Warnings [see and Warnings Precautions and Precautions (5.5) (5.5) elevations elevations in alanine in aminotransferase alanine aminotransferase and aspartate and aspartate median number medianofnumber units transfused of units transfused per monthper wasmonth 1.2 was 1.2 in Full Prescribing in Full Prescribing Information] Information] • Major Adverse • Major Adverse aminotransferase, aminotransferase, have beenhave reported beeninreported patientsinwith patients with in patientsintreated patients with treated Jakafiwith andJakafi 1.7 in and placebo 1.7 intreated placebo treated Cardiovascular Cardiovascular Events (MACE) Events [see(MACE) Warnings [seeand Warnings Precautions and Precautions chronic HBV chronic infections HBV infections taking Jakafi. taking TheJakafi. effect The of Jakafi effect of Jakafi patients. Thrombocytopenia In the two In Phase the two 3 clinical Phase 3 clinical (5.6) in Full(5.6) Prescribing in Full Prescribing Information]Information] • Thrombosis • Thrombosis [see [seepatients. Thrombocytopenia on viral replication on viral replication in patientsinwith patients chronic with HBV chronic infection HBV infection patientsinwho patients developed who developed Grade 3 orGrade 4 3 or 4 Warnings and Warnings Precautions and Precautions (5.7) in Full(5.7) Prescribing in Full Prescribing studies, instudies, is unknown. is unknown.

Patients with Patients chronic with HBV chronic infection HBVshould infection should thrombocytopenia, the medianthe time median to onset timewas to onset was Information] Information] • Secondary • Secondary Malignancies Malignancies [see Warnings [seeand Warnings and thrombocytopenia, be treatedbe andtreated monitored and monitored according according to clinical guidelines. to clinical guidelines. approximately approximately 8 weeks. Thrombocytopenia 8 weeks. Thrombocytopenia was generally was generally PrecautionsPrecautions (5.8) in Full(5.8) Prescribing in Full Prescribing Information].

Information].

Clinical Clinical SymptomSymptom Exacerbation Exacerbation FollowingFollowing Interruption Interruption or or reversible reversible with dose with reduction dose or reduction dose interruption. or dose interruption.

Trials Experience Trials Experience Because clinical Because trials clinical are conducted trials are conducted Discontinuation Discontinuation of Treatment of Treatment with Jakafi with Following Jakafi Following The median The time median to recovery time toofrecovery platelet of counts platelet above counts above under widely under varying widely conditions, varying conditions, adverse reaction adverserates reaction rates discontinuation discontinuation of Jakafi, symptoms of Jakafi, symptoms from from 149/L days. wasPlatelet 14 days. transfusions Platelet transfusions were were 50 × 109/L50was × 10 observed in observed the clinical in the trials clinical of a drug trialscannot of a drug be cannot directlybe directly myeloproliferative myeloproliferative neoplasmsneoplasms may returnmay to pretreatment return to pretreatment administered administered to 5% of patients to 5% ofreceiving patients Jakafi receiving and to Jakafi 4% and to 4% compared compared to rates in to therates clinical in the trials clinical of another trials ofdrug another drug levels overlevels a period overofaapproximately period of approximately one week.one Some week. Some patients control receiving regimens. control regimens.

Discontinuation Discontinuation and may not andreflect may not the reflect rates observed the rates in observed practice.in practice. of patientsofreceiving patients with patients MF have withexperienced MF have experienced one or more oneoforthemore of the

,

a

.

g

of treatment ofbecause treatment ofbecause thrombocytopenia of thrombocytopenia occurred inoccurred Table in Table 4: Polycythemia Vera: Laboratory Selected Laboratorydrugs [seedrugs 4: Polycythemia Vera: Selected Clinical [see Studies Clinical (14.4) Studies in full (14.4) Prescribing in full Prescribing < 1% of patients < 1% ofreceiving patients Jakafi receiving and Jakafi < 1% of andpatients < 1% of patients Abnormalities in the Open-Label, Abnormalities in the Open-Label, Active- ActiveInformation]; Information]; sixty-five patients sixty-fivecrossed patientsover crossed from over best from best receiving control receiving regimens. control regimens.

Patients with Patients a platelet withcount a platelet count controlledcontrolled Study up to Study Week up32 to of Week 32 of available therapy available to therapy treatment to treatment with Jakafi,with for Jakafi, a total of for a total of 9 9 9 9 a a to ×200 to /L 200 before × 10starting /L before Jakafi starting had Jakafi had of 100 × 10 of /L 100 10×/L10 Randomized Randomized TreatmentTreatment 230 patients 230treated patients with treated Jakafi.with TheJakafi. median The duration medianofduration of a higher frequency a higher frequency of Grade 3oforGrade 4 thrombocytopenia 3 or 4 thrombocytopenia exposure toexposure Jakafi fortothe Jakafi study forwas the study 49.7 weeks was 49.7 (range, weeks 0.7(range, 0.7 Jakafi JakafiBest Available Best Available compared compared to patientstowith patients a platelet with count a platelet greater count than greater than to 144.9 weeks) to 144.9 in the weeks) Jakafi in arm. the Jakafi One hundred arm. Oneand hundred nine and nine (N=110) (N=110) Therapy (N=111) Therapy (N=111) 9 /L (17% 7%). versus Neutropenia 7%). Neutropenia In the two In the two 200 × 109/L 200(17% × 10versus (47%) were patients on Jakafi werefor onatJakafi least for 1 year. at least There 1 year. wereThere were All GradeAllGradeGradeAllGrade GradeAll GradeGrade(47%) Gradepatients Phase 3 clinical Phasestudies, 3 clinical 1%studies, of patients 1% ofreduced patientsorreduced stoppedor stopped five fatal reactions adversetoreactions Jakafi, including to Jakafi,1including from toxic1 from toxic LaboratoryLaboratory Gradesb 3Grades4b Grades 3 4 3Grades 4 3 five 4fatal adverse Jakafi because Jakafiofbecause neutropenia. of neutropenia.

Table 2 provides Table 2the provides the Parameter Parameter (%) (%) (%)(%) (%)(%) (%)(%) (%)(%) (%)epidermal necrolysis epidermal and necrolysis 4 fromand neutropenia, 4 from neutropenia, anemia and/or anemia and/or (%) frequency frequency and severity and of severity clinical hematology of clinical hematology abnormalities abnormalities thrombocytopenia. thrombocytopenia.

An adverseAn reaction adverse resulting reactioninresulting treatment in treatment HematologyHematology reported forreported patientsforreceiving patientstreatment receiving with treatment Jakafiwith or Jakafi Anemia or discontinuation occurred inoccurred 18% of patients in 18% of treated patients withtreated with Anemia 72 < 1 72< 1 < 158 < 1 0 58 0 0 discontinuation 0 placebo in placebo the placebo-controlled in the placebo-controlled study. study.

Jakafi. An reaction adverse resulting reactioninresulting dose modification in dose modification Thrombocytopenia Thrombocytopenia 27 5 27< 1 5 24 < 1 3 24< 1 3 Jakafi. < 1 An adverse inoccurred 27%, andinan 27%, adverse and an reaction adverse resulting reactioninresulting in Table 2: Myelofibrosis: Table 2: Myelofibrosis: Worst Hematology Worst Hematology LaboratoryLaboratory NeutropeniaNeutropenia 3 0 3 < 1 0 10 < 1< 1 10 0 < 1occurred 0 treatment interruption treatment interruption occurred inoccurred 23%. Theinmost 23%.common The most common a Abnormalities Abnormalities in the Placebo-Controlled in the Placebo-Controlled Studya Study Chemistry Chemistry hematologic hematologic adverse reactions adverse(incidence reactions (incidence > 35%) are> 35%) are Jakafi Jakafi Placebo Placebo Hypercholesterolemia Hypercholesterolemia 35 0 35 0 0 8 0 0 8 0 0 anemia 0 andanemia thrombocytopenia. and thrombocytopenia.

The most common The most common (N=155) (N=155) (N=151) (N=151) Elevated ALTElevated ALT25 < 1 25 0 < 116 0 0 16 0 0 nonhematologic 0 nonhematologic adverse reactions adverse(incidence reactions (incidence ≥ 20%) are≥ 20%) are All GradeAllGrade Grade AllGrade GradeAll Grade GradeElevated Grade ASTElevated AST23 0 23 0 0 23 0 < 1 23 0 < 1infections 0 (pathogen infections not (pathogen specified) not and specified) viral infection. and viralTable infection.

7 Table 7 b b Laboratory Laboratory Grades Grades 3 4 Grades 3 4 3Grades 4 3 4 presents most frequent the mostnonlaboratory frequent nonlaboratory adverse reactions adverse reactions Hypertriglyceridemia 15 0 15 0 0 13 0 0 13 0 0 presents 0 the Parameter Parameter(%) (%)(%)(%) (%)(%) (%)(%) (%)(%) (%) Hypertriglyceridemia (%) a a occurring to Cycleup 7 Day to Cycle 1 of 7randomized Day 1 of randomized treatment. treatment. values Presented are worst values Grade arevalues worst regardless Grade values of regardless baseline of baseline occurring up Thrombocytopenia Thrombocytopenia 70 9 70 4 9 31 4 1 31 0 1 b Presented 0 b National Cancer National Institute Cancer Common Institute Terminology CommonCriteria Terminology for Adverse CriteriaEvents, for Adverse Events, Table 7: Chronic Table 7: Graft-Versus-Host Chronic Graft-Versus-Host Disease: All-Grade Disease: All-Grade Anemia Anemia 96 34 96 11 3487 11 16 87 3 16 version 3 3.0 version 3.0 (≥ 10%) and (≥ 10%) Grades and 3-5Grades (≥ 3%)3-5 Nonlaboratory (≥ 3%) Nonlaboratory NeutropeniaNeutropenia19 5 19 2 5 4 2 < 1 4 1 < 1 Acute 1 Graft-Versus-Host Acute Graft-Versus-Host Disease In Disease a single-arm, In a single-arm, Adverse Reactions Adverse Reactions Occurring Occurring in PatientsininPatients the in the a a Presented values Presented are worst values Grade arevalues worst regardless Grade values of regardless baseline of baseline open-labelopen-label study, 71 adults study,(ages 71 adults 18-73 (ages years) 18-73 wereyears) were b b Open-Label, Open-Label, Active-controlled Active-controlled Study up to Study Cycleup to Cycle National Cancer National Institute Cancer Common Institute Terminology CommonCriteria Terminology for Adverse CriteriaEvents, for Adverse Events, treated with treated Jakafiwith for aGVHD Jakafi for failing aGVHD treatment failing with treatment with version 3.0 version 3.0 7 Day 1 of7Randomized Day 1 of Randomized TreatmentTreatment steroids with steroids or without with or other without immunosuppressive other immunosuppressive drugs drugs AdditionalAdditional Data fromData the Placebo-Controlled from the Placebo-Controlled Study Study Jakafi Jakafi Best Available Best Available [see Clinical [see Studies Clinical (14.3) Studies in Full (14.3) Prescribing in Full Prescribing Information].

Information].

• 25% of patients • 25% oftreated patients with treated Jakafiwith andJakafi 7% ofand patients 7% of patients (N = 165) (N =Therapy 165) (NTherapy = 158) (N = 158) duration medianofduration treatment of with treatment Jakafiwith wasJakafi 46 days was 46 days treated with treated placebo withdeveloped placebo developed newly occurring newly or occurring or The medianThe All Grade All All Grade Grade All Grade (range, 4-382 (range, days).

4-382 There days). wereThere no fatal were adverse no fatalreactions adverse reactions worseningworsening Grade 1 abnormalities Grade 1 abnormalities in alanine in transaminase alanine transaminase a Gradesa Grades ≥ 3 Grades ≥ 3 Grades ≥3 ≥3 to Jakafi.

An to adverse Jakafi. Anreaction adverseresulting reactioninresulting treatment in treatment (ALT). The (ALT). incidence The of incidence greater of than greater or equal thantoorGrade equal2to Grade 2 b b (%) (%) (%) (%)(%) (%) (%) (%) Adverse Reactions Adverse Reactions discontinuation occurred inoccurred 31% of patients. in 31% ofThe patients. most The most elevations elevations was 2% forwas Jakafi 2% with for Jakafi 1% Grade with 1% 3 and Grade no 3 anddiscontinuation no common adverse commonreaction adverseleading reaction to treatment leading to treatment Infections and Infections infestations and infestations Grade 4 ALT Grade elevations.

4 ALT elevations.

• 17% of patients • 17% oftreated patients with treated with discontinuation discontinuation was infection was(10%). infection Table (10%).

5 shows Tablethe 5 shows theInfections (pathogen Infections (pathogen Jakafi andJakafi 6% ofand patients 6% oftreated patients with treated placebo withdeveloped placebo developed 1545 4415 1644 16 adverse reactions adverseother reactions than other laboratory than laboratory abnormalities. abnormalities.not specified) not specified) 45 newly occurring newly or occurring worsening or worsening Grade 1 abnormalities Grade 1 abnormalities in in Viral infections Viral infections 28 5 28 23 5 5 23 5 Table 5: Acute Table Graft-Versus-Host 5: Acute Graft-Versus-Host Disease: Disease: aspartate transaminase aspartate transaminase (AST). The (AST). incidence The of incidence Grade 2of Grade 2 Musculoskeletal Musculoskeletal and connective and connective tissue disorders tissue disorders Nonhematologic Adverse Reactions Adverse Reactions OccurringOccurring AST elevations AST elevations was < 1%was for Jakafi < 1% with for Jakafi no Grade with3noorGrade 4 3 or 4 Nonhematologic Musculoskeletal Musculoskeletal pain 18pain 1 18 13 1 013 0 in Patients ≥ 15% ofinPatients the Open-Label, in the Open-Label, Single- SingleAST elevations.

AST elevations.

• 17% of patients • 17% oftreated patients with treated Jakafiwith andJakafi and in ≥ 15% of General disorders Generaland disorders administration and administration site conditions site conditions Cohort Study < 1% of patients < 1% oftreated patients with treated placebo withdeveloped placebo developed newly newly Cohort Study Pyrexia Pyrexia 16 2 16 9 2 19 1 occurring or occurring worsening or worsening Grade 1 elevations Grade 1 elevations in cholesterol. in cholesterol.

Jakafi (N=71) Jakafi (N=71) Fatigue Fatigue 13 1 13 10 1 210 2 The incidence The of incidence Grade 2ofcholesterol Grade 2 cholesterol elevations elevations was wasAdverse Reactions a a b b Adverse Reactions All Grades All (%)Grades Grade(%) 3-4 (%) Grade 3-4Edema (%) Edema 10 1 10 12 1 112 1 < 1% for Jakafi < 1% with for Jakafi no Grade with3noorGrade 4 cholesterol 3 or 4 cholesterol Infections (pathogen Infections (pathogen 55 Vascular disorders Vascular disorders elevations.elevations.

Polycythemia Polycythemia Vera In a randomized, Vera In a randomized, 55 41 41 not specified) not specified) Hypertension Hypertension 16 5 16 13 5 713 7 open-label,open-label, active-controlled active-controlled study, 110study, patients 110with patients PV with PV Edema Edema 51 51 13 13 HemorrhageHemorrhage 12 2 12 15 2 215 2 resistant toresistant or intolerant to or of intolerant hydroxyurea of hydroxyurea received Jakafi received Jakafi HemorrhageHemorrhage 49 49 20 20Respiratory,Respiratory, thoracic and thoracic mediastinal and mediastinal disorders disorders and 111 patients and 111received patientsbest received available besttherapy available [see therapy [see Fatigue Fatigue 37 37 14 14 Cough Cough 13 0 13 8 0 08 0 Clinical Studies Clinical (14.2) Studies in Full (14.2) Prescribing in Full Prescribing Information].

Information].

Bacterial infections Bacterial infections 32 32 28 28 Dyspnea Dyspnea 11 1 11 8 1 18 1 The most frequent The mostadverse frequentreaction adversewas reaction anemia. was anemia. Dyspnea Dyspnea 32 32 7 7 Gastrointestinal Gastrointestinal disorders disorders Discontinuation Discontinuation for adverseforevents, adverse regardless events, regardless of of Viral infections Viral infections 31 31 14 14 Nausea Nausea 12 0 12 13 0 213 2 causality, was causality, observed was in observed 4% of patients in 4% oftreated patients with treated with ThrombosisThrombosis 25 25 11 11 Diarrhea Diarrhea 10 1 10 13 1 113 1 Jakafi. Table Jakafi.

3 presents Table 3the presents most frequent the mostnonhematologic frequent nonhematologic a Diarrhea Diarrhea 24 24 7 7 a National Cancer National Institute Cancer Common Institute Terminology CommonCriteria Terminology for Adverse CriteriaEvents for Adverse Events adverse reactions adverseoccurring reactions up occurring to Weekup32.to Week 32.

(CTCAE), 4.03 version 4.03 Rash Rash 23 23 3 (CTCAE), version 3 b Grouped that areterms composites that areofcomposites applicable adverse of applicable reaction adverse terms. reaction terms.

Table 3: Polycythemia Table 3: Polycythemia Vera: Nonhematologic Vera: Nonhematologic Adverse Adverse 21 4 b Grouped terms Headache Headache 21 4 ReactionsReactions OccurringOccurring in ≥ 5% ofinPatients ≥ 5% ofon Patients on Clinicallylaboratory relevant laboratory abnormalities abnormalities are shownare in shown in 20 13 13Clinically relevant HypertensionHypertension 20 Jakafi in the Jakafi Open-Label, in the Open-Label, Active-controlled Active-controlled 16 0 Table 8. Table 8.

Dizziness Dizziness 16 0 a a Study up to Study Week up32 toof Week Randomized 32 of Randomized TreatmentTreatment Selected laboratory Selected abnormalities laboratory abnormalities are listed in Table are listed 6 below in Table 6 below Table 8: Chronic Table 8:Graft-Versus-Host Chronic Graft-Versus-Host Disease: Selected Disease: Selected b b National Cancer National Institute Cancer Common Institute Terminology CommonCriteria Terminology for Adverse Criteria Events for Adverse Events Laboratory Laboratory Abnormalities Abnormalities in the Open-Label, in the Open-Label, Jakafi Jakafi Best Available Best Available (CTCAE), version (CTCAE), 4.03 version 4.03 (N=110) (N=110) Therapy (N=111) Therapy (N=111) Active-controlled Active-controlled Study up to Study Cycle up7toDay Cycle 1 7 Day 1 Selected laboratory Selected laboratory abnormalities abnormalities during treatment during treatment with with a a of Randomized of Randomized TreatmentTreatment Grade Grade All Grade All Grade All All Jakafi shownare in Table shown6.in Table 6.

3-4 a Grades 3-4 Grades 3-4 3-4 are Jakafi Gradesa Grades Jakafi Jakafi Best Available Best Available Adverse Reactions Adverse Reactions Table TableGraft-Versus-Host 6: Acute Graft-Versus-Host Disease: Selected Disease: Selected (%) (%) (%) (%) (%) (%) (%) (%) 6: Acute (N=165) (N=165) Therapy (N=158) Therapy (N=158) LaboratoryLaboratory Abnormalities Abnormalities WorseningWorsening from from Diarrhea Diarrhea 15 015 70 < 17 <1 All All All Grade Grade Grade All Grade Baseline inBaseline the Open-Label, in the Open-Label, Single Cohort Single Study Cohort Study Dizzinessb Dizzinessb 15 015 130 013 0 Gradesb Grades ≥ 3 bGrades ≥ 3 Grades ≥3 ≥3 c c Dyspnea Dyspnea 13 313 43 04 0 Test Test (%) Jakafi (N=71) Jakafi (N=71) LaboratoryLaboratory (%) (%) (%)(%) (%) (%) (%) Muscle Spasms Muscle Spasms 12 < 12 1 5< 1 05 0 HematologyHematology Worst grade Worst during grade treatment during treatment ConstipationConstipation 8 08 30 03 0 a a Anemia Anemia 82 1382 7513 875 8 (%) Grade (%) 3-4 (%) Grade 3-4 (%) All Grades All Grades Laboratory Laboratory Parameter Parameter d d Herpes Zoster Herpes Zoster 6 < 16 0< 1 00 0 Thrombocytopenia Thrombocytopenia27 1227 2312 923 9 Hematology Hematology Nausea Nausea 6 06 40 04 0 58 2058 5420 1754 17 e Anemia Anemia 75 75 45 45 NeutropeniaNeutropenia Weight GainWeight Gaine 6 06 < 10 0< 1 0 Thrombocytopenia Thrombocytopenia 75 75 61 61 Chemistry Chemistry Urinary TractUrinary Infections Tractf Infections 6 f 06 30 03 0 Hypercholesterolemia 88 1088 8510 885 8 Neutropenia Neutropenia 58 58 40 40 Hypercholesterolemia Hypertension Hypertension 5 < 15 3< 1 < 13 <1 Elevated AST Elevated AST 65 5 65 54 5 6 54 6 a a Chemistry Chemistry National Cancer National Institute Cancer Common Institute Terminology CommonCriteria Terminology for Adverse CriteriaEvents for Adverse Events Elevated ALTElevated ALT 73 1173 7111 1671 16 (CTCAE), version (CTCAE), 3.0 version 3.0 Elevated ALT Elevated ALT 48 48 8 8 b b includes dizziness includes and dizziness vertigo and vertigo Elevated ASTElevated AST 48 48 6 6 Gamma Gamma c c includes dyspnea includes and dyspnea dyspnea exertional and dyspnea exertional glutamyltransferase glutamyltransferase 81 4281 7542 3875 38 d d Hypertriglyceridemia Hypertriglyceridemia 11 11 1 1 increased increased includes herpes includes zoster herpes and post-herpetic zoster and post-herpetic neuralgia neuralgia e e a a includes weight includes increased weight andincreased abnormaland weight abnormal gain weight gain National Cancer National Institute Cancer Common Institute Terminology CommonCriteria Terminology for Adverse CriteriaEvents, for Adverse Events, Creatinine increased Creatinine increased 47 147 40 1 240 2 f f includes urinary includes tract infection urinary tract and cystitis infection and cystitis version 4.03 version 4.03 Elevated lipase Elevated lipase 38 1238 3012 930 9 Clinically relevant Clinicallylaboratory relevant laboratory abnormalities abnormalities are shownare shown Chronic Graft-Versus-Host Chronic Graft-Versus-Host Disease InDisease a PhaseIn3,a Phase 3, Elevated amylase Elevated amylase 35 835 25 8 425 4 in Table 4.in Table 4. randomized, randomized, open-label,open-label, multi-center multi-center study, 165study, patients 165 patients a a Presented values Presented are worst values Grade arevalues worst regardless Grade values of regardless baseline of baseline were treated were with treated Jakafiwith andJakafi 158 patients and 158were patients treated were treated b b National Cancer National Institute Cancer Common Institute Terminology CommonCriteria Terminology for Adverse CriteriaEvents, for Adverse Events, with best available with besttherapy available fortherapy cGVHD for failing cGVHD treatment failing treatment version 4.03 version 4.03 with steroids withwith steroids or without with or other without immunosuppressive other immunosuppressive

DRUG INTERACTIONS Fluconazole Concomitant use of Jakafi with fluconazole increases ruxolitinib exposure [see Clinical Pharmacology (12.3) in Full Prescribing Information], which may increase the risk of exposurerelated adverse reactions. Avoid concomitant use of Jakafi with fluconazole doses of greater than 200 mg daily. Reduce the Jakafi dosage when used concomitantly with fluconazole doses of less than or equal to 200 mg [see Dosage and Administration (2.5) in Full Prescribing Information]. Strong CYP3A4 Inhibitors Concomitant use of Jakafi with strong CYP3A4 inhibitors increases ruxolitinib exposure [see Clinical Pharmacology (12.3) in Full Prescribing Information], which may increase the risk of exposure-related adverse reactions. Reduce the Jakafi dosage when used concomitantly with strong CYP3A4 inhibitors except in patients with aGVHD or cGVHD [see Dosage and Administration (2.5) in Full Prescribing Information]. Strong CYP3A4 Inducers Concomitant use of Jakafi with strong CYP3A4 inducers may decrease ruxolitinib exposure [see Clinical Pharmacology (12.3) in Full Prescribing Information], which may reduce efficacy of Jakafi. Monitor patients frequently and adjust the Jakafi dose based on safety and efficacy [see Clinical Pharmacology (12.3) in Full Prescribing Information].

USE IN SPECIFIC POPULATIONS Pregnancy: Risk Summary When pregnant rats and rabbits were administered ruxolitinib during the period of organogenesis adverse developmental outcomes occurred at doses associated with maternal toxicity (see Data). There are no studies with the use of Jakafi in pregnant women to inform drug-associated risks. The background risk of major birth defects and miscarriage for the indicated populations is unknown. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The background risk in the U.S. general population of major birth defects is 2% to 4% and miscarriage is 15% to 20% of clinically recognized pregnancies. Data: Animal Data Ruxolitinib was administered orally to pregnant rats or rabbits during the period of organogenesis, at doses of 15, 30 or 60 mg/kg/day in rats and 10, 30 or 60 mg/kg/day in rabbits. There were no treatment-related malformations.

Adverse developmental outcomes, such as decreases of approximately 9% in fetal weights were noted in rats at the highest and maternally toxic dose of 60 mg/kg/day.

This dose results in an exposure (AUC) that is approximately 2 times the clinical exposure at the maximum recommended dose of 25 mg twice daily.

In rabbits, lower fetal weights of approximately 8% and increased late resorptions were noted at the highest and maternally toxic dose of 60 mg/kg/day. This dose is approximately 7% the clinical exposure at the maximum recommended dose. In a pre- and post-natal development study in rats, pregnant animals were dosed with ruxolitinib from implantation through lactation at doses up to 30 mg/kg/day. There were no drug-related adverse findings in pups for fertility indices or for maternal or embryofetal survival, growth and development parameters at the highest dose evaluated (34% the clinical exposure at the maximum recommended dose of 25 mg twice daily). Lactation: Risk Summary No data are available regarding the presence of ruxolitinib in human milk, the effects on the breast fed child, or the effects on milk production.

Ruxolitinib and/or its metabolites were present in the milk of lactating rats (see Data). Because many drugs are present in human milk and because of the potential for thrombocytopenia and anemia shown for Jakafi in human studies, discontinue breastfeeding during treatment with Jakafi and for two weeks after the final dose. Data: Animal Data Lactating rats were administered a single dose of [14C]-labeled ruxolitinib (30 mg/kg) on postnatal Day 10, after which plasma and milk samples were collected for up to 24 hours. The AUC for total radioactivity in milk was approximately 13-fold the maternal plasma AUC. Additional analysis showed the presence of ruxolitinib and several of its metabolites in milk, all at levels higher than those in maternal plasma.

Pediatric Use The safety and effectiveness of Jakafi for treatment of myelofibrosis or polycythemia vera in pediatric patients have not been established. The safety and effectiveness of Jakafi for treatment of

6

FCS Magazine

steroid-refractory aGVHD has been established for treatment of children 12 years and older. Use of Jakafi in pediatric patients with steroid-refractory aGVHD is supported by evidence from adequate and well-controlled trials of Jakafi in adults [see Clinical Studies (14.3) in Full Prescribing Information] and additional pharmacokinetic and safety data in pediatric patients. The safety and effectiveness of Jakafi for treatment of steroid-refractory aGVHD has not been established in pediatric patients younger than 12 years old. The safety and effectiveness of Jakafi for treatment of cGVHD after failure of one or two lines of systemic therapy has been established for treatment of children 12 years and older. Use of Jakafi in pediatric patients with cGVHD after failure of one or two lines of systemic therapy is supported by evidence from adequate and well-controlled trials of Jakafi in adults and adolescents [see Clinical Studies (14.3, 14.4) in Full Prescribing Information] and additional pharmacokinetic and safety data in pediatric patients. The safety and effectiveness of Jakafi for treatment of cGVHD has not been established in pediatric patients younger than 12 years old. Jakafi was evaluated in a single-arm, dose-escalation study (NCT01164163) in 27 pediatric patients with relapsed or refractory solid tumors (Cohort A) and 20 with leukemias or myeloproliferative neoplasms (Cohort B). The patients had a median age of 14 years (range, 2 to 21 years) and included 18 children (age 2 to < 12 years), and 14 adolescents (age 12 to < 17 years). The dose levels tested were 15, 21, 29, 39, or 50 mg/m2 twice daily in 28-day cycles with up to 6 patients per dose group. Overall, 38 (81%) patients were treated with no more than a single cycle of Jakafi, while 3, 1, 2, and 3 patients received 2, 3, 4, and 5 or more cycles, respectively. A protocol-defined maximal tolerated dose was not observed, but since few patients were treated for multiple cycles, tolerability with continued use was not assessed adequately to establish a recommended Phase 2 dose higher than the recommended dose for adults. The safety profile in children was similar to that seen in adults. Juvenile Animal Toxicity Data Administration of ruxolitinib to juvenile rats resulted in effects on growth and bone measures. When administered starting at postnatal day 7 (the equivalent of a human newborn) at doses of 1.5 to 75 mg/kg/day, evidence of fractures occurred at doses ≥ 30 mg/kg/day, and effects on body weight and other bone measures [e.g., bone mineral content, peripheral quantitative computed tomography, and x-ray analysis] occurred at doses ≥ 5 mg/kg/day. When administered starting at postnatal day 21 (the equivalent of a human 2-3 years of age) at doses of 5 to 60 mg/kg/day, effects on body weight and bone occurred at doses ≥ 15 mg/kg/day, which were considered adverse at 60 mg/kg/day. Males were more severely affected than females in all age groups, and effects were generally more severe when administration was initiated earlier in the postnatal period. These findings were observed at exposures that are at least 27% the clinical exposure at the maximum recommended dose of 25 mg twice daily. Geriatric Use Of the total number of patients with MF in clinical studies with Jakafi, 52% were 65 years and older, while 15% were 75 years and older. No overall differences in safety or effectiveness of Jakafi were observed between these patients and younger patients. Clinical studies of Jakafi in patients with aGVHD did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger subjects. Of the total number of patients with cGVHD treated with Jakafi in clinical trials, 11% were 65 years and older. No overall differences in safety or effectiveness of Jakafi were observed between these patients and younger patients. Renal Impairment Total exposure of ruxolitinib and its active metabolites increased with moderate (CLcr 30 to 59 mL/min) and severe (CLcr 15 to 29 mL/min) renal impairment, and ESRD (CLcr less than 15 mL/min) on dialysis [see Clinical Pharmacology (12.3) in Full Prescribing Information].

Modify Jakafi dosage as recommended [see Dosage and Administration (2.6) in full Prescribing Information].

Hepatic Impairment Exposure of ruxolitinib increased with mild (Child-Pugh A), moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment [see Clinical Pharmacology (12.3) in full Prescribing Information].

Reduce Jakafi dosage as recommended in patients with MF or PV with hepatic impairment [see Dosage and Administration (2.6) in full Prescribing Information].

Reduce Jakafi dosage as recommended for patients with Stage 4 liver aGVHD. Monitor blood counts more frequently for toxicity and modify the Jakafi dosage for adverse reactions if they occur for patients with Score 3 liver cGVHD [see Dosage and Administration (2.6) and Clinical Pharmacology (12.3) in full Prescribing Information]. OVERDOSAGE There is no known antidote for overdoses with Jakafi. Single doses up to 200 mg have been given with acceptable acute tolerability. Higher than recommended repeat doses are associated with increased myelosuppression including leukopenia, anemia and thrombocytopenia. Appropriate supportive treatment should be given. Hemodialysis is not expected to enhance the elimination of Jakafi.

Jakafi is a registered trademark of Incyte.

U.S. Patent Nos. 7598257; 8415362; 8722693; 8822481; 8829013; 9079912; 9814722; 10016429 © 2011-2021 Incyte Corporation.

Revised: September 2021 PLR-JAK-00054

IN THIS ISSUE FEATURES 10

Patient Feature: Faith Over Fear Leads Tarshia Rivera to Remission

14

Celebrating National Nurses Week

SPOTLIGHTS 16

FCS Wellbeing App Challenges Team Members

17

New Platform for the FCS Hematology Oncology Review

18

Advancements in Technology for FCS Gynecologic Oncologists

19

COA Hosts the 2022 Community Oncology Conference

DEPARTMENTS 22

People & Places

26

Foundation Update

28

Mission, Vision and Values Update

29

From Our Patients

We welcome your feedback, article suggestions and photos (high resolution please).

Email to FCSCommunications@FLCancer.com On the cover: FCS Patient Tarshia Rivera Photography by Kari Dodge/Sebrie Images

10 14 16 28 Summer 2022

7

Advanced treatments personalized to you.

Through next-generation sequencing, we take a deep look into your genes to create treatment plans personalized to you.

This provides a road map for immunotherapies that strengthen the way your cells fight cancer. Our patients also have access to the latest clinical trials delivering quality treatment and expertise in communities across Florida. We take care of the big things in cancer care, so you can make the most of the little moments— every step of the way.

FLCancer.com/LittleThings

NATHAN H. WALCKER, CHIEF EXECUTIVE OFFICER

PHYSICIAN LEADERSHIP

PRESIDENT & MANAGING PHYSICIAN DISCIPLINARY & ETHICS COMMITTEE CO-CHAIR MICHAEL DIAZ, MD QUALITY COMMITTEE CHAIR JORGE AYUB, MD FINANCE COMMITTEE CHAIR MATTHEW A. FINK, MD PHYSICIAN DIRECTOR OF CLINICAL RESEARCH GUSTAVO A. FONSECA, MD, FACP CHIEF MEDICAL OFFICER OF THERAPEUTICS AND ANALYTICS LUCIO N. GORDAN, MD COMPLIANCE COMMITTEE CHAIR DISCIPLINARY & ETHICS COMMITTEE CO-CHAIR NOEL A. MAUN, MD, PhD QUALITY COMMITTEE VICE CHAIR PARESH PATEL, MD

At Florida Cancer Specialists, our mission, vision and values guide our ongoing efforts to serve patients and remain at the forefront of community oncology and clinical research. In this issue, we share our refreshed company framework, developed with great thought, to clearly articulate our current aspirations and to define the principles we will abide by to achieve our goals.

In this issue, we salute our nursing professionals.

Our Nursing Excellence Award is now named in memory of FCS oncology nurse Brandi Riber, a truly special individual whose work, in addition to her own personal cancer journey, epitomized the very heart and soul of our organization.

We are also excited to share details of our new wellness program, FCS Wellbeing, which is making it easier for team members to carve out time to focus on their individual health. Given the daily pressures we all experience at work and at home, providing a robust platform of tools and resources is critically important.

As we mark the halfway point of 2022, I extend my sincere thanks for your ongoing efforts to ensure the delivery of world-class care to each patient who entrusts their care to FCS.

AUDIT COMMITTEE CHAIR ANJAN J. PATEL, MD COMPENSATION COMMITTEE CHAIR DAVID WENK, MD

EXECUTIVE LEADERSHIP CHIEF EXECUTIVE OFFICER NATHAN H. WALCKER

CHIEF OPERATING OFFICER JASON COE CHIEF ADMINISTRATIVE OFFICER JOYCE NELSON CHIEF FINANCIAL OFFICER RICH MACCLARY CHIEF INFORMATION OFFICER KEN STURTZ CHIEF LEGAL OFFICER & GENERAL COUNSEL NANCY ARDELL CHIEF PROCUREMENT OFFICER PAUL CHADWICK

IN PARTNERSHIP WITH

PUBLISHED BY

MICHAEL DIAZ, MD, PRESIDENT & MANAGING PHYSICIAN Each day we continue to drive Florida Cancer Specialists forward as a cancer care leader. We place great value on the importance of sharing best practices with our colleagues and peers to enhance policymaking, innovation and cancer care delivery.

We recently launched the FCS Hematology Oncology Review, an innovative mode for sharing the news of exciting treatments trialed at FCS and throughout the world that are greatly impacting the quality of patient care and outcomes.

FCS physicians and executive and senior leaders consistently serve as keynote presenters and active participants in forums sponsored by the Florida Society of Clinical Oncology, the Community Oncology Alliance and others.

Did you know that nursing is the nation’s largest health care occupation? It’s a statistic that has earned the profession the nickname of “the backbone of our healthcare system.” Each day across our practice, over 1,800 skilled and dedicated nursing professionals serve and care for our patients with kindness and compassion. Among them are our 2022 Excellence in Nursing Leadership and Brandi Riber Patient Care and Advocacy awardees, selected by their peers, for their outstanding efforts.

As one team, one mission, our physicians and team members continue to give their very best to ensure that our patients experience the best outcomes possible.

Thank you for all that you do.

Summer 2022

9

TARSHIA RIVERA

10

FCS Magazine

PATIENT FEATURE

Faith,

Determination,

Optimism Tarshia Rivera stubbornly persevered until remission became a reality

BY PAIGE AIGRET

PHOTO BY BKARI DODGE / SEBRIE IMAGES

N

o matter what life threw at her, Tarshia Rivera kept her faith.

“I always remember the saying, ‘He won’t give you more than you can bear,’ and I felt that I was strong enough to handle what He was giving me,” she said.

For Rivera, breast cancer was one more challenge that she had the confidence to overcome. She found strength through prayer, and it kept her optimistic.

A Fort Myers, Florida native and resident, Rivera is a former pharmacy technician and the mother of four children. At the time of her diagnosis, her youngest child was only 7 years old, while the others had reached young adulthood.

“I didn’t want him to grow up without his mother … that’s what kept me strong,” Rivera said of her young son. Her desire to be there for someone else fueled her determination to fight for her life.

The years leading up to her diagnosis were tumultuous ones for Rivera and her family. In 2013, she lost her father, then her aunt was diagnosed with lung and breast cancer. In August 2014, Rivera found out she, too, had cancer.

She was diagnosed with ERPR HER2negative breast cancer, an aggressive form of the disease, which only served to strengthen her resolve.

Rivera and her aunt supported each other and even went to treatments together for a time. But in November 2017, her aunt’s battle with breast cancer ended. The loss

was difficult, but Rivera’s determination was undiminished.

She underwent chemotherapy in Fort Myers under the care of FCS medical oncologist Frank Rodriguez, MD. In March 2015, she had a bilateral mastectomy. Still, the cancer returned.

When Rodriguez heard about a clinical trial for immunotherapy, he reached out to the medical oncologist for FCS’s Drug Development Unit, Judy Wang, MD, and told her he viewed Rivera as a candidate for the trial.

Rivera was determined and ready to try something new. “I can’t give up now,” she told herself. “I had been through so much — the loss of my hair, the pain of crying.”

In May 2016, Rivera went to Sarasota, where one of FCS’s three Drug Development Units is located, to start immunotherapy.

Wang was able to enroll her in three different clinical trials over the course of her treatment.

She began to heal.

But as the cancer receded, other health issues including high blood pressure arose.

Following the recommendations of an FCS nurse, Rivera changed her lifestyle.

“I started walking, and I would do squats and burpees,” Rivera said. It was a lot for her because she was still undergoing treatment. She decided to take a break from vigorous exercise and focus on walking and a healthier diet.

She cut out red meat and pork and even now sticks to eating mostly chicken, fish and turkey. She eats more vegetables and tries to avoid starches. Rivera credits her FCS nurse Summer 2022

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PATIENT FEATURE

Tarshia Rivera (center) flashes a wide smile, happy to be in remission and surrounded by her family; pictured from left to right: her son Ryan Rivera, husband Rene Rivera, son Broderick Jenkins and granddaughter Jeryaunah Davis.

PHOTO BY BKARI DODGE / SEBRIE IMAGES

“God put all those doctors and nurses with me for a reason …

They were awesome!” for leading her to the healthier lifestyle that she has maintained.

Unable to recall the nurse’s name, Rivera said she suffers with “brain fog,” sometimes called “chemo brain.” This mental cloudiness, according to the American Cancer Society, is a type of cognitive impairment related to cancer treatments.

There is one date, however, that Rivera will not forget.

“June 23, 2020. That’s when Dr. Wang told me I was in remission,” Rivera said. She made a point of entering the date in her phone as soon as she got the good news.

Wang recalled that exciting time, as well.

“With her last trial, her cancer shrunk down small enough that we said, ‘You know what, you’re basically in a remission, why don’t we stop your therapies, give you a break and give you a chance to kind of just be you?’”

Wang continued with a smile, “She is really loving life, we’re so proud of her.”

Rivera was relieved and elated, of course, but couldn’t celebrate much due to the COVID-19 pandemic. There was no big family gathering, dinner or vacation.

“I didn’t want to take any chances with my immune system,” Rivera said. At this writing, she still has not returned to attending church services, something she misses greatly.

Vaccines, however, have made it possible for her to comfortably visit her daughter and newly born grandchild in Georgia. There, she takes daily walks, practices social distancing, finds joy in being in nature, video chats with friends and family members and watches her church services on YouTube.

The pandemic still has Rivera uneasy, “but I think eventually I’ll get over that fear,” she said. “It’s faith over fear, so I’m going to have to go with my faith.”

She’s looking forward to her future and returning to normalcy. She’s won her battle with cancer — one that she wasn’t left to fight alone.

“God put all those doctors and nurses with me for a reason … They were awesome!” Rivera said, adding that she will be forever grateful.

“I did it, and look at me now; I’m living proof. Just don’t give up. Continue to go on your journey.”

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RECOGNIZING EXCELLENCE

2022 Nursing Excellence Awards

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o celebrate oncology nursing month and national nurses week, Florida Cancer Specialists sent out a call for nominations for the 2022 Oncology Nursing Excellence Awards. The response was tremendous.

More than 40 FCS nurses were nominated by their peers and fellow team members for their superior quality of oncology nursing and leadership capabilities. Through a challenging blind review, the top two nominees were selected. Winners were notified in a surprise site visit by FCS leaders, and each received a plaque, one paid time off day and a basket of goodies created by FCS Director of Nursing Diane Cope, PhD, APRN-BC, AOCN.

As Team Lead, Jade Valencia, RN, BSN, OCN is the “solid rock” that the FCS Lakewood Ranch nursing and pharmacy teams rely on daily. She never shies away from any task and proactively jumps in to help keep the clinic running smoothly. Jade greets patients by their first names and displays unfaltering kindness and patience to all. Her colleagues admire her special ability to handle difficult situations with her calm and reassuring manner. Despite having lost both her parents and sister within the past year due to COVID-19, she continues on with a positive attitude and smile on her face. Congratulations, Jade!

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2022 EXCELLENCE IN NURSING LEADERSHIP AWARDEE PATRICIA MOREHEAD, RN FCS Lake Nona Clinical Nurse Manager Patricia Morehead, RN is described as a leader who communicates effectively and always makes time to listen, teach and go the extra mile for her staff — demonstrating concern and empathy for all. In addition to being an outstanding clinical nurse manager, she is admired by her FCS Lake Nona colleagues for being an exceptional oncology nurse, who genuinely cares about what she does and for the special connections she develops with patients.

Patricia serves as a role model for all. It was noted on her nomination that, “She is the difference that she wants to see every day.” Congratulations, Patricia!

PHOTO BY ZOLGA_F / ISTOCK / GETTY IMAGES PLUS

2022 BRANDI RIBER PATIENT CARE AND ADVOCACY AWARDEE FRANCES “JADE” VALENCIA, RN, BSN, OCN FCS Lakewood Ranch

AWARDS & ACCOLADES

PATIENT CARE AWARD NAMED IN MEMORY OF BRANDI RIBER, RN Brandi Riber embodied the mission and values of FCS through her compassionate, patient-centered care as an oncology nurse at FCS Gladiolus.

We recognize all the 2022 Nursing Excellence Award nominees, who demonstrate compassion, nursing expertise, leadership skills and a commitment to patient advocacy. Nominees received a special gift and gift card through FCS recognition.

NOMINEES FOR PATIENT CARE AND ADVOCACY AWARD Kellie Ackernecht, RN, OCN Melissa Anderson, RN Vanessa Adrover, RN Alison Bradshaw, RN Dawn Michelle Callahan, RN Nicole Cracchiola, RN

Mariah Dunniway, RN Hannah Granger, RN Isabela Mateo, RN Holly Mills, RN, OCN Caroline Peacock, RN, OCN Amanda Renshaw, LPN

Catherine Ruck, RN, OCN Leslie Selph, LPN Chanel Tomick, RN Frances “Jade” Valencia, RN, BSN, OCN Tamara Witte, RN

NOMINEES FOR NURSING LEADERSHIP Gretchen Abbott, RN, OCN Jessica Anderson, RN, BSN, OCN Melissa Anderson, RN Cheryl Brerenton, RN, OCN Julie Brown, RN, OCN Theresa Calabello, RN Melissa Clough, RN, OCN Lorraine Collins, RN Nicole Cracchiola, RN

Jessica Rios Cruz, LPN Christina Drobneck, RN, OCN Cristina Estipona, RN, OCN Mukabajumba Gafabusa, RN Kelli Hutton, RN, OCN Dawn Landolph, RN, BSN, MPA Christina Mason, RN Trudy McDonald, RN, OCN Brittany Moe, RN, BSN, OCN

Patricia Morehead, RN Izzy Olivera, RN, OCN Rennae Revell, RN, OCN Becton Roddenberry, RN, BSN, OCN, CEN, EMT-P Ashley Rollins, LPN Catherine Ruck, RN, OCN Frances “Jade” Valencia, RN, BSN, OCN Teresa Warner, RN, OCN

Riber was first diagnosed with breast cancer in January 2010.

She had recently graduated from nursing school and started on the path to her dream job of becoming an oncology nurse.

Her daugher, Morgan, was just 3 years old. Four years later, she was diagnosed with metastatic breast cancer. Her cancer journey lasted for 11 years.

She passed away in December 2021, shortly after celebrating her daughter’s 14th birthday.

Remarkably, Riber missed very little work from the time of her diagnosis. Her own journey greatly influenced her work at FCS. Having been in their place, she cared for her patients with compassion and empathy, seeing that every need was met, and every question answered. “My patients are my greatest inspiration,” she would say. “They are constant reminders to never give up hope, stay positive and give every day your best.”

Riber’s story truly is one of hope that will inspire other FCS oncology nurses to exemplify her passion for excellence in nursing and patient care.

Summer 2022

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FOR YOUR PHONE

FCS Wellbeing, A New Health and Wellness Program at FCS

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stress, managing weight and even financial coaching, FCS team members can focus on self-care at their own pace through the application’s daily reminders. They can also track their preventative care appointments and connect directly to their FCS benefits.

With the ability to create groups, enter into challenges and encourage friends with motivating shoutouts, FCS Wellbeing powered by Virgin Pulse fosters the creation of strong social connections within the application and across the organization.

There are a variety of health-related challenges available for everyone to participate individually or as a team, such as drinking eight glasses of water daily, moving every hour and, everyone’s favorite, tracking steps. There are opportunities for our teams to stay healthy together with the ability to create unique team challenges, which are great for team building and collaboration.

Every activity logged within FCS Wellbeing powered by Virgin Pulse presents an opportunity for individuals to earn points which can lead to future discounted health premiums or cash once a certain threshold is met. Depending on the activity, participants can acquire anywhere from 10 to 500 points each time they accomplish a task. Just for registering, each individual earns 500 points right from the start.

Some of the easiest and best ways to gain points are through daily activities: ■ Browse healthy recipes — earn 10 points.

■ Track your healthy habits — start the day with a healthy meal, take the stairs, appreciate others — earn 10 points.

■ Sleep more than seven hours at night — earn 50 points.

While earning points toward a discounted premium or cash (depending on the type of medical plan enrollment) may be the initial goal for team members, FCS sees an even greater opportunity through the health and well-being platform. By encouraging self-care, team members should be healthier, happier and experience less stress. Additionally, FCS Wellbeing provides a foundation from which we can enhance our culture, values and organizational goals by creating an environment where every employee feels valued and motivated to succeed.

PHOTOS BY NORTONRSX AND PROSTOCK-STUDIO / ISTOCK / GETTY IMAGES PLUS

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iven the daily pressures we all experience both at work and home, our safety and wellness team recognized the immense benefits from placing a stronger focus on our overall well-being at Florida Cancer Specialists. This past March, FCS launched its new health and wellness program, FCS Wellbeing, through digital health and engagement partner, Virgin Pulse.

FCS Wellbeing powered by Virgin Pulse is designed to fit the needs and goals of our entire organization. In the past couple of years especially, so many of us have faced unforeseen challenges, mental and physical obstacles and even burnout. So, we could no longer be distracted from the importance of self-care.

FCS Wellbeing powered by Virgin Pulse engages team members to focus on their individual health and wellness every day. Through app-based interactions tailored to individual needs, the platform presents opportunities for meaningful interactions designed to kickstart healthy habits that will last.

Virgin Pulse created the platform to meet members where they are with customizable activities. There truly is something for everyone, from health checks and meetings with certified health coaches, to self-paced wellness journeys with topics ranging from eating healthy, sleeping better, reducing

DIGITAL RESOURCES

ON THE WEB

FCS Hematology Oncology Review A new website offers a platform for physicians to easily access relevant articles and studies.

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hief Medical Officer of Therapeutics and Analytics Lucio Gordan, MD, has made a habit of distributing top articles to Florida Cancer Specialists clinicians on a monthly basis, sharing relevant articles and studies as they become available in the oncology and hematology world. Traditionally, articles were compiled in a PDF and distributed via email. As expected, providers would often flag the email to come back to it when time allowed, but found their emails were quickly buried and likely forgotten.

The top articles were, and continue to be, a highly valuable resource for physicians. With the knowledge and understanding that the delivery method was not ideal, Gordan set out on a mission to reform his system of sharing the articles with his colleagues. The importance of being able to not only share but collaborate with clinicians spanning across the state of Florida on a regular basis was not lost either. And so, the idea came to create a website to host the varying articles.

“Our patients and our peers rely on us for deep knowledge and understanding of the latest advances in medicine, especially as they pertain to hematology and oncology,” said Gordan. “Much like our

ever-changing medical practice, we must also be innovative in how we distribute and receive information.”

As the new year began, the FCS Hematology Oncology Review was unveiled.

The website is easily accessible to FCS clinicians as well as providers across the world.

New articles continue to be posted each month, similar to their previous cadence, but with heightened interactive capabilities.

Complex search abilities allow site visitors to search by date, topic and even be grouped by the month they were added.

The site also encourages insight and collaboration where visitors may comment and react to articles. Even more important, sharing capabilities are built directly into each page aside every article. So now, if found particularly interesting or relevant, an article can be shared directly through a variety of channels including social media and email.

Within FCS we are fortunate to offer over 300 clinical trials, and while previously the top articles highlighted research occurring outside of FCS, we are equally supportive and interested in the studies being offered in our own practice. The FCS Hematology Oncology Review also presents a conduit to highlight the publications of our own physicians, creating a

“By sharing these articles we are building our wealth of knowledge of new observations and treatments as they come available.” distinguished collection of numerous medical advances being made every day in the oncology world.

“By sharing these articles we are building our wealth of knowledge on new observations and treatments as they come available,” Gordan remarked. “Many are studies or articles from the leading oncology physicians across the globe, including our own FCS physicians. Through this new site, we are providing a platform for our physicians to continue exploring how we can collectively advance the care we provide.”

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TRINITY, WESLEY CHAPEL AND TALLAHASSEE, FLORIDA

FCS Gynecologic Oncologists Delivering Advanced Clinical Training for Robotic Surgery

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hysicians from around the country are learning advanced surgical techniques from two Florida Cancer Specialists gynecologic oncologists who are skilled at using the da Vinci® robotic-assisted surgical system. Jessica Stine, MD, who provides care at FCS Trinity and Wesley Chapel locations, and Margarett Ellison, MD, with Gynecologic Oncology of Tallahassee, A Division of Florida Cancer Specialists, have each received designation as a National GYN Oncology Observation Site for Intuitive Surgical.

They join a prestigious list of nine sites in the U.S. providing peer-to-peer advanced clinic training for surgeons. Designations were made based on each physician’s extensive experience, and for meeting and exceeding best in class volume and efficiency metrics and clinical outcomes.

An advanced robotic surgeon, Dr. Stine performs the highest volume of GYN robotic surgery in the Tampa Bay area. Dr. Ellison has 22 years of specialized expertise with a focus on the management of gynecologic malignancies, radical pelvic surgery and robotic surgery.

During the past 20 years, da Vinci® platforms have been transformative, yielding enormous benefits for patients. As use expands in oncology treatment, opportunities for one-onone training and coaching on best practices with an experienced and highly regarded colleague are critically important.

“We are performing technically challenging procedures in a way that results in less pain and side effects, faster recovery time and better patient outcomes,” said Stine.

“I am pleased to have the opportunity to share my expertise with colleagues,” Ellison said, “which will benefit many more oncology patients locally and across the country.”

Dr. Ellison and Dr. Stine are joined by their colleagues Howard M. Goodman, MD, Antonella Leary, MD and Christopher McCann, DO in providing gynecologic oncology at FCS.

1. Dr. Stine performs a GYN robotic surgery on the da Vinici Xi. 2. Margarett Ellison, MD, practices at Gynecologic Oncology of Tallahassee, a division of FCS. 3. FCS gynecologic oncologist Jessica Stine, MD, practices at FCS Trinity and Wesley Chapel offices. 4. Howard M. Goodman, MD, practices gynecologic oncology at FCS Lake Worth and West Palm Beach locations. 5. Antonella Leary, MD, sees patients at FCS Wellington North and Palm Beach Gardens offices and also serves as a Principal Investigator with the National Gynecologic Oncology Group.

6. Christopher McCann, DO, joined FCS in June 2022 and is currently seeing gynecologic oncology patients in the FCS Lake Worth office.

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CONFERENCES, NEWS AND EVENTS

KISSIMMEE, FLORIDA

2022 Community Oncology Conference In March, physicians and senior leaders of Florida Cancer Specialists participated in the 2022 Community Oncology Conference hosted by the Community Oncology Alliance (COA) in Kissimmee, Florida. Among the speakers were FCS President and Managing Physician and COA Immediate Past President Michael Diaz, MD and FCS Vice President of Pharmacy/Rx To Go, Ray Bailey, BPharm, RPh.

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1. FCS President and Managing Physician and COA Immediate Past President Michael Diaz, MD, leads a discussion on “Employer/ Payer Alert: Why the Site of Cancer Care Delivery Matters.” 2. FCS President and Managing Physician Michael Diaz, MD, leads a second discussion, “Going After Pharmacy Benefit Managers.” 3. Senior Director of Business Development Craig Bracher, Chief Operating Officer Jason Coe, Director of Care Management Beth Wittmer, Vice President of Marketing Michelle Robey and Director of Marketing Kat Wade were all in attendance at COA 2022. 4. FCS Vice President of Pharmacy/Rx To Go Ray Bailey, BPharm, RPh, speaks to a full room on “The New World of Oral Cancer Drug Dispensing: Pharmacy Challenges and Solutions.”

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ORLANDO, FLORIDA

Florida Society of Clinical Oncology (FLASCO) 2022 Business of Oncology Summit and Spring Session

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lorida Cancer Specialists physicians and leaders joined colleagues at the Florida Society of Clinical Oncology (FLASCO) 2022 Business of Oncology Summit and Spring Session held in Orlando, Florida, May 6–8.

This year’s theme was “Surviving in the Covid World: Oncology 2022,” and addressed existing and future challenges in the current landscape of cancer care.

The session also featured clinical evidence-based discussions about best treatment options in breast and lung cancer and acute myeloid leukemia.

During the conference gala, Dr. Michael Diaz was presented with the Dorothy Green Phillips Legacy 2022 Award. Dorothy Green Phillips was Executive Director of FLASCO for over 20 years and retired at the end of 1999. Dorothy is well known in the oncology community both in Florida and nationally.

She has been a trailblazer of innovative collaboration and a passionate advocate for patients and providers.

As a way to further recognize Dorothy and her contributions to FLASCO, upon her retirement, the Dorothy Green Phillips Legacy Award was created to honor a FLASCO member whose contributions leave a lasting legacy, like Dorothy’s. Each year Dorothy has the honor of personally selecting the recipient.

Congratulations to Dr. Diaz!

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CONFERENCES, NEWS AND EVENTS

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1. Michael Diaz, MD, moderates a session on “Alternative Payment Models after OCM.” 2. FCS President and Managing Physician Michael Diaz, MD, receives the Dorothy Green Phillips Legacy Award for his work in the oncology space.

3. Dorothy Green Phillips presents FCS President & Managing Physician with her FLASCO Legacy Award at this year’s gala.

4. FCS Senior Vice President of Pharmacy Services Ray Bailey, BPharm, RPh, participated in a discussion on “In-House Dispensing of Oral Oncolytics.” 5. FCS Senior Director of Value Based Care TR Stickland was a panelist in the “Alternative Payment Models after OCM” discussion led by Michael Diaz, MD. 6. Michael Diaz, MD, also served on a panel discussing “The Impact of COVID-19 on Cancer Care.” 7. FCS Medical Oncologist Martin Dietrich, MD, PhD, participated in a panel discussing “PDL1>50%: Chemo/IO v. IO Monotherapy.” 8. FCS Medical Oncologist Faithlore Gardner, MD, participated in the Molecular Diagnostic Panel on Solid Tumor.

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PEOPLE & PLACES

ATLANTA, GEORGIA

National Community Oncology Dispensing Association (NCODA) 2022 Spring Session

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linicians and leaders shared the latest advances in oncology pharmacy operations and dispensing practices at the National Community Oncology Dispensing Association (NCODA) 2022 Spring Forum.

The multi-day conference delved into new opportunities to enhance the value of pharmacy services within medically integrated oncology practices. Several discussions involved leaders from Rx To Go, the in-house oral oncolytic pharmacy of FCS, that works exclusively with the statewide practice’s physicians, clinicians and patients to provide timely dispensing and convenient home delivery of medications.

A keynote presentation by FCS Medical Oncologist Michel Velez, MD, was

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entitled: Tukysa (tucatinib) A Treatment Option for Patients with HER2-positive Metastatic Breast Cancer. Serving as panelists during interactive workshops and discussions were: Ray Bailey, BPharm, RPh, FCS Senior Director of Pharmacy Services, with “NCODA’s Non-Profit Partner Update and Donor Story: Be the Match”; Chris Elder, PharmD, BCOP, FCS Clinical Oncology Pharmacist on “Putting Positive Quality Interventions into Action: Consistent Clinical Standards and NCODA Resources”; Natasha Khrystolubova, RPh, BPharm, BCOP, Director of Pharmacy Clinical Services for RX To Go Pharmacy, and Amy Terhune, CPhT, FCS Prior Authorization Supervisor on “Prior Authorizations and Multiple Appeal Process:

How to Build a Stronger Appeal”; and Kara Sammons, CPhT, FCS Associate Director of Pharmacy Services, with “NCODA’s Center of Excellence Medically Integrated Pharmacy Accreditation.”

A poster entitled “Burden of Chemotherapy-Induced Myelosuppression Among Patients with Extensive-Stage Small Cell Lung Cancer: A Retrospective Study of Data from Community Oncology Practices” provided a look at real-world data for patients with extensive-stage small cell lung cancer (ES-SCLC) and the burden of chemotherapy-induced myelosuppression (CIM). FCS Medical Oncologist Lowell L. Hart, MD, FACP, FCS Director of Pharmacy Operations Kristen Boykin, PharmD, RPh/ CPh, BCOP, BCPS; FCS Senior Director of Pharmacy Services Ray Bailey, BPharm, RPh; and FCS Chief Medical Officer of Therapeutics and Analytics Lucio N. Gordan, MD were collaborators in the study which shows that CIM has a significant trilineage impact that patients experience early in therapy. These findings are contrary to the popular bias that CIM only shows up in one cell line or later in therapy.

COLONIAL RIBBON CUTTING

New Cancer Center Opens in Fort Myers

In May, FCS opened a new, state-ofthe-art facility; the Fort Myers Colonial office. The new location, one of five FCS sites of service in Lee County, replaces the former FCS clinic on Colonial Center Drive.

Designed to enhance patient comfort and convenience, the new clinic has more than 20,000 square feet of space and includes 18 private exam rooms and 51 infusion therapy chairs. It includes an in-house specialty pharmacy and hematopathology laboratory, as well as access to mobile positron emission tomography (PET) scanning services. Patients will also have access to participate in clinical trial opportunities at the FCS Drug Development Unit in nearby Sarasota.

The medical oncologists providing care to patients at this location are: Tadeu Ambros, MD; Liliana Bustamante, MD; Lowell Hart, MD, FACP; Michael McCleod, DO, FACOI; Silvia A. Romero, MD; Ahsan Shah, MD; Gamini Soori, MD, MBA, FACP, FRCP, CPE; and Syed F. Zafar, MD.

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PEOPLE & PLACES

Sherry Lark

NEW LEADERSHIP

Vice President of Human Resources

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herry brings more than 20 years of extensive human resources and compensation experience on a global scale. She has held increasingly responsible leadership positions with a diverse range of healthcare, pharmaceutical and private and public sector companies.

As FCS Vice President of Human Resources, Sherry oversees the development of strategic initiatives to maximize workforce planning, talent management and recruitment practices; ensures the efficiency and effectiveness of HR processes and programs; and continuously enhances diversity initiatives to support FCS’s goal of becoming an employer of choice.

NEW LEADERSHIP

Tonja A. Wise, CHC, CHPC, CCS Vice President of Compliance, Compliance Officer

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onja oversees a wide range of initiatives to further strengthen FCS’s culture of ethical behavior and compliance.

Tonja is an experienced compliance and ethics leader. She began her career as Revenue Cycle Manager for an independent rehab facility and, subsequently, held increasingly responsible compliance leadership positions with a number of leading health care companies, including Kaiser Permanente and Shriners Hospitals for Children.

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Where will you find your practice’s next leader?

Within your oncology practice, a transition of leadership is inevitable. Whether you or your physician is looking to retire, or your practice is looking to make a change in leadership, a succession plan will help preserve your practice’s strategic and financial goals and encourage a smooth transition. Our business optimization consultants will help you identify your practice’s philosophies and candidate requirements and support you through the recruitment and hiring process.

To learn more about our Succession Planning Services, email us at practiceconsulting@amerisourcebergen.com. ©2022 AmerisourceBergen Corporation. All Rights Reserved. SP-100591

FOUNDATION UPDATE

FCS Foundation News & Events Our Mission: Providing non-medical financial assistance for essential everyday living expenses to adults undergoing cancer treatment in Florida to allow them to focus on fighting cancer. Due to the generosity of the Florida Cancer Specialists physicians, 100% of donations received go directly towards paying the essential non-medical expenses of an adult battling cancer.

2021 Annual Results

“I began volunteering at the Florida Cancer Specialists clinic in Orange City because I wanted to be a helping hand to those receiving chemotherapy.

Both my parents are cancer survivors, and I loved the idea of being able to give the same support I gave them to other people going through that battle.

I am in nursing school and wanted to get some experience as well. I love helping the nurses and working with them to help provide a safe and clean environment for all the patients who come in. It has been an amazing experience so far and I am grateful that I have had the opportunity to volunteer! #thankyou #volunteerappreciationweek”

2021 Annual Results

2021 Annual Results

“I want you and your team to know how grateful I am for all of the financial help. I am enjoying my studio apartment. I feel safe because it’s in a good location with a beautiful view. I appreciate you all for your patience with me when my anxiety level was so high.

Hopefully someday I will be able to repay you all for your kindness and consideration. You all have given me peace of mind, which is so important in my healing from this breast cancer.”

— Catherine Johnson, Titusville

— Amber, FCS Orange City

The Florida Cancer Specialists Foundation is a 501(c)(3) nonprofit organization that helps individuals with their essential living expenses while they undergo treatment for cancer. Cancer patients are able to receive assistance from the Foundation for their non-medical bills, such as overdue rent, mortgage, utilities and car payments. This financial assistance immediately impacts cancer patients and their families in communities throughout Florida, allowing them to focus on their recovery.

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Phone: 941-677-7181

/FLCancerFoundation

/florida-cancer-specialists-foundation

Grow Your Oncology Nursing Career.

Our nurses provide exceptional care for patients through every step of their cancer journey. We value their skill and expertise and provide the environment and tools to help them succeed. Schedules that allow for work-life balance. Robust education and training support. Limitless growth potential.

Full-time, part-time, seasonal opportunities available at nearly 100 locations across Florida.

FLCancer.com/Careers

FCS UPDATE

COMMITMENT TO CARE

Mission, Vision and Values Updated Refreshed platform serves as a critical foundation for the future of FCS

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ur mission, vision and values serve as the critical foundation for all that we do.

As Florida Cancer Specialists has grown and evolved in recent years to remain at the forefront of world-class cancer care and clinical research, executive leaders recognized the importance of revisiting this platform to reaffirm the company’s strategic direction.

“We have experienced immense growth and transformation in the past few years — not only in the number of practice locations, but in the types of services we have to offer and in our approach to care,” said FCS President and Managing Physician Michael Diaz, MD. “It is critical that we have the proper lens through which we look forward, make decisions and serve our patients and communities.”

After a months-long process that involved much thought, consideration and lively dialogue, FCS has introduced an updated platform that defines the company’s “why” and “how,” with a focus on excellence, patient experience and innovation.

“These are not just new words,” said FCS Chief Executive Officer Nathan H. Walcker. “Our refreshed mission, vision and values will serve to challenge and inspire each of us in the years to come.”

An interactive culture training program is being rolled out to all FCS physicians and team members to create a shared understanding of the new platform.

“We are investing time and resources to ensure that every FCS team member understands fully why we are here, what is expected of each of us every day and how our work contributes to the lives of those we serve and to the success of the organization,” Walcker explained. “With clarity and focus, our mission and values will become integrated into everything we do.”

“This refreshed foundation will be made visible to our patients and communities as evidence of our company-wide commitment to world-class, patient-centric cancer care,” Diaz noted. “At every touchpoint, FCS team members will continue keeping the patient at the center of all they do to confirm the many reasons why FCS is the best choice for community oncology care.”

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Our MISSION is the guiding light of the things we will do to achieve our vision.

MISSION Centered on you, inspired by hope, powered by science and innovation.

Our VISION articulates our destination and what we are striving to create in the future.

VISION To be the world-class provider of cancer care, delivering innovation, excellence and a personalized experience to patients in the communities we live and serve in.

Our VALUES form the foundation of how we perform work and conduct ourselves with each other and our patients.

VALUES PATIENT FIRST Keeping the patient at the center of everything we do.

ACCOUNTABILITY Taking responsibility for our actions.

COMMITMENT AND CARE Upholding the FCS vision through every action.

TEAM Working together, one team, one mission.

PATIENT FEEDBACK

From Our Patients FACEBOOK REVIEW HEALTH GRADES: 5 STARS

Dr. Barakat is an absolute pleasure to speak with. He is caring, considerate and listens to his patients. I only just met him, but first impressions are always the best and I truly Ayman Barakat, MD believe so is he. His office personnel are great as well.

Thanks, Dr. Barakat and the Florida Cancer Specialists team on County Line Road.

My name is James and my son Jeff is being treated at your institute with Dr. Alexander for Hodgkin lymphoma. We are so happy that our son is under his care and also so happy that Jeff feels right at home with the utmost and courteous attention he has received on his first Christopher appointment visit. Thank you, Alexander, DO so much, for making Jeff so very comfortable with the doctor treating him and his team. Thank you, again, with all our hearts for all your concern.

FACEBOOK REVIEW

Dr. Molthrop has been my doctor for 23 years and he is wonderful. I am so glad I found him when I had my first breast cancer diagnosis. He’s so compassionate.

DOCTOR WEBMD: 5 STARS David C. Molthrop, Jr., MD

GOOGLE REVIEW: 5 STARS

Dr. Rubin is amazing! He correctly diagnosed and treated my iritis when other doctors misdiagnosed it. I can’t thank him enough.

Dr. Gupta is an amazing oncologist who has treated me with kindness and empathy from my very first visit. She is extremely patient and takes time to explain all possible side Shaachi Gupta, effects. Dr. Gupta makes me MD, MPH feel like I am her only patient, based on her attention to detail and her genuine interest in my well-being. I highly recommend her for your cancer treatment needs.

Mark S. Rubin, MD

GOOGLE REVIEW: 5 STARS

I’ve been a patient since December of 2016. I was recently diagnosed with a new breast cancer and I literally put off moving out of the state so that Dr. Chu and his team could help me through this one.

GOOGLE REVIEW: 5 STARS

Dr. Lobo is kind, caring, brilliant and one of the best doctors that I’ve ever met. He takes the time to talk to me and answer questions. I’ve never felt rushed or not important. I was very sad to leave him when I moved. I saw Dr. Lobo for eight years.

Luis Chu, MD

Christopher Lobo, MDMPH

Summer 2022

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PATIENT FEEDBACK

GOOGLE REVIEW: 5 STARS

GOOGLE REVIEW: 5 STARS

Dr. Patel is a wonderful physician. Very caring and straightforward. My husband and I both have him as our doctor. I thank God for that and for making Dr. Patel such a wonderful doctor. He is very Paresh Patel, MD thorough and always stays one step ahead in your treatment plan. Also, all of the staff in every department are very kind and will do anything to help you.

I cannot speak highly enough of Dr. Gauncial. I have no doubt that I owe my life to her and the terrific staff surrounding her. She is warm and caring, and when in doctor mode she is absolutely brilliant. She always made sure I understood what was going on.

Elizabeth Guancial, MD

GOOGLE REVIEW: 5 STARS

Dr. Van den Bergh is my oncologist and has been a truly great and caring physician. I am confident in her decisions to help me get better and, hopefully, cured.

HEALTHGRADES REVIEW: 5 STARS

He has saved the life of my mother and my husband!

Dr. Ambinder knows what he is doing!

Roy Ambinder, MD

HEALTHGRADES REVIEW: 5 STARS

GOOGLE REVIEW: 5 STARS

Dr. Zafar is a very compassionate individual. We are very grateful for all his care.

We are so fortunate to have been referred to him. My sister is in good hands. His entire team is the best.

I was very happy with the care he gave my sister. I thank God for putting Dr. Blanco in her path. All doctors should have his bedside manner. May God bless him always.

Syed F. Zafar, MD

The staff is very helpful for all matters. Dr. Kamath is a very caring, patient and understanding provider who has many years of experience in his specialty and is held in high regard among his peers. He always takes time to answer your questions.

FCS Magazine

Rafael W. Blanco, MD

GOOGLE REVIEW: 5 STARS

GOOGLE REVIEW: 5 STARS

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Magali Van den Bergh, MD

Sachin Kamath, MD

Dr. Goodman truly is a good man! He was a godsend back in 2020 when I found out I would need emergency surgery.

Dr. Goodman performed two separate procedures on me and both were extremely successful.

I thank God for his life! The staff at Florida Cancer Specialists are also very professional and efficient.

Howard M. Goodman, MD

GOOGLE REVIEW: 5 STARS

GOOGLE REVIEW: 5 STARS

Excellent caring doctor. If you need a hematologist, Dr. Singh is the best.

Dr. Kosloff is incredible! She is intelligent, caring and understanding. When I am with her I feel like I am her only patient. I have her undivided attention. She does not sugar coat a situation and lays all facts Rebecca A. Kosloff, MD on the table. My prescribed treatment has given me a high quality of life which I intend to maintain, with her help, for a very long time. I am thankful to have her as my oncologist.

Arsh Deep Singh, MD

HEALTHGRADES REVIEW: 5 STARS

Love Dr. Byron. She is amazing and saved my life. Everything she said went the way she said it would. Her and her staff do everything to make cancer treatment as easy on you as it can be. They are all wonderful!

Highly recommend.

Elizabeth A. Byron, MD

GOOGLE REVIEW: 5 STARS

Love Dr. Gersten. He is very caring and can ease your mind right away. He has a great bedside manner and I trust him completely.

HEALTHGRADES REVIEW: 5 STARS

Dr Liliana Bustamante is by far the best oncologist and I am blessed to have her working with me throughout this journey.

She is caring and will listen to her patient with any Liliana Bustamante, MD questions they may have.

She is very knowledgeable and professional in the new treatments and studies for oncology.

GOOGLE REVIEW: 5 STARS

Today was my first appointment with Dr. Berman. I went to his Wellington office. His office staff and medical staff were efficient and very kind. Dr. Berman was extremely kind, thorough and put me at Barry S. Berman, MD ease quickly.

Todd A. Gersten, MD

GOOGLE REVIEW: 5 STARS

Dr. Tetreault is outstanding in every respect. His knowledge about the variety of treatments and the trajectory for each is reassuring. He is approachable, affable and takes time to Scott A. Tetreault, MD know and understand the patient, as well as the family.

He understands that treating the disease emotionally, as well as physically, is important to achieve a comfortable lifestyle as the patient goes through stages of a disease. His explanations of treatments, side effects and outcomes are so valuable for understanding what to expect. He willingly answers all questions and clearly keeps up to date. His good humor and outstanding communication skills are much appreciated. We think we’ve found the best person in our area, and our family is thankful every day for Dr. Tetreault.

Summer 2022

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Close to cancer experts.

Closer to what you love.

Florida Cancer Specialists’ top-ranked cancer experts provide the most advanced treatments in our local community.

From genetic screening to immunotherapies, our quality care brings effective, targeted treatment to you so you can stay close to home.

We take care of all the big things in cancer care, so you can focus on all the little moments that matter—every step of the way.

FLCancer.com/LittleThings