FCS-013 C360 Fall 2019 Issue

Welcome | 2

People + Places | 21

FCS Locations Map | 27

Fall 2019

Clinical Trials Separating Fact from Fiction |3

Advances in Gynecologic Oncology | 10 Q+A: Biosimilar Drugs | 16

Sorting out the “True and False” of Clinical Trials At Florida Cancer Specialists, we’re quite proud of our partnership with Sarah Cannon, one of the world's leading clinical research organizations. Our goal is to give patients the opportunity to participate in approved and exploratory therapies without long-distance travel. Since the inception of our program with Sarah Cannon Research Institute, we have enrolled more than 9,000 patients in studies.

The process of bringing more effective drugs to the marketplace will advance more quickly as more people are able to take part in research studies. The approaching opening of our second Drug Development Unit (DDU) in Lake Mary, in central Florida, will allow even further expansion and greater patient access.

There are several “myths” that persist around the subject of clinical trial participation. So, our “True or False” cover story and accompanying infographic will be of interest to anyone who would like to cut through the misinformation and get the facts.

2

DNA analysis, minimally invasive surgery, clinical research and other significant breakthroughs are helping women prevent gynecologic cancers or treat them earlier and more effectively.

FCS Gynecologic Oncologists Drs. Antonella Leary and Howard Goodman, practicing in Palm Beach Gardens and West Palm Beach respectively, discuss these advancements.

They also indicate that, despite the recent advancements in preventing, detecting and treating gynecologic cancers, endometrial and uterine cancers are actually on the rise.

Also in this issue, FCS Director of Pharmacy Operations Melody Chang and FCS Physician Dr. Jorge Ayub discuss biosimilar drugs in our “Q+A.” Although relatively few patients are familiar with biosimilars, they are becoming an increasingly popular choice.

I’m confident that you will enjoy this edition of Cancer 360 Plus. + Lucio N. Gordan, MD President & Managing Physician Florida Cancer Specialists

FALL 2019 Florida Cancer Specialists & Research Institute

Lucio N. Gordan, MD President & Managing Physician EXECUTIVE MANAGEMENT: Brad Prechtl, MBA Chief Executive Officer Todd Schonherz Chief Operating Officer Nathan Walcker Chief Financial Officer Sarah Cevallos Chief Revenue Cycle Officer Paul Chadwick Chief Procurement Officer Tom Clark Chief Legal Officer Shelly Glenn Chief Marketing & Sales Officer Mark Moch Chief Information Officer Joyce Nelson Chief Human Resources Officer

PHYSICIAN LEADERSHIP: Jose Alemar, MD Michael Diaz, MD Maen Hussein, MD James A. Reeves Jr., MD EXECUTIVE BOARD: Jose Alemar, MD Michael Diaz, MD Lucio N. Gordan, MD Joel S. Grossman, MD Maen Hussein, MD Sachin Kamath, MD Julio Lautersztain, MD Noel A. Maun, MD, PhD AJ Patel, MD Ivor Percent, MD Marilyn M. Raymond, MD Frank Rodriguez, MD Shalin R. Shah, DO David Wenk, MD

Valerie Eastwood Chief Compliance Officer

PUBLICATION TEAM MANAGING EDITORS Maryalice Keller Michelle Robey PUBLISHER/CREATIVE DIRECTOR Stephen A. Smith

COPY ASSISTANT Susan Hicks ART DIRECTOR Rosie White

WRITER Mark Zaloudek

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 2019 Florida Cancer Specialists & Research Institute 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

Feature

Clinical Trials

Separating Fact from Fiction Our true/false quiz may help dispel some falsehoods about cutting-edge research available to cancer patients.

3

M

edical breakthroughs would

not be possible without the

careful research of clinical trials.

The closely-monitored studies deserve credit for producing the medications and specialized treatments that are advancing cancer treatment.

Researchers say the process of bringing more effective drugs to the marketplace could advance even more quickly if more people took part in the investigational studies. But they acknowledge several obstacles, including the general public’s lack of awareness and misinformation about this key aspect of the drug-approval process.

4

Dr. James Reeves, director of research operations for Florida Cancer Specialists & Research Institute (FCS), and Katie Goodman, FCS director of clinical research, hope to dispel some common misunderstandings of clinical trial research with this short true/false quiz.

1. “I may be helping advance medical

research if I participate in a clinical trial, but I really don’t see any personal benefit for me.”

FALSE FOR SEVERAL REASONS. Most clinical trials compare the current standard of care to a treatment that earlier research suggests will be better.

In addition, even if a patient is assigned to the standard treatment, the trial conforms to the best available standard for drug dosing and administration. Research protocols are written to ensure that patients are treated with standard doses and schedules.

James A. Reeves Jr., MD Director of Research Operations Florida Cancer Specialists & Research Institute

Participants have the attention of a research nurse coordinator in addition to the doctors, nurses and mid-level staff on their care team.

The opportunity to gain early access to new drug therapies or drugs that have been approved for other types of cancer may be among the patient benefits.

2. “My health insurance may not cover

the cost of my participation.”

FALSE. The Patient Protection and Affordable Care Act (ACA) provides guarantees and protections so that an insurance company cannot prevent a qualified patient from participation.

Insurance companies and Medicare are legally bound to cover the reasonable patient costs of participation in a clinical research trial. Also, the cost of the drugs used in the study may be covered by the study, which can reduce the overall cost to insurers and/or Medicare.

Procedures such as scans, electrocardiograms (EKGs) and echocardiograms are often covered by the study budget when they are not “routine” for treatment of a medical condition but are required by the study.

Sarah Cannon | FCS Current Trial Menu* Type Open Protocols Breast 13 GI (Gastrointestinal) 10 GU (Genitourinary) 7 GYN (Gynecology) 2 Heme (Hematology Malignancy) 12 Lung 11 Phase 1 34 Multiple Tumor Types 13 CLL (Chronic Lymphocytic Leukemia) 2 Lym (Lymphoma) 16 Grand Total *Data current as of November 2019

120

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

3. “Patients may only get sugar pills

(placebos) as members of the researchers’ ‘control group’ in lieu of their regular medications.”

5

FALSE. The word “placebo” causes great concern on the part of patients considering a research trial but should not be a cause of worry.

Cancer patients will never receive less than the standard of care for their diagnosis. continued on page 8

CLL 2% Multiple Tumor Types

Lym 13%

Breast 11% GI 8%

11%

Phase 1 28%

GU 6%

Lung 9%

Heme 10%

GYN 2%

How We’re Advancing Therapies for Patients Sarah Cannon Research Institute and Florida Cancer Specialists’ Research Program

~9,000 1,600+ Patients Have Been

Patients Have

Enrolled on Innovative

Accessed Novel

Studies Since Inception

Therapies Through the

of the Research Program

DDU to Date

6

500+ 36 Patients Treated Per Year on Clinical Trials

Phase 1 Unit in Sarasota

Research Office Locations in 21 Counties in Florida

Second Phase 1 Unit Opening in Lake Mary in Early 2020

How It Works Patient Consult

Patient Assessment

Enrollment into Trial

Trial Updates

Physicians in

Physician and

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Patients Are

Referring

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Physicians

Refer Patients

Research

and Study

Physicians,

Are Kept

for Cutting-

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Up-to-Date on

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Patient’s

Team Conduct

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Medical

Screening,

and a Clinic

History to

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Determine

and Review

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the Patient for

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the Trial.

To learn more, visit FLCancer.com/ClinicalTrials

1001/19SF003/R2

Patient Referral

How We’re Advancing Therapies for Patients Comprehensive Clinical Trial Care Team Patient Support Team Study & Data Operations Team

Laboratory Technicians

Clinic Research Nurses, Physicians and Nurse Practitioners

Supports Patients Through Every Step of the Clinical Trial Process 7

Infusion Nurses Research Pharmacy Staff Enrollment Research Nurses

2/3

Sarah Cannon Has Been a Clinical Trial Leader in Two-Thirds of Approved Cancer Therapies Over the Last 10 Years

25+

Years of Advancing Science Through Clinical Research

To learn more, visit FLCancer.com/ClinicalTrials

To learn more, visit FLCancer.com/ClinicalTrials

19SCF003 - INFOGRAPHIC-FCS2019-r2.indd 2

10/1/19 1:07 PM

Clinical Trials: Separating Fact from Fiction continued from page 5

Suppose the current standard of care is the drug combination XYZ. A study looking at a new pill, “A,” is proposed. In the study, all patients receive the standard XYZ combination. Patients in the study are randomized to receive either XYZ plus “A” or XYZ plus a placebo.

Note that all patients in the study are getting the standard of care treatment. The study tests whether the addition of treatment “A” to XYZ is better than XYZ alone. This would be a “placebo-controlled study,” and neither the patient nor the medical team treating that patient would know whether a patient in the study is getting “A” or a placebo. This is to eliminate bias in interpreting the results of the study, often referred to as a double-blind study.

In short, clinical trials will never fail to provide a patient with their standard of care therapy.

Patients who receive a placebo will still receive the approved therapy that all patients with the same diagnosis would receive.

4. “These Clinical trials are primarily for cancer patients who have no other treatment options.”

FALSE. Nothing could be further from the truth. Clinical trials investigate all potential therapies, not only those for people who have no other options. This is how we will know what will work for every cancer patient.

Many trials today are looking to bring advances to patients who are newly diagnosed with cancer or who have had one prior regimen of treatment. We encourage patients to consider clinical trials from the very first opportunity, because this will allow them the greatest

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Setting a National Benchmark in Clinical Research Since its establishment in 1984, Florida Cancer Specialists (FCS) has regarded clinical research as a vital component of world-class cancer care. In 2005, the practice entered into a strategic partnership with Sarah Cannon Research Institute that has helped to catapult FCS patients to the very pinnacle of cancer care today.

By teaming up with Sarah Cannon, the research arm of HCA Healthcare’s global cancer institute, FCS is part of a network that reaches more clinical trial patients than any single cancer treatment center.

Patients with breast cancer, lung cancer, leukemia and many other forms of cancer are actively taking part in more than 120 clinical trials throughout Florida to help researchers find the next big breakthroughs in medicine and treatment protocols. Research is currently taking place at more than 36 FCS locations statewide through the collaboration with Sarah Cannon, one of the leading clinical trial organizations in the world.

New drugs and treatments cannot gain FDA approval and reach the marketplace without successful clinical trials. The closely-monitored studies (typically funded by

drug companies, the federal government and/or private institutions) require several phases of testing and extensive oversight to establish a drug or treatment method’s potential.

One of the main differentiators of the FCS Clinical Research Program is the inclusion of early phase trials, which are extremely rare in a community oncology practice, such as FCS. Phase 1 trials usually involve a small number of patients to determine the response in humans, the maximum tolerated dose, how the drug works in the body, the side effects and the duration of side effects. Phase II trials measure the effectiveness of the treatment in a specific and much larger patient population. Promising new drugs and therapies advance to Phase III, where they are compared to a standard therapy in a large population to help regulators determine whether the drug being tested warrants government approval.

number of options when it comes to managing a very complex disease over an extended period of time.

A patient who receives two or three standard regimens for cancer may inadvertently exclude themselves from many current trials. There are some trials that focus on patients who have exhausted standard treatments, but these are not readily available.

5. “Although I give my written consent

to participate, I don’t have to complete the study if I don’t want to.”

TRUE. A patient in a research trial can withdraw consent to participate at any time.

Research patients are provided written information in the form of a consent form before they decide to participate. The written consent that the patient signs is to document that the patient is aware of the trial, the potential side effects and the schedule of the trial. It is not a contract. This consent form is also updated throughout the time the research is conducted and patients will be given information should anything change.

Patients will always have the right to withdraw from a study at any time, for any reason. +

Helping Patients Find the Right Study How does a patient learn about a clinical trial that may be appropriate for them? Usually their oncologist is the person who makes a patient aware that a clinical trial is a possibility.

If the patient is agreeable to consider this, the doctor and research coordinator give the patient a consent form to review that spells out the rationale for the trial, as well as any known side effects.

If the patient consents to participate and meets the eligibility criteria for the study, then the patient is enrolled, gets appropriate lab tests and scans, and then starts treatment according to the study protocol.

For more information about clinical trials currently enrolling cancer patients at FCS visit FLCancer.com and click on the “Find a clinical trial” link, or call (239) 274-9930.

Matching the patient to the trial can be done by the doctor or research

coordinator. Increasingly, we are using

software that screens our electronic

medical records to find patients who

meet a study’s criteria.

James A. Reeves Jr., MD Director of Research Operations Florida Cancer Specialists & Research Institute

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Fighting Back Against Cancers Affecting Women 10

Several advancements in recent years are helping more women beat cervical, uterine, ovarian and other gynecologic cancers. And more help may be on the horizon.

S

ince the 1950s, PAP tests have saved the lives

of tens of thousands of women in the United

States. Nowadays, doctors and patients have a

much broader arsenal to fight cervical cancer and other cancers of the female reproductive system, including ovarian and uterine cancers. “We no longer view these cancers as death sentences.

Patients are living longer and with a higher quality of life,� says Dr. Antonella Leary, a gynecologic oncologist with Florida Cancer Specialists & Research Institute (FCS).

Dr. Leary and colleague Dr. Howard Goodman point to several advancements in recent years that are helping women prevent cancer or treat it earlier and more effectively.

Some of these breakthroughs include: • The increased use of the HPV (human papillomavirus) vaccine, which has drastically reduced the occurrence of cervical cancers, while other types of immunotherapy are helping curb some other forms of cancer • Minimally-invasive surgeries, including robotics, with less pain and shorter recovery times • DNA analysis that can help pinpoint the best treatment for shrinking or eliminating cancerous tumors • Ongoing research involving a growing number of clinical trials, expected to yield new drugs and treatment options

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Cervical Cancers on the Decline

Mortality from cervical cancer, once one of the most common causes of cancer deaths among women, has declined by more than 50 percent over the past several decades, with standard PAP test screenings and more recently, the widespread acceptance of the HPV vaccine, according to the American Cancer Society.

“The HPV vaccine has been a tremendous addition to the treatment and prevention of cervical cancer,” says Dr. Leary, who practices at the FCS location in Palm Beach Gardens.

Dr. Goodman, an FCS gynecologic oncologist who practices in West Palm Beach, agrees. “Every female age nine to 12 should be vaccinated with the HPV vaccine,” he says, adding that there are no known drawbacks to the vaccine other than a temporary discomfort at the injection site. continued on page 12

Fighting Back Against Cancers Affecting Women Continued From Page 11

The preventive measure is one of several forms of immunotherapy that enhance the ability of the body's immune system to fight off tumors. Others cancer inhibitors, known as PDL1 and PD1, “have been used with some success in endometrial cancer and cervical cancer, but we are just starting to see the results of [clinical] trials using these drugs for these diseases,” Dr. Goodman added.

Less-Invasive Surgeries and Robotics

The science of how best to treat tumors continues to improve.

“The use of minimally-invasive techniques, such as laparoscopy and robotics, has changed surgical practices and become the standard of care, especially as it relates to treatments of uterine cancers,” Dr. Goodman says.

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Adds Dr. Leary, “We have now adopted robotics for most endometrial cancers, which allows for shorter recovery, less incisional pain and a quicker return to work. We have also started adopting minimally invasive surgery in early-stage and some interval surgeries for ovarian cancer. This allows quicker time to begin adjuvant [additional] treatment, if necessary, with patients starting chemotherapy earlier.”

For some cancers, however, less invasive procedures haven't proven as successful.

“Women with cervical cancer have improved survivals when a radical hysterectomy is done with open surgery as opposed to something that's minimally invasive,” Dr. Goodman says. “Virtually all centers have gone back to open surgery for a radical hysterectomy.”

DNA Tests Guide Treatment Options

Getting a better understanding of a patient's DNA, or genome, is helping the medical community treat a variety of cancers of the reproductive system.

Long gone are the days when all ovarian and endometrial cancers were treated similarly. Today, DNA tests on tumors can help doctors choose the best course of treatment.

By identifying genetic abnormalities or mutations that cause tumors to grow, doctors can target the

“All ovarian and fallopian tube cancer patients should be genetically tested, as we are finding new and innovative treatments, or PARP inhibitors, with excellent responses. The tests often reveal harmful genetic mutations known as BRCA 1 and BRCA 2 linked to tumor growth.”

Antonella Leary, MD Florida Cancer Specialists

harmful cells with drugs known as PARP inhibitors and other cancer-fighting therapies that kill cancer cells and reduce tumor growth.

“All ovarian and Fallopian tube cancer patients should be genetically tested, as we are finding new and innovative treatments, or PARP inhibitors, with excellent responses,” Dr. Leary says. “The tests often reveal harmful genetic mutations known as BRCA 1 and BRCA 2 linked to tumor growth.”

Lynch syndrome is another genetic mutation which can lead to an increase in colon, uterine and early ovarian carcinomas, Dr. Leary noted. “Some of these cancers are preventable with early detection and screening, thus a good family history and testing are recommended,” she says.

Genetic testing also benefits a patient's siblings and offspring, often helping them decide whether to take preventive measures if they, too, carry a potentially cancer-causing gene mutation. For example, women who carry the BRCA 1 or BRCA 2 mutation can reduce their risk of developing breast cancer by 95 percent by opting for a so-called “prophylactic mastectomy” – elective surgery to have one or both breasts removed before tumors can develop, according to the National Cancer Institute. continued on page 20

Early Signs of Ovarian Cancer Ovarian cancer remains one of the most challenging cancers to treat because early detection is difficult.

With no reliable medical tests to screen for the disease in its earliest stages, experts recommend that women and their doctors be aware of possible indications of the often-deadly disease.

“Ovarian and Fallopian tube cancers are hard to find at an early stage and thus harder to treat.

That's why patients need to be educated on the signs and symptoms,” says Dr. Antonella Leary, a gynecologic oncologist with FCS. Early on, patients may experience abdominal bloating, changes in bowel or bladder habits, and abdominal pain and pressure, she said. Dr. Leary concedes that these symptoms are “all very vague, but if they persist, it could be a sign of something wrong.”

FCS gynecologic oncologist Dr. Howard Goodman adds that ovarian cancer has a reputation as a “silent killer.” He explains, “Frequently women notice some issue, but the signs are subtle or nonspecific, hence they are not brought to [a doctor's] attention. Typical complaints are bloating, early satiety [fullness when eating], increasing abdominal size, constipation and urinary frequency or menstrual pattern change.

Antonella Leary, MD Gynecologic Oncologist

“Ninety-nine percent of the time when a patient has these complaints, it is not ovarian cancer, but the doctor should be aware to keep this disease in mind.”

13

The Rising Appeal of Biosimilar Drugs When we think of manufactured drugs, we usually picture mass-produced pills made with compounds under tightly controlled conditions.

16

A more recent trend is the use of biologic drugs that are grown in a lab from living sources – typically proteins from human genes or other living organisms – and are used to prevent, treat or cure a variety of diseases, including cancer.

Although these “biologics” have been around for more than 100 years with the use of vaccines and insulin, their popularity has grown dramatically since the 1980s as they offer new options to target the immune system or other biological processes at the cellular level.

A new branch of biologic drugs known as biosimilar drugs has come along just within the past few years that further expands the choices doctors and patients have in treating various conditions. Like other biologics, biosimilar drugs come from cultures of living cells whose genes (DNA) can help treat or reverse a medical condition. Although few patients are familiar with biosimilars, the treatments are becoming an increasingly popular choice.

The U.S. Food and Drug Administration has already approved the use of 23 biosimilars, most of them in recent years, based on favorable studies of their effectiveness; some are not yet available commercially.

Two authorities on the subject, Melody Chang, RPh, MBA, BCOP and Dr. Jorge Ayub, were asked to shed some light on this growing field of medicine. Chang is a Board-certified oncology pharmacist and the director of pharmacy operations at Florida Cancer Specialists & Research Institute (FCS).

Dr. Ayub is an FCS hematologist and oncologist based in New Port Richey, Florida.

What do you want people to know about biosimilar drugs?

Chang: Biosimilars are essential to oncology care. They are the top drug expenditures for most outpatient clinics. As more biosimilars come to market in the next several years, their use in oncology will play a very important role. There is also a greater need for education among key stakeholders – physicians, nurses, pharmacists, payers and patients – to ensure their appropriate use.

Ayub: Biosimilars are important because they offer patients more treatment options at a lower cost.

Cost is a big advantage. Are there other advantages?

Chang: In addition to cost savings and increasing patients' access to biologics, more biosimilar competition means more opportunities for quality improvement in the manufacturing process. This could impact medication safety in a positive way.

Ayub: Another main advantage is they provide increased access to this important family of drugs. continued on page 18

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Q&A The Rising Appeal of Biosimilar Drugs continued from page 17

How equivalent are they to the original, or name-brand, drug?

Ayub: The drugs are highly similar but not the same, and they produce equivalent results. There are no meaningful differences in clinical outcomes. The features that they share are very important and include the amino acids sequence and the mechanism of action. Before approval, they have to demonstrate no clinically meaningful differences between a biosimilar and the reference product in terms of safety, purity and potency.

Why can't they be called generic drugs?

Chang: Generic drugs are chemically synthesized, with small molecular weight and are completely identical. In contrast, like all biological products, biosimilars are produced by living cells or organisms. They are complex in structure and large in molecule, and thus are usually not fully characterized and definitely not identical.

Ayub: They are not the same compound as the brand name.

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But they accomplish the same therapeutic and clinical results?

Chang: Until a biosimilar can be deemed “interchangeable� by the FDA, we cannot declare that they have the same therapeutic and clinical results in any given patient. We can only say that they will have no meaningful differences in the safety and efficacy of the clinical results.

Ayub: Biosimilar manufacturers have to collect data showing that they are comparable to the reference product.

Who should inquire about whether biosimilar drugs are a better option, patients or their doctors?

Ayub: The best individual to decide is the physician caring for the patient.

Chang: I agree that physicians are best equipped to help their patients understand the complexities of biosimilars and help them make decisions in their best interest.

When should patients rule out using a biosimilar drug?

Chang: If a patient has a sensitivity to a name-brand product, they should rule out using its biosimilar(s).

Ayub: If a patient doesn't feel comfortable using this option, then I wouldn't recommend it. +

Biosimilar Drugs Available at Florida Cancer Specialists FCS currently administers several biosimilar drugs to treat various cancers or other disorders such as:

Cervical cancer; colorectal cancer; glioblastoma; NSCLC (non-small cell lung cancer); renal cell cancer

Anemia due to: a) chronic kidney disease with or without hemodialysis

b) zidovudine c) chemotherapy; reduction of red blood cell transfusions in surgery

HER2 (Human Epidermal Growth Factor Receptor 2) + breast cancer; HER2 + gastric or esophageal junction adenocarcinoma

To decrease infection/FN (febrile neutropenia) in patients receiving chemotherapy; reduce time to neutrophil recovery and duration of fever after acute myeloid leukemia induction/consolidation; reduce duration of neutropenia/febrile neutropenia in patients with non-myeloid diagnosis undergoing bone marrow transplantation; mobilization for peripheral stem cell collection; reduce incidence and duration of severe neutropenia

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Fighting Back Against Cancers Affecting Women Continued From Page 13

“Genetic mutations are familial,” Dr. Leary says. “If you carry one, you should share these results with others in your family to allow for them to get tested.

“Prophylactic surgeries that we recommend are a hysterectomy and removal of the ovaries and Fallopian tubes if they carry the BRCA 1 mutation, and removal of the ovaries and Fallopian tubes for BRCA 2, both by the age of 35 or after childbearing. We also recommend a hysterectomy and removal of the ovaries and Fallopian tubes by the age of 50 for women with Lynch syndrome.”

Promising New Research, Clinical Trials

Ongoing medical research offers additional hope for beating the various cancers of a woman's reproductive tract. “More widespread genomic testing may bring to light a genetic abnormality that we can target,” Dr. Goodman says. “Doctors are increasingly turning to treatments based on the characteristics of the tumor, rather than strictly focusing on its point of origin,” he said.

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“More widespread genomic testing may bring to light a genetic abnormality that we can target. Doctors are already increasingly turning to treatments based on the characteristics of the tumor, rather than strictly focusing on its point of origin.”

Howard Goodman, MD Florida Cancer Specialists

Some clinical trials currently underway are showing encouraging results in preventing or treating endometrial and cervical cancers, he added.

Scientists are also at work developing better screening tests for ovarian cancer, which has been historically hard to detect in its early stages.

Healthy Lifestyles and Positive Attitudes are Important

Still, despite the recent advancements, health-care professionals are concerned that endometrial and uterine cancers are on the rise, partly the result of unhealthy lifestyles. “For uterine cancer, we know that obesity is a significant risk factor,” Dr. Goodman says. “Encouraging a healthy diet and exercise will help reduce the incidence of this disease.”

In an interview earlier this year with Prevention Online magazine, Dr. Leary pointed out that regardless of what type of cancer patients face, their mindset goes a long way in improving their outcome. “I strongly believe that going into treatment of any disease with a positive mindset and low stress level is optimal,” she says. “Stress and negative thoughts can hinder and prolong recovery and make it much harder to get through treatment.” +

People + Places

FCS Foundation Event Re-Caps

Tickets and sponsorship opportunities can be found at FCSF.org or by calling (941) 677-7181.

CRACK-UP CANCER September 14 It was a night of belly laughs, courtesy of four nationally recognized comics who entertained a sold-out crowd at Crack-up Cancer. The premier comedy benefit was held at the David A. Straz Jr. Performing Arts Center and netted $30,000.

SISTER HAZEL’S LYRICS FOR LIFE September 20 Platinum-selling band Sister Hazel hosted the third annual Lyrics for Life: An Evening of Making Music Matter at the Santa Fe College Fine Arts Center in their hometown of Gainesville. Attendees enjoyed cocktails and heavy hors d'oeuvres as they browsed the star-studded silent auction, featuring items from some of the music industry's biggest names. Patrons then experienced an intimate concert by Sister Hazel, with special guest artists Tom Higgenson (from The Plain White T's) and Shawn Mullins. An after-party with delicious desserts closed the evening. The sold-out show netted $100,000.

WINE WOMEN & SHOES LAKE MARY September 28 Stylish ladies who share a passion for pumps and a sweet spot for stilettos gathered for a fun evening of wine-tasting, boutique shopping and a fashion show. The fashionable fundraising event raised more than $138,800, a 16% increase over the prior year. Special thanks to Chair Jodi Murphy, Esq., from Murphy & Berglund, PLLC Attorneys at Law, and Honorary Co-Chairs & FCS Physicians Dr. Jennifer Cultrera and Dr. Maria Regina Flores.

11th ANNUAL PINK RIBBON WALK October 5 Community residents of all ages and dressed in pink gathered at Port Canaveral to walk for a cause.

Some came out extra early to warm up with a Zumba class. The 11th annual event netted over $20,000 to benefit cancer patients in Brevard County.

SOUTHERN STATE OF KIND October 12 Belles and gents slipped on their best duds and boots for a delightful evening of Southern hospitality. An annual tradition since 2014, it’s the Foundation’s largest event of the year.

Armature Works in downtown Tampa was the perfect venue for guests to enjoy home cookin’, country music and line dancing, and vie for fabulous live and silent auction packages. FCS Physicians Dr. R. Waide Weaver and Dr. David Wright co-chaired the sold-out event, which netted $277,000, nearly double the prior year.

PARTY UNDER THE STARS February 1 This festive evening “Under the Stars” features Powerhouse Next Generation, a Joan L. Kidd, MD, Fight for Life Concert Series, along with dining and a silent and live auction with fabulous prizes. FCS Physicians Dr. Fadi Kayali, Dr. Miquel Pelayo and Dr. Judy Wang are the honorary chairs for this annual signature event to be held at the Hyatt Regency Sarasota for the second year in a row.

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People + Places

FCS Expands State-of-the-Art Pathology Laboratory Centralized lab serves oncologists and cancer patients across the state

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A ribbon cutting ceremony was held in September to celebrate the opening of the new centralized FCS Pathology Laboratory in Fort Myers.

The 50,000-square-foot facility serves more than 230 physicians who practice at nearly 100 FCS sites throughout the state, providing complete and accurate tests and reports that are critical to cancer diagnosis and treatment. As integral members of the cancer care team, the Pathology Laboratory’s skilled hematopathologists and surgical pathologists provide a comprehensive testing menu that includes flow cytometry, histology and immunohistochemistry, cytogenetics, FISH (fluorescence in-situ hybridization) and central lab services.

Pathology Laboratory Medical Director Dr. Ryan Olson said, “With real-time access to patient health information through our online medical records system, our lab and our staff are seamlessly integrated into daily patient care, and we maintain highly personal communication with the oncologists we serve.”

“All of our testing is centralized and streamlined,” said Dr. Wilfredo Blasini, FCS co-director of Laboratory Services. “Our consistently fast turn-around time means that oncologists and their patients receive complete and accurate results quickly, which greatly minimizes patient anxiety.”

The expanded FCS Pathology Lab is sized to accommodate continued growth as well as ongoing clinical and technological advances. A Cytogenetics Lab Center was recently added and the possible expansion of molecular testing to include NGS (next generation sequencing) for both hematologic and surgical pathology specimens is also being explored.

The FCS Pathology Laboratory has achieved “Gold Standard” certification from the College of American Pathologists (CAP).

People + Places

New Wesley Chapel Location Brings World-Class Cancer Care Closer to Home for Pasco County Residents FCS celebrated the opening of its Wesley Chapel office, the sixth FCS location in Pasco County, with a ribbon-cutting ceremony on October 23.

Four board-certified medical oncology/hematology physicians are now providing a comprehensive range of cancer care treatments at this location, including chemotherapy, radiology (PET/CT imaging), laboratory and pharmacy services, care management and access to cutting-edge clinical trials.

The 3,000-square-foot facility, at 26823 Tanic Drive, features four exam rooms and seven chemotherapy infusion stations.

Physicians and Clinicians Stay Abreast of New Developments in Cancer Care 2019 Clinical Summit Recap

Dr. Stephen Orman was recognized for his years of service to FCS. He has served as FCS assistant managing partner since retiring from clinical practice in 2017. Currently, his sole focus is serving as chairman of the board of directors for American Oncology Network, LLC. He is pictured with Dr. Lucio Gordan (L) and Brad Prechtl (R).

More than 700 FCS physicians, nurse practitioners, physician assistants, senior managers and invited guests attended the 2019 Clinical Summit this fall in Orlando. The three-day annual event featured Research to Practice’s Year in Review continuing medical education (CME) program, as well as updates by FCS CEO Brad Prechtl, MBA, and FCS President & Managing Physician Dr. Lucio Gordan.

The summit also included a clinical trials and research update by Dr. Manish Patel, Dr. Judy Wang, Dr. Jim Reeves, Katie Goodman, RN, BSN, CCRP, and clinical experts from Sarah Cannon Research Institute.

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People + Places

Lake Mary Treatment Center and Sarah Cannon | FCS Drug Development Unit to Open in Early 2020

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The newest central Florida location of Florida Cancer Specialists is nearing completion in Lake Mary. The first shovels were turned on the project in February 2019. The 25,000-square-foot Drug Development Unit and treatment facility will combine medical oncology services and Phase 1 clinical trial options for cancer patients, reducing the need for patients to drive or travel out of state for care. The new DDU is part of Sarah Cannon Research Institute, one of the leading clinical research organizations in the world. As a strategic research site for Sarah Cannon, FCS conducts clinical trials at more than 36 locations throughout the state.

Lake Mary Mayor David Mealor noted, "There is nothing more personal than a family member diagnosed with cancer, and we won’t have to send them to Jacksonville or out of the state for the treatment they may need."

Dr. Shekeab Jauhari Joins FCS as Principal Investigator FCS welcomes Medical Oncologist/Hematologist Shekeab Jauhari, MD. He will lead Phase 1 clinical trials at the Lake Mary DDU when it opens in early 2020.

Dr. Jauhari earned his medical degree from the University of Miami Miller School of Medicine. He completed his internship and residency in internal medicine at the Hospital of the University of Pennsylvania in Philadelphia. He went on to complete his fellowship training in hematology and oncology at Duke University in Durham, NC. His numerous academic honors include the Conquer Cancer Foundation Young Investigator Award. During his fellowship at Duke University, he was closely involved in Phase I clinical trials and was a participant in the ASH Clinical Research Training Institute. He is the author of many publications pertinent to hematologic malignancies, including lymphomas and immune-based treatment approaches.

“We are delighted to welcome Dr. Jauhari to our team,” said Manish R. Patel, MD, director of the FCS Drug Development Unit. “He has excellent credentials and he shares our passion for advancing innovations that expand treatment options for our patients. Dr. Jauhari and his team will work very closely with our early phase trial unit in Sarasota. We expect that our new unit will grow quickly and add many more options to our existing Phase 1 program as part of FCS and Sarah Cannon.”

People + Places Florida Cancer Specialists & Research Institute and Humana Sign Multi-Year Agreement Partnership provides thousands of Humana members in-network access to FCS cancer care.

A new multi-year agreement between FCS and Humana Inc. (NYSE: HUM), effective October 1, 2019, has provided thousands of Humana members with in-network access to the comprehensive range of FCS oncology services. Humana members with coverage provided through Medicare, Medicaid and commercial plans can now receive oncology and hematology physician services, as well as radiation oncology, radiology, laboratory, pathology and pharmacy services at in-network rates.

FCS CEO Brad Prechtl, MBA, said, “We are so pleased to welcome Humana members. This agreement means that even more Florida residents can now access FCS providers and services and receive world-class cancer care, as well as treatments for other non-cancer related illnesses, close to where they live and work.”

“This agreement creates future opportunities for FCS and Humana to collaborate and develop value-based programs, which will further enhance the quality of patient care and reduce costs,” added FCS President & Managing Physician Dr. Lucio N. Gordan.

“The partnerships we have with our payers, such as Humana, are something we are dedicated to fostering to ensure we can provide long-term solutions that secure cancer care for anyone in need,” said Sarah Cevallos, FCS Chief Revenue Cycle Officer. “This partnership demonstrates our mutual commitment to achieve this goal. We are excited to collaborate with Humana and we are looking forward to a long-standing relationship.”

FCS and Cigna Expand Cancer Care Collaboration Enhanced program features treatment of all cancer diagnoses, additional treatment therapies.

FCS and Cigna have announced an important oncology-focused initiative, part of Cigna Collaborative Care, a value-based care model that uses incentives to engage health care professionals to improve patient health, affordability and overall patient experience. The Cigna Oncology Focus program started in July and is focused on quality and cost containment for people fighting cancer.

FCS and Cigna announced the first phase of their collaborative care arrangement in 2015.

“With the Cigna Oncology Focus program, patients benefit from two significant program enhancements,” said Dr. Lucio Gordan, FCS President & Managing Physician. “Those changes involve the inclusion of all categories of cancer diagnoses, versus a previous focus of breast, lung and colorectal cancers, leukemia and lymphoma. Also, the program includes the availability of additional therapy treatments for more types of cancers than previously,” he concluded.

Sarah Cevallos, FCS Chief Revenue Cycle Officer, noted, “Cigna has been an instrumental payer as our pioneer value-based care partner since 2016, when we started our initial program. We have had tremendous success learning from each other, with results that have shown a 28 percent lower inpatient admission rate compared to typical hospital admission rates of cancer patients outside of a value-based model of care like this.”

"Our priority is to ensure high quality care for our customers who are going through a difficult journey, and we continue to see substantial improvements in patient experience and efficiency from our collaboration with Florida Cancer Specialists," said Michael Howell, MD, market medical executive for Cigna in Florida.

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People + Places New Doctors + Updates

FCS welcomes Medical Oncologist Zanetta Lamar, MD to the Naples

Goodlette office, 1100 Goodlette Road, Naples.

Medical Oncologist Rina Patel, MD has joined FCS at the Palm Beach Gardens office, 3401 PGA Boulevard, Suite 200, Palm Beach Gardens.

Board-certified Medical Oncologist/Hematologist Mohsin Malik, MD joins FCS as a hospitalist and outpatient medical oncologist/hematologist in Orlando, Orange County, Tavares and the Oviedo area.

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Surgical Pathologist Joseph Huth, MD and Pathologist Chunlai Zuo, MD, MS have joined the staff of the newly expanded, state-of-the-art FCS pathology laboratory in Fort Myers.

FCS recently welcomed Hospitalists Jasmin Desai, MD in Tampa, and Madhavi L. Venigalla, MD in Sarasota.

Medical Oncologist Juan L. Castro, MD has joined FCS and is seeing patients at the Bradenton East location, 401 Manatee Avenue East, Suite B, Bradenton.

Board-certified Medical Oncologist Uma Iyer, MD has joined FCS and is practicing at the FCS Gainesville Cancer Center, 6420 W. Newberry Rd., East Wing, Suite 100, Gainesville.

Expanded news releases and complete physician bios can be found on the FCS website: FLCancer.com.

Where to Find Us

Altamonte Springs • Apopka Bonita Springs • Bradenton • Brandon Brooksville • Cape Coral • Clearwater Clermont • Crystal River • Davenport Daytona Beach • Deland • Englewood Fleming Island • Fort Myers • Gainesville Hudson • Inverness • Kissimmee The Villages • Lake City • Lake Mary Lake Wales • Lakewood Ranch • Lantana Largo • Lecanto • Leesburg • Naples New Port Richey • North Port • Ocala Okeechobee • Orange City • Orlando Ormond Beach • Oviedo • Palatka Palm Beach Gardens • Palm Coast Port Charlotte • Port Orange Saint Petersburg • Sarasota • Sebastian Sebring • Spring Hill • Stuart Sun City Center • Tallahassee • Tampa Tavares • Venice • Vero Beach • Wellington Wesley Chapel • West Palm Beach Winter Park • Zephyrhills

Blue Cross Blue Shield has recognized Florida Cancer Specialists as a Blue Distinction® Center for Cancer Care. FCS is the only community hematology and oncology practice in Florida to earn this distinction.

For more information about the Blue Distinction Specialty Care Program, visit bcbs.com/bluedistinction.

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