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Advanced Care in a Community Setting

T H E M A G A Z I N EFCS WINTER 2020

We appreciate your hard work and contributions in 2019.

Executive & Senior Management

We look forward to 2020!

Thank You!

Winter 2020 3

Winter 2020Contents

In This Issue

DEPARTMENTS 6 FCS News and Events30 Patient Letters

SPOTLIGHTS26 Executive Management Team Spotlight: CFO Nathan Walcker28 Office Spotlight: South Region Clinical Trials Research Office

FEATURES22 Ocala Cancer Center

FCS Vice President of Finance, Michael Essik and his wife, Julie

FCS Research Study ManagerPatrice Cowan

FCS Magazine is published quarterly.

We welcome your feedback, article suggestions and photos

(high resolution please). Email to: Marketing@FLCancer.com.

We appreciate your hard work and contributions in 2019.

Executive & Senior Management

We look forward to 2020!

Thank You!

4 FCS The Magazine

PRESIDENT EMERITUS & FOUNDER DR. WILLIAM N. HARWIN

PHYSICIAN LEADERSHIPPRESIDENT & MANAGING PHYSICIAN

LUCIO GORDAN, M.D.

DIRECTOR OF PATIENT ADVOCACY, DIRECTOR, EXECUTIVE BOARD

MICHAEL DIAZ, M.D.

SCIENTIFIC DIRECTOR OF CLINICAL RESEARCHLOWELL L. HART, M.D.

DIRECTOR OF RESEARCH OPERATIONS JAMES A. REEVES JR., M.D.

EXECUTIVE MANAGEMENTCHIEF EXECUTIVE OFFICER

BRAD PRECHTL

CHIEF OPERATING OFFICERTODD SCHONHERZ

CHIEF FINANCIAL OFFICERNATHAN WALCKER

CHIEF LEGAL OFFICERTOM CLARK

CHIEF REVENUE CYCLE OFFICERSARAH CEVALLOS

CHIEF PROCUREMENT OFFICERPAUL CHADWICK

CHIEF MARKETING & SALES OFFICERSHELLY GLENN

CHIEF INFORMATION OFFICERMARK MOCH

CHIEF HUMAN RESOURCES OFFICER JOYCE NELSON

CHIEF COMPLIANCE OFFICERVALERIE EASTWOOD

PUBLISHED BYIN PARTNERSHIP WITH

BRAD PRECHTL, CEO: As we conclude our 35th anniversary year, I want to recognize the amazing commitment of our physicians, nurses and staff members who have made our more than three decades of success possible. I am honored to have served as CEO of this practice for the last 10 years and to be a part of bringing world-class cancer care to local communities across the state.

During this past year, we have added many new physicians to the practice and opened several new locations to serve the more than 73,000 new patients we will treat by year’s end. One of our new locations, the Ocala Cancer Center, is highlighted in this edition of FCS Magazine; it is one of our most advanced cancer centers, offering both medical oncology and radiation oncology under one roof to increase convenience for patients in north central Florida.

I am also pleased to welcome the newest member of the FCS executive leadership team, Chief Financial Officer Nathan Walcker, who is profiled in this issue. He oversees finance and accounting operations, business planning and investments, as well as fiscal compliance policy and practices. Previously, Nathan served as a member of Bank of America Merrill Lynch’s healthcare investment banking group in New York, advising the firm’s public and emerging growth health care clients and private equity firms. Nathan earned an MBA from Columbia Business School and a bachelor’s degree in economics from Columbia University. Since Nathan, his wife Chelsea, and their daughter are originally from Minnesota, I’m sure they will enjoy a much warmer winter than in previous years!

LUCIO GORDAN, PRESIDENT & MANAGING PHYSICIAN: As you know, the FCS clinical research program rivals those of most academic medical centers and is a primary differentiator for our practice. Through our strategic partnership with Sarah Cannon Research Institute, one of the leading clinical trial organizations in the world, we are able to offer greater access to

national clinical trials than any other oncology practice in Florida. Our program includes Phase 1 clinical trials, which are often first in human, ensuring that FCS patients have access to the most promising new drugs, prior to approval by the FDA. Currently, we have 36 clinical sites that participate in our research program, including the South Region Clinical Trials Research Office in Fort Myers, which is spotlighted in this issue.

I am extremely proud of all that we, together, have accomplished this year and I look forward to the coming year, as we continue to bring the latest innovations and treatments to our patients and to demonstrate the true value of community oncology. We have achieved these goals because of the hard work and dedication of our incredible team of physicians, nurses, other clinicians and staff members. Thank you for all that you do and for always putting our patients first. Wishing all of you and your families a happy and healthy new year!

SENIOR MANAGEMENTRAY BAILEY

CHRISTY BANACHVICKI CARAWAYMELODY CHANGDIANE G. COPE

SANDRA CONNORDAVID CURRYRICH DYSONJEFF ESHAM

MARI ESPIN-SANCHEZMICHAEL ESSIKDAN FARRAR

ANDREW FISHERCLAUDIA FRENCH

INGA GONZALEZKATIE GOODMANDEBRA GREGORYJILL HAMMERICH

CHRIS HIGHTOWERKATHERINE HOGAN

SUE KEARNEYSHARON LAPKINKATE LEHMANJODI LOHNES

ROSE ANN MEYERSJOHN MILLS

MARILYN MORALESFRANK NUNZIATONICOLE PICAZIO

ANNIE PIGUEKAREN PITMANKAREN QUICK

MICHELLE ROBEYANNE RONCO

CAMILO RODRIQUEZJEFFREY RUBIN

TARA RUSKALYNN SAWYERLAURA SPERRY

TR STRICKLANDDENICE VEATCH

SAMANTHA WATKINSBETH WITTMER

TH

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AG

AZ

INEFCS

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FEBRUARY 1, 2020 • 5:30 –11 P.M.

HYATT REGENCY SARASOTA 1000 Boulevard of the Arts, Sarasota, FL 34236

FCSF.org/Stars2020

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KETS on SALE! ~

Join Honorary Chairs and Florida Cancer Specialists PhysiciansDr. Fadi Kayali, Dr. Miguel Pelayo and Dr. Judy Wang

for a special dinner and show

Featuring

POWERHOUSE THE NEXT GENERATION

Foundation

6 FCS The Magazine

FCSNews & Events

FCS EXPANDS STATE-OF-THE-ART PATHOLOGY LABORATORY

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

Approximately 25,000 square feet of the new space is dedicated to the more than 230 physicians who practice at nearly 100 FCS sites throughout the state. The Pathology Laboratory’s skilled hematopathologists and surgical pathologists provide a comprehensive testing menu. The expanded lab is sized to accommodate continued growth as well as ongoing clinical and technological advances.

NEW WESLEY CHAPEL LOCATION OPENS

The opening of the Wesley Chapel office, the sixth FCS location in Pasco County, was celebrated with a ribbon-cutting ceremony in October. Four Board-certified medical oncologists are now providing a comprehensive range of cancer care treatments at this location. The 3,000-square-foot facility features four exam rooms and seven chemotherapy infusion stations.

FCS NEWS & EVENTS

FCS ENGLEWOOD RIBBON CUTTING

A ribbon-cutting ceremony was held in June to celebrate the expansion of the Englewood office. The renovation will accommodate continued growth and provides a warm and welcoming environment for patients and caregivers.

GROUNDBREAKING FOR FCS SEBRING LOCATION

FCS broke ground for the new Sebring Cancer Center in August. The new location, opening in 2020, will include 13,500 square feet of space, 16 private exam rooms and 40 chemotherapy chairs. We’ve been a part of the Sebring community for many years and look forward to continuing to provide patients with access to world-class medicine close to home.

FCS TAKES THE WIN IN POLO UNDER THE OAKS

The annual Polo Under the Oaks event held in Tallahassee featured experienced players from state and international circuits and delighted nearly 300 spectators. The winning Florida Cancer Specialists-sponsored team included John Walsh, the host/creator of television’s “America’s Most Wanted” series. He and his wife, Reve, founded the Adam Walsh Child Resource Centers in memory of their late son. The resource centers became part of the National

Center for Missing & Exploited Children in 1990.

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FCSNews & Events

FCS FINANCIAL COUNSELORS POWER UP FOR SUCCESS

The FCS financial counselors’ second annual summit was held in Orlando in September. More than 200 team members attended the power-packed weekend of networking, shared learning, updates and fun. “It’s truly amazing to take the time to recognize and celebrate what our team accomplishes each and every day,” said Christy Banach, FCS director of patient financial services.

FCS SUPPORTS BAHAMAS RELIEF EFFORT

FCS was proud to partner with Piper Aircraft, headquartered in Vero Beach, and the Bahamian Ministry of Health to deliver urgently needed medical supplies to Rand Memorial Hospital in Freeport, Bahamas, which was among the many facilities impacted by Hurricane Dorian’s devastation. FCS Chief Procurement Officer Paul Chadwick coordinated the effort with Piper Aircraft.

POLICYMAKERS GAIN INSIGHTS INTO CANCER CARE THROUGH “SIT IN MY CHAIR“ PROGRAM

FCS recently showed policymakers the firsthand benefits of local cancer care and what it’s like to face a cancer diagnosis and treatment in a community oncology setting. The experience, called “Sit in My Chair,” provided an opportunity for state and federal legislators to learn about the critical issues facing cancer care patients and providers.

The tours were coordinated in conjunction with the Community Oncology Alliance (COA) and their Patient Advisory Network. Representatives spent time in several FCS clinics in Alachua, Lee, Collier and Pinellas counties. Spokespeople from the offices of U.S. Senators Marco Rubio and Rick Scott, as well as Congressman Gus Bilirakis, met with physicians and clinical teams during their visits.

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FCSNews & Events

#WOMENWHOCURIE

In honor of physicist and chemist Marie Curie’s birthday and her pioneering work with radioactive elements, FCS’ expert team of Board-certified radiation oncology physicians and medical physicists, dosimetrists, radiation therapists, nurses and support staff were proud to join with the Society for Women in Radiation Oncology to celebrate their profession.

Sherry Weaver-Lauer, Radiation Oncologist Dr. Luis Carrascosa, Kim Amos, Peggy Jackson, Terri Calabello, Mike Franke, Physicist Dr. Harrold Perarra, Laura Reese

HONORING WOUNDED WARRIORS

In November, FCS hosted wounded warriors, veterans and their families at the Tampa Bay Buccaneers football game. A pre-game tailgate party was held at the FCS Tampa Cancer Center. The honored guests were joined by FCS physicians and staff, Bucs cheerleaders and fans for food, games and giveaways as they got ready to cheer on their team!

As a Tampa Bay Buccaneers sponsor, Florida Cancer Specialists is proud to support the Wounded Warrior Project and honor the heroes who risk their lives to protect our world and make it a better place.

2019 CLINICAL SUMMIT — STAYING CURRENT WITH ONCOLOGY DEVELOPMENTS

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.

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. Dr. Orman is pictured here with FCS President & Managing Physician Dr. Lucio Gordan (l) and FCS CEO

Brad Prechtl, MBA (r).

MARKETING & SALES TEAM HOLDS ANNUAL WORKSHOP

FCS physician liaisons gathered with their colleagues from Marketing and the FCS Foundation for a two-day workshop in July. Executive and senior leaders provided updates about the organization’s direction and new developments in various service lines, as well as trends in community oncology.

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FCSNews & Events

Joined by a few Tampa Bay Buccaneers players and cheerleaders, our Hillsborough County physicians and teams celebrated their annual Thanksgiving patient appreciation dinner on Nov. 11.

PATIENT APPRECIATION DINNERS

Physicians and staff in Pinellas, Hernando and Hillsborough Counties recently hosted patient appreciation events. Hundreds of patients and their families gathered for food, giveaways and socializing. Our patients inspire us every day, and we are honored and grateful to spend time with them at these special events.

The Pinellas County patient appreciation event was held at the Highland Heights office on Nov. 15.

Over 500 patients and their families were honored at the Hernando County patient appreciation dinner. The physicians and staff enjoyed serving barbecue.

RADIATION /RADIOLOGY SUMMIT FOCUSES ON THE POWER OF ONE

Nearly 100 FCS radiation oncology team members gathered at One Bucs Place in June to review and celebrate their accomplishments and advancements. Presenters included FCS Chief Operating Officer Todd Schonherz, Medical Director of Radiation Oncology Dr. Sachin Kamath and FCS Vice President of Radiation Oncology & Radiation Jeff Esham.

The event’s Power of One theme showcased how the diverse team of radiation oncologists, physicists, dosimetrists, nurses, therapists, coders and clinical support staff collaborate around a single focus – their patients. Keynote motivational speaker and cancer survivor, Scott Greenberg, extended that message. “He stressed the importance of taking care of ‘the other number one’ – ourselves,” said Esham. For more than ten years, Greenberg ran a thriving multi-unit Edible Arrangements enterprise that received multiple recognitions for “Best Customer Service” and “Manager of the Year” awards out of more than 1000 worldwide franchise locations.

Raffles were held throughout the event and FCS physicians kindly gifted all attendees with an item of FCS logo apparel.

Jeff Esham, FCS vice president of radiation oncology & radiology, pictured with left to right: Michelle Curie, RN, Debi Luce, APRN, Kristin Burner, RN of FCS The Villages.

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FCSNews & Events

FCS LEADERS GATHER TO DRIVE OPERATIONAL EXCELLENCEThe FCS leadership team gathered in late October at Raymond James Stadium for the 2019 Operations Meeting. Presentations focused on cutting-edge advancements and best practice initiatives that will continue to enhance the cancer care FCS provides to patients and their families. “Our annual operations meeting is inspiring from start to finish,” said FCS Chief Operating Officer Todd Schonherz, who lead the extensive planning effort. “We take time to reflect on our accomplishments and, more importantly, how we will continue to position ourselves to serve our communities with world-class care.”

The ‘Survivor’ theme was a nod to special guest, Ethan Zohn (pictured at left with FCS COO Todd Schonherz), winner of the reality TV series, Survivor: Africa, who shared his inspiring story of his battle with Hodgkin’s lymphoma. “Ethan is a stellar example of how people with cancer are finding hope,” Schonherz said. “The lesson for us was about how his challenges became a source of strength, enabling him to have an immensely positive impact on so many lives.”

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This is more than just lip-service.

As the pioneers of performance-based contracting, we have

always been focused on the future of community oncology. That

long-standing commitment remains as the healthcare landscape

evolves due to changing regulations and industry standards.

Your success is our success.

Our purpose is to ensure your viability as an independent

practice and to help you grow. That can’t be fulfilled if we are

not providing the results and resources that you need-

and that forges lasting partnerships.

Care for you, so that you can care for patients.

As patient needs evolve, so do the tools and resources you

depend upon to meet those needs. We do our part by

investing in technology, research and other resources to

help you elevate the quality of patient care.

The True Purpose of your GPO

True partners in service.

True leaders in industry.

True innovators in care.

www.iononline.com

12 FCS The Magazine

11TH ANNUAL PINK RIBBON WALK

On Oct. 5, community residents of all ages, decked out in pink, rose early and gathered at Port Canaveral to walk for a cause. The 11th annual event netted over $35,000 to benefit cancer patients in Brevard County.

DEMONSTRATING THE POWER OF PINK

Three FCS physicians were selected to participate in the 2019 American Cancer Society® Real Men Wear Pink campaigns.

In Sarasota and Manatee counties, Dr. Fadi Kayali took center stage and kicked off his campaign at the Real Men Wear Pink fashion show held at the University Town Center Mall in Sarasota. Dr. Kayali raised$11,511 — well over his $2,500 goal.

Dr. Hafeez Chatoor and Dr. Michael Scott joined with colleagues in Tampa and raised nearly $85,000 — the largest amount in the Tampa campaign’s history.

Breast Cancer Awareness Month & FCS Foundation Pink Week 2019Each year in the U.S., more than 245,000 women and approximately 2,700 men are diagnosed with breast cancer. The rapid release of new therapies means that many more patients are living longer and with better quality of life. Throughout the month, FCS sponsored and participated in events to bring attention, support those affected by the diagnosis and raise money to benefit breast cancer patients

BREAST CANCER TAILGATE

The FCS Tampa Cancer Center hosted a Tampa Bay Buccaneers pre-game tailgate to honor cancer fighters and survivors

PINK WEEK 2019 AT FCS BRADENTON EASTLeft to right: Shante Byrd, Wendy McGrath, Megan Grebe, Deb Caplinger, Candice Baird, Linda Dunzik, PA, Flor Uscanga.

TALLAHASSEE PRESS CONFERENCE

FCS Medical Oncologist Paresh Patel, MD joined Susan G. Komen Executive Director Kate Watt and other advocates for a news conference in Tallahassee. With the backdrop of the state capitol building bathed in pink light in honor of Breast Cancer Awareness Month, they called on the Legislature to increase

public funding for early detection and to act to remove barriers for women and men to access life-saving treatment.

Dr. Hafeez Chatoor (far left) and Dr. Michael Scott (left)

Paresh Patel, MD

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Top row left to right: Shirley Hammonds, Megan Cook, Cara O’Keefe, Nancy Solak, Holly Aberle, Patrice Cowan. Bottom row left to right: Cathy Scarangella, Rayanne Thompson. Not pictured: Joyce Davis, Britney Johnson.

NEW TREATMENTS PROVIDING MORE CHOICES AND BETTER OUTCOMES

The rapid release of new therapies for breast cancer treatment means that many more patients are living longer and with better quality of life. Oral oncolytics, in particular, are increasingly replacing IV chemotherapy for the treatment of metastatic breast cancer.

“Three or four years ago there were many fewer options,” said Douglas Braun, CSP, PharmD, RPh, FCS pharmacy manager. Oral therapies travel directly to targeted cells to block cell mutations and prevent the cancer from spreading.

Because these oral drugs are self-administered, a close partnership between patient, oncologist and pharmacist is critical. With ready access to 99 percent of all available oral oncolytics, the FCS Rx To Go team of pharmacists, technicians and support staff can quickly dispense medications directly to patient homes; but their interactions with patients begin well before any pills are taken.

“We begin with education about the therapy, its proper use and potential side effects,” explains Braun, “and follow up

STRENGTH: A POWERFUL ELEMENT IN FIGHTING CANCER.

Champion kart racer Neil Breitenbach never thought breast cancer would happen to him.

The signs were there — countless times he had felt a twinge of pain as he crossed a seat belt over his chest, but he dismissed it. In 2008, while on vacation with his wife, he felt a sharp pain that he couldn’t ignore.

A lumpectomy revealed that he had stage three metastatic breast cancer. After surgery, he was referred to FCS. His team at the FCS Tampa Cancer Center, led by Medical Oncologist Dr. Matthew Fink, worked to put a personalized plan in place for Neil, and they’ve been fighting together ever since.

Neil is a fierce competitor. When he’s not at work or spending time with family, his mind is on the track. And in Neil’s mind, racing and fighting cancer have a lot in common. Both are hard. Both require dedication and the willingness to push yourself to your limits. But with the right team, you can take on any challenge.

More than 10 years after his initial diagnosis, Neil continues to visit his FCS office once a month for hormonal chemotherapy treatment. He’s accepted that his cancer journey will be a lifelong one, but he believes that his diagnosis has made him a kinder and more patient person. He sees the silver lining in every day — treating each new experience as an opportunity to live life to the fullest.

PINK WEEK QUILT

Assembled with colorful squares hand-decorated by FCS employees and their families in honor of loved ones impacted by cancer, a giant paper quilt brought awareness to all types of cancers during Pink Week 2019. Over $1,000 was raised, in part, through the sale of the squares, and was donated to the FCS Foundation in memory of Janice Spector, data specialist in the FCU Sarasota DDU office, who lost her cancer battle earlier this year.

to schedule refills, monitor compliance and assess patient response. With access to the patient’s electronic health record, we have a complete picture of the patient’s health and how therapies are being tolerated.”

Since the FDA approved the first class of targeted oral therapies for breast cancer treatment in 2015, pharmaceutical companies have steadily introduced new oral drugs. “It’s becoming more like managing a chronic disease in many patients,” Braun said.

As we continue to gain greater understanding about the progression of breast cancer, the future is very promising.

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FCSNews

We welcome the following physicians…

SHEKEAB JAUHARI, MD

Medical Oncologist/Hematologist Shekeab Jauhari, MD has joined FCS as a principal investigator. He will lead Phase 1 clinical trials at the Lake Mary Drug Development Unit when it opens in early 2020.

ZANETTA LAMAR, MD

FCS welcomes Medical Oncologist Zanetta Lamar, MD to the Naples Goodlette office, 1100 Goodlette Road, Naples.

MOHSIN MALIK, MD

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.

RINA PATEL, MD

Medical Oncologist Rina Patel, MD is practicing at the Palm Beach Gardens office, 3401 PGA Boulevard, Suite 200, Palm Beach Gardens.

CHUNLAI ZUO, MD, MS

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

We welcome the following hospitalists….

JASMIN DESAI, MD & MADHAVI L. VENIGALLA, MD

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

JUAN L. CASTRO, MD

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

UMA IYER, MD

Board-certified Medical Oncologist Uma Iyer, MD is practicing at the FCS Gainesville Cancer Center, 6420 W. Newberry Road, West Wing, Suite 100, Gainesville.

Uma Iyer, MD

Zanetta Lamar, MD Mohsin Malik, MD

Rina Patel, MD

Shekeab Jauhari, MD

Chunlai Zuo, MD, MS

Juan L. Castro, MD

Jasmin Desai, MD Madhavi L. Venigalla, MD

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We welcome the following individuals to the FCS Leadership Team!

MARI ESPIN-SANCHEZ DIRECTOR OF TOTAL REWARDS

As director of Total Rewards, Mari Espin-Sanchez is responsible for benefits, retirement and compensation, and for ensuring that the FCS Total Rewards strategy is aligned with the organization’s business objectives. She leads the benefits team and works in collaboration with compensation to deliver on key objectives to help position FCS as an employer of choice.

Mari is a seasoned benefits and human resources professional. Her 20 years of experience has spanned a range of industries and multinational organizations, including Wells Fargo, Avid Technology and Royal Caribbean Cruises. She holds a bachelor’s degree in business administration from Florida International University, and she has achieved numerous certifications, including a master certification in Human Services Response Safety & Emergency Services

TR STRICKLAND DIRECTOR OF VALUE-BASED CARE

TR Strickland oversees strategic initiatives, including the Oncology Care Model with CMMI, that propel FCS as a leader in value-based care, resulting in improved quality and patient experience while concurrently reducing the total cost of healthcare.

With over 15 years of experience in healthcare, he has served in various roles focused primarily in operations and client services. Prior to joining FCS, TR worked in healthcare technology and managed teams of engineers, project managers and product developers to align with sales and marketing for go-to market organizational strategic initiatives. TR also served as a captain in the U.S. Army, leading soldiers in garrison and combat missions.

He received an MBA in finance and accounting from Regis University in Denver, Colorado, and an undergraduate degree from the University of Central Florida. He is a certified project management professional.

TR currently resides in Orlando and enjoys spending time with his daughter, indulging in the various attractions the city has to offer. He is a football enthusiast and an avid Tampa Bay Bucs fan.

We congratulate our newly-promoted FCS leaders!

LAURA SPERRY DIRECTOR OF OPERATIONS

Laura oversees FCS clinic operations in north Florida. She joined FCS in April 2017 with the Fleming Island office and brings more than 25 years of healthcare experience, with 16 years focused in oncology. Previously, Laura was the practice administrator with a large multi-oncology group in the Jacksonville area and has managed multiple specialty groups throughout her career.

She graduated from Florida State University with a bachelor’s degree in political science and earned her MPA with a concentration in healthcare management from Western Michigan University.

In her spare time, Laura is an avid camper, loves watching college football, and enjoys spending time with her family and friends. She and her husband have a son and a daughter, both of whom are completing their university studies.

BETH WITTMER DIRECTOR OF CARE MANAGEMENT

A dedicated registered nurse since 1991, Beth has been working in the oncology field for more than a decade. She joined FCS in 2006 and transitioned from the office setting in 2015 to help develop the care management department. She was promoted to director of care management in July 2019. She has also been instrumental in the implementation of the Oncology Care Model for FCS.

Beth grew up in Alberta, Canada. She completed her BSN from Ohio University this past March after working 28 years as an associate degree registered nurse. She is an oncology certified nurse (OCN) and an active member of the Oncology Nursing Society at the national and local level. She is a frequent panel participant at professional conferences, and currently serves as a Community Oncology Alliance Patient Advocacy Network chapter leader for FCS and a member of the Keiser University Advisory Board in Fort Myers.

Beth lives in Sarasota with her husband. They have four children and are anxiously awaiting the arrival of their third grandchild. She’s a hockey fan (“the only thing to watch on TV in Canada,” she notes) and became a Lightning fan when they started out in Tampa over 25 years ago. And though she loves to snow ski, she says that’s about the only thing that would lure her back to the cold Canadian winter weather!

Mari Espin-Sanchez

TR Strickland

Laura Sperry

Beth Wittmer, RN, BSN, OCN

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FCSFCS Foundation Events & News

SOUTHERN STATE OF KIND

Belles and gents slipped on their best duds and boots for a delightful evening of Southern hospitality on Oct. 12. 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. The sold-out event netted $277,000, nearly double the prior year.

Left to right: Dr. Christopher George, Dr. Egberto Zayas, Dr. Michael Diaz, Dr. Hafeez Chatoor, Dr. Julia Cogburn, Dr. Julio Lautersztain, Dr. Nilini Hasija, Dr. Don Luong, Dr. David Wright, Dr. Renjitha Ignatius, Dr. R. Waide Weaver, Dr. Michael Scott.

FCS FOUNDATION DISTRIBUTES OVER $5.5 MILLION IN PATIENT GRANTS SINCE 2011

Board approves increase in annual grant amount

Since its inception in 2011, the FCS Foundation has provided over $5.5 million in grants to help cancer patients in need, including $1.16 million in grants as of October 2019, surpassing the prior year’s total.

In response to a 21 percent increase in patient applications in 2019, the FCS Foundation Board of Directors recently approved increasing the annual maximum individual grant amount from $1,500 to $2,000 beginning January 1, 2020.

“We have never turned any qualified patient away and the need continues to grow,” said FCS Physician & FCS Foundation Board Chairman Dr. Michael Diaz, noting American Cancer Society estimates that over 130,000 Florida residents will be newly diagnosed with cancer in the coming year.

FCS FOUNDATION NEWS & EVENTS

CRACK-UP CANCER

Sept. 14 was a night of belly laughs, courtesy of four nationally recognized comics who entertained a sold-out crowd at Crack-up Cancer, held at the David A. Straz Jr. Performing Arts Center in Tampa. The event raised $30,000.

Left to right: FCS Foundation Volunteer Program Manager North Rebecca Davis, FCS Foundation Development & Event Manager Taylor Montgomery, FCS Chief Marketing & Sales Officer Shelly Glenn.

SISTER HAZEL’S LYRICS FOR LIFE

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, Florida, on Sept. 20. Attendees enjoyed cocktails, hors d’oeuvres and a concert by Sister Hazel, with special guest artists Tom Higgenson (from The Plain White T’s) and Shawn Mullins. The sold-out show netted $100,000.

Left to right: Dr. Vijay Patel, Gainesville Office Manager Betty Ann Forsyth, Dr. Laura Dickerson, Dr. Andres Bhatia, Gainesville Assistant Office Manager Janet Dixon.

WINE WOMEN & SHOES LAKE MARY

Stylish ladies who share a passion for pumps and a sweet spot for stilettos gathered Sept. 28 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.

At left: Dr. Jennifer Cultrera At right: Dr. Gerardo Duran, Dr. Maria

Regina Flores.

Please see full Prescribing Information, including Patient Information.

Q The focus of today’s Q&A is patients with metastatic squamous NSCLC. Dr. Hart, could you explain your goal when treating these patients?

A Unfortunately, it’s still an incurable cancer, so our goal is to give them effective palliation. To me that means No. 1, to help control their symptoms and No. 2, give them the best quality of life that we can, which is part of the same thing, and extend their life if possible. By the time we get to second or third line therapy it’s difficult in an overall population of patients to make a big impact on their survival.

INDICATIONS AND USAGEGILOTRIF is indicated for the treatment of patients with metastatic squamous NSCLC progressing after platinum-based chemotherapy.

IMPORTANT SAFETY INFORMATION FOR GILOTRIF® (afatinib) TABLETSWARNINGS AND PRECAUTIONSDiarrhea• GILOTRIF can cause diarrhea which may be severe and can result in

dehydration with or without renal impairment. In clinical studies, some of these cases were fatal.

• For patients who develop Grade 2 diarrhea lasting more than 48 hours or Grade 3 or greater diarrhea, withhold GILOTRIF until diarrhea resolves to Grade 1 or less, and then resume at a reduced dose.

• Provide patients with an anti-diarrheal agent (e.g., loperamide) for self-administration at the onset of diarrhea and instruct patients to continue anti-diarrheal until loose stools cease for 12 hours.

Bullous and Exfoliative Skin Disorders• GILOTRIF can result in cutaneous reactions consisting of rash, erythema,

and acneiform rash. In addition, palmar-plantar erythrodysesthesia syndrome was observed in clinical trials in patients taking GILOTRIF.

• Discontinue GILOTRIF in patients who develop life-threatening bullous, blistering, or exfoliating skin lesions. For patients who develop Grade 2 cutaneous adverse reactions lasting more than 7 days, intolerable Grade 2, or Grade 3 cutaneous reactions, withhold GILOTRIF. When the adverse reaction resolves to Grade 1 or less, resume GILOTRIF with appropriate dose reduction.

• Postmarketing cases of toxic epidermal necrolysis (TEN) and Stevens Johnson syndrome (SJS) have been reported in patients receiving GILOTRIF. Discontinue GILOTRIF if TEN or SJS is suspected.

Interstitial Lung Disease • Interstitial Lung Disease (ILD) or ILD-like adverse reactions (e.g., lung

infiltration, pneumonitis, acute respiratory distress syndrome, or alveolitis allergic) occurred in patients receiving GILOTRIF in clinical trials. In some cases, ILD was fatal. The incidence of ILD appeared to be higher in Asian patients as compared to white patients.

GILOTRIF® (afatinib) tabletsSecond-line use in Metastatic Squamous NSCLC progressing after first-line platinum-based chemotherapy

The treatment of metastatic squamous non-small cell lung carcinoma (NSCLC) has had some significant recent advances. With the variety of treatments now available to be leveraged first line, we should consider all our second-line options and

examine how they can be used for different types of patients because many patients will progress. We spoke with Dr. Lowell Hart of Florida Cancer Specialists and Research Institute to learn about his perspective on treating metastatic squamous patients who have progressed after platinum-based chemotherapy.

The presentation is made on behalf of and financial support provided by Boehringer Ingelheim Pharmaceuticals, Inc. Dr. Hart’s comments reflect his opinions and do not constitute medical advice.

Lowell Hart, M.D.

DRUG REVIEW

Q Based on the October 2018 FDA approval of pembrolizumab in combination with a platinum doublet, has the standard of care changed when treating first line squamous patients?

A Yes, it has. Because of the presentation of data using a combination of chemotherapy with immune checkpoint therapies, specifically pembrolizumab, that has changed the standard of care for many patients with metastatic squamous NSCLC.

In the past those patients would generally receive platinum-based combination chemotherapy first, and they would get the immune therapy with the checkpoint inhibitor as their second line of treatment. That still does sometimes happen, and in some settings it might be appropriate, but I think more and more physicians are utilizing combination therapy with adding platinum-based chemotherapy and pembrolizumab specifically in the first line treatment. So that, I believe, has become the standard for most patients. That change has been within the last year.

Q What are some of the challenges for those patients that progress and require treatment?

A The biggest challenge is that you’re now using the two most effective combination types of treatment, platinum-based chemotherapy and immunotherapy, at the same time. They’re getting the upfront benefit of hitting the cancer with two different modalities of therapy, both of which are effective, so you’re going to get an additive effect. However, those patients by and large are going to progress at some point, and they’ll need a second line therapy. So, if the most effective treatments are used up front, then you’re left with a difficult choice as to what to use for second line therapy.

Q Gilotrif is an FDA approved treatment for patients with metastatic squamous NSCLC progressing after a platinum-based chemotherapy.1 Based on your experience, what does this option represent to patients?

A I think it’s very nice to have an oral option for that space because, more and more, the patients are going to be

Adverse reactionGILOTRIF (n=392)

Grade 3-4, %

Erlotinib (n=395)

Grade 3-4, %

GILOTRIF (n=392)

All grades, %

Erlotinib (n=395)

All grades, %

Gastrointestinal disordersDiarrheaStomatitis†

NauseaVomiting

11 4 2 1

3 1 1 1

753021 13

41 11 16 10

Skin and subcutaneous tissue disordersRash/acneiform dermatitis‡

Pruritus7 0

11 0

70 10

70 13

InfectionsParonychia§ 1 0 11 5

Metabolism and nutrition disordersDecreased appetite 3 2 25 26

Adverse reactions reported in LUX-Lung 8 in ≥10% of GILOTRIF-treated patients1

Disease control rate in LUX-Lung 8†

51%

40%

Dise

ase

cont

rol r

ate

(%)

GILOTRIF (n=398)

Erlotinib (n=397)

0

40

30

10

20

50

60

70

80

GILOTRIF

Erlotinib

Median OS in LUX-Lung 8*

Time (Months)

OS

(%)

0 63 12 159 18 21

0

20

40

60

80

100

24 27 30

Hazard ratio: 0.81 (95% CI, 0.69–0.95)P=0.008

GILOTRIF(40 mg orally once daily; n=398)

Erlotinib(150 mg once daily; n=397)

months7.9

19%reduction in

risk of death vs erlotinib

months6.8

(≥20% all grades & vs erlotinib-treated patients (n=395)) were diarrhea (75% vs 41%), rash/acneiform dermatitis (70% vs 70%), stomatitis (30% vs 11%), decreased appetite (25% vs 26%), and nausea (21% vs 16%).

• Serious adverse reactions were reported in 44% of patients treated with GILOTRIF. The most frequent serious adverse reactions reported in patients treated with GILOTRIF were pneumonia (6.6%), diarrhea (4.6%), and dehydration and dyspnea (3.1% each). Fatal adverse reactions in GILOTRIF-treated patients included ILD (0.5%), pneumonia (0.3%), respiratory failure (0.3%), acute renal failure (0.3%), and general physical health deterioration (0.3%).

DRUG INTERACTIONSEffect of P-glycoprotein (P-gp) Inhibitors and Inducers• Concomitant use of P-gp inhibitors (including but not limited to ritonavir,

cyclosporine A, ketoconazole, itraconazole, erythromycin, verapamil, quinidine, tacrolimus, nelfinavir, saquinavir, and amiodarone) with GILOTRIF can increase exposure to afatinib.

• Concomitant use of P-gp inducers (including but not limited to rifampicin, carbamazepine, phenytoin, phenobarbital, and St. John’s wort) with GILOTRIF can decrease exposure to afatinib.

USE IN SPECIFIC POPULATIONSLactation• Because of the potential for serious adverse reactions in breastfed infants

from GILOTRIF, advise women not to breastfeed during treatment with GILOTRIF and for 2 weeks after the final dose.

Females and Males of Reproductive Potential• GILOTRIF may reduce fertility in females and males of reproductive

potential. It is not known if the effects on fertility are reversible.

Renal Impairment• Patients with severe renal impairment (estimated glomerular filtration rate

[eGFR] 15 to 29 mL/min/1.73 m2) have a higher exposure to afatinib than patients with normal renal function. Administer GILOTRIF at a starting dose of 30 mg once daily in patients with severe renal impairment. GILOTRIF has not been studied in patients with eGFR <15 mL/min/1.73 m2 or who are on dialysis.

Hepatic Impairment• GILOTRIF has not been studied in patients with severe (Child Pugh

C) hepatic impairment. Closely monitor patients with severe hepatic impairment and adjust GILOTRIF dose if not tolerated.

GF PROF ISI 10.21.19

IMPORTANT SAFETY INFORMATION (CONT’D)

Please see full Prescribing Information, including Patient Information.

References: 1. GILOTRIF [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. 2. Soria JC, Felip E, Cobo M, et al. Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung (LUX-Lung 8): an open-label randomised controlled phase 3 trial. Lancet Oncol. 2015;16(8):897 907.

Nearly 8 months Overall Survival in LUX-Lung 81,2

In advanced SqCC of the lung progressing after platinum-based chemotherapy

Similar occurance of serious ARs vs erlotinib in advanced SqCC of the lung (LUX-Lung 8)1,2

44% of patients in each treatment arm experienced serious adverse reactions2

Treatment-related discontinuation due to any adverse reactions was similar in both arms (20% vs 17% for GILOTRIF vs erlotinib)2

Discontinuation of therapy in GILOTRIF-treated patients for adverse reactions was 20%. The most frequent adverse reactions that led to discontinuation in GILOTRIF-treated patients were diarrhea (4.1%) and rash/acne (2.6%).1

Estimates of survival were all significantly better with GILOTRIF vs erlotinib at2:• 6 months (63.6% [95% CI, 58.6–68.2] vs 54.6% [49.5–59.4]; P=0.0099)• 12 months (36.4% [95% CI, 31.6–41.2] vs 28.2% [23.8–32.9]; P=0.0155)• 18 months (22.0% [95% CI, 17.6–26.7] vs 14.4% [10.7–18.6]; P=0.0132)

Median PFS: 2.4 months with GILOTRIF vs 1.9 months with erlotinib (HR=0.82 [95% CI, 0.68–0.99];P=0.0427)1

CI=confidence interval; HR=hazard ratio; OS=overall survival; PFS=progression-free survival.

† In LUX-Lung 8, a head-to-head trial vs erlotinib in patients with metastatic SqCC of the lung with disease progression following ≥4 cycles of platinum-based chemotherapy; disease control (complete response, partial response, stable disease, non-complete response, and non-progressive disease) was a secondary endpoint. Excluding patients with non-complete response and non-progressive disease, disease control with afatinib was 37%, vs 29% with erlotinib, in a post hoc analysis2

† Includes stomatitis, aphthous stomatitis, mucosal inflammation, mouth ulceration, oral mucosa erosion, mucosal erosion, mucosal ulceration.

‡ Includes acne, dermatitis, acneiform dermatitis, eczema, erythema, exfoliative rash, folliculitis, rash, rash generalized, rash macular, rash maculopapular, rash pruritic, rash pustular, skin exfoliation, skin fissures, skin lesion, skin reaction, skin toxicity, skin ulcer.

§ Includes paronychia, nail infection, nail bed infection.

51% disease control rate for GILOTRIF vs. erlotinib in LUX-Lung 82getting their first line treatment with combination of chemotherapy and immunotherapy and then are going to need something else to be given, so it’s very nice to have a nonchemotherapy second or third line option for these patients, depending on how they’ve been treated.

Q Is there a need for mutation testing in order to use Gilotrif in patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy?

A No, there is not a need for testing. For the non-squamous NSCLC patients, it’s very important that they all be tested to see if they have an EGFR mutation and our physicians, of course, know that testing is now the standard of care. For squamous patients the efficacy of Gilotrif does not depend on having any particular mutation or not. So, that’s very important to keep in mind.

Q Does the efficacy following a platinum-based chemotherapy regimen warrant consideration of Gilotrif? Why?

A Yes. Randomized trial has been done comparing Gilotrif to another oral agent in that setting, and Gilotrif was the

superior agent tested. Not all patients responded, but control of the disease was enough to make Gilotrif warrant consideration. [See next page for LUX-Lung 8 Overall Survival and Disease Control Rate results and GILOTRIF adverse reactions summary table.]

Alternatives for these patients, if they were not placed on Gilotrif, would be to take another single agent chemotherapy drug or just go directly to hospice and supportive care. Obviously, if the patient has declined with their performance status so significantly that they are very debilitated, are not going to do well with oral agents and are extremely sick at that point, then the patient and the physician need to make a decision about other treatment options.

Q What adverse reactions were observed in the LUX-Lung 8 study?

A There was a similar occurrence of patients (44%) experiencing serious adverse reactions for both the afatinib and erlotinib arms in the study. [See next page for AR table.] Treatment-related discontinuation due to any adverse reactions was also similar in both arms (20% for GILOTRIF vs 17% for erlotinib).2

Q How significant is “disease control rate” in managing these patients?

A It’s meaningful because with any treatment, whether it would be with Gilotrif or whether it’s going to be with a second or third line chemotherapy, the objective response rate is going to be relatively low. For any of these it’s going to be in the five to 15 percent range. So, disease control is very important, meaning how long can the patient stay relatively stable before he/she needs to go onto another treatment? That’s a major factor, so, we’ve learned to take this more into account: What’s the patient’s experience in controlling their disease? Not only what we measure on a CT scan or an X-ray, but how long can we control that patient’s disease and keep him/her from having an obvious cancer progression that requires a change in treatment?

• Withhold GILOTRIF during evaluation of patients with suspected ILD, and discontinue GILOTRIF in patients with confirmed ILD.

Hepatic Toxicity• Hepatic toxicity as evidenced by liver function tests abnormalities has been

observed in patients taking GILOTRIF. In 4257 patients who received GILOTRIF across clinical trials, 9.7% had liver test abnormalities, of which 0.2% were fatal.

• Obtain periodic liver testing in patients during treatment with GILOTRIF. Withhold GILOTRIF in patients who develop worsening of liver function. Discontinue treatment in patients who develop severe hepatic impairment while taking GILOTRIF.

Gastrointestinal Perforation• Gastrointestinal (GI) perforation, including fatal cases, has occurred with

GILOTRIF. GI perforation has been reported in 0.2% of patients treated with GILOTRIF among 3213 patients across 17 randomized controlled clinical trials.

• Patients receiving concomitant corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or anti-angiogenic agents, or patients with increasing age or who have an underlying history of GI ulceration, underlying diverticular disease, or bowel metastases may be at an increased risk of perforation.

• Permanently discontinue GILOTRIF in patients who develop GI perforation.

Keratitis• Keratitis has been reported in patients taking GILOTRIF.• Withhold GILOTRIF during evaluation of patients with suspected keratitis.

If diagnosis of ulcerative keratitis is confirmed, interrupt or discontinue GILOTRIF. If keratitis is diagnosed, the benefits and risks of continuing treatment should be carefully considered. GILOTRIF should be used with caution in patients with a history of keratitis, ulcerative keratitis, or severe dry eye. Contact lens use is also a risk factor for keratitis and ulceration.

Embryo-Fetal Toxicity• GILOTRIF can cause fetal harm when administered to a pregnant woman.

Advise pregnant women and females of reproductive potential of the potential risk to a fetus.

• Advise females of reproductive potential to use effective contraception during treatment, and for at least 2 weeks after the last dose of GILOTRIF. Advise female patients to contact their healthcare provider with a known or suspected pregnancy.

ADVERSE REACTIONSAdverse Reactions observed in clinical trials were as follows:

Previously Treated, Metastatic Squamous NSCLC• In GILOTRIF-treated patients (n=392) the most common adverse reactions

IMPORTANT SAFETY INFORMATION (CONT’D)

Please see full Prescribing Information, including Patient Information.

DRUG REVIEW

Afatinib versus erlotinib as second-line treatment of patients with advanced squamous

cell carcinoma of the lung (LUX-Lung 8)2

Study Design:• Head-to-head randomized, multicenter, open-label phase III trial

assessed the safety and efficacy of GILOTRIF 40 mg orally once daily (n=398) vs erlotinib 150 mg once daily (n=397) in patients with metastatic SqCC of the lung with disease progression following ≥4 cycles of platinum-based chemotherapy

• Primary endpoint was PFS; key secondary endpoints included OS and disease control (complete response, partial response, stable disease, non-complete response, and non-progressive disease)

Results Summary:• Median PFS: 2.4 months with GILOTRIF vs 1.9 months with erlotinib

(HR=0.82 [95% CI, 0.68–0.99]; P=0.0427)• OS: 7.9 months for afatinib vs 6.8 months for erlotinib (HR=0.81

[95% CI, 0.69–0.95]; P=0.008)• Disease control (excluding patients with non-complete response

and non-progressive disease): 37% with afatinib vs 29% with erlotinib, in a post hoc analysis

Adverse reactionGILOTRIF (n=392)

Grade 3-4, %

Erlotinib (n=395)

Grade 3-4, %

GILOTRIF (n=392)

All grades, %

Erlotinib (n=395)

All grades, %

Gastrointestinal disordersDiarrheaStomatitis†

NauseaVomiting

11 4 2 1

3 1 1 1

753021 13

41 11 16 10

Skin and subcutaneous tissue disordersRash/acneiform dermatitis‡

Pruritus7 0

11 0

70 10

70 13

InfectionsParonychia§ 1 0 11 5

Metabolism and nutrition disordersDecreased appetite 3 2 25 26

Adverse reactions reported in LUX-Lung 8 in ≥10% of GILOTRIF-treated patients1

Disease control rate in LUX-Lung 8†

51%

40%

Dise

ase

cont

rol r

ate

(%)

GILOTRIF (n=398)

Erlotinib (n=397)

0

40

30

10

20

50

60

70

80

GILOTRIF

Erlotinib

Median OS in LUX-Lung 8*

Time (Months)

OS

(%)

0 63 12 159 18 21

0

20

40

60

80

100

24 27 30

Hazard ratio: 0.81 (95% CI, 0.69–0.95)P=0.008

GILOTRIF(40 mg orally once daily; n=398)

Erlotinib(150 mg once daily; n=397)

months7.9

19%reduction in

risk of death vs erlotinib

months6.8

(≥20% all grades & vs erlotinib-treated patients (n=395)) were diarrhea (75% vs 41%), rash/acneiform dermatitis (70% vs 70%), stomatitis (30% vs 11%), decreased appetite (25% vs 26%), and nausea (21% vs 16%).

• Serious adverse reactions were reported in 44% of patients treated with GILOTRIF. The most frequent serious adverse reactions reported in patients treated with GILOTRIF were pneumonia (6.6%), diarrhea (4.6%), and dehydration and dyspnea (3.1% each). Fatal adverse reactions in GILOTRIF-treated patients included ILD (0.5%), pneumonia (0.3%), respiratory failure (0.3%), acute renal failure (0.3%), and general physical health deterioration (0.3%).

DRUG INTERACTIONSEffect of P-glycoprotein (P-gp) Inhibitors and Inducers• Concomitant use of P-gp inhibitors (including but not limited to ritonavir,

cyclosporine A, ketoconazole, itraconazole, erythromycin, verapamil, quinidine, tacrolimus, nelfinavir, saquinavir, and amiodarone) with GILOTRIF can increase exposure to afatinib.

• Concomitant use of P-gp inducers (including but not limited to rifampicin, carbamazepine, phenytoin, phenobarbital, and St. John’s wort) with GILOTRIF can decrease exposure to afatinib.

USE IN SPECIFIC POPULATIONSLactation• Because of the potential for serious adverse reactions in breastfed infants

from GILOTRIF, advise women not to breastfeed during treatment with GILOTRIF and for 2 weeks after the final dose.

Females and Males of Reproductive Potential• GILOTRIF may reduce fertility in females and males of reproductive

potential. It is not known if the effects on fertility are reversible.

Renal Impairment• Patients with severe renal impairment (estimated glomerular filtration rate

[eGFR] 15 to 29 mL/min/1.73 m2) have a higher exposure to afatinib than patients with normal renal function. Administer GILOTRIF at a starting dose of 30 mg once daily in patients with severe renal impairment. GILOTRIF has not been studied in patients with eGFR <15 mL/min/1.73 m2 or who are on dialysis.

Hepatic Impairment• GILOTRIF has not been studied in patients with severe (Child Pugh

C) hepatic impairment. Closely monitor patients with severe hepatic impairment and adjust GILOTRIF dose if not tolerated.

GF PROF ISI 10.21.19

IMPORTANT SAFETY INFORMATION (CONT’D)

Please see full Prescribing Information, including Patient Information.

References: 1. GILOTRIF [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. 2. Soria JC, Felip E, Cobo M, et al. Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung (LUX-Lung 8): an open-label randomised controlled phase 3 trial. Lancet Oncol. 2015;16(8):897 907.

Nearly 8 months Overall Survival in LUX-Lung 81,2

In advanced SqCC of the lung progressing after platinum-based chemotherapy

Similar occurance of serious ARs vs erlotinib in advanced SqCC of the lung (LUX-Lung 8)1,2

44% of patients in each treatment arm experienced serious adverse reactions2

Treatment-related discontinuation due to any adverse reactions was similar in both arms (20% vs 17% for GILOTRIF vs erlotinib)2

Discontinuation of therapy in GILOTRIF-treated patients for adverse reactions was 20%. The most frequent adverse reactions that led to discontinuation in GILOTRIF-treated patients were diarrhea (4.1%) and rash/acne (2.6%).1

Estimates of survival were all significantly better with GILOTRIF vs erlotinib at2:• 6 months (63.6% [95% CI, 58.6–68.2] vs 54.6% [49.5–59.4]; P=0.0099)• 12 months (36.4% [95% CI, 31.6–41.2] vs 28.2% [23.8–32.9]; P=0.0155)• 18 months (22.0% [95% CI, 17.6–26.7] vs 14.4% [10.7–18.6]; P=0.0132)

Median PFS: 2.4 months with GILOTRIF vs 1.9 months with erlotinib (HR=0.82 [95% CI, 0.68–0.99];P=0.0427)1

CI=confidence interval; HR=hazard ratio; OS=overall survival; PFS=progression-free survival.

† In LUX-Lung 8, a head-to-head trial vs erlotinib in patients with metastatic SqCC of the lung with disease progression following ≥4 cycles of platinum-based chemotherapy; disease control (complete response, partial response, stable disease, non-complete response, and non-progressive disease) was a secondary endpoint. Excluding patients with non-complete response and non-progressive disease, disease control with afatinib was 37%, vs 29% with erlotinib, in a post hoc analysis2

† Includes stomatitis, aphthous stomatitis, mucosal inflammation, mouth ulceration, oral mucosa erosion, mucosal erosion, mucosal ulceration.

‡ Includes acne, dermatitis, acneiform dermatitis, eczema, erythema, exfoliative rash, folliculitis, rash, rash generalized, rash macular, rash maculopapular, rash pruritic, rash pustular, skin exfoliation, skin fissures, skin lesion, skin reaction, skin toxicity, skin ulcer.

§ Includes paronychia, nail infection, nail bed infection.

51% disease control rate for GILOTRIF vs. erlotinib in LUX-Lung 82

GILOTRIF® (afatinib) tablets, for oral useInitial U.S. Approval: 2013BRIEF SUMMARY OF PRESCRIBING INFORMATIONPlease see package insert for full Prescribing Information.

INDICATIONS AND USAGE: EGFR Mutation-Positive, Metastatic Non-Small Cell Lung Cancer: GILOTRIF is indicated for the first-line treatment of patients with meta-static non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test. Limita-tion of Use: The safety and efficacy of GILOTRIF have not been established in patients whose tumors have resistant EGFR mutations. Previously Treated, Metastatic Squa-mous NSCLC: GILOTRIF is indicated for the treatment of patients with metastatic squamous NSCLC progressing after platinum-based chemotherapy.

CONTRAINDICATIONS: NoneWARNINGS AND PRECAUTIONS: Diarrhea: Diarrhea has resulted in dehydration with or without renal impair-ment across the clinical experience; some cases were fatal. Grade 3-4 diarrhea occurred in 697 (16%) of the 4257 patients who received GILOTRIF across 44 clinical trials. In LUX-Lung 3, diarrhea occurred in 96% of patients treated with GILOTRIF (n=229), of which 15% were Grade 3 in severity and occurred within the first 6 weeks. Renal impairment as a consequence of diarrhea occurred in 6% of patients treated with GILOTRIF, of which 1.3% were Grade 3. In LUX-Lung 8, diarrhea occurred in 75% of patients treated with GILOTRIF (n=392), of which 10% were Grade 3 in severity and 0.8% were Grade 4 in severity. Renal impairment as a consequence of diarrhea occurred in 7% of patients treated with GILOTRIF, of which 2% were Grade 3 [see Adverse Reactions]. For patients who develop prolonged Grade 2 diar-rhea lasting more than 48 hours, or greater than or equal to Grade 3 diarrhea, withhold GILOTRIF until diarrhea resolves to Grade 1 or less, and resume GILOTRIF with appropriate dose reduction. Provide patients with an anti-diarrheal agent (e.g., loperamide) for self-administration at the onset of diarrhea and instruct patients to continue anti-diarrheal therapy until loose bowel movements cease for 12 hours. Bullous and Exfoliative Skin Disorders: Grade 3 cutaneous reactions characterized by bullous, blistering, and exfoliating lesions, occurred in 0.2% of the 4257 patients who received GILOTRIF across clinical trials. In LUX-Lung 3, the overall incidence of cutaneous reactions consisting of rash, erythema, and acnei-form rash was 90%, and the incidence of Grade 3 cutaneous reactions was 16%. In addition, the incidence of Grade 1-3 palmar-plantar erythrodysesthesia syndrome was 7%. In LUX-Lung 8, the overall incidence of cutaneous reactions consisting of rash, erythema, and acneiform rash was 70%, and the incidence of Grade 3 cutaneous reactions was 7%. In addition, the incidence of Grade 1-3 palmar-plantar erythro-dysesthesia syndrome was 1.5% [see Adverse Reactions]. Discontinue GILOTRIF in patients who develop life-threat-ening bullous, blistering, or exfoliating lesions. For patients who develop prolonged Grade 2 cutaneous adverse reactions lasting more than 7 days, intolerable Grade 2, or Grade 3 cuta-neous reactions, withhold GILOTRIF until the adverse reaction resolves to Grade 1 or less, and resume GILOTRIF with appropri-ate dose reduction. Postmarketing cases consistent with toxic epidermal necrolysis (TEN) and Stevens Johnson syndrome (SJS) have been reported in patients receiving GILOTRIF. The cases of TEN and SJS bullous skin reactions result from a distinct and separate mechanism of toxicity than the bullous skin lesions secondary to the pharmacologic action of the drug on the epidermal growth factor receptor. Discontinue GILOTRIF if TEN or SJS is suspected. Interstitial Lung Disease (ILD): Interstitial lung disease or ILD-like adverse reactions (e.g., lung infiltration, pneumonitis, acute respiratory distress syndrome, or alveolitis allergic) occurred in 1.6% of the 4257 patients who received GILOTRIF across clinical trials; of these, 0.4% were fatal. The incidence of ILD appeared to be higher in Asian patients (2.3%; 38/1657) as compared to Whites (1.0%; 23/2241). In LUX-Lung 3, the incidence of Grade ≥3 ILD was 1.3% and resulted in death in 1% of GILOTRIF-treated patients. In LUX-Lung 8, the incidence of Grade ≥3 ILD was 0.9% and resulted in death in 0.8% of GILOTRIF-treated patients. With-hold GILOTRIF during evaluation of patients with suspected ILD, and discontinue GILOTRIF in patients with confirmed ILD. Hepatic Toxicity: In 4257 patients who received GILOTRIF across clinical trials, 9.7% had liver test abnormalities, of which 0.2% were fatal. In LUX-Lung 3, liver test abnormal-ities of any grade occurred in 17.5% of the patients treated

with GILOTRIF, of which 3.5% had Grade 3-4 liver test abnor-malities. In LUX-Lung 8, liver test abnormalities of any grade occurred in 6% of the patients treated with GILOTRIF, of which 0.2% had Grade 3-4 liver test abnormalities. Obtain peri-odic liver testing in patients during treatment with GILOTRIF. Withhold GILOTRIF in patients who develop worsening of liver function. In patients who develop severe hepatic impairment while taking GILOTRIF, treatment should be discontinued. Gastrointestinal Perforation: Gastrointestinal perforation, including fatal cases, has occurred with GILOTRIF. Gastro- intestinal perforation has been reported in 0.2% of patients treated with GILOTRIF among 3213 patients across 17 randomized controlled clinical trials. Patients receiving concomitant corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs) or anti-angiogenic agents, or patients with increasing age or who have an underlying history of gastro-intestinal ulceration, underlying diverticular disease or bowel metastases may be at increased risk of perforation. Permanently discontinue GILOTRIF in patients who develop gastrointestinal perforation. Keratitis: Keratitis, characterized as acute or worsening eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain, and/or red eye occurred in 0.7% of patients treated with GILOTRIF among 4257 patients across clinical trials, of which 0.05% of patients experienced Grade 3 keratitis. Keratitis was reported in 2.2% patients in LUX-Lung 3, with Grade 3 in 0.4%. In LUX-Lung 8, keratitis was reported in 0.3% patients; there were no patients with ≥Grade 3 keratitis. Withhold GILOTRIF during evaluation of patients with suspected keratitis, and if diagnosis of ulcer-ative keratitis is confirmed, treatment with GILOTRIF should be interrupted or discontinued. If keratitis is diagnosed, the benefits and risks of continuing treatment should be care-fully considered. GILOTRIF should be used with caution in patients with a history of keratitis, ulcerative keratitis, or severe dry eye [see Adverse Reactions]. Contact lens use is also a risk factor for keratitis and ulceration. Embryo- Fetal Toxicity: Based on findings from animal studies and its mechanism of action, GILOTRIF can cause fetal harm when administered to a pregnant woman. Administration of afati-nib to pregnant rabbits during organogenesis at exposures approximately 0.2 times the exposure in humans at the recom-mended dose of 40 mg daily resulted in embryotoxicity and, in rabbits showing maternal toxicity, increased abortions at late gestational stages. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment, and for at least 2 weeks after the last dose of GILOTRIF. ADVERSE REACTIONS: The following adverse reactions are discussed in greater detail in other sections of the label-ing: Diarrhea [see Warnings and Precautions]; Bullous and Exfoliative Skin Disorders [see Warnings and Precautions]; Interstitial Lung Disease [see Warnings and Precautions]; Hepatic Toxicity [see Warnings and Precautions]; Keratitis [see Warnings and Precautions]. Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data in the Warnings and Precautions section reflect exposure to GILOTRIF for clinically significant adverse reactions in 4257 patients enrolled in LUX-Lung 3 (n=229) and LUX-Lung 8 (n=392), and 3636 patients with cancer enrolled in 42 studies of GILOTRIF administered alone or in combination with other anti-neoplastic drugs at GILOTRIF doses ranging from 10-70 mg daily or at doses 10-160 mg in other regimens. The mean exposure was 5.5 months. The population included patients with various cancers, the most common of which were NSCLC, breast, colorectal, brain, and head and neck. The data described below reflect exposure to GILOTRIF as a single agent in LUX-Lung 3, a randomized, active-controlled trial conducted in patients with EGFR mutation-positive, metastatic NSCLC, and in LUX-Lung 8, a randomized, active-controlled trial in patients with meta-static squamous NSCLC progressing after platinum-based chemotherapy. EGFR Mutation-Positive, Metastatic NSCLC: The data in Tables 1 and 2 below reflect the exposure of 229 EGFR-tyrosine kinase inhibitor-naïve, GILOTRIF-treated patients with EGFR mutation-positive, metastatic, non-squa-mous NSCLC enrolled in a randomized, multicenter, open-label trial (LUX-Lung 3). Patients received GILOTRIF 40 mg daily until documented disease progression or intolerance to the therapy. A total of 111 patients were treated with pemetrexed/cisplatin. Patients were treated with pemetrexed 500 mg/m² followed after 30 minutes by cisplatin 75 mg/m² every three weeks for a maximum of six treatment courses. The median exposure was 11 months for patients treated with

GILOTRIF and 3.4 months for patients treated with peme-trexed/cisplatin. The overall trial population had a median age of 61 years; 61% of patients in the GILOTRIF arm and 60% of patients in the pemetrexed/cisplatin arm were younger than 65 years. A total of 64% of patients on GILOTRIF and 67% of pemetrexed/cisplatin patients were female. More than two-thirds of patients were from Asia (GILOTRIF 70%; pemetrexed/cisplatin 72%). Serious adverse reactions were reported in 29% of patients treated with GILOTRIF. The most frequent serious adverse reactions reported in patients treated with GILOTRIF were diarrhea (6.6%); vomiting (4.8%); and dyspnea, fatigue, and hypokalemia (1.7% each). Fatal adverse reactions in GILOTRIF-treated patients in LUX-Lung 3 included pulmonary toxicity/ILD-like adverse reactions (1.3%), sepsis (0.43%), and pneumonia (0.43%). Dose reductions due to adverse reactions were required in 57% of GILOTRIF-treated patients. The most frequent adverse reactions that led to dose reduction in the patients treated with GILOTRIF were diarrhea (20%), rash/acne (19%), paronychia (14%), and stomatitis (10%). Discontinuation of therapy in GILOTRIF-treated patients for adverse reactions was 14.0%. The most frequent adverse reactions that led to discontinuation in GILOTRIF-treated patients were diarrhea (1.3%), ILD (0.9%), and paronychia (0.9%). Clinical trials of GILOTRIF excluded patients with an abnormal left ventricular ejection fraction (LVEF), i.e., below the institutional lower limit of normal. In LUX-Lung 3, all patients were evaluated for LVEF at screen-ing and every 9 weeks thereafter in the GILOTRIF-treated group and as needed in the pemetrexed/cisplatin group. More GILOTRIF-treated patients (2.2%; n=5) experienced ventricular dysfunction (defined as diastolic dysfunction, left ventricular dysfunction, or ventricular dilation; all < Grade 3) compared to chemotherapy-treated patients (0.9%; n=1). Tables 1 and 2 summarize common adverse reactions and laboratory abnormalities in LUX-Lung 3.Table 1 Adverse Reactions Reported in ≥10% of

GILOTRIF-Treated Patients in LUX-Lung 3*

Adverse Reaction

GILOTRIFn=229

Pemetrexed/Cisplatin n=111

All Grades(%)

Grade 3†

(%)All Grades

(%)

Grade 3†

(%)Gastrointestinal disordersDiarrhea 96 15 23 2Stomatitis1 71 9 15 1Cheilitis 12 0 1 0

Skin and subcutaneous tissue disordersRash/acneiform dermatitis2

90 16 11 0

Pruritus 21 0 1 0Dry skin 31 0 2 0

InfectionsParonychia3 58 11 0 0Cystitis 13 1 5 0

Respiratory, thoracic and mediastinal disordersEpistaxis 17 0 2 1Rhinorrhea 11 0 6 0

InvestigationsWeight decreased 17 1 14 1

General disorders and administration site conditionsPyrexia 12 0 6 0

Eye disordersConjunctivitis 11 0 3 0

*NCI CTCAE v 3.0†None of the adverse reactions in this table except stomatitis (one patient on GILOTRIF [0.4%]) were Grade 4 in severity.1Includes stomatitis, aphthous stomatitis, mucosal inflammation, mouth ulceration, oral mucosa erosion, mucosal erosion, mucosal ulceration2Includes acne, acne pustular, dermatitis, acneiform dermatitis, dermatosis, drug eruption, erythema, exfoliative rash, folliculitis, rash, rash erythematous, rash follicular, rash generalized, rash macular, rash maculo-papular, rash pruritic, rash pustular, skin disorder, skin erosion, skin exfoliation, skin fissures, skin lesion, skin reaction, skin toxicity, skin ulcer3Includes paronychia, nail infection, nail bed infectionOther clinically important adverse reactions observed in patients treated with GILOTRIF but that occurred at a higher incidence in pemetrexed/cisplatin-treated patients and not listed elsewhere in section 6 include: decreased appetite (29% Grades 1-4, 4% Grade 3), nausea (25% Grades 1-4, 4% Grade 3), and vomiting (23% Grades 1-4, 4% Grade 3).

Table 2 Laboratory Abnormalities Occurring in ≥10% of GILOTRIF Arm and at ≥2% Higher Incidence than in Chemotherapy Arm in LUX-Lung 3*

Laboratory Abnormality

GILOTRIFn=229

Pemetrexed/Cisplatinn=111

All Grades

(%)

Grades 3-4(%)

All Grades

(%)

Grades 3-4(%)

Increased alanine aminotransferase (ALT)

54 2 27 1

Increased alkaline phosphate

51 3 46 1

Decreased creatinine clearance

49 2 47 1

Increased aspartate aminotransferase (AST)

46 3 22 1

Decreased lymphocytes 38 9 32 14Decreased potassium 30 8 11 3Increased bilirubin 16 1 8 0

*NCI CTCAE v 3.0Previously Treated, Metastatic Squamous NSCLC: The safety of GILOTRIF was evaluated in 392 GILOTRIF-treated patients with metastatic squamous NSCLC enrolled in a randomized, multi-center, open-label trial (LUX-Lung 8). Patients were required to have received at least four cycles of platinum-based chemo-therapy, ECOG Performance Status (PS) 0 or 1, and normal left ventricular ejection fraction (LVEF). Patients received GILOTRIF 40 mg once daily (n=392) or erlotinib 150 mg once daily (n=395). Treatment continued until documented disease progression or intolerance to the therapy. Among the 392 GILOTRIF-treated patients, the median age was 65 years, 53% were 65 years of age or older, 84% were male, 72% were White, 25% were Asian, ECOG PS 0 (32%) or 1 (68%). The median exposure was 2.1 months for patients treated with GILOTRIF, 15% were exposed for at least 6 months, and 5% were exposed for at least 12 months. Serious adverse reac-tions occurred in 44% of patients treated with GILOTRIF. The most frequent serious adverse reactions in patients treated with GILOTRIF were pneumonia (6.6%), diarrhea (4.6%), and dehydration and dyspnea (3.1% each). Fatal adverse reactions in GILOTRIF-treated patients included ILD (0.5%), pneumonia (0.3%), respiratory failure (0.3%), acute renal failure (0.3%), and general physical health deterioration (0.3%). Dose reductions due to adverse reactions were required in 27% of GILOTRIF-treated patients and discontinuation of GILOTRIF for adverse reactions was required for 20%. The most frequent adverse reactions that led to dose reduction in the patients treated with GILOTRIF were diarrhea (15%), rash/acne (5.9%), and stomatitis (3.1%). The most frequent adverse reactions that led to discontinuation in GILOTRIF-treated patients were diarrhea (4.1%) and rash/acne (2.6%). Tables 3 and 4 summa-rize common adverse reactions and laboratory abnormalities in LUX-Lung 8.Table 3 Adverse Reactions Reported in ≥10% of

GILOTRIF-Treated Patients in LUX-Lung 8*

Adverse Reaction

GILOTRIFn=392

Erlotinibn=395

All Grades

(%)

Grade 3-4(%)

All Grades

(%)

Grade 3-4(%)

Gastrointestinal disordersDiarrhea 75 11 41 3Stomatitis1 30 4 11 1Nausea 21 2 16 1Vomiting 13 1 10 1

Skin and subcutaneous tissue disordersRash/acneiform dermatitis2

70 7 70 11

Pruritus 10 0 13 0InfectionsParonychia3 11 1 5 0

Metabolism and nutrition disordersDecreased appetite 25 3 26 2

*NCI CTCAE v 3.01Includes stomatitis, aphthous stomatitis, mucosal inflammation, mouth ulceration, oral mucosa erosion, mucosal erosion, mucosal ulceration2Includes acne, dermatitis, acneiform dermatitis, eczema, erythema, exfoliative rash, folliculitis, rash, rash generalized, rash macular, rash maculo-papular, rash pruritic, rash pustular, skin exfoliation, skin fissures, skin lesion, skin reaction, skin toxicity, skin ulcer3Includes paronychia, nail infection, nail bed infection

Table 4 Laboratory Abnormalities Occurring in ≥10% of GILOTRIF Arm and at ≥2% Higher Incidence than in Erlotinib Arm in LUX-Lung 8*

Laboratory Abnormality

GILOTRIFn=392

Erlotinibn=395

All Grades

(%)

Grades 3-4(%)

All Grades

(%)

Grades 3-4(%)

Increased alkaline phosphate

34 2 31 0

Decreased white blood cell count

12 1 8 1

Decreased potassium

11 1 8 1

*NCI CTCAE v 3.0

Other clinically important laboratory abnormalities observed in patients treated with GILOTRIF that are not listed in Table 4 are: increased alanine aminotransferase (10% Grade 1-4; 1% Grade 3-4), increased aspartate aminotransferase (7% Grade 1-4; 1% Grade 3-4), and increased bilirubin (3% Grade 1-4; 0 Grade 3-4). Less Common Adverse Reactions: Other adverse reactions reported in patients treated with GILOTRIF in LUX-Lung 3 and LUX-Lung 8 include: Skin and subcuta-neous disorders: nail disorders occurred in 9.2% and 2.8% of patients, respectively. Postmarketing Experience: The following adverse reactions have been identified during post-approval use of GILOTRIF. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Pancreatitis; Toxic epidermal necrolysis/Stevens Johnson syndrome.

DRUG INTERACTIONS: Effect of P-glycoprotein (P-gp) Inhibitors and Inducers: Concomitant taking of P-gp inhib-itors (including but not limited to ritonavir, cyclosporine A, ketoconazole, itraconazole, erythromycin, verapamil, quini-dine, tacrolimus, nelfinavir, saquinavir, and amiodarone) with GILOTRIF can increase exposure to afatinib. Concomitant taking of P-gp inducers (including but not limited to rifampicin, carbamazepine, phenytoin, phenobarbital, and St. John’s wort) with GILOTRIF can decrease exposure to afatinib.

USE IN SPECIFIC POPULATIONS: Pregnancy: Risk Summary: Based on findings from animal studies and its mechanism of action, GILOTRIF can cause fetal harm when administered to a pregnant woman. There are no available data on the use of GILOTRIF in pregnant women. Administration of afatinib to pregnant rabbits during organogenesis at expo-sures approximately 0.2 times the exposure in humans at the recommended dose of 40 mg daily resulted in embryotoxicity and, in rabbits showing maternal toxicity, increased abortions at late gestational stages [see Data]. Advise a pregnant woman of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated back-ground risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respec-tively. Data: Animal Data: In an embryo-fetal development study in rabbits, administration of afatinib to pregnant animals at doses of 5 mg/kg (approximately 0.2 times the exposure by AUC at the recommended human dose of 40 mg daily) or greater during the period of organogenesis caused increased post-implantation loss, and in animals showing maternal toxic-ity, abortion at late gestational stages. In the same study, at the high dose level of 10 mg/kg (approximately 0.7 times the exposure by AUC at the recommended human dose of 40 mg daily), there were reduced fetal weights, and increases in the incidence of runts, as well as visceral and dermal variations. In an embryo-fetal development study in rats, there were skeletal alterations consisting of incomplete or delayed ossifications and reduced fetal weight at a dose of 16 mg/kg (approximately twice the exposure based on AUC at the recommended human dose of 40 mg daily). Lactation: Risk Summary: There are no data on the presence of afatinib in human milk or its effects on the breastfed infant or on milk production. Afatinib was present in the milk of lactating rats [see Data]. Because of the potential for serious adverse reactions in nursing infants from GILOTRIF, advise a lactating woman not to breastfeed during treatment with GILOTRIF and for 2 weeks after the final dose. Data: Afati-nib was present in the milk of lactating rats at concentrations 80 and 150 times higher than those found in plasma at 1 and 6 hours after administration. Females and Males of Repro-ductive Potential: Contraception: Females: GILOTRIF can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with GILOTRIF, and for at least 2 weeks after the last dose of GILOTRIF [see Use in Specific Populations]. Infertility: Based on results from an animal fertility

study, GILOTRIF may reduce fertility in females and males of reproductive potential. It is not known if the effects on fertil-ity are reversible. Pediatric Use: Safety and effectiveness of GILOTRIF in pediatric patients have not been established. Geriatric Use: LUX-Lung 3 did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In LUX-Lung 8, 53% of the 398 patients randomized to receive afatinib were 65 years of age or older and 11% were 75 years or older. In an exploratory subgroup analysis of LUX-Lung 8, the hazard ratio for overall survival (OS) in patients less than 65 years old was 0.68 (95% CI: 0.55, 0.85) and in patients 65 years or older was 0.95 (95% CI: 0.76, 1.19). No overall differences in safety were observed between patients 65 years and older and younger patients. Renal Impairment: Patients with severe renal impairment have a higher exposure to afatinib than patients with normal renal function. Administer GILOTRIF at a starting dose of 30 mg once daily in patients with severe renal impairment. Adjustments to the starting dose of GILOTRIF are not necessary in patients with mild or moderate renal impairment. Dosing recommendations for patients with eGFR <15 mL/min/1.73 m2 or on dialysis cannot be provided as GILOTRIF has not been studied in these patient populations. Hepatic Impairment: GILOTRIF has not been studied in patients with severe (Child Pugh C) hepatic impairment. Adjustments to the starting dose of GILOTRIF are not neces-sary in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment. Closely monitor patients with severe hepatic impairment and adjust GILOTRIF dose if not tolerated.

OVERDOSAGE Overdose was reported in 2 healthy adolescents each of whom ingested 360 mg of GILOTRIF (as part of a mixed-drug ingestion) resulting in nausea, vomiting, asthenia, dizziness, headache, abdominal pain, and elevated amylase [<1.5 times upper limit of normal (ULN)]. Both subjects recovered.

PATIENT COUNSELING INFORMATION: See FDA- approved patient labeling (Patient Information). Diarrhea: Advise patients that diarrhea occurs in nearly all patients who receive GILOTRIF. Inform patients that diarrhea may result in dehydration and renal impairment if not treated. Advise patients to notify their physician if diarrhea develops and to seek medi-cal attention promptly for severe or persistent diarrhea [see Warnings and Precautions and Adverse Reactions]. Bullous and Exfoliative Skin Disorders: Advise patients to minimize sun exposure with protective clothing and use of sunscreen while taking GILOTRIF [see Warnings and Precautions]. Interstitial Lung Disease: Advise patients to immediately report any new or worsening lung symptoms, or any combination of the follow-ing symptoms: trouble breathing or shortness of breath, cough, fever [see Warnings and Precautions]. Hepatic Toxicity: Advise patients that they will need to undergo liver function monitoring periodically. Advise patients to immediately report any symp-toms of a liver problem [e.g., skin or the whites of eyes turn yellow, urine turns dark or brown (tea colored), pain on the right side of stomach, bleeds or bruises more easily than normal, lethargy] [see Warnings and Precautions]. Keratitis: Advise patients to immediately report eye problems (e.g., eye pain, swelling, redness, blurred vision, or other vision changes) [see Warnings and Precautions]. Left Ventricular Dysfunction: Advise patients to contact a healthcare professional immediately for any of the following: new onset or worsening shortness of breath or exercise intolerance, cough, fatigue, swelling of the ankles/legs, palpitations, or sudden weight gain [see Adverse Reactions]. Instructions for Taking GILOTRIF: Advise patients to take GILOTRIF on an empty stomach at least 1 hour before or 2 hours after eating. Advise patients not to take a missed dose within 12 hours of the next dose. Embryo-Fetal Toxicity: Advise pregnant women and females of reproductive potential that GILOTRIF can result in fetal harm. Advise female patients to contact their healthcare provider with a known or suspected pregnancy. Advise females of reproductive potential to use effective contraception during treatment with GILOTRIF and for at least 2 weeks after the last dose of GILOTRIF [see Use in Specific Populations]. Lactation: Advise women not to breast-feed during treatment with GILOTRIF and for 2 weeks after the last dose of GILOTRIF [see Use in Specific Populations]; Infertility: Advise females and males of reproductive potential of the potential for reduced fertility from GILOTRIF [see Use in Specific Populations].

Copyright © 2019 Boehringer Ingelheim International GmbH ALL RIGHTS RESERVED

Revised: October 2019 GF-BS (11-19) CL-GF-100021

22 FCS The Magazine

COVER STORY

Left to right: Radiation Oncologist Dr. Sachin Kamath, Radiation Oncologist Dr. Luis Carrascosa, Medical Oncologist Dr. Vipul Patel

Winter 2020 23

Ocala Cancer CenterNew state-of-the-art facility keeps treatment local

Being told she had breast cancer was not the surprise Barbara Dehart expected to receive on Valentine’s Day 2017. The longtime Ocala resident was enjoying her work at a local florist and looking

forward to celebrating the special day with her husband and daughter before the diagnosis changed her plans.

Fortunately, when Barbara was referred to Dr. Vipul Patel, a Board-certified medical oncologist at Florida Cancer Specialists & Research Institute (FCS), she found easy access to some of the most advanced cancer treatments, cutting-edge diagnostics and a range of support services. Best of all, she didn’t need to travel far from home.

“I knew instantly I was surrounded by good people,” Barbara recalls. “Everyone bent over backwards to help me. They truly cared about me as a person.”

Dr. Patel and his fellow FCS Board-certified physicians have been providing expert care to Marion County residents for years at three locations in greater Ocala. “We live here, we work here and we are dedicated to serving our neighbors,” said Dr. Patel.

FCS opened its brand-new, state-of-the-art Ocala Cancer Center in July 2019. It is the first and only comprehensive center of its kind in Marion County, serving patients needing treatment for a broad range of cancers, blood disorders and other diseases.

The 21,000-square-foot center includes 17 exam rooms, 47 chemotherapy infusion stations, as well as diagnostics and radiation oncology services. Patients also receive access to national clinical trials, 24/7 care-management support, pathology laboratory services and specialty pharmacy services, including home delivery of oral medications.

“It’s been quite a major project for us,” said FCS Board-certified Radiation Oncologist Dr. Sachin Kamath. “The physicians in the community were a major driving factor, because up until that point, they felt they really needed to send their patients to Gainesville or Tampa to get these treatments.”

24 FCS The Magazine

Exceptional Technology & Clinical Care

The addition of radiation oncology services and next-generation imaging technology — a first for Marion County — is immensely valuable to the Center’s physicians and patients.

Radiation oncologists rely on medical imaging procedures to identify, diagnose and treat many different cancers and conditions. For example, the Center’s next-generation PET/CT scanner utilizes Computerized Axial Tomography (CAT), or CT scans, to provide views of internal organs, bones, soft tissue and blood vessels with immense clarity and detail. These scans and other tests are now performed on site.

If radiation treatment is recommended, the Varian VitalBeam® linear accelerator (LINAC) uses high-energy beams of radiation to pinpoint and destroy cancer cells, with great precision, to any area of the body.

“These treatments are incredibly precise and can be tailored to each patient’s individual needs,” explains FCS Board-certified Radiation Oncologist Dr. Luis Carrascosa.

“Because we have the newest, safest and most advanced technology, we can more accurately target tumors, avoid healthy tissue and reduce side effects.”

Access to FCS’ robust clinical trials program, provided in partnership with the Sarah Cannon Research Institute, one of the leading clinical trials organizations in the world, is another benefit provided to patients.

February Fundraiser

What: FCS Foundation’s second annual Farm to Table event. All proceeds provide non-medical financial assistance to cancer patients.When: 5 p.m. to 9 p.m., Feb. 8Where: Castle Gate Farm, 13009 S. Highway 475, Ocala, FL 34480

Winter 2020 25

A Place for Healing that Feels Like Home

“We are advancing care in our community,” said Dr. Kamath. Patients have taken note. Dr. Kamath said he spoke recently with a patient who said she has observed major differences in her care today compared with when she received her cancer diagnosis about 15 years ago.

“She said now that we’ve got this comprehensive multidisciplinary approach, ‘I feel like you are all working together and you’re presenting me with a plan… it’s not about the physicians or the healthcare team, but it’s really about the patient.’”

Barbara Dehart agrees. She considers the doctors, nurses and staff more like siblings than caregivers, and the camaraderie among patients “makes everything easier and brighter.”

“When I go there, it lifts my spirits,” she says. Indeed, FCS makes sure that cancer is a journey no one

must take alone.

A Nod to Ocala’s Heritage

Along the walls and hallways of the Ocala Cancer Center, you’ll find artwork that pays tribute to the city’s nickname: Horse Capital of the World.

“It was nice to incorporate a bit of a horse theme into our facility, which has really had a good response from patients,” said FCS Radiation Oncologist Dr. Luis Carrascosa. “They really like it.”

Horseshoes and pictures of thoroughbreds adorn the walls, one of many elements at the Center aimed to reduce stress and provide a more comfortable experience.

In fact, the new building was developed with feedback and guidance from the Ocala Cancer Center’s Patient Advisory Board. FCS integrated evidence-based design, such as the use of colors, lighting and natural elements - to enhance the patient experience and also to improve operational efficiencies for providers. An outdoor healing garden, funded by FCS physicians, features plants, art sculptures, bench seating and a calming water component.

“Everybody really came together to help support us and make this happen,” said FCS Radiation Oncologist Dr. Sachin Kamath.

Patrick Acevedo, MD Shilpa Oberoi, MDMohammad Kamal, MD Craig Reynolds, MD

The Ocala Cancer Center team includes these medical oncologists:

26 FCS The Magazine

Nathan H. Walcker: Seeing the Bigger Picture BY ZANDRA WOLFGRAM

Winter 2020 27

EXECUTIVE MANAGEMENT TEAM SPOTLIGHT

Nathan “Nate” Walcker was born in the American heartland in Omaha, Nebraska — hometown of Warren Buffett, arguably one of the world’s top financial minds. Walcker earned a degree in

economics from Columbia University and an MBA in finance at Columbia Business School — the same Ivy League halls walked by Buffett and former New York Yankees great Lou Gehrig, later the eponymous namesake for ALS, the same disease that would claim Walcker’s late father when he was a young boy.

Like these entrepreneurial trailblazers, Walcker is a tenacious “heavy hitter” -- clearly one of the reasons he was tapped for his role as FCS’ new chief financial officer.

“One of the aspects I really enjoy about my seat at FCS is the ability to work across disciplines and not be pigeon-holed as the bean counter.’” Walcker shares. “This role spans enterprise-wide to finance, risk management, procurement, real estate, strategy and beyond.”

Walcker is an “avid reader,” counting the Greek classics, W.H. Auden and even Deepak Chopra among his favorites. He also is “a big believer in the power of motivational sayings to crystalize and articulate his message and strategy.” One of his favorites: “You can’t manage what you can’t measure.”

Just three months into his new role with FCS, this analytical and numbers-oriented executive looks to institute his philosophy of being both “data driven and purpose driven” in everything that he does.

“Whether you’re talking revenue cycle management or looking at KPIs (key performance indicators) for your department, or you’re hands-on providing care in a clinic,” Walcker says, “understanding and appreciating when you see variance of wait time or the amount of time it takes to see a financial counselor helps stitch together a mosaic that drives business intelligence and process improvement across our organization.”

His focus as CFO is clear. “Being a good steward of the organization’s capital, its people and the community is goal one, two and three — full stop,” he says decisively.

“I work as hard as I do because I’ve seen the impacts that chronic disease, cancer and other healthcare challenges have on families,” he says. Just a few short months after his father passed away from ALS, Walcker lost his grandfather to a brain tumor.

Get to Know Our New CFO

Since 2005, and until he arrived at Florida Cancer Specialists in the summer of 2019, Manhattan had been home for Nathan Walcker.

Most recently he was a member of Bank of America Merrill Lynch’s Global Healthcare Investment Banking Group, responsible for advising leading healthcare companies on mergers, acquisitions and capital structure strategies. Nate got his start on Wall Street on the Merrill Lynch trading floor in New York and went on to earn increasing responsibility as an investment banker and strategic advisor. Over the past decade he’s worked closely with company founders and principals of emerging growth and multi-national healthcare companies, helping to evaluate, plan and execute capital investments and also pursue growth opportunities.

He vacationed in Florida over the years, mostly in the Miami area. As of this writing, he was in the process of moving wife, Chelsea, two-year-old daughter, Olivia and rescue dog, Bailey, to the Sunshine State. The 6-foot- 4-inch former offensive lineman for Columbia University’s football team has just one hesitation.

“The only thing I miss about New York is the food,” he laments. “What’s lacking here is the ability to get a slice at 2 a.m. and a bacon, egg and cheese on a Kaiser roll.”

Beyond serving up food at all hours, the city that never sleeps made an indelible impact on Walcker, who confesses that spending the better part of his 20’s and 30’s there gave him more than a successful start to his career.

“Given it is a cultural mixing pot, it taught me empathy … to appreciate others where they are,” he says. “Everyone is spring loaded differently, but ultimately, we’re all trying to do the same thing.”

Making a difference is important to Walcker. He is a past board member of Lime Connect, a nonprofit that connects high potential students and professionals with disabilities to professional development opportunities. While in New York, he tutored underprivileged kids in math and economics, and he also served as an overnight volunteer at a men’s homeless shelter.

“You treat everyone as a human being,” he says, “no matter what.”

“Being a good steward of the organization’s capital, its people and the community is goal one, two and three — full stop.”

NATHAN WALCKER

What does Walcker see for the future of FCS finance? “There will always be new ways for us to be opportunistic with respect to the direction of the organization,” he says. “Finding new pockets of growth across our organization, whether that is driving expansion, adding and investing ancillaries and modalities or investing in our real estate strategy, we’re continuously seeking to move FCS forward to be the national leader of community-based medical oncology.”

28 FCS The Magazine

OFFICE SPOTLIGHT

South Region Clinical Trials Research Office BY HANNAH BURKE

W ithin the world of research, you frequently hear the acronym “GCP” — good clinical practices, says Patrice Cowan, research study manager at Florida Cancer Specialists

& Research Institute’s (FCS) south region research office.Honoring that high-quality standard for patients, through

careful collection of data and late phase clinical trial management, is what Cowan’s team strives for every day.

“The FCS Research staff is responsible for ensuring thatt the integrity of data is maintained, that patients are safe and reporting any type of adverse effects that may occur throughout the study,” says Cowan. “It takes a village, and everyone is committed to contributing and improving our patients’ lives.”

FCS houses four late phase research regions across Florida. Within the south region, there are 12 FCS clinics that enroll, screen and see patients in research studies.

Left to right: Cathy Scarangella, research regulatory coordinator; Rayanne Thompson, research pharmacy coordinator; Megan Cook, research regulatory coordinator; Joyce Davis, research pharmacy coordinator; Nancy Solak, clinical research coordinator; Brittney Johnson, research support specialist; Patrice Cowan, research study manager. Not pictured: Shirley Hammonds, research regulatory coordinator.

Winter 2020 29

Cowan, who manages the regulatory and pharmacy team at her office in Fort Myers, oversees the receipt and transport of drugs and study supplies between satellite sites and also monitors studies throughout their life cycles.

“FCS is unique in that we’ve been able to enroll patients for clinical trials that represent all tumor types, and we readily have all varieties of drugs available with which to treat them,” says Cowan. “This gives patients the opportunity to participate in approved, exploratory therapies that they may need access to and, as we are a community facility, patients never have to travel far to find a clinic that will play a role in their cancer treatments.”

There are four phases in clinical trials. Upon entering the late phase, the FDA or sponsors are requesting approval for marketing the drug. By this point, there has been some indication that a drug has garnered positive results in a number of participants; and that the benefits outweigh the risks. There is the potential that a drug will work better than what is currently available.

“We are heavily, heavily regulated.” Cowan stresses. “And not one person in our office says something is or isn’t their job. It’s a team effort, and we all share an understanding that we’re here to ensure the study is ethical and that the rights and welfare of participants are protected.”

“Collecting years and years of data may sound mundane, but coming out on the other side, seeing how patients benefit and contributing to medical knowledge That’s is the driving force behind our team.”

FCS Research Study Manager Patrice Cowan

30 FCS The Magazine

Dear Physicians & Staff of FCS New Port Richey West,

I would like to thank the staff, especially Dr. Kulkarni, Dr. Sokol, Sophie and Shannon. Everyone consistently played a part in improving my grandmother’s health and making her smile, and then those people made her smile even more. My grandma passed away a few days ago, which is breaking my heart, but I am thankful for the extra time I got with her thanks to this fabulous medical group.

Everyone was always full of compassion, kindness and love. My grandma went from dreading having to go to radiation every day to wanting to make sure she gave everyone there a card on Nurse’s Day because they all were so nice to her. I am so grateful for all the good you all did for her health, not just because it extended my time with her, but also because it made her more comfortable.Thank you, truly, for the great experiences we had with you. It eases the mind during such hard times to be surrounded by such amazing people. Thank you to Shannon and the HR team for always helping with my FMLA paperwork. And another thanks to the rock makers!! This was another one of her favorite parts about coming (lol). She had quite a few which I will display around her urn.- A grateful granddaughter

From the moment I met Dr. Padmaja Sai, I knew that I was in good hands. She

came highly recommended … and for good reason. She does her research and

knows about this disease. Each visit she made me feel as though I was her only

patient, and, at that moment, I am all that was important. Everything that was

going on in my body was explained to me, drawn out on paper and explained

to me again. The planned treatment was handled the same way. I knew what

was happening every step of the way.

We met in April. I had four chemo treatments from May to July 2019. I did not

get sick once, and my body managed. Her staff from the first greeting at the

front desk to the lab technicians to the nurses — all of them are super. They ask

you how you feel and actually listened to my answers. They all made a dark part

of my life brighter.

Thank you … thank you for loving what you do and most of all for taking care

of ME, when I needed the help.

- A grateful patient

FCSPatient Letters

Winter 2020 31

It is gratifying always to receive letters from appreciative patients. Their kind words remind us why we chose our careers in medicine and inspire us to do our best work. If you have a letter from a patient that you would like to see published, please submit it via email to FCS Marketing at marketing@FLCancer.com.

Dear Dr. Tetreault,

I write now to thank you and to commend you.

I thank you for being so forthright about the assessment of and therapeutic prospects for the upper tract urothelial cell carcinoma in my right renal pelvis. Your knowledge of the UK study of UTUC that had not yet even been published convinced me that you had thought about and searched the literature about UTUC.

Of course, I do not presume to judge your professional competence — as I have neither the knowledge nor the expertise to do so. But the fact that Dr. Robert Bradford, my urological surgeon for whom I have great esteem, expressed his recognition of your expertise — by referring me to you — was and is sufficient for me to have complete confidence in you.

But the piéce de résistance of my admiration and respect for you is the care and diligence with which you follow your patients’ progress. For example, when the first follow-up PET scan suggested some hyperactive areas in the liver that could have been metastatic lesions, your office notified me promptly of a logical response to the findings. But the most impressive thing to me was that you personally called me to ensure that I followed up on the findings — and to inform me that significant progress had been made in therapeutic options even for metastatic UTUC. I believe that such personal involvement of a doctor nowadays is exceptional. Even though I had practiced medicine for 30 years, I lacked full appreciation of the angst I felt as the one confronted with a highly malignant, uniformly fatal cancer.

With all of my follow-up diagnostic studies, I have requested that you be given the reports.

I am extremely pleased that so far there is no evidence of cancer. But if I have need of an oncologist again, I will call on you. You have my respect and my loyalty.

Sincerely,

- D.W., MD Patient of Dr. Scott Tetreault To the staff of

FCS Sarasota Downtown:

All of the employees —

reception, nurses’ aides, nurses,

doctors, etc. — are the kindest

people I have ever met. They

take a scary experience and help

to make it less so.

FCSPatient Letters

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