Cancer360 Gainesville Edition

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Special Edition: The FCS Gainesville Cancer Center

FCS Gainesville Cancer Center: Dedicated to Unmatched, Community-Based Care | 3 The Value of Community Oncology | 8 Q+A with Hematopathologist Dr. Ryan Olson | 12 FCS Clinical Trials: Providing Access to Life-Saving Advances | 14 A Conversation with Dr. James Reeves Jr., FCS Director of Research Operations | 18 Fundraisers Bring Hope to Families Touched by Cancer

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Florida Cance r Specialists is the only Blue Cross B lue Shield Blue Distinct ionÂŽ Center for Cancer C are in the Gaine sville area


Introducing the Florida Cancer Specialists Gainesville Cancer Center Welcome to a special edition of Cancer 360+ magazine focusing on the exceptional cancer care that is available here in the Gainesville community. Over the past five years, there has been tremendous progress made in the fight against cancer and we, the physicians of the Gainesville Cancer Center, have been taking the initiative to ensure that our patients throughout Alachua County, and in many surrounding areas, are able to access the numerous advancements in cancer treatment and supportive services. One of the true differentiators of our practice is the Florida Cancer Specialists (FCS) Clinical Research Program, highlighted in this publication. This program is unsurpassed in the number of national clinical trials we can offer to qualifying patients; in fact, in the past three years, the majority of new cancer drugs approved for use in the United States were studied in clinical trials with Florida Cancer Specialists participation. In addition to clinical research, a broad variety of resources and services are available at the Gainesville Cancer Center, providing the utmost convenience to our patients. Here are just a few examples: 2

Pathology Lab – Profiled in this edition, the FCS Pathology Lab is a state-of-the-art facility staffed with five hematopathologists, two surgical pathologists and highly-specialized laboratory scientists who serve the needs of our practice in an extremely time-sensitive manner. Infusion Therapy - Under the supervision of our BoardCertified Physicians, our dedicated teams of Nurse Practitioners, Physician Assistants, Registered Nurses and Pharmacy Technicians specialize in providing personalized care when administering these types of medications. These infusions include, but are not limited to, therapies for dehydration, infections, renal failure, diabetes, cancer or other diseases such as osteoporosis, multiple sclerosis, Crohn’s disease, rheumatoid arthritis or asthma. Onsite PET/CT Scanner - In our continuous commitment to patient care, FCS has invested in specialized software and state-of-the-art technology, which minimizes radiation exposure, while producing the highest quality images. The sensitivity and accuracy of imaging information is of extreme value in determining your treatment options and monitoring how well treatment is working. We hope you will use this special edition to learn more about FCS and many advantages we offer. We are honored to serve our patients and their families and provide the highest quality of cancer care, under one roof, here in our own community. + Andres Bhatia, MD Lucio N. Gordan, MD Manuel de la Puerta, MD Amy Nance, MD Laura C. Dickerson, MD Vijay Patel, MD

Special Edition: The FCS Gainesville Cancer Center 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 WRITERS Hannah Burke, David Chesnick, Elaine Ganick, Tisha Keller 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 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 Gainesville Cancer Center: Dedicated to Unmatched, Community-Based Care By Tisha Keller & Elaine Ganick

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he sleek, glass-and-metal exterior of the Florida Cancer Specialists (FCS) office in Gainesville is impressive, no doubt; however, the cool, new, modern building belies a warm, welcoming staff that is the heart of the community oncology practice. From her office situated in the middle of clinic operations, Senior Office Manager Betty Ann Forsyth hears the laughter and witnesses the smiles of her staff and patients every day.

“We are like family,” she says. “Our physicians and staff live in the communities we serve, and everyone, from the physicians to the front desk patient service specialists (PSS), is exceptional in how they treat each other.” And, Forsyth believes, that also carries over to the more than 200 patients each day who are treated at the Gainesville Cancer Center. continued on page 4

Physicians at the FCS Gainesville Cancer Center (L-R): Vijay Patel, MD; Manuel de la Puerta, MD; Laura C. Dickerson, MD; Andres Bhatia, MD; Amy Nance, MD; and Lucio N. Gordan, MD.

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FCS Gainesville Cancer Center: Dedicated to Unmatched, Community-Based Care continued from page 3

Even though FCS is a large, statewide practice with nearly 100 locations, its “hometown feel” is widely recognized as one of its greatest assets. This is especially true in the Gainesville community. Executive management has focused on creating a family atmosphere from the top down, and every office integrates a community-based approach to treatment, innovation and care. It takes a large staff (including 6 physicians and 10 advanced clinical practitioners) to handle the patient volume, but Forsyth maintains the Gainesville office is a great example of this mission.

The Gainesville Cancer Center offers many of the comforts of home to patients, including a large, comfortable 65-chair infusion room for oncology and hematology patients. Onsite diagnostic imaging, laboratory services and Clinic Trials, offered through the FCS partnership with Sarah Cannon Research Institute, ensures patients don’t have to travel for potentially lifesaving research and testing. For physician appointments, the facility boasts 33 exam rooms to provide patients the privacy of their own space while minimizing any wait time. And if they need radiation treatment, the practice

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(L-R): Onsite PET/CT scanner; dramatic interior design. Opposite page, top: The 65-chair infusion room; one of 33 inviting, well-equipped exam rooms. Bottom: The sleek , contemporary building welcomes more than 7,000 patient visits per month.

“I have visited other FCS offices,” Forsyth continues. “I can say that FCS has a track record of hiring wonderful staff and leadership.” Forsyth joined the FCS family 13 years ago. She’s worked in the medical field in many capacities, holding positions as a Medical Assistant, Registered Nurse, RN Supervisor and Manager. “In all the roles I’ve held, I have always had exceptional leadership,” she says. “This stands true today with the physicians I support and Senior Management.” Forsyth feels that this leadership flows down to her and then through her Management Team to the staff. “I believe this is what makes our office significant,” she explains. “The respect we have for one another shows through our actions and dedication to our patients.”

partners with colleagues at The Cancer Center of North Florida Regional Healthcare. Supportive, integrative care, including acupuncture, counseling and nutrition, is available for patients during treatment through collaboration with Joseph J. Williams of Sunshine Integrative Health.

Volunteers Bring Heartfelt Support

With a smile, a bottle of water, a snack, a warm blanket or a listening ear, the FCS Foundation Volunteers are a big part of the Gainesville Cancer Center’s heart. These caring individuals support the non-medical needs of patients in an effort to provide comfort and companionship. In addition to providing valuable service to individuals battling cancer, the Volunteer Program represents a wonderful opportunity for FCS Gainesville to liaise


on behalf of the FCS Foundation, fostering community relationships through the outreach efforts of its volunteers. The Gainesville Cancer Center is one of the busier sites in the FCS network, treating patients who travel from up to a 100-mile radius. Excellent coordination of care with other specialties and community recognition as a premier cancer treatment center make the Gainesville Cancer Center a standout. Staff and physicians get involved in annual community events, such as “Run Amuck with the Duck,” which raises much-needed funds for the

patient services and clinical research projects of the Bonnie J. Addario Lung Cancer Foundation. They also support the American Cancer Society and the FCS Foundation annually. The dedication to patients and superior care makes Gainesville Cancer Center a wonderful example of the Florida Cancer Specialists’ mission, and it makes Forsyth proud. “Many of the staff have been with FCS for many years. We are like family,” she beams. “Our patients often express their gratitude for feeling welcomed by our facility. We are blessed to have such an exceptional crew that works so well together.” +

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Meet the Physicians at the FCS Gainesville Cancer Center Andres Bhatia, MD

Manuel de la Puerta, MD

Laura C. Dickerson, MD

Dr. Andres Bhatia was born in Santurce, Puerto Rico. After completing undergraduate studies at University of Massachusetts – Amherst, he received his medical degree from Universidad Central del Caribe. He then completed his Internal Medicine residency in 1990 and a Hematology and Medical Oncology Fellowship in 1994 at Cleveland Clinic Foundation.

Dr. de la Puerta was born in Madrid, Spain. He received his medical degree from Universidad Complutense in Madrid and completed his Internal Medicine residency at Polyclinic Medical Center in Harrisburg, Pennsylvania. He was a Fellow in Hematology and Oncology at the University of Florida and then was an internist and oncologist for the Veteran’s Administration Hospitals in the Gainesville area.

Dr. Laura Dickerson maintains a broad practice encompassing medical oncology, benign and malignant hematology. After undergraduate studies at the University of California – Berkley in Civil Engineering, she attended medical school at Wake Forest University in Winston-Salem, North Carolina. She completed her internship and residency at the University of Florida, as well as a Medical Oncology and Hematology Fellowship.

He has been certified in Internal Medicine since 1990, Medical Oncology since 1993, and Hematology since 1993. In 2004, Dr. Bhatia was reboarded in Hematology and Medical Oncology. Dr. Bhatia joined Gainesville Hematology Oncology Associates in 1993, prior to the practice’s merger with Florida Cancer Specialists in 2010. He is a member of the American Society of Clinical Oncology and has been Chief of Staff at North Florida Regional Medical Center since 2011.

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Dr. Bhatia is married to Jennifer and has three children. He enjoys Gator sports and jogging.

He joined Gainesville Hematology Oncology Associates in 2001, prior to the practice’s merger with Florida Cancer Specialists in 2010. Dr. de la Puerta is board certified in Medical Oncology and Hematology, and he won the American Society of Clinical Oncology Travel Award for his research in Apoptosis. He is a member of the American Society of Clinical Oncology, the American Society of Hematology, and the Alachua Medical Society. He is also an active member of the cancer team at Shands at AGH and North Florida Regional Medical Center.

An investigator in multiple clinical research trials, Dr. Dickerson is board certified in Internal Medicine, Medical Oncology, and Hematology. She is an active member of the Cancer Team at North Florida Regional Medical Center. She joined Gainesville Hematology and Oncology Associates in 2007, prior to the practice’s merger with Florida Cancer Specialists in 2010. Dr. Dickerson has special interests in breast cancer, lung cancer, colorectal cancer and thromboembolic disease. Her research interests during her fellowship included osteonecrosis of the jaw in cancer patients treated with zoledronic acid and/or pamidronate, as well as venous thromboembolism prophylaxis in neurosurgical patients. .


Lucio N. Gordan, MD

Amy Nance, MD

Vijay Patel, MD

Dr. Lucio Gordan graduated from medical school at the State University of Londrina College of Medicine in Brazil. Subsequently, he served his internship and residency at the University of Iowa Hospitals and Clinics in Iowa City. In 2003, he completed a Fellowship in Hematology and Medical Oncology at the University of Florida.

Dr. Amy L. Nance earned her medical degree from the Mercer University School of Medicine (Macon, GA) and attended Emory University School of Medicine (Atlanta, GA) for her Internal Medicine residency. She completed a Fellowship in Hematology/Oncology at the University of North Carolina in Chapel Hill. In addition to her academic achievements, Dr. Nance received two research training grants for Hematology and Oncology from the University of North Carolina.

Dr. Vijay Patel attended Ross University School of Medicine in Dominica. He completed his residency at the University of Kansas Medical Center in Kansas City, Kansas, where he began practicing as a community oncologist/ hematologist in 2008.

Dr. Gordan is board certified in Medical Oncology, Hematology and Internal Medicine. He serves on the Florida Cancer Specialists Executive Board, American Oncology Network (AON) Executive Board, Florida Association of Clinical Oncology (FLASCO) Executive Committee, Community Oncology Alliance (COA) Board of Directors, and he is the head of Quality and Medical Informatics at Florida Cancer Specialists. He also serves as the Oncology Advisor/Leadership at North Florida Regional Medical Center (HCA) and consults for International Oncology Network (ION), IntrinsiQ in clinical affairs and analytics. Dr. Gordan has received several grants for research, published articles in peerreviewed journals and, in 2013, was awarded the prestigious FRIST Award from HCA in recognition of his service in the community and North Florida Regional Medical Center. Dr. Gordan is married, with one daughter. In his spare time, he enjoys traveling, reading, horseback riding, photography and tennis.

As a cancer researcher, Dr. Nance is actively engaged in clinical research and has been published in several peer-reviewed journals. She is board certified in Internal Medicine, Medical Oncology/ Hematology, and she has special interest in cancers of the breast, lung and colon. Dr. Nance enjoys spending time with her family, running and traveling.

From 2011-2015, he served as Director of both the Cancer and Palliative Care departments at the West Jefferson Medical Center in Marrero, Louisiana. Fluent in English and Gujarati, Dr. Patel has a keen interest in research and clinical trials. He has been published in the American Journal of Clinical Oncology, the Journal of Hematology & Oncology, and Blood, a weekly medical journal published by the American Society of Hematology. In addition, Dr. Patel has presented abstracts at the annual national conference of the American Society of Hematology. Dr. Patel is board certified in Internal Medicine, Medical Oncology, and Hematology.

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New Report on the Value of Communi+y Oncology Study determines that cancer care delivered in a hospital setting is more expensive than in independent community oncology practices By David Chesnick 8

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ith annual cancer care costs estimated to surpass $170 billion by the end of the decade, the findings of a new study of the cost differentials for cancer patients treated in community-based settings versus treatment in hospital outpatient settings is particularly timely and of vital importance. The report, The Value of Community Oncology: Site of Care Cost Analysis, is the work of Dr. Lucio Gordan, Medical Director of the Division of Quality & Informatics at Florida Cancer Specialists, and Xcenda, a global health economics consultancy. The Community Oncology Alliance (COA), a nonprofit dedicated to advocating for community oncology practices and the patients they serve, released the report.

The Value of Community Oncology Site of Care Cost Analysis

September 25, 2017

The study suggests that the monthly cost of cancer care for patients with breast, lung and colorectal cancer treated in a community clinic setting is approximately $8,000 less than treatment in a hospital-based practice, irrespective of the treatment regimen, branded vs. generic agents used, or tumor type. continued on page 10


“It is disappointing to see data that hospital-based cancer care is more expensive than community practices while, at the same time, more patients are being forced into hospitals.” Lucio N. Gordan, MD Medical Director, Division of Quality & Informatics Florida Cancer Specialists & Research Institute

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Dr. Lucio Gordan Lauds Value-Based, High-Quality Care Model in Keynote Address Dr. Lucio Gordan, who practices at the Florida Cancer Specialists (FCS) Gainesville Cancer Center, was the keynote speaker at the recent American Journal of Managed Care (AJMC) Institute of Value-Based Medicine event, held April 2018 in Orlando. The program focused on the topic of “Advancing Quality in Oncology Care” and was open to Oncologists, Pharmacists, Nurses and Administrators of Oncology Practices. In his address to Care Administrators and fellow Physicians, Dr. Gordan explained that Oncology practices are changing “due to costs, concerns about access to care, and the transition away from fee-for-service to value-based, high-quality care.” Value-based, high quality care seeks to reduce healthcare costs, such as unnecessary emergency room visits, while maintaining high quality care.

FCS Associate Director of Care Management, Don Champlain, who was also a speaker at the dinner program, explained the rapid growth and success of the FCS Care Management Program and how the program has supported the focus on patient-centered care. As a participant in the Oncology Care Model (OCM), Florida Cancer Specialists has been a leader in the transition to value-based care and has successfully implemented OCM requirements, such as 24/7 patient access to a Care Manager and better care coordination. The results have been impressive. According to Dr. Gordan, payer partners have seen a decrease in hospitalization stays and costs. Overall, within the OCM population, there has been a 16 percent decrease in hospitalization rates since July 2016, when the program formally began at FCS.

To read the full article in the American Journal of Managed Care: http://www.ajmc.com/newsroom/with-the-oncology-care-model-everyone-has-to-be-engaged-including-patients


“More than a decade of data has consistently shown that hospitals are a tremendous driver of excessive spending on cancer care. It is crazy that our country continues to push more and more cancer care into the much more expensive hospital setting as we seek ways to reduce runaway health care spending.” Ted Okon Executive Director Community Oncology Alliance (COA)

New Report on the Value of Community Oncology continued from page 8

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Despite this cost disparity, concern is that the report comes at a time when we are experiencing a substantial decline in community-owned practices in the USA. It’s a trend driven by lower reimbursement rates for chemotherapy administration, increasing costs of regulatory compliance, rising facility expenses and pressure from payers. All of these trends are leading to hospital acquisitions and corporate mergers. According to COA’s 2016 Community Oncology Practice Impact Report, 1146 independent community oncology practices have closed, merged or been acquired since 2006. While the primary cost drivers of higher hospital costs for cancer care are chemotherapy and physician visits, Dr. Gordan also cites the migration of patients from community oncology practices to hospital-based settings. Add to this the challenges of value-based care, information technology costs, and an aging population with more patients staying in treatment because they live longer. “As a physician, I am constantly concerned about the financial toxicity of cancer care. It is disappointing to see data that hospital-based cancer care is more expensive than community practices, while at the same time, more patients are being forced into hospitals,” Dr. Gordan says.

Unin+ended Consequences: The 340B Drug Discount Program

Another significant driver of the move to mergers and acquisitions, according to the report, is the 340B Drug Discount Program, a federal program that’s intended to help treat the indigent, uninsured, and underserved. 340B requires drug manufacturers to provide outpatient drugs at significantly lower prices to eligible healthcare organizations. While many thought that the discounted price of drugs under this program would result in savings passed on to payers and patients, evidence indicates it’s had precisely the opposite effect, and it has contributed to raising costs for the very people it was intended to help. The COA found that in 2014 and 2015, 74.5% of the acquisitions of community oncology clinics were by hospitals with 340B drug discount pricing. “More than a decade of data has consistently shown that hospitals are a tremendous driver of excessive spending on cancer care,” according to COA Executive Director Ted Okon. “Congress and the administration need to step forward and address this by reining in the abuses of the 340B program and implementing site payment parity. It is crazy that our country continues to push more and more cancer care into the much more expensive hospital setting as we seek ways to reduce runaway health care spending.”


Wha+ it Means for Patients

As a result, patients diagnosed with cancer face a daunting challenge in finding access to the affordable, high-quality care essential to an optimal outcome. They are confronted with increases in premiums, the disappearance of preferred provider organizations, and the unavailability of public health exchanges that provide adequate coverage. Patients are also experiencing the economic strain of shifting payment models, insurance exchanges, practice consolidations, and administrative and regulatory challenges. Finally, they face a more limited oncology

54% Lung

Breast

66%

Colorectal

Total Cost of Cancer Care in Hospital Setting

46 %

Compared with the same treatment delivered in independent, community oncology practices Source: The Value of Community Oncology Site of Care Cost Analysis, September 25, 2017

workforce because of the difficulty of replacing retiring clinicians and the sparsity of oncologists in rural settings. In addition to evaluating differences in costs, the study also looked at the Emergency Department (ED) visits made by patients receiving treatments at both hospitals and community-based oncology practices. It found the rate of ED visits for cancer patients following chemotherapy were equally striking. Within 72 hours of receiving a chemotherapy infusion in a hospital outpatient setting, patients were 40% more likely to visit the ED. Within 10 days, hospital outpatients were 24% more likely to need ED care. It’s Dr. Gordan’s opinion that the cost differentials in the community setting are because of doctors and support staff who are, quite simply, more efficient.

Across All Cancers

The study, which supports other reports that have been conducted over the last decade but is more substantial, provides more specific information regarding types of cancers, performs a matched analysis between the hospital and community-based settings, and includes hospitalization and ED visits. The findings were dramatic: Across all cancers, the total cost of treatment for a patient receiving chemotherapy in a hospital outpatient setting is 59.9 % higher than for someone treated in a community practice – $20,060 compared to $12,548. Taken on its own, the monthly cost of chemotherapy is 71% more expensive in a hospital setting - $8,443 compared to $4,933. Even more dramatic are the cost comparisons between physician visits, which are 333% higher at hospitals - $3,316 as compared to $765.

Where Do We Go From Here?

The chief reason for doing the study, according to Dr. Gordan, was to demonstrate that the incorporation of independent communitybased oncology practices into hospitals would not only mean more expensive and less efficient care but also diminished access for those in small towns and rural settings. “I hope we’ll get this study to Congress,” Dr. Gordan says. “I hope to inform them because policymakers, providers, payers and patients need to take a long hard look at the impact that site of care has on cancer patients, not just in terms of cost, but also in outcomes, quality of care and satisfaction. It is clear that community oncology should be the preferred, first-choice treatment setting for cancer patients.” +

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Through the Lens: 5 Ques+ions with Hematopathologist Dr. Ryan Olson You can hear in his voice the enthusiasm Dr. Ryan Olson has for his work and the energy he brings to his role as Medical Director of Florida Cancer Specialists & Research Institute’s Pathology Lab. Olson joined the lab in 2011, a year after its opening. He’s overseen its growth from a staff of six to 24, a group that now performs about 5,000 biopsies a year. The Pathology Lab, combined with the FCS Central Lab, covers 10,000 square feetof space and serves more than 220 medical oncologists. We caught up with the father of two-year-old twins and took a few minutes to learn more about him, the lab, and the work that he and his team do.

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Pathologists are “the doctors’ doctors.” What drew you to pathology?

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While in medical school and planning a career in ENT as a head and neck surgeon, I went to the Pathology Lab to look at the liver biopsy of a patient with auto-immune hepatitis I was writing about. I ran into my old pathology professor, David Jones, who asked if I’d ever considered pathology. I hadn’t. It’s not a core rotation, which means we study it from a book — we really don’t experience it. He gave me quite a sales pitch. Within a week I switched from ENT to pathology for my residency. The scientific investigations we get to do — defining diseases, studying them, doing research — are all part of the appeal. So are the autonomy and freedom from red tape with insurance companies. The only drawback is that we don’t work directly with patients, though we do impact them in a truly significant way.

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What are the advantages, to referring physicians and patients, of a facility like this? At FCS, everything is integrated, so communication between the oncologists and us is seamless. We know one another. They know they can reach me by text, email, cell phone, or at the office. If they have a question, if they want to discuss a case, add a test, or need a result quickly, we can accommodate them. In hospitals, pathologists are more removed. Here, we’re directly integrated into the patient’s care system. That means their medical records are available to us, so we have unparalleled insight into what the doctor is concerned about. We always know exactly what we’re looking for, and if we don’t, we can easily contact the doctor for information. We also have the backing of the FCS. They support us in making sure we have the personnel and equipment we need to stay on the cutting edge and continually expand our capabilities. We can usually get back to a doctor within 24 to 48 hours with the results of an innovative test, like flow cytometry that can diagnose and classify certain cancers. In an emergency, we can often get back within hours. With Acute Promyelocytic Leukemia, for example, where hours can mean survival, we can have that diagnosis within hours of receiving a sample. That’s much more quickly than a hospital lab can.


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What are some of the challenges of running such a fast-paced, high-volume lab? Our challenges are what make us better. For example, there’s the volume of work. We do a lot of it, and we do a lot of highly specialized testing. After five years here, I’ve done as many bone marrow biopsies as my mentor in hematopathology did in 20 years. The entirety of what we do is blood, blood marrow and lymph nodes, as opposed to a generalist who only does a few of them a month. That gives us unequaled experience and expertise. Then there are the challenges we don’t have, because we get tremendous support from billing, compliance, marketing, and the rest of the FCS team. I have a luxury many pathologists working in hospitals don’t have — the freedom to devote myself entirely to my work and my staff. Our facilities and personnel are top-notch, which breeds a real desire for the best in the field to want to work with us. And they do. That’s why, when the College of American Pathology inspected us, we received a perfect review.

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Your lab has been described as state-ofthe-art. Can you tell us about how it’s equipped? First, you need to know the work that we do. The Pathology Lab is made up of three departments:

Histology, where we examine cells on slides; Immunohistochemistry (IHC), where we examine which proteins being produced by cells are healthy and which are cancerous; and FISH (fluorescent in situ hybridization), where testing detects and localizes the presence or absence of specific DNA sequences on chromosomes at the molecular level. We have a robotic computer that actually takes a slide, puts it under its own microscope and analyzes up to 200 cells per slide. Then a licensed FISH technologist does an analysis. So both the computer and a human being check each cell. If there’s a discrepancy in findings, the computer knows the location of every cell, so a correct determination can be made. For IHC, we work directly with Leica Bio Systems, who provide us with cutting-edge anti-bodies that look for different proteins in the tissue. In short, every biopsy is being evaluated by a highly trained and experienced pathologist who processes everything using state-of-the-art, cutting-edge techniques and technology.

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And how about your staff? What is it about them that distinguishes your lab? Kim Fortunato, our Histology Manager, and Silvia Fernandez, our Flow Cytometry Manager, deserve much of the credit. They have decades of experience coupled with great expertise. Frankly, they make my life easier, because I can trust and rely on them. Because we’re so specialized and have done so many cases in the last few years, we’ve gained experience and expertise that most pathologists might not get in a career. +

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

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“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.” Pamela Klein


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iagnosed with advanced adenocarcinoma lung cancer with the ROS1 gene mutation, 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. 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 USA 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, Florida, led by Director of Drug Development, Dr. Manish Patel and Associate Director, Dr. Judy Wang. “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. 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. 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, 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

continued on page 16

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FCS Clinical Trials Provide Access to Life-Saving Advances continued from page 15

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). 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, Illinois.

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Based largely upon the results of this clinical trial, the U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation to durvalumab for patients with locally advanced,

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

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 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.”

Gainesville Cancer Center Offers Community Trial Navigation for Local Clinical Research Trials Florida Cancer Specialists & Research Institute (FCS), the leading community oncology/ hematology practice in the state, is pleased to announce the availability of a local Trial Navigator at Gainesville Cancer Center (GCC), located at 6420 W. Newberry Road, East Wing-Suite 100, Gainesville. Offering comprehensive care and a wide range of treatments, GCC has an established record of broad clinical research on all types of cancer. With the local Trial Navigator, patients can now search for and learn about clinical trials that are offered in the North Florida community. Currently, there are more than 50 clinical trials being offered at GCC. To access the Trial Navigator for Gainesville Cancer Center, go to FLCancer.com/GainesvilleTrials.


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

As a statewide practice, Florida Cancer Specialists has been a long-time advocate of clinical research in the community oncology setting. The practice’s pioneering work in this area resulted in a strategic partnership with the Sarah Cannon Research Institute, one of the leading clinical trial organizations in the world. Together, Sarah Cannon and FCS have forged a revolutionary clinical trials program within the FCS statewide network that sets a national benchmark for community oncology and rivals most academic medical centers. The success of the FCS Clinical Trials Program can be attributed to the efforts of many dedicated physicians and senior leaders in the practice. Almost 70% of FCS oncologists are Physician Investigators participating in clinical trial research; there are also 124 Advanced Registered Nurse Practitioners (ARNPs) and Physician Assistants (PAs) who take part in clinical trials research, as well as 100 full-time research staff, who work exclusively in the FCS Clinical Trials program.

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Gainesville medical oncologist Dr. Lucio Gordan is a strong supporter of clinical research and encourages patients to ask their oncologist if they might qualify for a clinical trial. “Patients obviously deserve the best care,” Dr. Gordan says, “and that includes access to national clinical trials. We always look for an appropriate clinical trial that can improve outcomes and possibly even provide a cure. In the meanwhile, we try to stall the progression of the cancer, maintain the quality of life and perform excellent symptom control in the hopes of a new modality or drug. And this is not a theoretical idea; we see patients all the time who are getting amazing outcomes with new immunotherapies or other targeted treatments that came from clinical trials.” +


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Leading a Golden Age of Research A Conversation with Dr. James Reeves Jr., Director of Research Operations, Florida Cancer Specialists By David Chesnick When we spoke with Dr. Reeves, he had just returned from a Sarah Cannon symposium in Nashville. As he describes it, the meeting’s theme was “Let us peer into the future.” He says, “You can see the momentum building, both in the basic science and in the translation of that science into treatment that’s going to make the lives of people with cancer better.” As someone who began his training in what he refers to as the “dark ages” of the ’80s, and subsequently survived a bout with prostate cancer, Reeves is obviously passionate about the work he’s doing and the fruit it’s bearing. “It’s just an incredibly exciting and fulfilling time in cancer research.”


“It’s just an incredibly exciting and fulfilling time in cancer research.” James A. Reeves Jr., MD Director of Research Operations Florida Cancer Specialists & Research Institute

How did you get involved in the research end of care? In the early ’90s, academic centers were doing most of the research. We slowly began developing our own internal research programs. But the big push came in the late ’90s, when we started working with Sarah Cannon Research Institute, one of the leading clinical trials organizations in the world. That’s grown into us becoming a big player in terms of the number of patients we put in Research Trials in conjunction with Sarah Cannon.

What is your relationship with Sarah Cannon? FCS is a strategic partner of theirs, but we are separate practices. Operationally, Sarah Cannon oversees all of our Research Trials and does the heavy lifting on the regulatory and contracting sides, managing and administering our work. We participate in a significant number of the trials that they have running.

What would you say are the advantages of participating in a trial close to home, as opposed to at an academic center? Early on, most research trials require more of the patient than standard therapy, in terms of laboratory study, scanning and office visits. So, if you’re going to an academic center, you’re having a lot of travel time back and forth. If I have patients in a Moffitt trial, those patients are going back and forth to Tampa a lot, and once there, they’re typically there all day, even if the treatment itself is not very long. Of the new cancer drugs approved by the FDA in the last three years, the majority were studied in Clinical Trials with FCS participation. That’s quite impressive. That’s true, but for each of those drugs, there were multiple trials in multiple locations. It’s not as though we did the entire development here,

How did FCS earn its designation as a Phase 1 trial site? My colleague, Dr. Lowell Hart, started a small Phase 1 unit in Fort Myers in conjunction with Sarah Cannon to see if we could get a Phase 1 trial done, and it was pretty successful. That led to the establishment of a freestanding Phase 1 unit in Sarasota. So basically, it grew organically. And we recruited physicians who only work in Phase 1 and don’t routinely see patients like the rest of us do.

continued on page 20

James A. Reeves Jr., MD Hometown: Shreveport, Louisiana Medical School: Louisiana State University Internship & Residency: University of Alabama at Birmingham Fellowship in Oncology/Hematology: University of Alabama Board Certification: Internal Medicine, Medical continued on page 20 Oncology and Hematology

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FCS Partnership with Sarah Cannon Raises the Bar for Community-Based Clinical Research

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Q+A: Leading a Golden Age of Research continued from page 19

but we did participate in trials for all of them. The benefit of our involvement is our institutional knowledge about what the drugs are and how to handle them, as well as their side effects and the nuances of using them.

Which of these trials have been the most exciting to you, and which do you anticipate will have the greatest impact on cancer care, patient survivorship and quality of life?

According to the National Institutes of Health, only about two percent of cancer patients participate in clinical trials in the United States. That’s a perplexing statistic for most oncologists, who recognize the critical role clinical research holds in the treatment of cancer. While virtually everyone acknowledges the benefit clinical research has for the advancement of promising cancer treatments in the future, the advantages for current cancer patients are often overlooked, according to the nearly 140 Physician Investigators who participate in clinical trials research at Florida Cancer Specialists. FCS has been a long-time advocate of clinical research in the community oncology setting. The practice’s pioneering work in this area resulted in a strategic partnership with the Sarah Cannon Research Institute, one of the leading clinical trial organizations in the world. Together, Sarah Cannon and FCS have forged a revolutionary Clinical Trial Program within the FCS statewide network that sets a national benchmark for community oncology and rivals most academic medical centers. The success of the FCS Clinical Trials Program can be attributed to the efforts of many dedicated physicians and senior leaders in the practice. Almost 70 percent of FCS Oncologists are Physician Investigators participating in clinical trials research; there are also 124 Advanced Registered Nurse Practitioners (ARNPs) and Physician Assistants (PAs) who take part in clinical trials research, as well as 100 full-time research staff, who work exclusively in the FCS Clinical Trials program.

If I had to choose just one class of drugs, I’d pick the immunotherapy drugs. For example, a patient of mine who was in decline with metastatic lung cancer had gotten on a research trial for Opdivo® before it was approved for lung cancer by the FDA. She’s had progressive improvement in her function and quality of life. That’s an example of what we see with immunotherapy.

What is the most important thing for patients to know about FCS clinical trials? Our mission is to give the patient the best treatment we can, whether it’s standard therapy alone or enhanced through a

For a more complete understanding of clinical trials, and how to participate in them, visit the “Your Resources” area of our website: FLCancer.com


research trial. We look for new trials because we know the drugs we’re investigating are likely to be as effective, if not more effective, than standard therapy, and the research trials are a mechanism to try to prove that. Another page on our website, Understanding & Participating in Clinical Trials, provides very useful information about enrolling in a trial, and what to expect while enrolled.

How does FCS help patients to “navigate” their way to the trials that are most appropriate for them? Through our partnership with Sarah Cannon, FCS is part of a network that reaches more clinical trial patients than any single cancer center. Together, we’ve enrolled more than 6,000 patients in innovative studies to find more effective treatments for many types of cancer. Patients who are interested in participating in one of our Clinical Trials can visit Your Care – Clinical Trials at FLCancer.com and search for a trial by clinic location, cancer type or line of therapy. Our clinical research team can be reached by phone at (239) 274-9930, or by email at ClinicalTrials@FLCancer.com. +

This “Mudder” Didn’t Let Cancer Bog Her Down

Empathetic Caregiver Jeanie Harris Has Experienced Both Sides of the Cancer Treatment Equation By Hannah Burke

Self-described “Jeep girl” Jeanie Harris, RN, OCN, is an oncology nurse at Florida Cancer Specialists Gainesville Cancer Center. Harris specializes as an infusion nurse within the chemo room, with the primary duties of administering medication, observing patients and assisting with their needs during their visits. She’s been a nurse for more than 25 years, 12 with FCS. Shocked to discover a lump in her breast weeks after a routine mammogram in October 2016, she knew her journey would begin where she works. Jeannie officially learned of her cancer diagnosis while she was caring for patients at FCS, prompting her to immediately schedule a double mastectomy. Not only did Jeanie benefit from highly specialized and local treatment, her co-workers even “donated” their own paid time off so she could get her last surgery. It was all very humbling to this mother of three. Jeanie was also comforted by positive feedback from her patients as they saw her battling cancer right alongside them. She always knew her co-workers were quality caregivers, but being a patient gave her a fresh perspective as she experienced their professionalism firsthand. Now fully recovered, Harris doesn’t speak about her journey as a tale of woe. Instead, she counts her blessings and focuses on the positive opportunities cancer afforded her, such as marching across Washington D.C.’s Capitol Hill as a patient advocate and appearing on local newscasts in Gainesville while participating in the Pink Heals tour. Cancer has never slowed her down. She describes herself running the Divas 5K Marathon in St. Augustine as “bald, with a crown, and a smile on my face.” Today, this tough “mudder” is also a grandmother. And with cancer behind her, Jeanie and her husband enjoy loading up the Jeep to go camping and kayaking several times a month.

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SAVE the DATES

Gainesville Area Fundraisers Bring Hope to Families Touched by Cancer 9th Annual “Run Amuck with the Duck” in Gainesville Raises Awareness and Critical Funds for Patient Services and Clinical Research

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For more than a decade, Caren Gorenberg has been on a journey for lung cancer answers. This active non-smoker and mother of four was diagnosed in 2006 with one of the most virulent forms of lung cancer. The key to Caren’s form of lung cancer was an apparent genetic mutation. She is making it her mission to spread the word about lung cancer, which is increasingly occurring in women, particularly in non-smokers. In 2010, Caren led runners and walkers on a 5-K fundraising event that started at the FCS Gainesville Cancer Center and ended at the duck pond at North Florida Regional Medical Center. Funds raised were donated to the Bonnie J. Addario Lung Cancer Foundation for lung cancer research. That first event was a great success, leading to even more successful “runs” in the years that followed. Reflecting Caren’s amazing spirit and unfailing sense of humor, her event is called “Run Amuck with the Duck.” The namesake for the event is a small stuffed duck named Crackers. He was present during Caren’s lung surgery and has been her steadfast companion during chemotherapy sessions for the past three years, acquiring many fans at the FCS Gainesville Cancer Center.

Physicians and staff from the FCS Gainesville Cancer Center joined the fun for the 9th Annual “Run Amuck with the Duck” in Gainesville in March 2018. Participants walked, jogged or ran to raise awareness and critical funds for patient services and clinical research projects in the local community. Pictured in the front row: Tiffany Gorenberg Townsend, Jamie Gorenberg, Aidan Gorenberg Screwvala (in duck costume), Hayley Gorenberg, Zoe Gorenberg Screwvala, Caren Gorenberg. Back row: Dick Gorenberg, George Sands, Mike Gorenberg, Pete Gorenberg, Dr. Lucio Gordan, and Mayor Lauren Poe.

SAVE THE DATE!

Run Amuck with the D uck

March 2, 2019

Caren’s story is inspiring, and she is always willing to share it. Grateful to be alive, she’s proud this annual event will support efforts to help other lung cancer patients. The 2018 “Run Amuck with the Duck” raised nearly $60,000, and plans for the 2019 event have already begun.


Making Strides Against Breast Cancer

Come together with survivors, caregivers, and men and women from all walks of life who are passionate about saving lives from breast cancer. Two “Strides” events are scheduled for the Gainesville area in mid-October. Come out and celebrate your shared efforts, inspire each other, and take comfort in the knowledge that, because of your dedication, no one walks alone. Register online for easy check-in the day of the walk. All event participants, including children, need to register for the walk. If you do not register online prior to the event, please visit the check-in area upon arrival. For complete information, visit www.makingstrideswalk.org.

Making Strides of Ocala | Saturday, October 13, 2018 Contact Jodi Sanders: (352) 240-5063 OcalaFLstrides@cancer.org Making Strides of Gainesville | Saturday, October 20, 2018 Contact Stevie Doyle: (352) 240-5055 GainesvilleFLstrides@cancer.org

“Light The Night” with the Leukemia & Lymphoma Society

The Leukemia & Lymphoma Society’s “Light The Night Walk” funds treatments that are saving the lives of patients today. LLS is making cures happen by providing patient support services, advocating for lifesaving treatments, and pioneering the most promising cancer research anywhere. And it’s all happening now. Each year friends, families and coworkers form teams to raise money in support of our mission. This fall, teams and their communities will “Light The Night” as they gather together to celebrate, honor and remember those touched by cancer. For complete information, visit www.lightthenight.org. LLS “Light the Night” Gainesville Tuesday, November 13, 2018 North Lawn, Ben Hill Griffin Stadium, 157 Gale Lemerand Drive, Gainesville

“Lyrics for Life” Benefits Camp Hazelnut and the Florida Cancer Specialists Foundation Sister Hazel’s Lyrics for Life, presented by Rich and Carissa Blaser, was another success, raising funds for the nonprofit Lyrics for Life’s Camp Hazelnut and the Florida Cancer Specialists Foundation. The event took place in early September at the Santa Fe College Fine Arts Hall, with delicious cuisine, cocktails and a silent auction featuring items from some of the music industry’s biggest names. The evening included an intimate concert by Gainesville’s own Sister Hazel, along with some very special guests. FCS Gainesville Cancer Center Medical Oncologist, Dr. Lucio Gordan, shared, “Lyrics for Life is a great way to raise funds for the FCS Foundation while getting the community involved, and I am excited to be a part of it.” The mission of Lyrics for Life is to make a difference in the fight against pediatric cancer. Ken Block and his bandmates founded the nonprofit in memory of Ken’s younger brother, Jeffrey, who succumbed to cancer after diagnosis at age 14. The charity unites musicians and celebrities for fundraising events benefiting cancer research and patient-care charities. The 2017 Lyrics for Life event raised $200,000. Camp Hazelnut’s goal is to create a playful, safe, uplifting experience for kids and families navigating the overwhelming challenges of a cancer diagnosis. This October, campers will again embark on a great adventure to discover (or rediscover) the magic that can only be created at camp. For more information, visit www.lyricsforlife.org/camp-hazelnut.

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6420 W. Newberry Road East Wing, Suite 100 Gainesville, FL 32605

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North Florida Regional Medical Center

Blue Cross Blue Shield has recognized Florida Cancer Specialists as a Blue DistinctionÂŽ 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