Cancer 360 | Summer 2018 by Florida Cancer Specialists

From Our CMSO | 2 Foundation Update | 16 People + Places | 18

SPRING 2018

FCS Clinical Trials Provide Access to Life-Saving Cancer Advances | 3 Q+A With Oncologist and Lung Cancer Researcher Dr. Maen Hussein | 14

FCS Locations Map | 23

Care Management: Providing a Full-Circle Approach to Cancer Treatment | 10

Care Management: Elevating the Cancer Patient’s Experience in a Changing Health Care Environment As health care delivery in the U.S. shifts from volume to value-based, the traditional payment model is being replaced with a framework that rewards improved quality, outcomes, and reimbursement. In this value-based care model, treatment is delivered by a coordinated “community” that is expertly and precisely focused on the patient’s experience and well-being.

At Florida Cancer Specialists, our commitment is to do what’s best for each patient, every time. Our Care Management Team ensures that patients receive personalized care, spend less time in the hospital or ER, and receive immediate help managing the side effects of treatment. Director of Care Management, Don Champlain, and the other members of his highly-motivated Care Management Team, Beth Wittmer, Jennifer Bailey, and Robin Warnberg, share their compelling story in this issue of Cancer 360+. Also in this issue, we highlight the research being conducted by FCS Physicians. At the June 2018 annual meeting of the American Society of Clinical Oncology (ASCO), Physician Investigators from Florida Cancer Specialists will contribute and present data from more than 35 clinical trials. This strong showing demonstrates the impact of the 11-year partnership between FCS and the Nashville-based Sarah Cannon Research Institute, one of the world’s leading clinical research organizations conducting community-based clinical trials. Look for our informative “Q+A” with Dr. Maen Hussein, who practices at our Tavares location, and The Villages Cancer Center. There’s also a profile of Terri Prechtl and the motivation behind her volunteerism to help the FCS Foundation fulfill its mission. Terri is just one of more than 250 volunteers who serve at 41 FCS locations throughout Florida. Her dedication and kind heart are an inspiration to us all. +

SPRING 2018 Florida Cancer Specialists & Research Institute William N. Harwin, MD President & Founder EXECUTIVE MANAGEMENT: Brad Prechtl, MBA Chief Executive Officer

EXECUTIVE BOARD: Jose Alemar, MD Roy M. Ambinder, MD Jorge Ayub, MD Todd Schonherz Michael Diaz, MD Chief Operating Officer Lucio N. Gordan, MD Joel S. Grossman, MD Tom Clark William N. Harwin, MD Chief Legal Officer Maen Hussein, MD Shelly Glenn Sachin Kamath, MD Chief Marketing & Sales Officer Julio Lautersztain, MD Scott Lunin, MD Sarah Cevallos Vikas Malhotra, MD Chief Revenue Cycle Officer Noel A. Maun, MD, PhD Stephen V. Orman, MD PHYSICIAN LEADERSHIP: Ivor Percent, MD Michael Diaz, MD Marilyn M. Raymond, MD Lucio N. Gordan, MD Frank Rodriguez, MD Lowell L. Hart, MD Shalin R. Shah, DO William N. Harwin, MD Gerald H. Sokol, MD, MSc, FCP Stephen V. Orman, MD David Wenk, MD James A. Reeves Jr., MD PUBLICATION TEAM MANAGING EDITOR Maria Ramos-Person PUBLISHER/CREATIVE DIRECTOR Steve Smith WRITER David Chesnick COPY ASSISTANT Susan Hicks ART DIRECTOR Rosie White

Cancer 360 Plus is published by Florida Cancer Specialists & Research Institute to inform healthcare providers and patients of advances in multidisciplinary cancer treatment. Editorial features are developed in harmony with our goals to optimize health, quality of life and clinical outcomes for cancer patients and their families. Our writers cover a wide variety of topics related to modern advances in medical and radiation oncology, clinical research, coping with cancer treatment side effects, profiles of FCS physicians and researchers, news of our drug development unit and the nonprofit FCS Foundation. © Copyright 2018 Florida Cancer Specialists & Research Institute

Shelly H. Glenn Chief Marketing & Sales Officer Florida Cancer Specialists

Material provided in this publication is intended to be used as general information only and should not replace the advice of your physician. Always consult your physician for individual care. Publication developed by Consonant Custom Media www.consonantcustom.com

FCS Clinical Trials Provide Access to Life-Saving Advances FCS Community-Based Clinical Research Program Rivals Many Academic Medical Centers

â&#x20AC;&#x153;The era of generic chemotherapy drugs is ending. We are going to have really targeted therapies that deal with the origins of a tumor to turn off the mutation.â&#x20AC;? Augusto Villegas, MD

Augusto Villegas, MD FCS Fleming Island

continued on page 4

iagnosed with advanced adenocarcinoma lung cancer with the ROS1 gene mutation, Tampa Bay resident Pamela Klein participated in a clinical trial at the FCS Phase 1 Drug Development Unit (DDU) and it changed her life. Klein has achieved a complete response to treatment for more than two years. “I knew that I had this really rare gene mutation. If I didn’t want to just receive chemo, killing cells all throughout my body, I needed to consider other forms of treatment. Florida Cancer Specialists & Research Institute had the clinical trial that I needed. It was a trial specifically for my mutation,” Klein said.

“It is particularly gratifying that the DDU has contributed so much to the body of knowledge about new cancer treatments,” Dr. Patel said. “Our strong relationship with Sarah Cannon has been pivotal.” The DDU is one of only five Phase 1 research sites in the Sarah Cannon network. One of the most important benefits of the Sarah Cannon partnership to patients is that early phase trials are now much larger than ever before, and more questions are being answered earlier in the process.

Pamela and others like her are what fuel the FCS quest to prolong and save lives through research. Thanks to its strategic partnership with Sarah Cannon, one of the leading clinical trial organizations in the world, the program at FCS has come to rival that of many academic hospitals. It helped put FCS on the cutting edge of identifying newer targeted immunotherapies that are changing the future of cancer treatment, and it has helped the nation’s largest privately-held oncology/hematology practice set the benchmark for community care. In the past three years, the majority of new cancer drugs approved for use in the U.S. were studied in clinical trials with Florida Cancer Specialists participation. As a community practice, FCS is able to bring these potentially life-saving advances to its patients in a setting close to home. The breadth of this work has helped raise the practice’s profile. Last year, nearly 20 FCS clinical studies were presented at the annual meeting of the American Society of Clinical Oncology (ASCO), an event held this past June in Chicago, IL, attended by more than 30,000 oncology professionals from around the world. More than half of the FCS co-authored presentations at the meeting were from research done by the Phase 1 Drug Development Unit (DDU) in Sarasota, FL, led by Director of Drug Development, Dr. Manish Patel and Associate Director, Dr. Judy Wang.

Katie Goodman, RN, BSN, CCRP Director of Clinical Research, Florida Cancer Specialists

“The field is moving much more quickly. It’s gratifying to see patient clinical responses this early in the life of these drugs.” Manish Patel, MD

The impact of the research being done at FCS on higher survival rates and a better quality of life for patients cannot be overestimated. “The field is moving much more quickly,” Dr. Manish Patel said of the presentations at ASCO from the Phase 1 DDU, noting that advanced technologies also play a role. “It’s gratifying to see patient clinical responses this early in the life of these drugs.”

Extending Survival in Patients with Stage 3 Non-Small-Cell Lung Cancer

In addition to the breakthrough research being done by the Phase 1 DDU in Sarasota, FL, 139 FCS physicians are currently running 150 Phase II and III Trials at 36 locations around the state, taking promising treatments that are not yet proven one step closer to approval and widespread use, according to Director of Clinical Research, Katie Goodman. Representative of these Phase II and III Trials, is Dr. Augusto Villegas’ work on a study that demonstrated the effectiveness of durvalumab in extending progression-free survival (PFS) in patients with Stage III Non-Small-Cell Lung Cancer (NSCLC) after concurrent chemoradiotherapy (cCRT).

Read the Full Articles To read the full New England Journal of Medicine (NEJM) article co-authored by Dr. Villegas, visit: www.nejm.org For the full article by Dr. Spitz, published in the November 2017 issue of Gynecologic Oncology, visit: www.sciencedirect.com/science/article

The FCS Phase 1 Drug Development Unit (DDU) in Sarasota, FL, is led by Director of Drug Development, Dr. Manish Patel and Associate Director, Dr. Judy Wang.

The article, which Dr. Villegas co-authored, appeared in the New England Journal of Medicine (NEJM): Durvalumab After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer November 16, 2017. In addition to publication, Dr. Villegas’ study was presented at the 2017 European Society for Medical Oncology (ESMO) conference, held in Madrid, Spain, and at the 2017 Annual Meeting of American Society of Clinical Oncology (ASCO) in Chicago, IL. Based largely upon the results of this clinical trial, the US Food and Drug Administration (FDA) granted breakthrough therapy designation to durvalumab for patients with locally advanced, unresectable NSCLC who do not relapse after platinum-based chemoradiotherapy. Due to its promise, the drug is also being studied for use against other forms of cancer. “The era of generic chemotherapy drugs is ending,” according to Dr. Villegas. “We are going to have really targeted therapies that deal with the origins of a tumor to turn off the mutation.” “We’re learning that not all cancers are the same. With lung cancer, every patient previously received the same treatment. But now, we can ask, ‘What subtype? What variations? What mutations?’ ”

continued on page 22

FDA breakthrough therapy designation

A BTK inhibitor for the treatment of adult patients with MCL who have received at least one prior therapy…1

CALQUENCE

GO STRONG

FOCUSED ON EFFICACY WITH DURABLE RESPONSES IN R/R MCL1 80% ORR [95% CI: 72, 87] / 40% CR [95% CI: 31, 49] / IRC-assessed per 2014 Lugano classiﬁcation* / Median DoR not reached at 15.2 month median follow-up

INDICATION AND USAGE CALQUENCE is a Bruton tyrosine kinase (BTK) inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

IMPORTANT SAFETY INFORMATION Hemorrhage Serious hemorrhagic events, including fatal events, have occurred in the combined safety database of 612 patients with hematologic malignancies treated with CALQUENCE monotherapy. Grade 3 or higher bleeding events, including gastrointestinal, intracranial, and epistaxis, have been reported in 2% of patients. Overall, bleeding events, including bruising and petechiae of any grade, occurred in approximately 50% of patients with hematological malignancies.

The mechanism for the bleeding events is not well understood. CALQUENCE may further increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies, and patients should be monitored for signs of bleeding. Consider the beneﬁt-risk of withholding CALQUENCE for 3 to 7 days pre- and post-surgery, depending upon the type of surgery and the risk of bleeding. Infection Serious infections (bacterial, viral, or fungal), including fatal events and opportunistic infections, have occurred in the combined safety database of 612 patients with hematologic malignancies treated with CALQUENCE monotherapy. Grade 3 or higher infections occurred in 18% of these patients. The most frequently reported Grade 3 or 4 infection was pneumonia. Infections due to hepatitis B virus (HBV) reactivation and progressive multifocal leukoencephalopathy (PML) have occurred.

Please see Brief Summary of complete Prescribing Information on adjacent pages.

Monitor patients for signs and symptoms of infection and treat as medically appropriate. Consider prophylaxis in patients who are at increased risk for opportunistic infections. Cytopenias In the combined safety database of 612 patients with hematologic malignancies, patients treated with CALQUENCE monotherapy experienced Grade 3 or 4 cytopenias, including neutropenia (23%), anemia (11%), and thrombocytopenia (8%), based on laboratory measurements. Monitor complete blood counts monthly during treatment. Second Primary Malignancies Second primary malignancies, including non-skin carcinomas, have occurred in 11% of patients with hematologic malignancies treated with CALQUENCE monotherapy in the combined safety database of 612 patients. The most frequent second primary malignancy was skin cancer, reported in 7% of patients. Advise protection from sun exposure.

✦ ✦

Proven safety proﬁle Twice-daily dosing with a low pill burden1

Atrial Fibrillation and Flutter In the combined safety database of 612 patients with hematologic malignancies treated with CALQUENCE monotherapy, atrial fibrillation and atrial flutter of any grade occurred in 3% of patients, and Grade 3 in 1% of patients. Monitor for atrial fibrillation and atrial flutter and manage as appropriate. ADVERSE REACTIONS The most common adverse reactions (≥20%) of any grade were anemia,* thrombocytopenia,* headache (39%), neutropenia,* diarrhea (31%), fatigue (28%), myalgia (21%), and bruising (21%). *Treatment-emergent decreases (all grades) of hemoglobin (46%), platelets (44%), and neutrophils (36%) were based on laboratory measurements and adverse reactions. The most common Grade ≥3 non-hematological adverse reaction (reported in at least 2% of patients) was diarrhea (3.2%). Dosage reductions or discontinuations due to any adverse reaction were reported in 1.6% and 6.5% of patients, respectively.

Increases in creatinine 1.5 to 3 times the upper limit of normal occurred in 4.8% of patients. DRUG INTERACTIONS Strong CYP3A Inhibitors: Avoid co-administration with a strong CYP3A inhibitor. If a strong CYP3A inhibitor will be used short-term, interrupt CALQUENCE. Moderate CYP3A Inhibitors: When CALQUENCE is co-administered with a moderate CYP3A inhibitor, reduce CALQUENCE dose to 100 mg once daily. Strong CYP3A Inducers: Avoid co-administration with a strong CYP3A inducer. If a strong CYP3A inducer cannot be avoided, increase the CALQUENCE dose to 200 mg twice daily. Gastric Acid Reducing Agents: If treatment with a gastric acid reducing agent is required, consider using an H2-receptor antagonist or an antacid. Take CALQUENCE 2 hours before taking an H2-receptor antagonist. Separate dosing with an antacid by at least 2 hours.

Avoid co-administration with proton pump inhibitors. Due to the long-lasting effect of proton pump inhibitors, separation of doses may not eliminate the interaction with CALQUENCE. SPECIFIC POPULATIONS There is insufficient clinical data on CALQUENCE use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Advise women of the potential risk to a fetus. It is not known if CALQUENCE is present in human milk. Advise lactating women not to breastfeed while taking CALQUENCE and for at least 2 weeks after the final dose. *Tumor response was assessed according to the Lugano classification for non-Hodgkin’s lymphoma (NHL). CR=complete response; DoR=duration of response; IRC=Independent Review Committee; ORR=overall response rate (defined as the proportion of patients who achieved a CR or PR); PR=partial response; R/R=relapsed/refractory. Reference: 1. CALQUENCE [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2017.

VISIT CALQUENCE.COM

CALQUENCE® (acalabrutinib) capsules, for oral use Initial U.S. Approval: 2017 Brief Summary of Prescribing Information. For complete prescribing information consult official package insert. INDICATIONS AND USAGE CALQUENCE is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14) in the full Prescribing Information]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. DOSAGE AND ADMINISTRATION Recommended Dosage The recommended dose of CALQUENCE is 100 mg taken orally approximately every twelve hours until disease progression or unacceptable toxicity. Advise patients to swallow capsule whole with water. Advise patients not to open, break or chew the capsules. CALQUENCE may be taken with or without food. If a dose of CALQUENCE is missed by more than 3 hours, it should be skipped and the next dose should be taken at its regularly scheduled time. Extra capsules of CALQUENCE should not be taken to make up for a missed dose. Dose Modifications Adverse Reactions Recommended dose modifications of CALQUENCE for Grade 3 or greater adverse reactions are provided in Table 1. Table 1: Recommended Dose Modifications for Adverse Reactions Adverse Reaction Dose Modification Occurrence (Starting dose = 100 mg twice daily) Grade 3 or greater Interrupt CALQUENCE. non-hematologic toxicities, First and Second Once toxicity has resolved to Grade 1 or baseline level, CALQUENCE therapy may Grade 3 thrombocytopenia be resumed at 100 mg twice daily. with bleeding, Grade 4 Interrupt CALQUENCE. thrombocytopenia Once toxicity has resolved to Grade 1 or Third or baseline level, CALQUENCE therapy may be resumed at 100 mg daily. Grade 4 neutropenia lasting longer than Fourth Discontinue CALQUENCE. 7 days Event

Adverse reactions graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.

Dose Modifications for Use with CYP3A Inhibitors or Inducers Recommended dose modifications are described below [see Drug Interactions (7) in the full Prescribing Information]. CYP3A

Inhibition

Induction

Co-administered Drug

Recommended CALQUENCE use Avoid concomitant use. If these inhibitors will be used short-term Strong CYP3A inhibitor (such as anti-infectives for up to seven days), interrupt CALQUENCE. Moderate CYP3A inhibitor 100 mg once daily. Avoid concomitant use. Strong CYP3A inducer If these inducers cannot be avoided, increase CALQUENCE dose to 200 mg twice daily.

Concomitant Use with Gastric Acid Reducing Agents Proton Pump Inhibitors: Avoid concomitant use [see Drug Interactions (7) in the full Prescribing Information]. H2-Receptor Antagonists: Take CALQUENCE 2 hours before taking a H2-receptor antagonist [see Drug Interactions (7) in the full Prescribing Information]. Antacids: Separate dosing by at least 2 hours [see Drug Interactions (7) in the full Prescribing Information]. CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Hemorrhage Serious hemorrhagic events, including fatal events, have occurred in the combined safety database of 612 patients with hematologic malignancies treated with CALQUENCE monotherapy. Grade 3 or higher bleeding events, including gastrointestinal, intracranial, and epistaxis have been reported in 2% of patients. Overall, bleeding events including bruising and petechiae of any grade occurred in approximately 50% of patients with hematological malignancies. The mechanism for the bleeding events is not well understood. CALQUENCE may further increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies and patients should be monitored for signs of bleeding. Consider the benefit-risk of withholding CALQUENCE for 3-7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding. Infection Serious infections (bacterial, viral or fungal), including fatal events and opportunistic infections have occurred in the combined safety database of 612 patients with hematologic malignancies treated with CALQUENCE monotherapy. Consider prophylaxis in patients who are at increased risk for opportunistic infections.

Grade 3 or higher infections occurred in 18% of these patients. The most frequently reported Grade 3 or 4 infection was pneumonia. Infections due to hepatitis B virus (HBV) reactivation and progressive multifocal leukoencephalopathy (PML) have occurred. Monitor patients for signs and symptoms of infection and treat as medically appropriate. Cytopenias In the combined safety database of 612 patients with hematologic malignancies, patients treated with CALQUENCE monotherapy experienced Grade 3 or 4 cytopenias, including neutropenia (23%), anemia (11%) and thrombocytopenia (8%) based on laboratory measurements. In the CALQUENCE clinical Trial LY-004, patients’ complete blood counts were assessed monthly during treatment. Second Primary Malignancies Second primary malignancies, including non-skin carcinomas, have occurred in 11% of patients with hematologic malignancies treated with CALQUENCE monotherapy in the combined safety database of 612 patients. The most frequent second primary malignancy was skin cancer, reported in 7% of patients. Advise protection from sun exposure. Atrial Fibrillation and Flutter In the combined safety database of 612 patients with hematologic malignancies treated with CALQUENCE monotherapy, atrial fibrillation and atrial flutter of any grade occurred in 3% of patients, and Grade 3 in 1% of patients. Monitor for atrial fibrillation and atrial flutter and manage as appropriate. ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Hemorrhage [see Warnings and Precautions (5.1) in the full Prescribing Information] • Infection [see Warnings and Precautions (5.2) in the full Prescribing Information] • Cytopenias [see Warnings and Precautions (5.3) in the full Prescribing Information] • Second Primary Malignancies [see Warnings and Precautions (5.4) in the full Prescribing Information] • Atrial Fibrillation and Flutter [see Warnings and Precautions (5.5) in the full Prescribing Information] Clinical Trials Experience As clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described in this section reflect exposure to CALQUENCE (100 mg twice daily) in 124 patients with previously treated MCL in Trial LY-004 [see Clinical Studies (14) in the full Prescribing Information]. The median duration of treatment with CALQUENCE was 16.6 (range 0.1 to 26.6) months. A total of 91 (73.4%) patients were treated with CALQUENCE for ≥ 6 months and 74 (59.7%) patients were treated for ≥ 1 year. The most common adverse reactions (≥ 20%) of any grade were anemia, thrombocytopenia, headache, neutropenia, diarrhea, fatigue, myalgia, and bruising. Grade 1 severity for the non-hematologic, most common events were as follows: headache (25%), diarrhea (16%), fatigue (20%), myalgia (15%), and bruising (19%). The most common Grade ≥ 3 non-hematological adverse reaction (reported in at least 2% of patients) was diarrhea. Dose reductions or discontinuation due to any adverse reaction were reported in 1.6% and 6.5% of patients, respectively. Tables 2 and 3 present the frequency category of adverse reactions observed in patients with MCL treated with CALQUENCE. Table 2: Non-Hematologic Adverse Reactions* in ≥ 5% (All Grades) of Patients with MCL in Trial LY-004 Body System Adverse Reactions

CALQUENCE 100 mg twice daily N=124 All Grades (%) Grade ≥ 3 (%)

Nervous system disorders Headache 39 Gastrointestinal disorders Diarrhea 31 Nausea 19 Abdominal pain 15 Constipation 15 Vomiting 13 General Disorders Fatigue 28 Musculoskeletal and connective tissue disorders Myalgia 21 Skin & subcutaneous tissue disorders Bruising† 21 Rash† 18 Vascular disorders 8 Hemorrhage/Hematoma† Respiratory, thoracic & mediastinal disorders Epistaxis 6

1.6 3.2 0.8 1.6 1.6 0.8 0.8 0.8 0.8 -

* Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. † Bruising: Includes all preferred terms (PTs) containing ‘bruise,’ ‘contusion,’ ‘petechiae,’ or ‘ecchymosis’ Rash: Includes all PTs containing ‘rash’ Hemorrhage/hematoma: Includes all PTs containing ‘hemorrhage’ or ‘hematoma’

CALQUENCE® (acalabrutinib) capsules, for oral use Table 3: Hematologic Adverse Reactions Reported* in ≥ 20% of Patients with MCL in Trial LY-004 Hematologic Adverse Reactions

CALQUENCE 100 mg twice daily N=124 All Grades (%)

Grade ≥ 3 (%)

Hemoglobin decreased

Platelets decreased

Neutrophils decreased

* Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03; based on laboratory measurements and adverse reactions.

Increases in creatinine 1.5 to 3 times the upper limit of normal occurred in 4.8% of patients. DRUG INTERACTIONS Strong CYP3A Inhibitors Clinical • Co-administration of CALQUENCE with a strong CYP3A inhibitor Impact (itraconazole) increased acalabrutinib plasma concentrations [see Clinical Pharmacology (12.3) in the full Prescribing Information]. • Increased acalabrutinib concentrations may result in increased toxicity. Prevention or • Avoid co-administration of strong CYP3A inhibitors with CALQUENCE. Management • Alternatively, if the inhibitor will be used short-term, interrupt CALQUENCE [see Dosage and Administration (2.2) in the full Prescribing Information]. Moderate CYP3A Inhibitors Clinical • Co-administration of CALQUENCE with a moderate CYP3A inhibitor Impact may increase acalabrutinib plasma concentrations [see Clinical Pharmacology (12.3) in the full Prescribing Information]. • Increased acalabrutinib concentrations may result in increased toxicity. Prevention or • When CALQUENCE is co-administered with moderate CYP3A inhibitors, Management reduce acalabrutinib dose to 100 mg once daily. Strong CYP3A Inducers Clinical • Co-administration of CALQUENCE with a strong CYP3A inducer Impact (rifampin) decreased acalabrutinib plasma concentrations [see Clinical Pharmacology (12.3) in the full Prescribing Information]. • Decreased acalabrutinib concentrations may reduce CALQUENCE activity. Prevention or • Avoid co-administration of strong CYP3A inducers with CALQUENCE. Management • If a strong CYP3A inducer cannot be avoided, increase the acalabrutinib dose to 200 mg twice daily. Gastric Acid Reducing Agents • Co-administration of CALQUENCE with a proton pump inhibitor, H2-receptor antagonist, or antacid may decrease acalabrutinib plasma concentrations [see Clinical Pharmacology (12.3) in the full Prescribing Information]. Clinical • Decreased acalabrutinib concentrations may reduce Impact CALQUENCE activity. • If treatment with a gastric acid reducing agent is required, consider using a H2-receptor antagonist (e.g., ranitidine or famotidine) or an antacid (e.g., calcium carbonate). Antacids H2-receptor Prevention or antagonists Management Proton pump inhibitors

Separate dosing by at least 2 hours [see Dosage and Administration (2.2) in the full Prescribing Information]. Take CALQUENCE 2 hours before taking the H2-receptor antagonist [see Dosage and Administration (2.2) in the full Prescribing Information]. Avoid co-administration. Due to the long-lasting effect of proton pump inhibitors, separation of doses may not eliminate the interaction with CALQUENCE.

USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary Based on findings in animals, CALQUENCE may cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform the drugassociated risk. In animal reproduction studies, administration of acalabrutinib to pregnant rabbits during organogenesis resulted in reduced fetal growth at maternal exposures (AUC) approximately 4 times exposures in patients at the recommended dose of 100 mg twice daily (see Data). Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data Animal Data In a combined fertility and embryo-fetal development study in female rats, acalabrutinib was administered orally at doses up to 200 mg/kg/day starting 14 days prior to mating through gestational day [GD] 17. No effects on embryo-fetal development and survival were observed. The AUC at 200 mg/kg/day in pregnant rats was approximately 16-times the AUC in patients at the recommended dose of 100 mg twice daily. The presence of acalabrutinib and its active metabolite were confirmed in fetal rat plasma. In an embryo-fetal development study in rabbits, pregnant animals were administered acalabrutinib orally at doses up to 200 mg/kg/day during the period of organogenesis (from GD 6-18). Administration of acalabrutinib at doses ≥ 100 mg/kg/day produced maternal toxicity and 100 mg/kg/day resulted in decreased fetal body weights and delayed skeletal ossification. The AUC at 100 mg/kg/day in pregnant rabbits was approximately 4-times the AUC in patients at 100 mg twice daily. Lactation Risk Summary No data are available regarding the presence of acalabrutinib or its active metabolite in human milk, its effects on the breastfed child, or on milk production. Acalabrutinib and its active metabolite were present in the milk of lactating rats. Due to the potential for adverse reactions in a breastfed child from CALQUENCE, advise lactating women not to breastfeed while taking CALQUENCE and for at least 2 weeks after the final dose. Pediatric Use The safety and efficacy of CALQUENCE in pediatric patients have not been established. Geriatric Use Eighty (64.5%) of the 124 MCL patients in clinical trials of CALQUENCE were 65 years of age or older, and 32 patients (25.8%) were 75 years of age or older. No clinically relevant differences in safety or efficacy were observed between patients ≥ 65 years and younger. PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Hemorrhage Inform patients to report signs or symptoms of severe bleeding. Inform patients that CALQUENCE may need to be interrupted for major surgeries [see Warnings and Precautions (5.1) in the full Prescribing Information]. Infections Inform patients to report signs or symptoms suggestive of infection [see Warnings and Precautions (5.2) in the full Prescribing Information]. Cytopenias Inform patients that they will need periodic blood tests to check blood counts during treatment with CALQUENCE [see Warnings and Precautions (5.3) in the full Prescribing Information]. Second Primary Malignancies Inform patients that other malignancies have been reported in patients who have been treated with CALQUENCE, including skin cancer. Advise patients to use sun protection [see Warnings and Precautions (5.4) in the full Prescribing Information]. Atrial Fibrillation and Flutter Counsel patients to report any signs of palpitations, lightheadedness, dizziness, fainting, shortness of breath, and chest discomfort [see Warnings and Precautions (5.5) in the full Prescribing Information]. Dosing Instructions Instruct patients to take CALQUENCE orally twice daily, about 12 hours apart. CALQUENCE may be taken with or without food. Advise patients that CALQUENCE capsules should be swallowed whole with a glass of water, without being opened, broken, or chewed [see Dosage and Administration (2.1) in the full Prescribing Information]. Missed Dose Advise patients that if they miss a dose of CALQUENCE, they may still take it up to 3 hours after the time they would normally take it. If more than 3 hours have elapsed, they should be instructed to skip that dose and take their next dose of CALQUENCE at the usual time. Warn patients they should not take extra capsules to make up for the dose that they missed [see Dosage and Administration (2.1) in the full Prescribing Information]. Drug Interactions Advise patients to inform their healthcare providers of all concomitant medications, including over-the-counter medications, vitamins and herbal products [see Drug Interactions (7) in the full Prescribing Information]. Lactation Advise women not to breastfeed during treatment with CALQUENCE and for at least 2 weeks after the final dose [see Use in Specific Populations (8.2) in the full Prescribing Information]. Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 Under license of Acerta Pharma B.V. CALQUENCE is a registered trademark of the AstraZeneca group of companies. ©AstraZeneca 2017 10/17 US-14202 11/17

Providing a Full-Circle Approach to Cancer Treatment

Feature

Care Management Team Looks After Patients in Between Office Visits

he Florida Cancer Specialists Care Management Team is making a powerful difference in the lives of patients who may be experiencing some of the side effects of treatment or who have questions and concerns about issues such as diet or exercise. Oftentimes, concerns arise outside of regularly scheduled office hours; however, these patients now have highly-trained Care Managers who are available 24/7 by phone. Not only do patients receive personalized care, they also spend less time in the hospital ER. “When it is not medically necessary, patients don’t have to go to the ER or hospital,” Florida Cancer Specialists Director of Care Management, Don Champlain, says. “They want to be able to be treated locally, stay in their home, surrounded by their loving support system of family and friends. We help them achieve that.” Don’s voice reflects pride in his team’s response. As Champlain explains, Care Management is there in between office visits. “We have dedicated Oncology Nurses available by phone 24/7, 365 days a year. And they make a significant difference in how a patient does through their treatment.” Hurricane Irma severely tested the Care Management Team. This was particularly true in the Jacksonville/Fleming Island area, where severe flooding caused a slew of challenges. However, because of the excellent planning by FCS Operations leaders

and staff, Care Management was able to stay in touch with patients and assist them with everything from emergencies to answering simple questions and providing reassurance through a difficult time.

Creating a New Dynamic for Cost of Care Beyond care for patients, the team has helped to impact the cost of care for many. Until recently, Medicare and most insurers made payments based on volume. Now that the paradigm is shifting from fee-for-service to value-based quality care, the Care Management Team has been instrumental in leading the effort for FCS.

Understanding the Emotional Component of Care

“Chemo is not always easy, and for some patients, the therapy can cause side effects,” Champlain added. “That’s where our certified Oncology Nurses come into play, performing a vital role in helping those patients manage their symptoms at home. You can’t overstate how that can impact a patient emotionally.”

continued on page 12

Providing a Full-Circle Approach to Cancer Treatment continued from page 11

Beth Wittmer, Manager of Care Management and the first member of Champlain’s team, tells the story of a young woman with breast cancer who was having a particularly difficult time dealing with her disease. “I spoke with her about three times a week,” Wittmer says. “I educated her about the available resources in her community, helped her develop an exercise program, and referred her to a nutritional expert. Most important to her was that I was there when she needed someone to lean on. While not every patient needs that level of support, we want them to know that we are here if they do.”

To further broaden that support, the Care Management Team is expanding, adding licensed Clinical Social Workers, like Jennifer Bailey and Robin Warnberg, who are able to help cancer patients with difficult issues, including depression. “We’re able to provide extra support and offer resources to help our patients and their families cope with the emotional impact of the disease,” Bailey states.

“One of our goals,” Champlain says, “is to take as many burdens off the patient’s shoulders as possible. That can mean everything from working with the FCS location where they’re being treated to helping them deal with their insurance company to obtain permissions, or making them aware of resources in their community.

“We also help them develop and maintain a healthy nutritional plan that will aid them to better tolerate treatment. There’s no overstating the importance of that While the medical aspect of our involvement.”

side of treatment is generally the focus, Don Champlain and the Care Management Team understand that helping with the stress of battling cancer is often just as important to the patients as the medical component of their treatment.

“I had a patient with a terminal diagnosis of pancreatic cancer who was understandably upset and grappling with a number of issues, including whether or not to have treatment. We spoke on several occasions about her feelings and what was important to her. We got to a point where she was able to reconcile her diagnosis and was comfortable getting treatment while pursuing a quality of life that satisfied her.”

Creating Individualized Care Plans

to both the patient and their referring doctor, so everyone involved in the decision making process is kept in the loop.

The Care Management team may also be the liaison between the patient’s referring physician and the oncologist. Each patient is provided with an individualized care plan. The team explains that regimen

Central Triage

Central Triage was created to help ease a patient’s mind so they aren’t burdened with extraneous issues and they can put all their energies into battling their cancer. Central Triage also assists patients with everything from refilling prescriptions to completing disability and FMLA paperwork. “Our goal is to respond to all inquiries within 24 hours,” Champlain says.

When a patient is hospitalized, the Care Management team is there to facilitate what might otherwise be a difficult and lonely time. When the patient returns home, the team is there to make sure they have the physical help they need in those first difficult days of recovery. No patient or their family members should ever have to battle cancer alone. Now, they no longer have to. From diagnosis, through treatment and every step after treatment, the extraordinary people of the FCS Care Management Team will be there to support the patient throughout the cancer journey. +

â&#x20AC;&#x153;We have dedicated Oncology Nurses available to patients by phone 24/7, 365 days a year. And they make a significant difference in how a patient does through their treatment.â&#x20AC;? Don Champlain, RN, MHA Director of Care Management Florida Cancer Specialists Shown with Beth Wittmer, FCS Manager of Care Management.

Patients Are His Purpose Whether Leading a Clinical Trial or Creating an Individualized Care Plan, Dr. Maen Husseinâ&#x20AC;&#x2122;s Top Priority is Always His Patients

As Principal Investigator on a recent lung cancer trial conducted by Florida Cancer Specialists (FCS) and Sarah Cannon, Dr. Maen Hussein is a prominent researcher, as well as a strong advocate for patient participation in clinical studies. A member of the FCS Executive Board, Dr. Hussein has also been instrumental in developing and expanding the FCS Clinical Trials Program in Central Florida, especially in The Villages. The father of two young sons, Dr. Hussein is deeply involved in his community, volunteering at the free Leesburg Hospital Community Clinic with his wife, Michelle Viveiros, ARNP. He also sees patients in need at his office in Tavares, using resources FCS has set aside for low income patients who qualify for assistance. The Immigrant Lawyers Association of Central Florida recognized his generosity with a well-deserved Immigrant Achievement Award.

What was noteworthy about your recent lung cancer study presentation? What does this mean for cancer patients moving forward? The presentation discussed advances in immunotherapy and its role in treating advanced lung cancer. It explained how this type of therapy is a new class with a different mechanism of action, expectations for its use, and the various side effects patients might experience and how to manage them.

Can you tell us about some of the clinical trials with which you’ve been involved? As a Principal Investigator for many lung cancer trials, I have been privileged to participate in trials that study immunotherapy in different settings and stages. For instance, one of the studies examined the efficacy of two years vs. one year of immunotherapy in second-line therapy for Stage 4 lung cancer; it demonstrated the advantage of prolonged therapy. Right now, I’m anxiously waiting for the results of a clinical trial that examined adding immunotherapy in combination with standard of care chemotherapy in first-line treatment for advanced non-small cell lung cancer (NSCLC). Also, I have presented safety and efficacy data for nivolumab in an ongoing clinical trial for patients with metastatic non-small cell lung cancer. This particular study had 824 patients and the findings were presented at the World Conference on Lung Cancer. What made this clinical trial unique was that it included patients in a community setting and showed that physicians like those at FCS are as capable of providing this type of therapy as those at large academic centers.

What led you to do research in general and in lung cancer, specifically? One of the main reasons I wanted to be an oncologist is that I felt research in this area was in its infancy. It was evolving fast, and the advances in diagnosis and treatment were fascinating, with lots to discover. I wanted to be part of that. I love caring for patients, so I want to be part of finding ways to improve their outcomes. Research is one of the ways to do that. When I moved to Florida in 2006, I started a research program in our practice with the support of my partners. In 2011, when I joined FCS, I was approached by the research division to head the lung cancer trials in our area. Since many of my patients are diagnosed with the disease, and I was already involved in some of those clinical trials, I agreed. I’m glad I made that decision, because research at FCS is very organized and managed by a dedicated staff with whom I am honored to work.

Do you participate in clinical studies for other types of cancer, besides lung cancer? I’ve participated in a number of other clinical trials, including trials involving head and neck cancer, pancreatic cancer, melanomas, colon cancer and benign hematology trials investigating iron infusions.

How do you address the importance of patients participating in clinical trials? Mortality from cancer is dropping. People are living longer and with better quality of life, even with advanced cancer. One important reason for clinical trial participation is to find answers to the many questions we have about diagnosis and treatments. I encourage every patient diagnosed with cancer to consider a clinical trial; they may help themselves, as well as others who are diagnosed in the future. Patients who participate are our heroes, because they pave the way for others to receive better treatments.

What are the advantages of a clinical trial that is available locally? Patients can access state-of-the-art-medications without traveling. If they suffer from complications or side effects, it’s easier to avoid emergency room visits. Another advantage is patients don’t have to drive back home for hours after a long day of receiving treatment.

Your patients praise you for the time you spend helping them understand their cancer diagnosis and treatment options. Why do you think it’s important to counsel your patients? Some patients may have misconceptions about clinical trials. Educating patients about their importance and the medications being tested will help improve participation and outcomes. +

Maen Hussein, MD Hometown: Amman, Jordan Currently Resides: Leesburg, Florida Medical School: University of Jordan, Amman, Jordan Internship and Residency: Islamic Hospital, Amman, Jordan; Albasheer General Hospital, Amman, Jordan; Security Forces Hospital, Riyadh-KSA; Brown University, Memorial Hospital of Rhode Island, Pawtucket, Rhode Island Fellowship in Oncology/Hematology: Saint Louis University, St. Louis, Missouri Board Certification: Medical Oncology; Hematology; Internal Medicine

FCS Foundation Update

Volunteers are Terri-fic!

Providing Selfless Support to Patients, Staff and FCS Foundation Fundraising For Terri Prechtl, it is as simple as lending a listening ear, holding a hand, tucking a patient into a warming blanket or bringing them a snack. FCS Foundation Volunteers like Terri, who assist in the FCS infusion rooms, touch the lives of patients in ways big and small, helping to ease their journey during treatment. Some of the FCS Foundation Volunteers are former patients, caregivers or retired medical personnel whose commitment to caring for the sick has never waned. Most, like Terri, a former nurse who volunteers at the FCS Lakewood Ranch location, have been touched by the disease, having battled it themselves or had a family member who has. In Terri’s case, it was her father.

16 16

“When my dad had cancer, I would go with him to treatment, and I saw how hard the nurses worked to keep him and others comfortable. I knew that there was something I could do to help.” For Terri, volunteering was a natural impulse. She started volunteering at a nursing home when she was only 10; that experience led her to nursing, which provided her with a deep and abiding satisfaction.

“When my dad had cancer, I would go with him to treatment, and I saw how hard the nurses worked to keep him and others comfortable. I knew that there was something I could do to help.” Terri Prechtl Lead Patient Support Volunteer FCS Foundation

A Sense of Purpose

According to Lynn Rasys, Executive Director of the FCS Foundation, “The Volunteer Program gives participants the opportunity to give back to their communities, to share their skills and talents, and to have a positive impact on those battling cancer.” “When they finish their shifts, they are really happy,” she explains, “They know they’ve provided comfort and made someone’s day a little brighter. Patients aren’t the only ones who appreciate our efforts. The nurses are grateful for their work, because it allows them to remain focused on care.” The program has also led to friendships. “Without this program, I might not have met my fellow volunteers. However, because we share a common passion and desire to serve, our lives intersect frequently and friendships have been formed,” Terri explains.

Valuable Support

The Foundation has Volunteer Program Managers who are responsible for recruiting, screening, training, scheduling and supporting volunteers. Each volunteer works a minimum of a three-hour shift the same day every week on a monthly schedule. In addition to the volunteers working at the FCS Foundation office, there are currently almost 300 active volunteers serving at 41 FCS locations throughout the state. Keeping with the FCS philosophy of community-based care, volunteers work in the community where they live. In addition to the FCS locations, volunteers also play an important role in the Foundation’s mission. Working in our Foundation office, they process applications, answer phones and help with data entry and filing. They also assist with the planning and preparation for FCS Foundation fundraisers. Terri, whose husband is Florida Cancer Specialists CEO, Bradley Prechtl, MBA, hosts events that help to provide non-medical aid to patients who may no longer be able to pay their rent, utilities and other essential bills. Terri is particularly pleased that the intimate “Party Under the Stars” gathering that she and Brad first hosted at their home in 2013 has grown into a major fundraiser that raised more than $200,000 in January of this year.

BY THE NUMBERS

Interest and participation in the FCS Foundation’s Volunteer Program grows exponentially every year. Here’s what we’re doing, by the numbers: Clinic Volunteers 2017 2016

261 193

35% INCREASE

FCS Clinics with a Volunteer Program 2017 2016

41 27

52% INCREASE (Plus the volunteers at the FCS Foundation office in Sarasota)

Patient Grants Awarded in 2017 $

1,104,000

(Over $3.5 million awarded since inception)

40% of recipients are non-FCS patients

2,700

assistance request applications received (double vs. 2016)

About The Florida Cancer Specialists Foundation: The Florida Cancer Specialists (FCS) Foundation provides financial support to qualified cancer patients in the state of Florida for expenses such as rent or mortgage, car payments and utility bills. By giving patients peace of mind in knowing that their bills are being paid while they are undergoing treatment, the FCS Foundation allows them to concentrate on what really matters – fighting cancer. Due to the generosity of the Florida Cancer Specialists partner physicians in covering all overhead expenses for the Foundation, 100 percent of donations received go directly towards paying the essential non-medical living expenses of an adult battling cancer. The Foundation is a 501(c)(3) nonprofit organization and located at 5204 Paylor Lane in Sarasota, Florida. Learn more about the FCS Foundation at: Foundation.FLCancer.com or call 941.677.7181 Contact: Florida Cancer Specialists Foundation Lynn Rasys, Executive Director LRasys@FLCancer.com or call 941.677.7184

F oundation The FCS Foundation’s fundraising events, from the Golf Tournament to the fashion shows to the annual “Shades of Pink” Gala, that are now staples of the FCS Foundation’s fundraising efforts, are only possible with the extraordinary generosity and efforts of volunteers. Thanks to the volunteers, 100 percent of the proceeds at the events goes to FCS Foundation grant recipients. Whatever they do, at FCS locations, at the office or in planning events, their selfless goal is always the same… to provide assistance to people undergoing treatment so they can focus on fighting cancer. +

HOW CAN YOU HELP?

Visit http://found ation.flcance r.com/ volunteer/ to learn more about volunteer opp ortunities.

Terri Prechtl Lead Patient Support Volunteer FCS Foundation

People + Places

Great Gatsby Themed “50 Shades of Roaring Pink” Event Raises $200,000 to Help Cancer Patients Pay for Vital Living Expenses FCS Physicians, Drs. Christopher George and Julio Lautersztain, were the honorary co-chairs of the Florida Cancer Specialists Foundation’s Annual “50 Shades of Pink” Gala held at the Grand Hyatt Tampa Bay in October 2017. Guests experienced a “Great Gatsby” theme that featured flappers, a covert speakeasy, casino games, live jazz and swing music.

At the FCS Foundation’s “50 Shades of Roaring Pink” Gala (L-R): FCS patient and FCS Foundation recipient, Valarie Schlosser, and Barbara Long.

The event raised $200,000, with all proceeds directly benefiting the FCS Foundation, providing financial assistance for non-medical living expenses to qualified cancer patients currently undergoing treatment in Florida. The annual “50 Shades of Pink” fundraiser was born in 2014 when Barbara Long cancelled her wedding and faced a dilemma. She had already paid a nonrefundable deposit for the reception venue. After learning about the FCS Foundation, Barbara chose to donate the venue deposit and chair a fundraiser to benefit the Foundation (see our story in the Fall/Winter 2017 issue of C360+). This year’s event, “Shabby Chic Shades of Pink,” will be held Saturday, October 6th, 2018 at Armature Works, 1910 N. Ola Avenue, Tampa, at 7:00 p.m. Presented by Celgene and co-chaired by Drs. Michael T. Scott and Hafeez Chatoor, the event will feature dinner, dancing, and live and silent auctions.

At the St. Petersburg - Pasadena blanket warmer dedication (L-R): FCS Physician Liaison Manager Maria Ramos-Person, VP of Practice Operations Jeff Rubin, Dave and Bobbi Norris, FCS Physician Dr. Vu Tran Ho, CMSO Shelly Glenn, and Physician Liaison Sandy Brooks.

Giving the Gift of Warmth: Blanket Warmers Donated to FCS Centers in St. Petersburg - Pasadena and Downtown Sarasota Dave and Bobbi Norris of the Make a Difference Foundation were on hand this winter for the dedication of a new blanket warmer their foundation donated to the FCS St. Petersburg - Pasadena center. In memory of her spouse, Janice Berrier recently donated another blanket warmer to our Sarasota Downtown location. Warm blankets provide comfort to patients undergoing chemotherapy.

People + Places

2017 Clinical Summit

Nearly 250 FCS Physicians, Nurse Practitioners, Physician Assistants and Senior Managers attended the 2017 FCS Clinical Summit, held October 27-29 at the Ritz-Carlton Grande Lakes in Orlando. The Clinical Summit is the yearly opportunity for FCS Physicians, Nurse Practitioners, Physician Assistants and Senior Managers from across the state to come together to discuss advances in Oncology and Hematology, as well as clinical research opportunities. “It’s one very important and relevant Oncology topic after another,” said Dr. James A. Reeves, Director of Research Operations. “The material covers most of the important subjects and diagnoses that doctors see every day.” Figure Skater, Olympic Gold Medalist and Author Scott Hamilton kicked off the program by sharing the inspiring story of his battle with cancer. Dr. Diane Cope Publishes Article Examining Role of Advanced Practitioners in Maintaining Patient Adherence on Oral Oncolytics FCS Director of Nursing Diane Cope, PhD, ARNP, BC, AOCNP, was second author of a review and interventional article that examined the role of the Advanced Practitioner (AP) in maintaining compliance in patients taking oral oncolytics. Published recently in the Journal of the Advanced Practitioner in Oncology (JADPRO), the review highlighted many of the barriers to adherence that patients face and analyzed the role of APs in mitigating some of these issues.

New Doctors + Updates

1 Medical Oncologist, Gamini Soori, MD, MBA, FACP, FRCP, CPE, has joined the statewide FCS practice and will be working at three FCS locations: Ft. Myers Colonial, 8931 Colonial Center, Suite, 200, Ft. Myers; Cape Coral Cay West, 1708 Cape Coral Pkwy. West, Suite 10, Cape Coral; and Ft. Myers Gladiolus, 8260 Gladiolus Dr., Ft. Myers. 2 Medical Oncologist/Hematologist, J. Wynn

Sullivan, DO, has joined FCS and will be seeing patients at the FCS Palatka office, 600 Zeagler Drive, Palatka.

3 FCS Medical Oncologist/Hematologist, Dr. Karin Bigman, has relocated from the Ormond Beach South office to the Daytona Cancer Center, 224 Memorial Medical Parkway Suite 300, Daytona Beach, joining Drs. Eric Harris and Mudussara Khan. Expanded news releases and complete physician bios can be found at the FCS website: FLCancer.com.

Second Annual Polo Brunch Features All-Star Player, Cancer Survivor and Philanthropist Brandon Phillips In early March, International Polo Club Palm Beach was the scene of the FCS Foundation’s Second Annual Polo Brunch, which set an event record, raising $135,000 with all proceeds going to the FCS Foundation. The event was chaired by Linda and Jeffrey Phipps Sr., and Honorary Chairs included FCS physicians Drs. Elizabeth Byron, Todd Gersten, Daniel Spitz, Raul Storey and Sumithra Vattigunta-Gopal. International All-Star Polo Player, Cancer Survivor and Philanthropist Brandon Phillips shared his story as Keynote Speaker. At 14, Brandon was diagnosed with non-Hodgkin’s lymphoma and given only six weeks to live. After months of treatment, Brandon beat the odds and today is cancer-free. He is now a Brand Ambassador for the Leukemia & Lymphoma Society (LLS). In addition to hearing Brandon’s inspiring story, guests enjoyed brunch, beverages and a polo match.

Pictured in photo left to right: FCS Physicians Dr. Raul Storey, Dr. Beth Byron, Dr. Sumithra Vattigunta-Gopal, Dr. Daniel Spitz, Dr. Todd Gersten and FCS Foundation Board Co-Chair Jeffrey Phipps, Sr. and wife, Linda.

People + Places

FCS Pinellas Patient Appreciation On November 17, the Florida Cancer Specialists Pinellas County physicians and staff members joined together to serve a Thanksgiving dinner to more than 400 patients and their families.

Florida Cancer Specialists Joins the Tampa Bay Buccaneers to Honor Wounded Warriors FCS joined the Tampa Bay Buccaneers in honoring military veterans, especially wounded warriors and their families, at the Bucs game on November 12, 2017, with guest speaker Brian Ford, Buccaneers COO. Prior to the game, a celebratory Tailgate Party was held at the Tampa Cancer Center, where FCS patients and staff, vets and Bucs fans gathered

for great food, games and giveaways, as they got ready to cheer on their favorite NFL team. As a Tampa Bay Buccaneers sponsor, Florida Cancer Specialists is proud to support the Wounded Warriors Project and to honor the men and women who have so bravely sacrificed for our nation.

People + Places

Record-Setting “Party Under the Stars” Benefits Foundation The FCS Foundation’s Fifth Annual “Party Under the Stars” event, held in January 2018, raised a record amount of more than $200,000, with all proceeds going to the FCS Foundation. This year, the popular fundraiser honored FCS Foundation Board Chair Brad Prechtl, MBA, who also serves as Florida Cancer Specialists CEO, and his wife Terri Prechtl, who is the FCS Foundation Lead Patient Support Volunteer at the FCS Lakewood Ranch location (see our story in this issue of C360+). Drs. Richard Brown, Anjan Patel and Miguel Pelayo served as Honorary Chairs of the “New York City Rooftop” themed event, along with this year’s co-chairs, Celgene representative Kim Wyar and Genentech representative Dwight Henry.

L-R: Foundation Board Member Cory J. Person, FCS Chief Operating Officer Todd Schonherz, Terri and FCS CEO Brad Prechtl, MBA, FCS Chief Marketing & Sales Officer Shelly Glenn, FCS Foundation Executive Director Lynn Rasys.

Eligibility To qualify for a grant, a patient must: • Be 18 years of age or older • Be a current resident of the state of Florida • Have an annual combined household income at or below 200% of the national poverty level • Be actively receiving cancer treatment in Florida

How to Apply • Applications are available on the Foundation’s website at Foundation.FLCancer.com • FCS Financial Counselors can help patients apply • Contact Client Services at 941-677-7181 • Email us at Foundation@FLCancer.com

Upcoming Events Contact the Foundation for details and tickets. Visit Foundation.FLCancer.com.

To learn more about sponsoring next year’s Party Under the Stars, please contact FCS Foundation Executive Director, Lynn Rasys at LRasys@FLCancer.com and/or call (941) 677-7184.

Helping for the “Here + Now”

While patients battle their cancer, the FCS Foundation helps them combat their bills. Apply for Help Electronically The Florida Cancer Specialists Foundation has made it possible for patients in need to apply for assistance electronically, so they can get the help they need faster. Application can be made by visiting

www.regpacks.com/fcsfoundation2017.

9/15/18 Crack Up Cancer 2018 Ferguson Hall at The Straz Center, Tampa 10/6/18 Shabby Chic Shades of Pink Armature Works, Tampa Presented by Celgene 10/19/18 Wine Women & Shoes, Sanibel Marriott Resort, Sanibel Harbour 11/3/18 Wine Women & Shoes, Lake Mary Westin Lake Mary Orlando North, Lake Mary

F oundation Foundation.FLCancer.com

FCS Clinical Trials Provide Access to Life-Saving Advances continued from page 5

It’s why Dr. Villegas and the other FCS Physicians who participate in clinical trials strongly believe that, as he says, “They are part of outstanding care.” Dr. Augusto Villegas practices at the FCS Fleming Island location, in a suburb of Jacksonville, FL, with his partners, Dr. Jeffrey Bubis and Dr. Elizabeth Kent.

Evaluating the Safety and Efficacy of Etirinotecan Pegol (EP) in Women with Recurrent Platinum-Resistant or Refractory Ovarian Cancer (PROC)

According to the National Institutes of Health, the majority of women with ovarian cancer experience a recurrence of the disease, resulting in a need for several lines of treatment. When the disease progresses during therapy or within four weeks after the last dose, it is referred to ‘platinum refractory’; ‘platinum resistant’ is defined as disease progressing within six months of platinum-based therapy.

Dr. Daniel Spitz, who practices at the FCS location in West Palm Beach, FL, is a co-author of a new study evaluating the safety and efficacy of etirinotecan pegol (EP) in women with recurrent platinum refractory or resistant ovarian cancer. Published in the November 2017 issue of Gynecologic Oncology, the Phase II Study sought to demonstrate improved tolerability of EP, with a trend toward progression-free survival (PFS) and the added convenience of less-frequent dosing, administered at 21-day intervals.

The primary purpose of the study was to further define the activity of EP when it was administered as a fourth-line regimen in patients with PROC. The study demonstrated an overall response rate (ORR) of 15%, with clinical benefit achieved in more than half of the patients and a median progression-free survival (PFS) and overall survival (OS) of 4.4 months and 10.2 months, respectively. Compared to other single agents used in advanced PROC, these results were encouraging. The study concluded that “further evaluation earlier in the disease course and in combination is warranted.”

The FCS Research Mission

FCS Chief Executive Officer, Bradley Prechtl, MBA, stated, “Florida Cancer Specialists is dedicated to refining the science and study of malignancies and sharing knowledge and new findings that will rapidly advance and improve cancer treatments for our patients. The fact that we had so many presentations accepted at ASCO is a reflection of the strong commitment to clinical research at FCS.” For patients, the significance of that commitment cannot be overstated. As Pamela Klein declared, “I can definitively say that the reason I’m still here is due to the actions of my physician at Florida Cancer Specialists and the fact that they offer Clinical Trials for patients like me with rare gene mutations.” +

Have a suggestion for editorial content?

Interested in sponsoring our next issue?

Contact Maria Ramos-Person: mperson@FLCancer.com

Florida Cancer Specialists & Research Institute (FCS), founded in 1984, is the largest independent medical oncology/hematology practice in the United States, with nearly 100 locations. FCS delivers world-class cancer care in community-based settings, providing innovative clinical research and cutting-edge technologies that help advance targeted treatments and genetically-based immunotherapies. FCS serves patients on the Gulf coast from Naples to Tallahassee, in central Florida communities, and on the east coast from Palm Coast to Palm Beach County. For a listing of locations, helpful information about your first visit, and other patient resources, visit FLCancer.com

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