First page 1 Next page Last page

FCS Magazine Spring 2022

Welcome to interactive presentation, created with Publuu. Enjoy the reading!

Spring 2022 1

SPRING 2022

Leader

in Transition

Dr. Lucio Gordan

assumes new,

‘data-driven’ role

2 FCS Magazine

In the phase 3 RESPONSE* trial, Jakaﬁ demonstrated superior results† vs BAT‡

(25/110) of patients receiving Jakafi achieved Hct control and ≥35% spleen volume

reduction at week 32 vs <1% (1/112) of patients receiving BAT (P < 0.0001)11§

23%

Composite Primary Endpoint

For adults with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea (HU)

Indications and Usage

Jakafi is indicated for treatment of polycythemia vera (PV) in adults who

have had an inadequate response to or are intolerant of hydroxyurea.

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

• 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

In a subset of patients, these characteristics may

indicate advanced PV despite treatment with HU

at the maximum tolerated dose and phlebotomy.1,7-10

Hct

≥45%

WBC count

>11 × 109/L

Disease-related

SYMPTOMS

BAT, best available therapy; Hct, hematocrit; MPN-SAF, Myeloproliferative Neoplasm Symptom Assessment Form; TSS, Total Symptom Score; WBC, white blood cell.

*The RESPONSE (Randomized study of Efficacy and Safety in POlycythemia vera with JAK iNhibitor ruxolitinib verSus bEst available care) trial was a randomized, open-label, active-controlled phase

3 trial comparing Jakafi with BAT in 222 patients with PV. Patients enrolled in the study had been diagnosed with PV for at least 24 weeks, had an inadequate response to or were intolerant of HU,

required phlebotomy for Hct control, and exhibited splenomegaly. All patients were required to demonstrate Hct control between 40% and 45% prior to randomization. After week 32, patients were

able to cross over to Jakafi treatment.11,12

†The composite primary endpoint was defined as Hct control without phlebotomy eligibility and a ≥35% spleen volume reduction as measured by CT or MRI. To achieve the Hct control endpoint, patients

could not become eligible for phlebotomy between weeks 8 and 32. Phlebotomy eligibility was defined as Hct >45% that is ≥3 percentage points higher than baseline or Hct >48% (lower value).11,12

‡BAT included HU (60%), interferon/pegylated interferon (12%), anagrelide (7%), pipobroman (2%), lenalidomide/thalidomide (5%), and observation (15%).11

§Jakafi 95% CI, 0.15-0.32; BAT 95% CI, 0.00-0.05.11

In a subset of patients, these characteristics may

indicate advanced PV despite treatment with HU

at the maximum tolerated dose and phlebotomy.1,7-10

PV is a hematologic malignancy that can

become advanced in a subset of patients1-6

adults with polycythemia vera (PV) who ha

PV is a hematologic malignancy t

become advanced in a subset of

EVERY DAY COUNTS.

JAKAFI CAN HELP.

Spring 2022 3

aPatients with data at both baseline (value >0) and week 32 were included in this analysis. Negative values indicate a reduction in the

severity of symptoms.12

RESPONSE was an open-label trial and, therefore, not designed to evaluate differences in symptoms11

Patient-reported outcomes were assessed using the MPN-SAF symptom diary. The MPN-SAF diary was administered daily in an

electronic diary format to score 14 disease-related symptoms on a scale of 0 (absent) to 10 (worst possible). At baseline, median TSS

was 23.4 (range, 0-106) in the group receiving Jakafi and 33.3 (range, 0-118) in the group receiving BAT.12,15

Exploratory Endpoint

0.4%

BAT

Jakaﬁ

-20

-40

-60

-80

-100

Median Change in Symptom Score

From Baseline to Week 32, %

-49.6%

-94.9%

-61.1%

-99.5% -100%

-51.5%

-44%

-80.2%

-64.1%

-41.8%

-37.1%

-93.9%

-65.9%

-4.2%

-2.1%

3.9%

-4.4%

11.1%

16.7%

7.9%

10.9%

17.2%

15.7%

1.4%

Cytokine

Symptoms

Hyperviscosity

Symptoms

Splenomegaly

Symptoms

Tiredness

Itching

Muscle Ache

Sweating While Awake

Night Sweats

Concentration Problems

Headache

Dizziness

Vision Problems

Ringing in Ears

Numbness or Tingling

in Hands or Feet

Skin Redness

Early Satiety

Abdominal Discomfort

Median Percent Change in Symptom Score From Baseline to Week 3212a

At week 32, 49% (36/74) of patients receiving Jakafi and

5% (4/81) of patients receiving BAT had at least a 50%

reduction in the 14-item MPN-SAF TSS12

Patients receiving Jakafi had reductions in all symptom

clusters reported, whereas patients receiving BAT had

an increase in scores of many symptoms12

From The New England Journal of Medicine, Vannucchi AM, Kiladjian JJ,

Griesshammer M, et al, Ruxolitinib versus Standard Therapy for the Treatment of

Society. Reprinted with permission from Massachusetts Medical Society.

To achieve the Hct control endpoint, patients could not become eligible for phlebotomy between weeks 8 and 32. Phlebotomy eligibility was defined as Hct >45%

that is ≥3 percentage points higher than baseline or Hct >48% (lower value)11,12

(66/110) of patients receiving Jakafi achieved Hct control at week 32 vs 19% (21/112) of patients receiving BAT11

60%

Individual Component of the Primary Endpoint

Analysis was conducted in week 32 Hct control

responders, beginning at week 3213

Progression events for the evaluation of

duration of absence of phlebotomy eligibility

included ﬁ rst of 2 consecutive Hct assessments

that conﬁ rms phlebotomy eligibility, death, or

development of MF or acute leukemia15

Reprinted from The Lancet Haematology, 7(3), Kiladjian J-J, Zachee P,

Hino M, Long-term efficacy and safety of ruxolitinib versus best available

therapy in polycythaemia vera (RESPONSE): 5-year follow up of a phase

100

108

120

132

144

156

168

180

192

204

216

228

240

252

264

Probability, %

No. of responders/events/censor: 66/16/50

Duration of Response, wk

+ Censoring times

– Jakaﬁ

No. at risk

Events

66 66 66 66 66 66 64 63 62 60 58 58 56 56 56 56 56 55 54 54 53 51 49 49 48 48 48 44 44 44 42 42 42 41 40 39 39 39 39 38 28 5 3 1 0

0 0 0 0 0 0 0 1 2 4 5 5 6 6 6 6 6 7 8 8 9 10 10 10 10 10 10 12 12 12 14 14 14 15 15 16 16 16 16 16 16 16 16 16 16

Probability of Maintaining Hct Controla at 5 Years in RESPONSE Trial13,14

aAbsence of phlebotomy eligibility

73%

Kaplan-Meier Estimate: Durability of Hct Control at 5 Years

(95% CI, 0.60-0.83)

Intervene with Jakaﬁ in your appropriate patients with advanced PV

INTERVENEJAKAFI.COM

INTERVENE WITH JAKAFI IN YOUR PATIENTS WITH ADVANCED PV

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. Barosi G, et al. Br J Haematol. 2010;148(6):961-963.

2. Parasuraman S, et al. Exp Hematol Oncol. 2016;5:3. 3. Mascarenhas J. Clin

Lymphoma Myeloma Leuk. 2016;16 Suppl:S124-S129. 4. Rumi E, et al. Blood.

2017;129(6):680-692. 5. Michiels JJ, et al. World J Hematol. 2013;2(3):71-88.

6. Michiels JJ. World J Crit Care Med. 2015;4(3):230-239. 7. Marchioli R, et al.

N Engl J Med. 2013;368(1):22-33. 8. Barbui T, et al. Blood. 2015;126(4):560-561.

9. Emanuel RM, et al. J Clin Oncol. 2012;30(33):4098-4103. 10. Verstovsek S, et al.

Cancer. 2014;120(4):513-520. 11. Jakafi Prescribing Information. Wilmington, DE:

Incyte Corporation. 12. Vannucchi AM, et al. N Engl J Med. 2015;372(5):426-435.

13. Kiladjian J-J, et al. Lancet Haematol. 2020;7(3):e226-e237. 14. Kiladjian J-J, et al.

Lancet Haematol. 2020;7(Suppl):1-18. 15. Data on file. Incyte Corporation. Wilmington, DE.

Jakafi and the Jakafi logo are registered trademarks of Incyte.

BRIEF SUMMARY: For Full Prescribing Information,

see package insert.

INDICATIONS AND USAGE Myelofibrosis 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. Polycythemia Vera Jakafi

is indicated for treatment of polycythemia vera (PV) in

adults who have had an inadequate response to or are

intolerant of hydroxyurea. Acute Graft-Versus-Host

Disease Jakafi is indicated for treatment of steroid-

refractory acute graft-versus-host disease (aGVHD) in adult

and pediatric patients 12 years and older. Chronic Graft-

Versus-Host Disease Jakafi is indicated for treatment of

chronic graft-versus-host disease (cGVHD) after failure of

one or two lines of systemic therapy in adult and pediatric

patients 12 years and older.

CONTRAINDICATIONS None.

WARNINGS AND PRECAUTIONS Thrombocytopenia,

Anemia and Neutropenia Treatment with Jakafi can

cause thrombocytopenia, anemia and neutropenia. [see

Adverse Reactions (6.1) in Full Prescribing Information].

Manage thrombocytopenia by reducing the dose or

temporarily interrupting Jakafi. Platelet transfusions may

be necessary [see Dosage and Administration (2) in Full

Prescribing Information]. Patients developing anemia may

require blood transfusions and/or dose modifications of

Jakafi. Severe neutropenia (ANC less than 0.5 × 109/L)

was generally reversible by withholding Jakafi until

recovery. 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 [see

Dosage and Administration (2) in Full Prescribing

Information]. Risk of Infection Serious bacterial,

mycobacterial, fungal and viral infections have occurred

[see Adverse Reactions (6.1) in Full Prescribing

Information]. Delay starting therapy with 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 Tuberculosis infection has been reported in

patients receiving Jakafi. Observe patients receiving

Jakafi for signs and symptoms of active tuberculosis and

manage promptly. Prior to initiating Jakafi, patients

should be evaluated for tuberculosis risk factors, and

those at higher risk should be tested for latent infection.

Risk factors include, but are not limited to, prior residence

in or travel to countries with a high prevalence of

tuberculosis, close contact with a person with active

tuberculosis, and a history of active or latent tuberculosis

where an adequate course of treatment cannot be

confirmed. For patients with evidence of active or latent

tuberculosis, consult a physician with expertise in the

treatment of tuberculosis before starting Jakafi. The

decision to continue Jakafi during treatment of active

tuberculosis should be based on the overall risk-benefit

determination. Progressive Multifocal

Leukoencephalopathy Progressive multifocal

leukoencephalopathy (PML) has occurred with Jakafi

treatment. If PML is suspected, stop Jakafi and evaluate.

Herpes Zoster Advise patients about early signs and

symptoms of herpes zoster and to seek treatment as

early as possible if suspected. Hepatitis B Hepatitis B viral

load (HBV-DNA titer) increases, with or without associated

elevations in alanine aminotransferase and aspartate

aminotransferase, have been reported in patients with

chronic HBV infections taking Jakafi. The effect of Jakafi

on viral replication in patients with chronic HBV infection

is unknown. Patients with chronic HBV infection should

be treated and monitored according to clinical guidelines.

Symptom Exacerbation Following Interruption or

Discontinuation of Treatment with Jakafi Following

discontinuation of Jakafi, symptoms from

myeloproliferative neoplasms may return to pretreatment

levels over a period of approximately one week. Some

patients with MF have experienced one or more of the

following adverse events after discontinuing Jakafi: fever,

respiratory distress, hypotension, DIC, or multi-organ

failure. If one or more of these occur after discontinuation

of, or while tapering the dose of Jakafi, evaluate for and

treat any intercurrent illness and consider restarting or

increasing the dose of Jakafi. Instruct patients not to

interrupt or discontinue Jakafi therapy without consulting

their physician. When discontinuing or interrupting

therapy with Jakafi for reasons other than

thrombocytopenia or neutropenia [see Dosage and

Administration (2.7) in Full Prescribing Information],

consider tapering the dose of Jakafi gradually rather than

discontinuing abruptly. Non-Melanoma Skin Cancer

(NMSC) Non-melanoma skin cancers including basal cell,

squamous cell, and Merkel cell carcinoma have occurred

in patients treated with Jakafi. Perform periodic skin

examinations. Lipid Elevations Treatment with Jakafi has

been associated with increases in lipid parameters

including total cholesterol, low-density lipoprotein (LDL)

cholesterol, and triglycerides [see Adverse Reactions (6.1)

in Full Prescribing Information]. The effect of these lipid

parameter elevations on cardiovascular morbidity and

mortality has not been determined in patients treated

with Jakafi. Assess lipid parameters approximately 8-12

weeks following initiation of Jakafi therapy. Monitor and

treat according to clinical guidelines for the management

of hyperlipidemia. Major Adverse Cardiovascular

Events (MACE) Another JAK-inhibitor has increased the

risk of MACE, including cardiovascular death, myocardial

infarction, and stroke (compared to those treated with

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. Thrombosis

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 MF and 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. Secondary

Malignancies 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. ADVERSE REACTIONS The following clinically

significant adverse reactions are discussed in greater

detail in other sections of the labeling: • Thrombocytopenia,

Anemia and Neutropenia [see Warnings and Precautions

(5.1) in Full Prescribing Information] • Risk of Infection

[see Warnings and Precautions (5.2) in Full Prescribing

Information] • Symptom Exacerbation Following

Interruption or Discontinuation of Treatment with Jakafi

[see Warnings and Precautions (5.3) in Full Prescribing

Information ] • Non-Melanoma Skin Cancer [see Warnings

and Precautions (5.4) in Full Prescribing Information]

• Lipid Elevations [see Warnings and Precautions (5.5)

in Full Prescribing Information] • Major Adverse

Cardiovascular Events (MACE) [see Warnings and Precautions

(5.6) in Full Prescribing Information] • Thrombosis [see

Warnings and Precautions (5.7) in Full Prescribing

Information] • Secondary Malignancies [see Warnings and

Precautions (5.8) in Full Prescribing Information]. Clinical

Trials Experience Because clinical trials are conducted

under widely varying conditions, adverse reaction rates

observed in the clinical trials of a drug cannot be directly

compared to rates in the clinical trials of another drug

and may not reflect the rates observed in practice.

Myelofibrosis The safety of Jakafi was assessed in 617

patients in six clinical studies with a median duration of

follow-up of 10.9 months, including 301 patients with MF in

two Phase 3 studies. In these two Phase 3 studies,

patients had a median duration of exposure to Jakafi of

9.5 months (range 0.5 to 17 months), with 89%

of patients treated for more than 6 months and 25% treated

for more than 12 months. One hundred and eleven (111)

patients started treatment at 15 mg twice daily and 190

patients started at 20 mg twice daily. In patients starting

treatment with 15 mg twice daily (pretreatment platelet

counts of 100 to 200 × 109/L) and 20 mg twice daily

(pretreatment platelet counts greater than 200 × 109/L),

65% and 25% of patients, respectively, required a dose

reduction below the starting dose within the first 8 weeks

of therapy. In a double-blind, randomized, placebo-

controlled study of Jakafi, among the 155 patients

treated with Jakafi, the most frequent adverse reactions

were thrombocytopenia and anemia [see Table 2].

Thrombocytopenia, anemia and neutropenia are dose-related

effects. The three most frequent nonhematologic adverse

reactions were bruising, dizziness and headache [see

Table 1]. Discontinuation for adverse events, regardless of

causality, was observed in 11% of patients treated with Jakafi

and 11% of patients treated with placebo. Table 1 presents

the most common nonhematologic adverse reactions

occurring in patients who received Jakafi in the double-blind,

placebo-controlled study during randomized treatment.

Table 1: Myelofibrosis: Nonhematologic Adverse

Reactions Occurring in Patients on Jakafi in

the Double-blind, Placebo-controlled Study

During Randomized Treatment

Jakafi

(N=155)

Placebo

(N=151)

Adverse

Reactions

All

Gradesa

(%)

Grade

(%)

Grade

(%)

All

Grades

(%)

Grade

(%)

Grade

(%)

Bruisingb

< 1

Dizzinessc

< 1

Headache

Urinary Tract

Infectionsd

< 1

Weight Gaine

< 1

Flatulence

< 1

Herpes Zosterf

< 1

a National Cancer Institute Common Terminology Criteria for Adverse Events

(CTCAE), version 3.0

b includes contusion, ecchymosis, hematoma, injection site hematoma,

periorbital hematoma, vessel puncture site hematoma, increased tendency

to bruise, petechiae, purpura

c includes dizziness, postural dizziness, vertigo, balance disorder, Meniere’s

Disease, labyrinthitis

d includes urinary tract infection, cystitis, urosepsis, urinary tract infection

bacterial, kidney infection, pyuria, bacteria urine, bacteria urine identified,

nitrite urine present

e includes weight increased, abnormal weight gain

f includes herpes zoster and post-herpetic neuralgia

Description of Selected Adverse Reactions: Anemia

In the two Phase 3 clinical studies, median time to

onset of first CTCAE Grade 2 or higher anemia was

approximately 6 weeks. One patient (< 1%) discontinued

treatment because of anemia. In patients receiving Jakafi,

mean decreases in hemoglobin reached a nadir of

approximately 1.5 to 2.0 g/dL below baseline after 8 to 12

weeks of therapy and then gradually recovered to reach a

new steady state that was approximately 1.0 g/dL below

baseline. This pattern was observed in patients regardless

of whether they had received transfusions during therapy.

In the randomized, placebo-controlled study, 60% of

patients treated with Jakafi and 38% of patients receiving

placebo received red blood cell transfusions during

randomized treatment. Among transfused patients, the

median number of units transfused per month was 1.2

in patients treated with Jakafi and 1.7 in placebo treated

patients. Thrombocytopenia In the two Phase 3 clinical

studies, in patients who developed Grade 3 or 4

thrombocytopenia, the median time to onset was

approximately 8 weeks. Thrombocytopenia was generally

reversible with dose reduction or dose interruption.

The median time to recovery of platelet counts above

50 × 109/L was 14 days. Platelet transfusions were

administered to 5% of patients receiving Jakafi and to 4%

of patients receiving control regimens. Discontinuation

Spring 2022 5

of treatment because of thrombocytopenia occurred in

< 1% of patients receiving Jakafi and < 1% of patients

receiving control regimens. Patients with a platelet count

of 100 × 109/L to 200 × 109/L before starting Jakafi had

a higher frequency of Grade 3 or 4 thrombocytopenia

compared to patients with a platelet count greater than

200 × 109/L (17% versus 7%). Neutropenia In the two

Phase 3 clinical studies, 1% of patients reduced or stopped

Jakafi because of neutropenia. Table 2 provides the

frequency and severity of clinical hematology abnormalities

reported for patients receiving treatment with Jakafi or

placebo in the placebo-controlled study.

Table 2: Myelofibrosis: Worst Hematology Laboratory

Abnormalities in the Placebo-Controlled Studya

Jakafi

(N=155)

Placebo

(N=151)

Laboratory

Parameter

All

Gradesb

(%)

Grade

(%)

Grade

(%)

All

Grades

(%)

Grade

(%)

Grade

(%)

Thrombocytopenia

Anemia

Neutropenia

< 1

a Presented values are worst Grade values regardless of baseline

b National Cancer Institute Common Terminology Criteria for Adverse Events,

version 3.0

Additional Data from the Placebo-Controlled Study

• 25% of patients treated with Jakafi and 7% of patients

treated with placebo developed newly occurring or

worsening Grade 1 abnormalities in alanine transaminase

(ALT). The incidence of greater than or equal to Grade 2

elevations was 2% for Jakafi with 1% Grade 3 and no

Grade 4 ALT elevations. • 17% of patients treated with

Jakafi and 6% of patients treated with placebo developed

newly occurring or worsening Grade 1 abnormalities in

aspartate transaminase (AST). The incidence of Grade 2

AST elevations was < 1% for Jakafi with no Grade 3 or 4

AST elevations. • 17% of patients treated with Jakafi and

< 1% of patients treated with placebo developed newly

occurring or worsening Grade 1 elevations in cholesterol.

The incidence of Grade 2 cholesterol elevations was

< 1% for Jakafi with no Grade 3 or 4 cholesterol

elevations. Polycythemia Vera In a randomized,

open-label, active-controlled study, 110 patients with PV

resistant to or intolerant of hydroxyurea received Jakafi

and 111 patients received best available therapy [see

Clinical Studies (14.2) in Full Prescribing Information].

The most frequent adverse reaction was anemia.

Discontinuation for adverse events, regardless of

causality, was observed in 4% of patients treated with

Jakafi. Table 3 presents the most frequent nonhematologic

adverse reactions occurring up to Week 32.

Table 3: Polycythemia Vera: Nonhematologic Adverse

Reactions Occurring in ≥ 5% of Patients on

Jakafi in the Open-Label, Active-controlled

Study up to Week 32 of Randomized Treatment

Jakafi

(N=110)

Best Available

Therapy (N=111)

Adverse Reactions

All

Gradesa

(%)

Grade

3-4

(%)

All

Grades

(%)

Grade

3-4

(%)

Diarrhea

< 1

Dizzinessb

Dyspneac

Muscle Spasms

< 1

Constipation

Herpes Zosterd

< 1

Nausea

Weight Gaine

< 1

Urinary Tract Infectionsf

Hypertension

< 1

a National Cancer Institute Common Terminology Criteria for Adverse Events

(CTCAE), version 3.0

b includes dizziness and vertigo

c includes dyspnea and dyspnea exertional

d includes herpes zoster and post-herpetic neuralgia

e includes weight increased and abnormal weight gain

f includes urinary tract infection and cystitis

Clinically relevant laboratory abnormalities are shown

in Table 4.

Table 4: Polycythemia Vera: Selected Laboratory

Abnormalities in the Open-Label, Active-

controlled Study up to Week 32 of

Randomized Treatmenta

Jakafi

(N=110)

Best Available

Therapy (N=111)

Laboratory

Parameter

All

Gradesb

(%)

Grade

(%)

Grade

(%)

All

Grades

(%)

Grade

(%)

Grade

(%)

Hematology

Anemia

< 1

Thrombocytopenia

< 1

Neutropenia

< 1

Chemistry

Hypercholesterolemia

Elevated ALT

< 1

Elevated AST

< 1

Hypertriglyceridemia

a Presented values are worst Grade values regardless of baseline

b National Cancer Institute Common Terminology Criteria for Adverse Events,

version 3.0

Acute Graft-Versus-Host Disease In a single-arm,

open-label study, 71 adults (ages 18-73 years) were

treated with Jakafi for aGVHD failing treatment with

steroids with or without other immunosuppressive drugs

[see Clinical Studies (14.3) in Full Prescribing Information].

The median duration of treatment with Jakafi was 46 days

(range, 4-382 days). There were no fatal adverse reactions

to Jakafi. An adverse reaction resulting in treatment

discontinuation occurred in 31% of patients. The most

common adverse reaction leading to treatment

discontinuation was infection (10%). Table 5 shows the

adverse reactions other than laboratory abnormalities.

Table 5: Acute Graft-Versus-Host Disease:

Nonhematologic Adverse Reactions Occurring

in ≥ 15% of Patients in the Open-Label, Single-

Cohort Study

Jakafi (N=71)

Adverse Reactionsa

All Gradesb (%)

Grade 3-4 (%)

Infections (pathogen

not specified)

Edema

Hemorrhage

Fatigue

Bacterial infections

Dyspnea

Viral infections

Thrombosis

Diarrhea

Rash

Headache

Hypertension

Dizziness

a Selected laboratory abnormalities are listed in Table 6 below

b National Cancer Institute Common Terminology Criteria for Adverse Events

(CTCAE), version 4.03

Selected laboratory abnormalities during treatment with

Jakafi are shown in Table 6.

Table 6: Acute Graft-Versus-Host Disease: Selected

Laboratory Abnormalities Worsening from

Baseline in the Open-Label, Single Cohort Study

Jakafi (N=71)

Worst grade during treatment

Laboratory Parameter

All Gradesa (%)

Grade 3-4 (%)

Hematology

Anemia

Thrombocytopenia

Neutropenia

Chemistry

Elevated ALT

Elevated AST

Hypertriglyceridemia

a National Cancer Institute Common Terminology Criteria for Adverse Events,

version 4.03

Chronic Graft-Versus-Host Disease In a Phase 3,

randomized, open-label, multi-center study, 165 patients

were treated with Jakafi and 158 patients were treated

with best available therapy for cGVHD failing treatment

with steroids with or without other immunosuppressive

drugs [see Clinical Studies (14.4) in full Prescribing

Information]; sixty-five patients crossed over from best

available therapy to treatment with Jakafi, for a total of

230 patients treated with Jakafi. The median duration of

exposure to Jakafi for the study was 49.7 weeks (range, 0.7

to 144.9 weeks) in the Jakafi arm. One hundred and nine

(47%) patients were on Jakafi for at least 1 year. There were

five fatal adverse reactions to Jakafi, including 1 from toxic

epidermal necrolysis and 4 from neutropenia, anemia and/or

thrombocytopenia. An adverse reaction resulting in treatment

discontinuation occurred in 18% of patients treated with

Jakafi. An adverse reaction resulting in dose modification

occurred in 27%, and an adverse reaction resulting in

treatment interruption occurred in 23%. The most common

hematologic adverse reactions (incidence > 35%) are

anemia and thrombocytopenia. The most common

nonhematologic adverse reactions (incidence ≥ 20%) are

infections (pathogen not specified) and viral infection. Table 7

presents the most frequent nonlaboratory adverse reactions

occurring up to Cycle 7 Day 1 of randomized treatment.

Table 7: Chronic Graft-Versus-Host Disease: All-Grade

(≥ 10%) and Grades 3-5 (≥ 3%) Nonlaboratory

Adverse Reactions Occurring in Patients in the

Open-Label, Active-controlled Study up to Cycle

7 Day 1 of Randomized Treatment

Jakafi

(N = 165)

Best Available

Therapy (N = 158)

Adverse Reactionsb

All

Gradesa

(%)

Grade

≥ 3

(%)

All

Grades

(%)

Grade

≥ 3

(%)

Infections and infestations

Infections (pathogen

not specified)

Viral infections

Musculoskeletal and connective tissue disorders

Musculoskeletal pain

General disorders and administration site conditions

Pyrexia

Fatigue

Edema

Vascular disorders

Hypertension

Hemorrhage

Respiratory, thoracic and mediastinal disorders

Cough

Dyspnea

Gastrointestinal disorders

Nausea

Diarrhea

a National Cancer Institute Common Terminology Criteria for Adverse Events

(CTCAE), version 4.03

b Grouped terms that are composites of applicable adverse reaction terms.

Clinically relevant laboratory abnormalities are shown in

Table 8.

Table 8: Chronic Graft-Versus-Host Disease: Selected

Laboratory Abnormalities in the Open-Label,

Active-controlled Study up to Cycle 7 Day 1

of Randomized Treatmenta

Jakafi

(N=165)

Best Available

Therapy (N=158)

Laboratory Test

All

Gradesb

(%)

Grade

≥ 3

(%)

All

Grades

(%)

Grade

≥ 3

(%)

Hematology

Anemia

Thrombocytopenia

Neutropenia

Chemistry

Hypercholesterolemia

Elevated AST

Elevated ALT

Gamma

glutamyltransferase

increased

Creatinine increased

Elevated lipase

Elevated amylase

a Presented values are worst Grade values regardless of baseline

b National Cancer Institute Common Terminology Criteria for Adverse Events,

version 4.03

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 exposure-

related 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

Jakafi is a registered trademark of Incyte.

U.S. Patent Nos. 7598257; 8415362; 8722693; 8822481;

8829013; 9079912; 9814722; 10016429

Revised: September 2021 PLR-JAK-00054

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.

Spring 2022 7

DEPARTMENTS

People and Places

Foundation Update

From Our Patients

SPOTLIGHTS

Data Governance

Strategic Partnership

Value-Based Care

FCS Operations Team Meeting

FEATURES

Physician Leaders Take on

New Roles in the New Year

Conquering Breast Cancer

THIS

ISSUE

We welcome your feedback, article suggestions

and photos (high resolution please).

Email to FCSCommunications@FLCancer.com

On the cover: Dr. Lucio Gordan with one of his

horses at his Gainesville farm.

Photography by Blake Jones

We have a lot in

common with you—

The patient is at the heart

of everything we do

Scan the QR code below with your smartphone or visit

annexushealth.com/fcs to view a personal message

from our Co-Founder and CEO Joe Baffone to all of you

at Florida Cancer Specialists. We are passionate about

helping you help your patients gain access to the care

they need—faster and with less financial toxicity.

Spring 2022 9

PHYSICIAN LEADERSHIP

PRESIDENT & MANAGING PHYSICIAN

MICHAEL DIAZ, 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

CHIEF COMPLIANCE OFFICER

VALERIE EASTWOOD

PUBLISHED BY

IN PARTNERSHIP WITH

NATHAN H. WALCKER,

CHIEF EXECUTIVE OFFICER

Across our practice, we have

embraced this new year of

opportunities and challenges at

full speed.

Data increasingly drives the

actions we take and the decisions we

make. In this issue, we shine the spotlight on our recently

launched Data Governance Program. It’s a significant

initiative that is enhancing our ability to consistently

provide exceptional patient care.

You’ll also want to read about our value-based care

activities, which continue to rank FCS among the top-

performing oncology practices in the country for quality

and cost-saving measures.

At all times our work is centered around those who

entrust their care to us. There is no greater reward than to

hear from our patients that choosing FCS was their best

decision ever.

Amy Rodriquez, a breast cancer survivor, tells of her

experience with Dr. David Wright and the Tampa Cancer

Center team. She describes how every person she

encountered welcomed and embraced her like family. The

care and support she received enabled her to return to

military service, cancer free.

I could not be more proud of the hard work and

dedication of our talented and caring physicians and team

members. Together we will continue to push FCS to new

heights of success and deliver on our promise to our patients

by providing world-class cancer care, close to home.

MICHAEL DIAZ, MD,

PRESIDENT & MANAGING

PHYSICIAN

As an oncologist, it is a privilege

and an amazing opportunity to

help make the world a better place

for cancer patients. In my new

role as FCS President & Managing

Physician, I look forward to helping FCS achieve many

more milestones as an innovative leader in community-

based oncology care.

While I am energized by the successes that are ahead

of us, certain things will remain constant — above all, our

commitment as one team to one mission.

We will continue to lead the way in cutting-edge cancer

innovations and discoveries and introduce supportive

services that ease stress for patients and families and

improve their overall quality of life.

Another constant is our steadfast commitment to

improving the access and affordability of cancer care.

No voices are better equipped to make an impact

than our dedicated CPAN advocates. They are the

patients, survivors, caregivers and clinicians who have

experienced cancer firsthand. We are so fortunate

for their partnership, and in this issue, you will learn

how they are helping eliminate barriers to life-saving

community-based cancer care.

Every day, it is our privilege and our passion to serve

our patients. Thank you for all you do to help us deliver

on our mission.

10 FCS Magazine

LEADERSHIP FEATURE

Spring 2022 11

LEADERSHIP FEATURE

BY EMMA WITMER, PHOTOS BY BLAKE JONES

bit of rearranging at the executive level has positioned

FCS to achieve new heights of success.

Michael Diaz, MD, FCS Executive Board member,

Director of Patient Advocacy and medical oncologist at

two FCS locations in St. Petersburg, began the new year as FCS

President & Managing Physician. He succeeds Lucio Gordan, MD,

who, after serving as FCS’s physician leader for three years,

has stepped into a new role that will allow him to continue

supporting strategic initiatives in clinical advancements, value-

based care and much more.

“Our journey in creating our national reputation

has involved many years of hard work, dedication and

commitment, and we are so grateful to Dr. Gordan for his

outstanding leadership,” said FCS Chief Executive Officer

Nathan H. Walcker. “Dr. Diaz is perfectly positioned to

take on this role at this time,” he added, citing his long-term

commitment to patients and his career focus on ensuring

access and affordability to cancer care.

Diaz has been influential in both state and national policy,

often organizing grassroots campaigns to block legislation

that could pose harm to cancer patients. As a member of

the Florida Medicaid Pharmaceutical and Therapeutics

Committee, Diaz has worked to revamp the practices of

pharmacy benefit managers and helped develop alternative

oncology payment models with the American Society of

Clinical Oncology, Community Oncology Alliance and the

Centers for Medicare and Medicaid Services Innovation.

Diaz says, “Patients need and deserve to get excellent quality,

and there is no reason that should be sacrificed for monetary

reasons. You can balance both, and that’s what I have been

striving to do.”

As FCS President & Managing Physician, Diaz is

committed to working on behalf of patients and healthcare

Michael Diaz, MD

President & Managing

Physician

Lucio Gordan, MD

Chief Medical Officer of

Therapeutics and Analytics

Physician Leaders

Take on New Roles

in the New Year

Following his passion,

Chief Medical Officer

of Therapeutics and

Analytics Dr. Lucio

Gordan shifts his focus

to data and technology

and spending more

time with his family, wife

Valeria and daughter

Julia, on their farm.

12 FCS Magazine

providers and continuing his focus on

quality, research, advocacy and innovation.

His priorities involve networking with

other medical disciplines to centralize

patient care, addressing health disparities

with pharmaceutical companies and

investing in more personalized treatment

through the continued advancement of

next-generation sequencing.

“It’s an amazing honor and privilege

to take on the role of president,” Diaz

said. “My colleagues have expressed their

confidence in what I’ve done in the past,

and they are trusting me to continue to do

that in the future. I take that very seriously.

I am going to continue to do everything I

can to earn that confidence and respect.”

For Gordan, his new role as Chief

Medical Officer of Therapeutics and

Analytics is a thrilling opportunity to

dive more deeply into a topic that has

been a lifelong passion and can prove

revolutionary in the quality of care offered

to FCS patients.

Data and informatics have always

fascinated Gordan. As a child growing up

in Brazil, Gordan taught himself to do

coding and developed computer software

beginning at age 11. He was insatiably

curious about how data could be used to

help others and to improve understanding

of the challenges in the world around him.

As a practicing medical oncologist with

FCS’s Gainesville Cancer Center, Gordan

understands the importance of data to

improve patient care.

Data allows clinicians to provide

personalized treatment based on key

factors in the patient’s demographic

information, medical history and

genomics. A data-driven approach

expedites the process of finding the right

medications and leads to improvement

in drug adherence, dose density and dose

intensity. Well-organized data is also a

key factor in getting qualified patients

into potentially life-saving clinical trials.

FCS is sitting on a treasure trove of data.

It’s a massive undertaking to sort through

all of it, but with the help of the Data

Governance Committee and other FCS

teams, Gordan is ready for the challenge.

“As it was during my time as President

& Managing Physician, my goal as Chief

Medical Officer of Therapeutics and

Analytics is to move the needle a bit faster

to impact our full patient population,”

he said.

Spring 2022 13

LEADERSHIP FEATURE

Gordan reserves weekend mornings for exercising

his horses. He owns a 30-acre farm near Gainesville,

where he keeps a few mini-donkeys and a dozen

horses. His favorite horse, a Hanoverian-Tennessee

Walker named Redford, is always up for a ride.

“They are my psychiatrists on staff,” Gordan

said of his horses, with whom he spends regular

non-office hours. “When I was president, the

executives knew not to call me between 8 a.m.

and noon on Saturday and Sunday. If they did,

they knew not to expect an answer.”

Refreshed by pastoral pursuits, Gordan

returns to data, whose utility he understands

and appreciates.

A DIFFERENT KIND OF SADDLE AND REINS PROVIDE PASTIME AND PASSION

14 FCS Magazine

hose who know Amy Rodriguez will

tell you she’s more than a fighter.

She’s a warrior.

Her 17 years of service as

a U.S. Army National Guard Staff

Sergeant have earned Rodriguez more

than a dozen honors, including the Joint

Service Commendation Medal, the Army

Achievement Medal and the Army

Commendation Medal.

Still, Rodriguez’s recent triumph over

breast cancer is her sweetest victory yet.

After a long and arduous year-and-a-half

of treatment, Rodriguez is grateful for the

chance to keep serving her community and

country and to continue raising her son

and watching him grow up.

“I have FCS to thank for that,”

Rodriguez said.

The Tampa native received her breast

cancer diagnosis in 2020, after a concerning

self-exam.

“I had an aunt who had breast cancer

years prior, so I was very adamant about

regularly checking myself,” she said. “When

I found a lump, I didn’t think much of it,

but I mentioned it to my mother-in-law.

She insisted I get it checked out.”

Two weeks later, Dr. Abigail Beard

at USF Health confirmed Rodriguez’s

worst fear and referred her to Dr. David

D. Wright at FCS. Seeing Wright for

treatment, Rodriguez said, was “the best

decision ever, hands down. I felt very

comfortable with him and with his patient

care staff. The way they welcomed me made

me feel like I was a part of their family.”

Wright, who sees patients at FCS’s

Brandon Cancer Center, New Tampa

and the Tampa Cancer Center, attended

medical school at the University of South

Florida’s Moffitt Cancer Center. It was

during his first year of school that Wright’s

mother received her own cancer diagnosis.

“My mother’s oncologist treated her

like she was family,” Wright told FCS in a

video testimony. “He spent time with her

like she was the only person that mattered

to him, and I’m sure he had about 20

other patients waiting. Her outcome

was very good; he became a friend of the

family and she’s still with us. I realized the

important thing, for me, was the personal

touch. Now, I have patients that have

become part of my life.”

Rodriguez remembers how, at her very

first visit with Wright, he called her by her

first name, as if they were already friends.

Wright took the time to get to know

her, she said, and ensured that she was

comfortable from the very beginning.

“When I walked in for treatment every

day after, I was always greeted with a

smile,” Rodriguez said. “From the front

door staff to the individuals who put in my

IV, everyone was amazing.”

BY HANNAH BURKE

Conquering

Breast Cancer

Warrior spirit helped Amy Rodriguez

stay positive

PATIENT SPOTLIGHT

Spring 2022 15

PATIENT SPOTLIGHT

One day, Rodriguez took it upon herself,

while undergoing chemotherapy, to shave her

head. She continued filling in her eyebrows

and doing her makeup, but she still grappled

with the insecurities that follow such a drastic

change. What if she was now unrecognizable?

Turns out, at Rodriguez’s next appointment,

an FCS staff member would supply her with

a much-needed boost of confidence.

“I can’t recall her name, but I remember

coming in and seeing her look at me with

just the widest smile,” Rodriguez said. “Her

eyes were just gleaming, and she told me,

‘You are so beautiful.’ She remembered me.”

After months of treatment, a double

mastectomy and reconstructive surgery,

Rodriguez said she’s “feeling great — as

though I’m back to myself.” She finished

her last round of treatment in May 2021,

is forging ahead with her military career,

and reports that, despite everything, she

continues to pass her physical fitness tests.

Rodriguez is, to many, a hero.

Last November, she was officially

recognized as such by the Tampa Bay

Buccaneers at Raymond James Stadium.

Prior to the Bucs’ home game against the

Chicago Bears, Rodriguez, the “Hero of

the Game,” received the traditional honor

of “rallying the Krewe” by ringing the

bell of the team’s pirate ship. She beamed,

danced and beckoned the crowd to match

her enthusiasm.

For Rodriguez, that fervor isn’t reserved

just for game days, but for every day she

can continue living, serving others and

loving her family.

“I 100% believe that Florida Cancer

Specialists helped me beat cancer,”

Rodriguez said. “Thank you, care team.

Thank you for loving me through both

your actions and words, and thank you for

making this experience something I will

never forget.”

“I 100% believe

that Florida Cancer

Specialists helped me

beat cancer…Thank you,

care team. Thank you

for loving me through

both your actions and

words, and thank you for

making this experience

something I will

never forget.”

Traveling the world, U.S. Army National Guard Staff

Sergeant Amy Rodriguez has built a lifetime of

unforgettable experiences.

16 FCS Magazine

BY HANNAH BURKE

Data

Governance

Company-wide initiative will provide

standards for collection and storage

ast year, Florida Cancer Specialists enthusiastically

launched its Data Governance Program, an initiative

designed to institute policies, processes and standards

for how data is collected, organized, stored and used

throughout the organization.

The FCS Data Governance Committee was established

to oversee the program’s implementation and monitor its

progress. FCS Chief Executive Officer Nathan H. Walcker

serves as executive sponsor of the committee and Vice

President of Informatics Trevor Heritage, PhD has taken on

the role of committee chair.

It was important to FCS that the committee include

representatives from the organization’s teams and

departments. Data plays a role in every sector of FCS

operations, so this initiative impacts everyone.

For instance, FCS data may also correlate with how

clinical interventions and observations are documented, or

the way in which patient information is attained at intake

and later stored, analyzed and secured. Data can relate to

billing and claims, or even include the acronyms used by

FCS to refer to its clinic locations.

“Like other organizations of our size, complexity and

structure, there are many possible ways in which the

cross-system exchange of data and information could be

inconsistent,” Heritage said. “So, it is vital that we have a

plan in place to strengthen the management of our data and

ensure that it is reliable, secure and being properly used. By

doing this, we can more efficiently and deliberately use our

organization’s data to continue providing world-class cancer

care for our patients.”

Spring 2022 17

DATA GOVERNANCE

For more than three decades, FCS

has been dedicated to its mission of

providing communities across Florida with

premier cancer care and treatment. As the

organization continues to grow and evolve,

FCS believes it is imperative that its data

infrastructure, practices and protocols

follow suit.

Walcker said employees will be kept

apprised of developments in its new “data

driven culture” via updates from the Data

Governance Committee members, who

will serve as the program’s central decision

makers. They plan to furnish reports on

process improvement milestones and

contemporary examples of the program’s

impact across FCS.

In addition to the Data Governance

Committee, subject matter users and experts

who frequently use and interact with data

comprise the FCS Data Stewards Council.

They will work to break down data silos

by identifying the best ways for individual

departments to gather, manage and implement

data, as well as how to effectively receive and

apply data created by other FCS branches.

While the framework for data governance

has been set, it will take time, patience

and cooperation from all team members

to realize the program’s full vision. The

Data Governance Committee has already

identified both short- and long-term goals,

and, Walcker said, “Its progress will be

frequently monitored and communicated.”

“By doing this, we can more efficiently and

deliberately use our organization’s data to continue

providing world-class cancer care for our patients.”

18 FCS Magazine

BY EMMA WITMER

Strategic

Partnership

FCS and COA advance

interests of patients

uilding a better system for cancer

care is a job too big for one

organization, no matter how

dedicated its staff may be.

Given that reality, FCS partners with

organizations such as the Community

Oncology Alliance (COA).

Rose Gerber is Director of Patient

Advocacy and Education for COA’s

Patient Advocacy Network (CPAN)

that works closely with FCS and other

practices around the country to spearhead

policymaking, innovation and reform of

the cancer care system.

“I just love the FCS chapter,” Gerber

said. “They keep me inspired. A lot of what

I do is educating and mentoring others. I

try my best to keep leaders interested, and

when I have leaders like Beth Wittmer,

Dr. Mike Diaz and Dr. Lucio Gordan,

who are high-ranking within the practice

and truly support advocacy, I know we can

accomplish great things.”

FCS launched its CPAN chapter in

2014, under the joint leadership of then

Director of Care Management Don

Champlain, RN, MHA, and current

Director of Care Management Beth

Wittmer, RN, OCN. The two served as co-

chairs of the chapter for three years until,

sadly, Champlain lost his battle with cancer.

Over the last eight years, Wittmer and

Gerber have worked side by side to educate

clinicians, patients, survivors and their

families on the complex system of cancer

care and empower them to act.

As the CPAN chapter leader for FCS,

Wittmer is in constant contact with liaisons

throughout the FCS network to garner

support. She organizes quarterly physician-led

speaking events with patients and families

to provide education and identify what

ADVOCACY SPOTLIGHT

Spring 2022 19

ADVOCACY SPOTLIGHT

legislation is coming up that could be helpful

or detrimental to their care. Even with the

challenges posed by COVID-19 restrictions,

Wittmer has persevered with virtual events.

“Our goal with CPAN is to make

people more aware of what they can do by

standing up and advocating for cancer care

and the difference that it truly makes in the

community setting,” Wittmer said. “We

are always looking for ways to bring more

awareness to the importance of this chapter

and the need for more patients, families

and FCS team members to get involved.

FCS doctors and nurses have added

powerful voices to numerous state and

national CPAN events by identifying

patients willing to share their cancer

stories through the “I AM Community

Oncology” campaign. In addition, FCS

has invited Sen. Rick Scott and Sen. Marco

Rubio to experience FCS facilities through

the “Sit in My Chair” event. Prior to the

pandemic, live visits were hosted in FCS

clinics throughout the state.

Time and again, CPAN advocates from

FCS have espoused the importance of

affordable and easily accessible care and the

value of clinical trials, and they regularly

speak on CPAN patient advisory boards at

statewide events and on Capitol Hill.

One issue that the chapter has worked to

address is the impact of pharmacy benefit

managers on access to medication.

FCS and CPAN have also worked in

tandem to block legislation like the Trump

administration’s Most Favored Nation

proposal, which would have barred at least

20 percent of cancer patients on Medicare

from access to treatment.

“We want to de-complicate these issues

so that patients and their families have a

good understanding of what their rights are

and so that their voices can be heard at the

legislative level,” Wittmer said.

“The work we do with CPAN is so

important,” added FCS President &

Managing Physician Michael Diaz, MD.

“The better we initiate and educate our

patients, the better they can advocate for

themselves. It helps them understand

how and where they can turn for support,

and it helps them understand that they

are not alone in this process. If we can

work together, we can help them navigate

through what can be one of the most

difficult times in anyone’s life.”

“Our goal with CPAN

is to make people more

aware of what they can

do by standing up and

advocating for cancer

care and the difference

that it truly makes in the

community setting.”

Top: Dr. Lucio Gordan and Alachua County representatives participate in Sit in My Chair,

an opportunity for local representatives to gain an understanding of the community

oncology experience from the patient's perspective.

Bottom: Members of the CPAN committee join together at the last in-person COA

Conference in 2019.

Email the FCS CPAN group for more

information or to learn how you can get

involved at CPAN@FLCancer.com.

20 FCS Magazine

BY HANNAH BURKE

FCS Retains

Top Ranking

Among OCM

Participants

n 2016, the Center for Medicare & Medicaid

Innovation (CMMI) developed the Oncology

Care Model (OCM), a national payment

program that provides high-caliber, efficiently

managed cancer care at a lower price to Medicare

beneficiaries.

FCS has been enrolled in the program since its

inception, and according to CMMI’s most recent

OCM reconciliation data, has once again been

ranked at the top among the 126 participating

oncology practices across the country.

With its community-based and personalized

practices, state-of-the-art clinical trial offerings and

dedication to offering patients individualized, world-

class cancer care, FCS’s ranking comes as no surprise

to FCS Chief Executive Officer Nathan H. Walcker.

“Our value-based practice initiatives at FCS

are programmatic, intentional and thoughtfully

designed to be organized squarely around the

patient, yielding consistent results that outpace

industry benchmarks and make good on our

commitment to prioritize patient outcomes and

quality,” Walcker said.

“I could not be prouder of our entire team and

their steadfast commitment to delivering value-based

oncology care in communities across Florida.”

FCS provides care for more than 22,000 OCM

beneficiaries annually and has recorded more than

VALUE-BASED CARE PROGRAM

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32