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FCSTHE MAGAZINE

Spring 2016

ELEVATING PATIENT SUPPORT

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Spring 2016 3

Spring 2016contents

in this issue

Departments 5 FCS News

22 FCS Events

31 Get to Know Dr. Storey-Rojas

33 Patient Letters

38 Radar Screen

spotlights18 Administrative Spotlight: SARAH CEVALLOS

Shining in the shadows20 Office Spotlight: TALLAHASSEE

Providing a personal touch28 Nurse Spotlight: LORI PADDEN

Connecting with patients34 Research Spotlight: IMMUNOTHERAPY

Changing the landscape of oncology treatment

35 Radiology Spotlight: Bone Scans Detecting and monitoring cancer

36 Doctor Spotlight: Dr. Lucio Gordan Going above and beyond

Features8 An Amazing Trajectory17 Dr. Richard Brown

Finding a Meaningful Life27 Cigna Partnership for Care

Management

The world traveling Gordan family.

4 FCS The Magazine

physician leaDershipPresident

WiLLiaM N. HaRWiN, M.D. AssistAnt MAnAging PArtner,

director, executive BoArd STEPHEN V. ORMaN, M.D.

MedicAl director MaRK S. RubiN, M.D.

scientific director of clinicAl reseArch, director, drug develoPMent ProgrAM

LOWELL L. HaRT, M.D.director of reseArch oPerAtions

RObERT C. WHORF, M.D.

executive managementchief executive officer

bRaD PRECHTL chief oPerAting officer

TODD SCHONHERzgenerAl counsel

TOM CLaRK chief MArketing & sAles officer

SHELLy GLENNchief revenue cycle officer

SaRaH CEVaLLOS

senior management

Ray baiLEy CHRiSTy baNaCH JEREMy bEHLiNG

LOiS bROWN MELiSa CHaNDLER

MELODy CHaNG DaViD CuRRy RiCH DySON JEFF ESHaM

MiCHaEL ESSiK iNGa GONzaLEz KaTiE GOODMaN ERiC GRiNDSTaFF

CHRiSTOPHER HOuSER LEVESTER JONES

SuE KEaRNEy NiCOLE PiCaziO

LOiS POEL JEFFREy RubiN

TaRa RuSKa LyNN SaWyER

DENiCE VEaTCH SaMaNTHa WaTKiNS

Dear Colleagues,

As an organization, FCS is at the forefront of patient advocacy. Our first two Core/C.A.R.E. Values say it best: “Continuously Support the Patient” and “Always Do the Right Thing.” This is the primary reason why FCS has joined a coalition of over 300 cancer organizations and other healthcare and advocacy groups that are opposed to the “Medicare Experiment” proposed by CMS (Centers for Medicaid and Medicare) in late March.

CMS announced that it plans to “experiment” with alternative reimbursement plans for medications covered under Medicare Part B. If implemented, the CMS proposal could change the way cancer patients receive treatment and restrict patient access to the newest, most advanced cancer treatments.

This so-called “experiment” was ill conceived and did not seek any input from the oncology community. It certainly is not in the best interest of our patients and, if implemented, could cause a shift away from community-based cancer care and force patients to leave their doctor to seek treatment in a hospital setting, which will not only cost more for the patient, but also be more expensive for CMS, as well.

We know that modern cancer treatment is not a one-size-fits-all approach. Cancer is an extremely complex disease that requires individualized treatment for each patient, based on that person’s unique genetic profile. FCS physicians have expressed their deep concerns that the proposed experiment could lead to restrictions on how a physician chooses to treat patients and could therefore interfere with the sacred trust between doctor and patient.

Medicare beneficiaries represent some of our oldest and sickest patients and these patients sometimes require that we try multiple prescription drugs and/or biologics before we find the ones that are most effective for that individual. Often, two people with exactly the same type of cancer may not respond in the same way to the same drug or medication – so treatment becomes even more complicated at that point and may require several types of therapies before the most appropriate one is found. These vulnerable Medicare patients should not have to face mandatory participation in an initiative that may force them to switch to a less appropriate (and potentially less effective) treatment.

The Community Oncology Alliance (COA) is leading the effort to reach out to leaders in Congress and urge them to stop CMS from instituting its plan. I am personally asking our physicians, nurses and other clinicians, employees, patients and their families to get involved in this critically-important issue. Let’s do the right thing for our patients by contacting our Senators and Congressional Representatives and asking them to Stop the Medicare Experiment on Cancer Drugs! To take action, go online to CancerExperiment.org and fill out the form.

Brad Prechtlceo

Message from

Brad prechtl

editor'sletter

FCSTHE MAGAZINE

PuBlished By

in PArtnershiP With

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FCSnews

✚ fcs Announces Alliance with Alltrust insuranceFCS has chosen Alltrust Insurance, a leading brokerage

firm in the employee benefits industry, to advise and develop improved benefits packages for the more than 2,300 FCS employees throughout Florida.

“Alltrust has been working closely with our HR team to maximize our employee benefit plans, as well as to engage and educate our employees to become efficient consumers of healthcare,” said FCS CEO Brad Prechtl. “As a provider of healthcare services, FCS is keenly aware of just how important it is for individuals to understand their healthcare benefits. Our partnership with Alltrust will not only ensure that our employees have a broad range of excellent benefits, but also that they have a thorough understanding of their plan, so that they can become knowledgeable decision makers when it comes to their overall health and well-being.”

✚ naples fundraising gala will Assist Patients in needDealing with a cancer diagnosis and subsequent treatment

is stressful enough without having to worry about how to pay for essentials such as rent or the electric bill. Patients suddenly discover that cancer not only strikes their body, but their family, friends, profession and their finances.

The FCS Foundation, which provides financial assistance for non-medical bills to qualified cancer patients so they can focus on battling their illness, hosted the “Time to Remember” gala on Saturday, April 16, at The Ritz-Carlton in Naples. The sold out event featured a live performance by soul diva, music legend and the First Lady of Motown, Martha Reeves and The Vandellas. The magical Motown-inspired evening included cocktails, dinner, dancing and a live auction of unique items and experiences, including “Fund-a-Family” live bidding where proceeds will go directly to support families of cancer patients.

✚ trio Promoted to ranks of senior Management teamFCS has announced three promotions to the Senior

Management team. Christy Banach has been named Director of Patient Services, Melisa Chandler was promoted to Director of Revenue Cycle, and Nicole Picazio is now Director of Contracting and Credentialing.

“These three outstanding women have all been with the company for a number of years and have held a variety of positions within the financial services department and contributed to the overall success of FCS,” said Chief Revenue Cycle Officer Sarah Cevallos. “Their expertise and leadership have helped to provide a positive experience for our patients and their families during some of the most challenging circumstances of our patients’ lives. We are very proud to welcome Christy, Melisa and Nicole to our Senior Management Team.”

✚ American cancer society asks legislators to ‘Pass the Buck’Brad Prechtl, serving as chairman of the American Cancer

Society’s CEOs Against Cancer Florida Chapter, and dozens of cancer patients, survivors and advocates from the American Cancer Society Cancer Action Network took to the Capitol steps recently. Their mission was to encourage Florida’s legislature to increase the surcharge on packs of cigarettes by at least $1. Supporters say the increase will help improve Floridians quality of life, increase the economy and save lives.

FCS CEO brad Prechtl, chairman of the american Cancer Society’s CEOs against Cancer Florida Chapter, leads the charge in Tallahassee to advocate for a healthier future for Floridians. The large group rallied in support of increasing the surcharge on a pack of cigarettes.

Nicole PicazioMelisa ChandlerChristy banach

6 FCS The Magazine

FCSnews

FCS COO Todd Schonherz said, “Each of these outstanding individuals has demonstrated leadership qualities that have advanced their departments and contributed to the overall success of FCS, as well. Jeff Rubin has been with the company for 12 years and has consistently proven to be an invaluable resource for achieving strategic goals. Inga Gonzalez, who joined FCS in 2011, and Michael Essik, who came to FCS in 2013, have likewise shown great skill in executing numerous programs that have driven innovation and helped to navigate the many changes in our industry. These three leaders are highly regarded and valued members of our Senior Management Team.”

✚ fcs celebrates grand opening of Brandon cancer centerThe new $10 million Brandon Cancer Center celebrated

its grand opening on Nov. 20 with a ribbon cutting conducted by patients, staff and dignitaries. The office is located in a 38,400-square-foot medical building featuring evidence-based design and state-of-the-art doctors’ offices, exam rooms, PET/CT, high-dynamic-range imaging equipment and a linear accelerator.

✚ dr. Antonella leary Joins fcs in Palm Beach countyFCS has announced that Antonella

Leary, M.D., has joined FCS and will be seeing patients at the FCS cancer centers in Palm Beach Gardens and Wellington.

FCS CEO Brad Prechtl commented, “Dr. Leary will bring an added dimension to our practice locations in Palm Beach Gardens and Wellington, focusing on female malignancies, including cervical, vulvar, uterine and ovarian carcinomas. She offers patients innovative and highly effective treatment options and we’re happy to have her join the FCS family.”

✚ dr. geetha kamath named “community hero” by tampa Bay lightningDr. Geetha Kamath, who practices

at the St. Pete and Clearwater East locations of FCS, was honored as the 14th Lightning Community Hero of the 2015–16 season by the Tampa Bay Lightning at a Lightning game in December. Dr. Kamath has been providing free medical services for the St. Petersburg Free Clinic for the past 35 years and estimates she has served more than 6,000 needy patients during that time, many of whom were homeless.

Dr. Kamath’s volunteer work also extends well beyond her community practice in St. Petersburg. She provided disaster relief in Haiti after the devastating earthquake in 2010.

In honor of her work, Dr. Kamath received a $50,000 donation from the Lightning Foundation and the Lightning Community Heroes program. She plans to donate the money to the St. Petersburg Free Clinic.

✚ Michael essik, inga gonzalez and Jeff rubin earn PromotionsFCS has announced the promotions of three senior

leaders. Michael Essik has been promoted to Vice President of Finance, Inga Gonzalez has been named Senior Regional Director in Central Florida and Jeff Rubin assumes responsibilities as Vice President of Practice Operations.

antonella Leary, M.D.

Michael Essik inga Gonzalez Jeff Rubin

Dr. Geetha Kamath

Physicians, staff, patients and dignitaries attend a ribbon cutting at the brandon Cancer Center.

Spring 2016 7

FCSnews

Patients undergoing chemotherapy, infusion and radiation therapy will be treated in the new center.

FCS physicians led the festivities and thanked staff and supporters for their efforts and contributions to serving patients in the community. “This Brandon Cancer Center offers a wide range of treatments and services all under one roof, optimizing convenience for our patients in the Brandon community,” CEO Brad Prechtl said. Access to the company’s Phase 1, 2 and 3 clinical trials will also be available to patients seen at the center.

✚ sarah cevallos named chief revenue cycle officerFCS has named Sarah Cevallos

Chief Revenue Cycle Officer. Sarah will assume a broad range of responsibilities as she oversees Revenue Cycle for the organization.

FCS CEO Brad Prechtl said, “Sarah has consistently demonstrated leadership qualities that have earned the respect of her peers and the employees in the departments she oversees. Over the past seven years at FCS, she has developed a strong track record for achieving strategic improvements within her areas of responsibility. We rely on leaders like Sarah to contribute to the company’s overall success.”

✚ Brad Prechtl named florida chair of ceos Against cancerFCS CEO Brad Prechtl has been

named Chair of the Florida Chapter of CEOs Against Cancer, a program of the American Cancer Society (ACS). The nearly 400 members of the program represent a powerful network of business leaders who bring passion, expertise and resources needed to prevent, treat and cure this disease, which costs U.S. employers $225.8 billion each year.

“We are excited Brad will be our leader as we continue to grow the CEOs Against Cancer Florida Chapter,” said Ralph DeVitto, Executive Vice President, Florida Division, American Cancer Society. “His commitment and dedication to the American Cancer Society is an inspiration to all and we feel fortunate to have him as a partner in our mission to save lives from cancer.”

✚ Annual Barbecue Attracts record AttendanceAlmost 500 patients and their families attended the

second annual Patient Appreciation Barbecue dinner at the Spring Hill office of FCS. Physicians Thomas Tang, Mary Li and Vikas Malhotra put on their chef hats and joined other FCS staffers in serving lots of great food. The fun evening event also featured prizes, music and special guest appearances by cheerleaders and running back Bobby Rainey from the Tampa Bay Buccaneers.

brad Prechtl

Sarah Cevallos

a crowd of almost 500 turned out for the event.

Tampa bay buccaneers running back bobby Rainey and patient Mary Goswick enjoy the festivities.

FCS doctors and staff host the Patient appreciation barbecue. Left to Right: Julie anning, Dr. Thomas Tang, Dr. Vikas Malhotra, Dr. Mary Li, alison Murty.

8 FCS The Magazine

an amazing trajectoryFCS: Thirty-Two Years and CountingBY TISHA CREwS KELLER

CovEr STory

Spring 2016 9

In 1984, Dr. Bill Harwin found Fort Myers, Florida. He was instantly attracted to its (then) new

airport and the beauty of Sanibel and Captiva Island. Southwest Florida also had what he could

clearly see was a growing need for his specialty in the area’s aging population.

Harwin decided to focus a new oncology/hematology practice with one goal in mind: to provide good quality of care and longevity of life for cancer patients with every tool at his disposal. This is still Harwin’s goal and is central to the mission of Florida Cancer Specialists, which quickly grew from Harwin’s solo practice to 93 locations and nearly 350 doctors, nurse practitioners and physician assistants.

The story of how FCS grew into the largest independent cancer care organization in Florida is one of determination and an unwavering focus on patient needs.

growth on demandHarwin explains that the practice began expanding organically,

adding an additional physician partner only 1.5 years after opening its doors. Growth accelerated as word spread about Harwin’s expertise and the need for oncology services grew in Southwest Florida. Soon, offices were opened in Punta Gorda, in response to patient demand, and in Bonita Springs, where a new doctor was interested in joining Harwin’s practice.

From there, offices spread to Charlotte and Collier counties, as well as north to the Tampa area. In the early 1990s, Harwin renamed his sprawling oncology practice, “Florida Cancer Specialists.” Harwin, now President and Managing Partner of FCS, wanted to keep to simple design and to be clear about the mission of what he was trying to do: provide the highest level of cancer treatment, delivered by specialists, to the people of Florida in the communities where they lived.

Perhaps one of the most important additions during the early growth period of FCS was Dr. Mark Rubin, the architect of its electronic medical record-keeping system. Harwin says that one of the most important aspects of medical practice success is having a great electronic medical record, or EMR. Especially in oncology, which uses information and diagnoses from a variety of sources on a medical team, having an accessible, easily updated, on-demand medical record for each patient is key.

“Dr. Rubin was critical,” Harwin explains, “because having an outstanding EMR that everyone could use not only made practicing oncology much more efficient, but it made it easier to bring on new partners and made FCS more cohesive overall.” Around 2006, the partners decided that all new joining physicians must have the same EMR in place to ease transitions. The lion’s share of credit for that decision—and its great success—goes to Rubin, who researched, purchased and directed the adoption of a standard EMR while he was still practicing with a full slate of oncology patients.

technological AdvancesBesides the use of standard electronic medical records, Harwin’s

FCS also had great business processes in place, which made it the envy of oncologists statewide.

“Billing and collecting is so important with such expensive cancer treatment drugs,” Harwin says. “We had very good people running a wonderful business office that put standard procedures in place.”

This propelled FCS in many ways, and allowed the organization and its doctors to focus on patient care, research and providing ancillary services to increase the quality of life for those being treated.

By 2009, Harwin and his partners realized they needed someone at the helm to focus on the business aspects of FCS — efficiencies, processes, organizational excellence and service expansion. Brad Prechtl began as CEO that year and growth increased dramatically. When Prechtl started, FCS had grown to 49 physicians. Today, the organization includes 93 locations, almost 200 board-certified doctors and 150 physician extenders, including physician assistants and nurse practitioners.

Prechtl has preserved the original focus of FCS despite its skyrocketing growth. Providing specialized, world-class care with a hometown feel is still what he strives to instill in each and every FCS partner and employee.

“The philosophy when FCS started was always to be focused on ensuring that before anything else is considered, we are delivering the highest quality of care for our patients,” Prechtl explains. “We will never do anything to put a patient at risk. We are always going to do everything to make sure their best interests are met.”

FCS accomplishes this by maintaining a low ratio of patients to doctors and by providing services in an almost intuitive manner. Physicians like the FCS model because they get the best of the small practice environment — they can be involved in as much of the day-to-day practice management as they want — but they also benefit from the advantage of professional practice management and the economies of scale a large organization provides. For instance, having 93 (and counting) locations is a key component of the FCS business model.

Cancer patients typically fare better if they are able to stay close to home. Providing clinics in convenient locations not only reduces the burden of travel and time, but also makes the added cost of transportation a non-issue.

Seventy percent of FCS patients rely on either Medicare or Medicaid. They may not have the resources to travel long distances — and if they aren’t feeling well or are elderly, they don’t want to get in a car and travel. Similarly, the vast majority

10 FCS The Magazine

of cancer patients will have a family member or friend accompany them to treatments. So, if you’re the adult child of a patient, you may have to leave work to take your parent to treatment and you could be waiting for several hours several times a week — all factors adding to the tangible costs of cancer care.

Under Prechtl and Harwin’s leadership, FCS has brought as many ancillary services as possible under the local roof, including extensive labs, in-house hematopathology for bone marrow interpretation, in-house pharmacy, radiology services, PET and CT scans and more. These offerings add value to the life and experience of both patient and support system members.

It’s worth noting that these are services are not typically offered at practices with even 10-20 physicians. What’s more, the model allows local autonomy in many aspects, including what is offered at individual clinics. Sometimes, local charities may offer certain services such as nutritional counseling, support groups, massage therapy, acupuncture and more. Some FCS clinics offer these things themselves.

“The fact that patients can get most all services from one location is a big help,” Prechtl points out. “A convenient and comfortable environment is also very important. They see their own doctor when needed, instead of a resident or fellow that may be on rotation in an academic medical center. At FCS, patients always see their board-certified attending physician.”

FCS’s unique Rx To Go program is a point of particular pride for Prechtl. With its own central pharmacy located at its corporate headquarters in Fort Myers, FCS is able to fill up to 85 percent of the prescriptions written for oral oncolytic drugs. This provides convenience, of course, but Prechtl is quick to add that it also affords an additional level of review — and protection — for FCS patients.

“Our pharmacists have access to the electronic medical records, so if dosages change upon refill, that would be caught by the pharmacist’s review of the EMR,” he explains. In addition, the Rx To Go program uses FedEx to deliver prescriptions to patients at home — and the turnaround time from writing the script to fulfillment is extremely fast. Ray Bailey, Cathy Hogan and the RX to Go team have refined this program and others over the past eight years, and the goal is always to keep care and customer service at a superior level. Under his leadership, FCS has added an average of 30 physicians per year over the last four years.

going forwardWhen a person is diagnosed with cancer, few words offer the

same potential as “clinical trial.” FCS offers Phase I, II and III clinical research trials — more than any other institution in the state, including academic medical centers, according to Prechtl. Patients are often eligible to enroll in a clinical research trial to add to their treatment. This allows access to the latest advances in cancer treatment.

“These amazing new drugs and emerging technologies are the centerpiece of the FCS mission,” says Dr. Stephen Orman, medical oncologist and FCS Assistant Managing Partner. He is

passionate about advances in treatment and revolutionary new ways to target, treat and help the body eradicate cancer; Orman is especially passionate about newer molecular targeted treatments derived from a better understanding of cancer growth.

“In my early years of practicing oncology, there were only a handful of effective drugs with limited impact on patient survival,” he explains. “Although there were many more effective chemotherapy drugs developed over the decades that improved results and minimized side effects, a paradigm shift in treatment developed relatively recently. Targeted antibody-based therapy uses immune proteins (antibodies) to specifically target cancer cells, resulting in better treatment with higher rates of cure.”

Orman says that at the same time, treatments targeting specific molecular pathways of cancer growth were developed that turned diseases thought incurable, such as Chronic Myelogenous Leukemia, into a potentially curable condition. This work continues today in clinical trials at FCS, with an explosion of agents in Phase 1 trials (usually first in human) targeting very specific pathways being tested by researchers, including Dr. Manish Patel and Dr. Judy Wang at FCS Sarasota. By creating personalized treatment from genetic markers in a patient’s own tumor, FCS can potentially provide additional options for effective cancer management.

In addition, Orman says that immunotherapy holds tremendous promise. FCS has participated in several clinical trials for agents that unmask cancer and augment the body’s immune response to it. This work will have significant implications in the future treatment of many forms of cancer.

But, Orman is quick to point out that prevention is still an important component of health.

“A clean environment, healthy lifestyle of diet and exercise, maintaining a smoke-free society, and limiting exposure to our Florida sun are important factors that we each control,” Orman says.

FCS has a unique opportunity to offer cutting-edge cancer care in the communities it calls home. Orman believes that through physician leadership, FCS can ensure that the primary focus on world-class care to patients will remain unencumbered by the usual policies and politics of larger corporate medical organizations.

FCS is uniquely able to focus its corporate-scale facilities and services on individual patients, without the burdensome hospital or institutional structure. Being nimbler and patient-centered is what Prechtl and his team are aiming for, as they continue to enhance the bottom-up model of care and practice management.

“Curing cancer within the next few decades can now be seen as an attainable goal,” Orman posits. “In the near future, there will certainly be a reduction in cancer rates and mortality.”

Harwin adds, “One of the most important goals for anyone in oncology is research. Nothing is more important than finding new and improved ways to treat and maybe cure cancer patients.”

It is clear that FCS is certainly poised to catapult into the future and embrace the promise of revolutionized cancer care.

CovEr STory

Spring 2016 11

FCSnews

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Accommodations at the JW Marriott & Ritz-Carlton are limited. To guarantee your room,

register for the CME program, events, etc., please reserve by 5.15.16.

For More InformationFor More InformationPlease contact: Shelly at 770.365.6168 | SGlenn@FLCancer.com

or Lynn at 941.677.7182 | LClemens@FLCancer.com

12 FCS The Magazine

VISIT WWW.CYRAMZAHCP.COM FOR MORE INFORMATION, INCLUDING CYRAMZA MONOTHERAPY TRIAL DATAWARNING: HEMORRHAGE, GASTROINTESTINAL PERFORATION, AND IMPAIRED WOUND HEALINGHemorrhage: CYRAMZA increased the risk of hemorrhage and gastrointestinal hemorrhage, including severe and sometimes fatal hemorrhagic events. Permanently discontinue CYRAMZA in patients who experience severe bleeding.Gastrointestinal Perforation: CYRAMZA can increase the risk of gastrointestinal perforation, a potentially fatal event. Permanently discontinue CYRAMZA in patients who experience a gastrointestinal perforation.Impaired Wound Healing: Impaired wound healing can occur with antibodies inhibiting the VEGF pathway. Discontinue CYRAMZA therapy in patients with impaired wound healing. Withhold CYRAMZA prior to surgery and discontinue CYRAMZA if a patient develops wound healing complications.

IMPORTANT SAFETY INFORMATION FOR CYRAMZA

Warnings and PrecautionsHemorrhage • CYRAMZA increased the risk of hemorrhage and gastrointestinal

hemorrhage, including severe and sometimes fatal hemorrhagic events. In study 1, which evaluated CYRAMZA as a single agent in advanced gastric cancer, the incidence of severe bleeding was 3.4% for CYRAMZA and 2.6% for placebo. In study 2, which evaluated CYRAMZA plus paclitaxel, the incidence of severe bleeding was 4.3% for CYRAMZA plus paclitaxel and 2.4% for placebo plus paclitaxel. Patients with gastric cancer receiving nonsteroid anti-inflammatory drugs (NSAIDs) were excluded from enrollment in studies 1 and 2; therefore, the risk of gastric hemorrhage in CYRAMZA-treated patients with gastric tumors receiving NSAIDs is unknown. Permanently discontinue CYRAMZA in patients who experience severe bleeding.

Arterial Thromboembolic Events (ATEs)• Serious, sometimes fatal, ATEs including myocardial infarction, cardiac

arrest, cerebrovascular accident, and cerebral ischemia occurred in clinical trials including 1.7% of 236 patients who received CYRAMZA as a single agent for gastric cancer in study 1. Permanently discontinue CYRAMZA in patients who experience a severe ATE.

Hypertension• An increased incidence of severe hypertension occurred in patients

receiving CYRAMZA as a single agent (8%) as compared to placebo (3%) and in patients receiving CYRAMZA plus paclitaxel (15%) as compared to placebo plus paclitaxel (3%). Control hypertension prior to initiating treatment with CYRAMZA. Monitor blood pressure every 2 weeks or more frequently as indicated during treatment. Temporarily suspend CYRAMZA for severe hypertension until medically controlled. Permanently discontinue CYRAMZA if medically significant hypertension cannot be controlled with antihypertensive therapy or in patients with hypertensive crisis or hypertensive encephalopathy.

Infusion-Related Reactions (IRRs)• Prior to the institution of premedication recommendations across clinical

trials of CYRAMZA, IRRs occurred in 6 out of 37 patients (16%), including 2 severe events. The majority of IRRs across trials occurred during or following a first or second CYRAMZA infusion. Symptoms of IRRs included rigors/tremors, back pain/spasms, chest pain and/or tightness, chills, flushing, dyspnea, wheezing, hypoxia, and paresthesia. In severe cases, symptoms included bronchospasm, supraventricular tachycardia, and hypotension. Monitor patients during the infusion for signs and symptoms

of IRRs in a setting with available resuscitation equipment. Immediately and permanently discontinue CYRAMZA for grade 3 or 4 IRRs.

Gastrointestinal Perforations• CYRAMZA is an antiangiogenic therapy that can increase the risk of

gastrointestinal perforation, a potentially fatal event. Four of 570 patients (0.7%) who received CYRAMZA as a single agent in clinical trials experienced gastrointestinal perforation. In study 2, the incidence of gastrointestinal perforations was also increased in patients who received CYRAMZA plus paclitaxel (1.2%) as compared to patients who received placebo plus paclitaxel (0.3%). Permanently discontinue CYRAMZA in patients who experience a gastrointestinal perforation.

Impaired Wound Healing• Impaired wound healing can occur with antibodies inhibiting the VEGF

pathway. CYRAMZA has not been studied in patients with serious or nonhealing wounds. CYRAMZA, an antiangiogenic therapy, has the potential to adversely affect wound healing. Discontinue CYRAMZA therapy in patients with impaired wound healing. Withhold CYRAMZA prior to surgery. Resume CYRAMZA following the surgical intervention based on clinical judgment of adequate wound healing. If a patient develops wound healing complications during therapy, discontinue CYRAMZA until the wound is fully healed.

Clinical Deterioration in Child-Pugh B or C Cirrhosis• Clinical deterioration, manifested by new onset or worsening

encephalopathy, ascites, or hepatorenal syndrome, was reported in patients with Child-Pugh B or C cirrhosis who received single-agent CYRAMZA. Use CYRAMZA in patients with Child-Pugh B or C cirrhosis only if the potential benefits of treatment are judged to outweigh the risks of clinical deterioration.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS)• RPLS has been reported at a rate of <0.1% in clinical studies with CYRAMZA.

Confirm the diagnosis of RPLS with MRI and discontinue CYRAMZA in patients who develop RPLS. Symptoms may resolve or improve within days, although some patients with RPLS can experience ongoing neurologic sequelae or death.

Proteinuria Including Nephrotic Syndrome• Monitor proteinuria by urine dipstick and/or urinary protein creatinine ratio

for the development of worsening of proteinuria during CYRAMZA therapy. Withhold CYRAMZA for urine protein levels that are ≥2 g over 24 hours. Reinitiate CYRAMZA at a reduced dose once the urine protein level returns to <2 g over 24 hours. Permanently discontinue CYRAMZA for urine protein levels >3 g over 24 hours or in the setting of nephrotic syndrome.

Thyroid Dysfunction• Monitor thyroid function during treatment with CYRAMZA. Embryofetal Toxicity• Based on its mechanism of action, CYRAMZA can cause fetal harm when

administered to pregnant women. Animal models link angiogenesis, VEGF, and VEGF Receptor 2 (VEGFR2) to critical aspects of female reproduction, embryofetal development, and postnatal development. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with CYRAMZA and for at least 3 months after the last dose of CYRAMZA.

Most Common Adverse Reactions—Single Agent• The most commonly reported adverse reactions (all grades; grade 3/4)

occurring in ≥5% of patients receiving CYRAMZA and ≥2% higher than placebo in study 1 were hypertension (16% vs 8%; 8% vs 3%), diarrhea (14% vs 9%; 1% vs 2%), headache (9% vs 3%; 0% vs 0%), and hyponatremia (6% vs 2%; 3% vs 1%).

• The most common serious adverse events with CYRAMZA in study 1 were anemia (3.8%) and intestinal obstruction (2.1%). Red blood cell transfusions were given to 11% of CYRAMZA-treated patients vs 8.7% of patients who received placebo.

• Clinically relevant adverse reactions reported in ≥1% and <5% of CYRAMZA-treated patients in study 1 were: neutropenia (4.7% vs 0.9%), epistaxis (4.7% vs 0.9%), rash (4.2% vs 1.7%), intestinal obstruction (2.1% vs 0%), and arterial thromboembolic events (1.7% vs 0%).

• Across clinical trials of CYRAMZA administered as a single agent, clinically relevant adverse reactions (including grade ≥3) reported in CYRAMZA-treated patients included proteinuria, gastrointestinal perforation, and infusion-related reactions. In study 1, according to laboratory assessment, 8% of CYRAMZA-treated patients developed proteinuria vs 3% of placebo-treated patients. Two patients discontinued CYRAMZA due to proteinuria. The rate of gastrointestinal perforation in study 1 was 0.8% and the rate of infusion-related reactions was 0.4%.

Most Common Adverse Reactions—Combination With Paclitaxel• The most commonly reported adverse reactions (all grades; grade 3/4)

occurring in ≥5% of patients receiving CYRAMZA plus paclitaxel and ≥2% higher than placebo plus paclitaxel in study 2 were fatigue/asthenia (57% vs 44%; 12% vs 6%), neutropenia (54% vs 31%; 41% vs 19%), diarrhea (32% vs 23%; 4% vs 2%), epistaxis (31% vs 7%; 0% vs 0%), hypertension (25% vs 6%; 15% vs 3%), peripheral edema (25% vs 14%; 2% vs 1%), stomatitis (20% vs 7%; 1% vs 1%), proteinuria (17% vs 6%; 1% vs 0%), thrombocytopenia (13% vs 6%; 2% vs 2%), hypoalbuminemia (11% vs 5%; 1% vs 1%), and gastrointestinal hemorrhage events (10% vs 6%; 4% vs 2%).

• The most common serious adverse events with CYRAMZA plus paclitaxel in study 2 were neutropenia (3.7%) and febrile neutropenia (2.4%); 19% of patients treated with CYRAMZA plus paclitaxel received granulocyte colony-stimulating factors.

• Adverse reactions resulting in discontinuation of any component of the CYRAMZA plus paclitaxel combination in 2% or more patients in study 2 were neutropenia (4%) and thrombocytopenia (3%).

• Clinically relevant adverse reactions reported in ≥1% and <5% of the CYRAMZA plus paclitaxel-treated patients in study 2 were sepsis (3.1% for CYRAMZA plus paclitaxel vs 1.8% for placebo plus paclitaxel) and gastrointestinal perforations (1.2% for CYRAMZA plus paclitaxel vs 0.3% for placebo plus paclitaxel).

Drug Interactions• No pharmacokinetic interactions were observed between ramucirumab

(CYRAMZA) and paclitaxel.Use in Specific Populations• Pregnancy: Based on its mechanism of action, CYRAMZA can cause fetal

harm. Animal models link angiogenesis, VEGF, and VEGF Receptor 2 (VEGFR2) to critical aspects of female reproduction, embryofetal development, and postnatal development. There are no available data on CYRAMZA use in pregnant women to inform any drug-associated risks. No animal studies have been conducted to evaluate the effect of ramucirumab on reproduction and fetal development. Advise females of reproductive potential of the potential risk for maintaining pregnancy, risk to the fetus, and risk to newborn and infant development, and to use effective contraception during CYRAMZA therapy and for at least 3 months following the last dose of CYRAMZA.

• Lactation: Because of the potential risk for serious adverse reactions in nursing infants from ramucirumab, advise women that breastfeeding is not recommended during treatment with CYRAMZA.

• Females of Reproductive Potential: Advise females of reproductive potential that based on animal data CYRAMZA may impair fertility.

Please see Brief Summary of Prescribing Information for CYRAMZA, including Boxed Warnings for hemorrhage, gastrointestinal perforation, and impaired wound healing, on next page.

RB-G HCP ISI 17SEP2015

References: 1. CYRAMZA (ramucirumab) [package insert]. Indianapolis, IN: Eli Lilly and Company; 2015. 2. Wilke H, Muro K, Van Cutsem E, et al; for the RAINBOW Study Group. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014;15(11):1224-1235. 3. Data on file, Eli Lilly and Company. ONC09302014b.

PP-RB-US-0358 11/2015 PRINTED IN USA © Lilly USA, LLC 2015. All rights reserved.

CYRAMZA is a trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.

CYRAMZA® (ramucirumab) PLUS PACLITAXEL SIGNIFICANTLY EXTENDED OVERALL SURVIVAL (OS)1

• Median PFS with CYRAMZA plus paclitaxel was 4.4 months (95% CI: 4.2, 5.3) vs 2.9 months (95% CI: 2.8, 3.0) with placebo plus paclitaxel (hazard ratio 0.64 [95% CI: 0.54, 0.75]; P<0.001)1

– The percentage of events at the time of analysis was 85% (279 patients) and 88% (296 patients), respectively

• Significantly more patients responded to CYRAMZA combined with paclitaxel (28%; 95% CI: 23, 33) than to placebo plus paclitaxel (16%; 95% CI: 13, 20) (P<0.001)†1,2

CYRAMZA PLUS PACLITAXEL ALSO SIGNIFICANTLY DELAYED DISEASE PROGRESSION AND PROVIDED SIGNIFICANTLY GREATER ORR VS PLACEBO PLUS PACLITAXEL (SUPPORTIVE EFFICACY OUTCOME MEASURES)*1

The phase III RAINBOW trial evaluated the efficacy and safety of CYRAMZA plus paclitaxel vs placebo plus paclitaxel in patients with locally advanced or metastatic gastric or GE junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- and platinum-containing chemotherapy. Major efficacy outcome measure was OS. Supportive efficacy outcome measures were progression-free survival (PFS) and objective response rate (ORR). All patients were Eastern Cooperative Oncology Group performance status 0 or 1. Prior to enrollment, 97% of patients had progressed during treatment or within 4 months after the last dose of first-line chemotherapy for metastatic disease. Twenty-five percent of patients had received anthracycline in combination with platinum/fluoropyrimidine therapy, while 75% did not. Patients were randomized 1:1 to CYRAMZA 8 mg/kg (n=330) or placebo (n=335) every 2 weeks (on days 1 and 15) of each 28-day cycle. Patients in both arms received paclitaxel 80 mg/m2 on days 1, 8, and 15 of each 28-day cycle.1,3

• The percentage of deaths at the time of analysis was 78% (256 patients) and 78% (260 patients) in the CYRAMZA plus paclitaxel and placebo plus paclitaxel treatment arms, respectively1

CI=confidence interval. *Intent-to-treat (ITT) population.† ITT population. ORR was defined as complete plus partial response. Disease progression and tumor response were assessed by investigators in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.2

OS

PR

OB

AB

ILIT

Y

30% INCREASEIN MEDIAN OS

1.0

0.8

0.6

0.4

0.2

0.0

TIME FROM RANDOMIZATION (MONTHS)

330

335

308

294

267

241

228

180

185

143

148

109

116

81

78

64

60

47

41

30

24

22

13

13

6

5

1

2

0

0 2 4 6 8 10 12 14 16 18 20 22 24 26 28

0

Number at Risk

CYRAMZA + paclitaxelPlacebo+ paclitaxel

Hazard Ratio=0.81(0.68, 0.96); P=0.017

CYRAMZA+ paclitaxelPlacebo+ paclitaxel

9.6MONTHS

CYRAMZA+ paclitaxel

(8.5, 10.8)

7.4MONTHS

Placebo+ paclitaxel(6.3, 8.4)

RAINBOW OS: MEDIAN - MONTHS (95% CI)*1 MAJOR OUTCOME MEASURE

CYRAMZA as a single agent, or in combination with paclitaxel, is indicated for the treatment of patients with advanced or metastatic gastric or gastroesophageal (GE) junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.

This information is presented for informational purposes only and is not intended to provide reimbursement or legal advice. Providers are encouraged to contact third-party payers for specific information on their coverage, coding, and payment policies. Please consult with your legal counsel or reimbursement specialist for any reimbursement or billing questions. For more information please call the Lilly PatientOne Program at 1-866-472-8663.

NEW PERMANENT J-CODE FOR CYRAMZA: J9308, injection, ramucirumab, 5 mgEffective January 1, 2016

CLIENT: Lilly FINISH SIZE: 17” wide x 11” high

JOB#: 30455-4 “A size” ARTIST: DL

LOCATION: Mechanicals COLLECT DATE:

R|O|U|T|I|N|G| |S|T|A|G|E M10ED CW AD CPM ACD AE inserv

B:11.5 in

B:17.375 in

LT:11 inST:10.75 in

LT:17 inST:15.5 in

S:9.625 in

S:14 in

Spring 2016 13

VISIT WWW.CYRAMZAHCP.COM FOR MORE INFORMATION, INCLUDING CYRAMZA MONOTHERAPY TRIAL DATAWARNING: HEMORRHAGE, GASTROINTESTINAL PERFORATION, AND IMPAIRED WOUND HEALINGHemorrhage: CYRAMZA increased the risk of hemorrhage and gastrointestinal hemorrhage, including severe and sometimes fatal hemorrhagic events. Permanently discontinue CYRAMZA in patients who experience severe bleeding.Gastrointestinal Perforation: CYRAMZA can increase the risk of gastrointestinal perforation, a potentially fatal event. Permanently discontinue CYRAMZA in patients who experience a gastrointestinal perforation.Impaired Wound Healing: Impaired wound healing can occur with antibodies inhibiting the VEGF pathway. Discontinue CYRAMZA therapy in patients with impaired wound healing. Withhold CYRAMZA prior to surgery and discontinue CYRAMZA if a patient develops wound healing complications.

IMPORTANT SAFETY INFORMATION FOR CYRAMZA

Warnings and PrecautionsHemorrhage • CYRAMZA increased the risk of hemorrhage and gastrointestinal

hemorrhage, including severe and sometimes fatal hemorrhagic events. In study 1, which evaluated CYRAMZA as a single agent in advanced gastric cancer, the incidence of severe bleeding was 3.4% for CYRAMZA and 2.6% for placebo. In study 2, which evaluated CYRAMZA plus paclitaxel, the incidence of severe bleeding was 4.3% for CYRAMZA plus paclitaxel and 2.4% for placebo plus paclitaxel. Patients with gastric cancer receiving nonsteroid anti-inflammatory drugs (NSAIDs) were excluded from enrollment in studies 1 and 2; therefore, the risk of gastric hemorrhage in CYRAMZA-treated patients with gastric tumors receiving NSAIDs is unknown. Permanently discontinue CYRAMZA in patients who experience severe bleeding.

Arterial Thromboembolic Events (ATEs)• Serious, sometimes fatal, ATEs including myocardial infarction, cardiac

arrest, cerebrovascular accident, and cerebral ischemia occurred in clinical trials including 1.7% of 236 patients who received CYRAMZA as a single agent for gastric cancer in study 1. Permanently discontinue CYRAMZA in patients who experience a severe ATE.

Hypertension• An increased incidence of severe hypertension occurred in patients

receiving CYRAMZA as a single agent (8%) as compared to placebo (3%) and in patients receiving CYRAMZA plus paclitaxel (15%) as compared to placebo plus paclitaxel (3%). Control hypertension prior to initiating treatment with CYRAMZA. Monitor blood pressure every 2 weeks or more frequently as indicated during treatment. Temporarily suspend CYRAMZA for severe hypertension until medically controlled. Permanently discontinue CYRAMZA if medically significant hypertension cannot be controlled with antihypertensive therapy or in patients with hypertensive crisis or hypertensive encephalopathy.

Infusion-Related Reactions (IRRs)• Prior to the institution of premedication recommendations across clinical

trials of CYRAMZA, IRRs occurred in 6 out of 37 patients (16%), including 2 severe events. The majority of IRRs across trials occurred during or following a first or second CYRAMZA infusion. Symptoms of IRRs included rigors/tremors, back pain/spasms, chest pain and/or tightness, chills, flushing, dyspnea, wheezing, hypoxia, and paresthesia. In severe cases, symptoms included bronchospasm, supraventricular tachycardia, and hypotension. Monitor patients during the infusion for signs and symptoms

of IRRs in a setting with available resuscitation equipment. Immediately and permanently discontinue CYRAMZA for grade 3 or 4 IRRs.

Gastrointestinal Perforations• CYRAMZA is an antiangiogenic therapy that can increase the risk of

gastrointestinal perforation, a potentially fatal event. Four of 570 patients (0.7%) who received CYRAMZA as a single agent in clinical trials experienced gastrointestinal perforation. In study 2, the incidence of gastrointestinal perforations was also increased in patients who received CYRAMZA plus paclitaxel (1.2%) as compared to patients who received placebo plus paclitaxel (0.3%). Permanently discontinue CYRAMZA in patients who experience a gastrointestinal perforation.

Impaired Wound Healing• Impaired wound healing can occur with antibodies inhibiting the VEGF

pathway. CYRAMZA has not been studied in patients with serious or nonhealing wounds. CYRAMZA, an antiangiogenic therapy, has the potential to adversely affect wound healing. Discontinue CYRAMZA therapy in patients with impaired wound healing. Withhold CYRAMZA prior to surgery. Resume CYRAMZA following the surgical intervention based on clinical judgment of adequate wound healing. If a patient develops wound healing complications during therapy, discontinue CYRAMZA until the wound is fully healed.

Clinical Deterioration in Child-Pugh B or C Cirrhosis• Clinical deterioration, manifested by new onset or worsening

encephalopathy, ascites, or hepatorenal syndrome, was reported in patients with Child-Pugh B or C cirrhosis who received single-agent CYRAMZA. Use CYRAMZA in patients with Child-Pugh B or C cirrhosis only if the potential benefits of treatment are judged to outweigh the risks of clinical deterioration.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS)• RPLS has been reported at a rate of <0.1% in clinical studies with CYRAMZA.

Confirm the diagnosis of RPLS with MRI and discontinue CYRAMZA in patients who develop RPLS. Symptoms may resolve or improve within days, although some patients with RPLS can experience ongoing neurologic sequelae or death.

Proteinuria Including Nephrotic Syndrome• Monitor proteinuria by urine dipstick and/or urinary protein creatinine ratio

for the development of worsening of proteinuria during CYRAMZA therapy. Withhold CYRAMZA for urine protein levels that are ≥2 g over 24 hours. Reinitiate CYRAMZA at a reduced dose once the urine protein level returns to <2 g over 24 hours. Permanently discontinue CYRAMZA for urine protein levels >3 g over 24 hours or in the setting of nephrotic syndrome.

Thyroid Dysfunction• Monitor thyroid function during treatment with CYRAMZA. Embryofetal Toxicity• Based on its mechanism of action, CYRAMZA can cause fetal harm when

administered to pregnant women. Animal models link angiogenesis, VEGF, and VEGF Receptor 2 (VEGFR2) to critical aspects of female reproduction, embryofetal development, and postnatal development. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with CYRAMZA and for at least 3 months after the last dose of CYRAMZA.

Most Common Adverse Reactions—Single Agent• The most commonly reported adverse reactions (all grades; grade 3/4)

occurring in ≥5% of patients receiving CYRAMZA and ≥2% higher than placebo in study 1 were hypertension (16% vs 8%; 8% vs 3%), diarrhea (14% vs 9%; 1% vs 2%), headache (9% vs 3%; 0% vs 0%), and hyponatremia (6% vs 2%; 3% vs 1%).

• The most common serious adverse events with CYRAMZA in study 1 were anemia (3.8%) and intestinal obstruction (2.1%). Red blood cell transfusions were given to 11% of CYRAMZA-treated patients vs 8.7% of patients who received placebo.

• Clinically relevant adverse reactions reported in ≥1% and <5% of CYRAMZA-treated patients in study 1 were: neutropenia (4.7% vs 0.9%), epistaxis (4.7% vs 0.9%), rash (4.2% vs 1.7%), intestinal obstruction (2.1% vs 0%), and arterial thromboembolic events (1.7% vs 0%).

• Across clinical trials of CYRAMZA administered as a single agent, clinically relevant adverse reactions (including grade ≥3) reported in CYRAMZA-treated patients included proteinuria, gastrointestinal perforation, and infusion-related reactions. In study 1, according to laboratory assessment, 8% of CYRAMZA-treated patients developed proteinuria vs 3% of placebo-treated patients. Two patients discontinued CYRAMZA due to proteinuria. The rate of gastrointestinal perforation in study 1 was 0.8% and the rate of infusion-related reactions was 0.4%.

Most Common Adverse Reactions—Combination With Paclitaxel• The most commonly reported adverse reactions (all grades; grade 3/4)

occurring in ≥5% of patients receiving CYRAMZA plus paclitaxel and ≥2% higher than placebo plus paclitaxel in study 2 were fatigue/asthenia (57% vs 44%; 12% vs 6%), neutropenia (54% vs 31%; 41% vs 19%), diarrhea (32% vs 23%; 4% vs 2%), epistaxis (31% vs 7%; 0% vs 0%), hypertension (25% vs 6%; 15% vs 3%), peripheral edema (25% vs 14%; 2% vs 1%), stomatitis (20% vs 7%; 1% vs 1%), proteinuria (17% vs 6%; 1% vs 0%), thrombocytopenia (13% vs 6%; 2% vs 2%), hypoalbuminemia (11% vs 5%; 1% vs 1%), and gastrointestinal hemorrhage events (10% vs 6%; 4% vs 2%).

• The most common serious adverse events with CYRAMZA plus paclitaxel in study 2 were neutropenia (3.7%) and febrile neutropenia (2.4%); 19% of patients treated with CYRAMZA plus paclitaxel received granulocyte colony-stimulating factors.

• Adverse reactions resulting in discontinuation of any component of the CYRAMZA plus paclitaxel combination in 2% or more patients in study 2 were neutropenia (4%) and thrombocytopenia (3%).

• Clinically relevant adverse reactions reported in ≥1% and <5% of the CYRAMZA plus paclitaxel-treated patients in study 2 were sepsis (3.1% for CYRAMZA plus paclitaxel vs 1.8% for placebo plus paclitaxel) and gastrointestinal perforations (1.2% for CYRAMZA plus paclitaxel vs 0.3% for placebo plus paclitaxel).

Drug Interactions• No pharmacokinetic interactions were observed between ramucirumab

(CYRAMZA) and paclitaxel.Use in Specific Populations• Pregnancy: Based on its mechanism of action, CYRAMZA can cause fetal

harm. Animal models link angiogenesis, VEGF, and VEGF Receptor 2 (VEGFR2) to critical aspects of female reproduction, embryofetal development, and postnatal development. There are no available data on CYRAMZA use in pregnant women to inform any drug-associated risks. No animal studies have been conducted to evaluate the effect of ramucirumab on reproduction and fetal development. Advise females of reproductive potential of the potential risk for maintaining pregnancy, risk to the fetus, and risk to newborn and infant development, and to use effective contraception during CYRAMZA therapy and for at least 3 months following the last dose of CYRAMZA.

• Lactation: Because of the potential risk for serious adverse reactions in nursing infants from ramucirumab, advise women that breastfeeding is not recommended during treatment with CYRAMZA.

• Females of Reproductive Potential: Advise females of reproductive potential that based on animal data CYRAMZA may impair fertility.

Please see Brief Summary of Prescribing Information for CYRAMZA, including Boxed Warnings for hemorrhage, gastrointestinal perforation, and impaired wound healing, on next page.

RB-G HCP ISI 17SEP2015

References: 1. CYRAMZA (ramucirumab) [package insert]. Indianapolis, IN: Eli Lilly and Company; 2015. 2. Wilke H, Muro K, Van Cutsem E, et al; for the RAINBOW Study Group. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014;15(11):1224-1235. 3. Data on file, Eli Lilly and Company. ONC09302014b.

PP-RB-US-0358 11/2015 PRINTED IN USA © Lilly USA, LLC 2015. All rights reserved.

CYRAMZA is a trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.

CYRAMZA® (ramucirumab) PLUS PACLITAXEL SIGNIFICANTLY EXTENDED OVERALL SURVIVAL (OS)1

• Median PFS with CYRAMZA plus paclitaxel was 4.4 months (95% CI: 4.2, 5.3) vs 2.9 months (95% CI: 2.8, 3.0) with placebo plus paclitaxel (hazard ratio 0.64 [95% CI: 0.54, 0.75]; P<0.001)1

– The percentage of events at the time of analysis was 85% (279 patients) and 88% (296 patients), respectively

• Significantly more patients responded to CYRAMZA combined with paclitaxel (28%; 95% CI: 23, 33) than to placebo plus paclitaxel (16%; 95% CI: 13, 20) (P<0.001)†1,2

CYRAMZA PLUS PACLITAXEL ALSO SIGNIFICANTLY DELAYED DISEASE PROGRESSION AND PROVIDED SIGNIFICANTLY GREATER ORR VS PLACEBO PLUS PACLITAXEL (SUPPORTIVE EFFICACY OUTCOME MEASURES)*1

The phase III RAINBOW trial evaluated the efficacy and safety of CYRAMZA plus paclitaxel vs placebo plus paclitaxel in patients with locally advanced or metastatic gastric or GE junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- and platinum-containing chemotherapy. Major efficacy outcome measure was OS. Supportive efficacy outcome measures were progression-free survival (PFS) and objective response rate (ORR). All patients were Eastern Cooperative Oncology Group performance status 0 or 1. Prior to enrollment, 97% of patients had progressed during treatment or within 4 months after the last dose of first-line chemotherapy for metastatic disease. Twenty-five percent of patients had received anthracycline in combination with platinum/fluoropyrimidine therapy, while 75% did not. Patients were randomized 1:1 to CYRAMZA 8 mg/kg (n=330) or placebo (n=335) every 2 weeks (on days 1 and 15) of each 28-day cycle. Patients in both arms received paclitaxel 80 mg/m2 on days 1, 8, and 15 of each 28-day cycle.1,3

• The percentage of deaths at the time of analysis was 78% (256 patients) and 78% (260 patients) in the CYRAMZA plus paclitaxel and placebo plus paclitaxel treatment arms, respectively1

CI=confidence interval. *Intent-to-treat (ITT) population.† ITT population. ORR was defined as complete plus partial response. Disease progression and tumor response were assessed by investigators in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.2

OS

PR

OB

AB

ILIT

Y

30% INCREASEIN MEDIAN OS

1.0

0.8

0.6

0.4

0.2

0.0

TIME FROM RANDOMIZATION (MONTHS)

330

335

308

294

267

241

228

180

185

143

148

109

116

81

78

64

60

47

41

30

24

22

13

13

6

5

1

2

0

0 2 4 6 8 10 12 14 16 18 20 22 24 26 28

0

Number at Risk

CYRAMZA + paclitaxelPlacebo+ paclitaxel

Hazard Ratio=0.81(0.68, 0.96); P=0.017

CYRAMZA+ paclitaxelPlacebo+ paclitaxel

9.6MONTHS

CYRAMZA+ paclitaxel

(8.5, 10.8)

7.4MONTHS

Placebo+ paclitaxel(6.3, 8.4)

RAINBOW OS: MEDIAN - MONTHS (95% CI)*1 MAJOR OUTCOME MEASURE

CYRAMZA as a single agent, or in combination with paclitaxel, is indicated for the treatment of patients with advanced or metastatic gastric or gastroesophageal (GE) junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.

This information is presented for informational purposes only and is not intended to provide reimbursement or legal advice. Providers are encouraged to contact third-party payers for specific information on their coverage, coding, and payment policies. Please consult with your legal counsel or reimbursement specialist for any reimbursement or billing questions. For more information please call the Lilly PatientOne Program at 1-866-472-8663.

NEW PERMANENT J-CODE FOR CYRAMZA: J9308, injection, ramucirumab, 5 mgEffective January 1, 2016

CLIENT: Lilly FINISH SIZE: 17” wide x 11” high

JOB#: 30455-4 “A size” ARTIST: DL

LOCATION: Mechanicals COLLECT DATE:

R|O|U|T|I|N|G| |S|T|A|G|E M10ED CW AD CPM ACD AE inserv

B:11.5 inB:17.375 in

LT:11 inST:10.75 in

LT:17 inST:15.5 in

S:9.625 inS:14 in

14 FCS The Magazine

CYRAMZA® (ramucirumab) injection RB-G HCP BS 29APR2015 CYRAMZA® (ramucirumab) injection RB-G HCP BS 29APR2015

CYRAMZA RB-G HCP BS 29APR2015 - 7 x 10 PRINTER VERSION 1 OF 3

CYRAMZA® (ramucirumab) injectionBRIEF SUMMARY: For complete safety, please consult the full Prescribing Information.

WARNING: HEMORRHAGE, GASTROINTESTINAL PERFORATION, AND IMPAIRED WOUND HEALING

Hemorrhage: CYRAMZA increased the risk of hemorrhage and gastrointestinal hemorrhage, including severe and sometimes fatal hemorrhagic events. Permanently discontinue CYRAMZA in patients who experience severe bleeding.

Gastrointestinal Perforation: CYRAMZA can increase the risk of gastrointestinal perforation, a potentially fatal event. Permanently discontinue CYRAMZA in patients who experience a gastrointestinal perforation.

Impaired Wound Healing: Impaired wound healing can occur with antibodies inhibiting the VEGF pathway. Discontinue CYRAMZA therapy in patients with impaired wound healing. Withhold CYRAMZA prior to surgery and discontinue CYRAMZA if a patient develops wound healing complications.

INDICATIONS AND USAGEGastric CancerCYRAMZA as a single agent, or in combination with paclitaxel, is indicated for the treatment of patients with advanced or metastatic, gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.

CONTRAINDICATIONSNone.

WARNINGS AND PRECAUTIONSHemorrhageCYRAMZA increased the risk of hemorrhage and gastrointestinal hemorrhage, including severe and sometimes fatal hemorrhagic events. In Study 1, the incidence of severe bleeding was 3.4% for CYRAMZA and 2.6% for placebo. In Study 2, the incidence of severe bleeding was 4.3% for CYRAMZA plus paclitaxel and 2.4% for placebo plus paclitaxel. Patients with gastric cancer receiving nonsteroid anti-inflammatory drugs (NSAIDs) were excluded from enrollment in Studies 1 and 2; therefore, the risk of gastric hemorrhage in CYRAMZA-treated patients with gastric tumors receiving NSAIDs is unknown. In Study 3, the incidence of severe bleeding was 2.4% for CYRAMZA plus docetaxel and 2.3% for placebo plus docetaxel. Patients with NSCLC receiving therapeutic anticoagulation or chronic therapy with NSAIDS or other antiplatelet therapy other than once daily aspirin or with radiographic evidence of major airway or blood vessel invasion or intratumor cavitation were excluded from Study 3; therefore the risk of pulmonary hemorrhage in these groups of patients is unknown. In Study 4, the incidence of severe bleeding was 2.5% for CYRAMZA plus FOLFIRI and 1.7% for placebo plus FOLFIRI. Permanently discontinue CYRAMZA in patients who experience severe bleeding.Arterial Thromboembolic EventsSerious, sometimes fatal, arterial thromboembolic events (ATEs) including myocardial infarction, cardiac arrest, cerebrovascular accident, and cerebral ischemia occurred in clinical trials including 1.7% of 236 patients who received CYRAMZA as a single agent for gastric cancer in Study 1. Permanently discontinue CYRAMZA in patients who experience a severe ATE.HypertensionAn increased incidence of severe hypertension occurred in patients receiving CYRAMZA as a single agent (8%) as compared to placebo (3%) and in patients receiving CYRAMZA plus paclitaxel (15%) as compared to placebo plus paclitaxel (3%), in patients receiving CYRAMZA plus docetaxel (6%) as compared to placebo plus docetaxel (2%), and in patients receiving CYRAMZA plus FOLFIRI (11%) as compared to placebo plus FOLFIRI (3%). Control hypertension prior to initiating treatment with CYRAMZA. Monitor blood pressure every two weeks or more frequently as indicated during treatment. Temporarily suspend CYRAMZA for severe hypertension until medically controlled. Permanently discontinue CYRAMZA if medically significant hypertension cannot be controlled with antihypertensive therapy or in patients with hypertensive crisis or hypertensive encephalopathy.Infusion-Related ReactionsPrior to the institution of premedication recommendations across clinical trials of CYRAMZA, infusion-related reactions (IRRs) occurred in 6 out of 37 patients (16%), including two severe events. The majority of IRRs across trials occurred during or following a first or second CYRAMZA infusion. Symptoms of IRRs included rigors/tremors, back pain/spasms, chest pain and/or tightness, chills, flushing, dyspnea, wheezing, hypoxia, and paresthesia. In severe cases, symptoms included bronchospasm, supraventricular tachycardia, and hypotension. Monitor patients during the infusion for signs and symptoms of IRRs in a setting with available resuscitation equipment. Immediately and permanently discontinue CYRAMZA for Grade 3 or 4 IRRs.

Gastrointestinal PerforationsCYRAMZA is an antiangiogenic therapy that can increase the risk of gastrointestinal perforation, a potentially fatal event. Four of 570 patients (0.7%) who received CYRAMZA as a single agent in clinical trials experienced gastrointestinal perforation. In Study 2, the incidence of gastrointestinal perforations was also increased in patients that received CYRAMZA plus paclitaxel (1.2%) as compared to patients receiving placebo plus paclitaxel (0.3%). In Study 3, the incidence of gastrointestinal perforation was 1% for CYRAMZA plus docetaxel and 0.3% for placebo plus docetaxel. In Study 4, the incidence of gastrointestinal perforation was 1.7% for CYRAMZA plus FOLFIRI and 0.6% for placebo plus FOLFIRI. Permanently discontinue CYRAMZA in patients who experience a gastrointestinal perforation.Impaired Wound HealingImpaired wound healing can occur with antibodies inhibiting the VEGF pathway. CYRAMZA has not been studied in patients with serious or non-healing wounds. CYRAMZA, an antiangiogenic therapy, has the potential to adversely affect wound healing. Withhold CYRAMZA prior to surgery. Resume following the surgical intervention based on clinical judgment of adequate wound healing. If a patient develops wound healing complications during therapy, discontinue CYRAMZA until the wound is fully healed.Clinical Deterioration in Patients with Child-Pugh B or C CirrhosisClinical deterioration, manifested by new onset or worsening encephalopathy, ascites, or hepatorenal syndrome was reported in patients with Child-Pugh B or C cirrhosis who received single-agent CYRAMZA. Use CYRAMZA in patients with Child-Pugh B or C cirrhosis only if the potential benefits of treatment are judged to outweigh the risks of clinical deterioration.Reversible Posterior Leukoencephalopathy Syndrome Reversible Posterior Leukoencephalopathy Syndrome (RPLS) has been reported with a rate of <0.1% in clinical studies with CYRAMZA. Confirm the diagnosis of RPLS with MRI and discontinue CYRAMZA in patients who develop RPLS. Symptoms may resolve or improve within days, although some patients with RPLS can experience ongoing neurologic sequelae or death.Proteinuria Including Nephrotic Syndrome In Study 4, severe proteinuria occurred more frequently in patients treated with CYRAMZA plus FOLFIRI compared to patients receiving placebo plus FOLFIRI. Severe proteinuria was reported in 3% of patients treated with CYRAMZA plus FOLFIRI (including 3 cases [0.6%] of nephrotic syndrome) compared to 0.2% of patients treated with placebo plus FOLFIRI. Monitor proteinuria by urine dipstick and/or urinary protein creatinine ratio for the development of worsening of proteinuria during CYRAMZA therapy. Withhold CYRAMZA for urine protein levels that are 2 or more grams over 24 hours. Reinitiate CYRAMZA at a reduced dose once the urine protein level returns to less than 2 grams over 24 hours. Permanently discontinue CYRAMZA for urine protein levels greater than 3 grams over 24 hours or in the setting of nephrotic syndrome.Thyroid Dysfunction Monitor thyroid function during treatment with CYRAMZA. In Study 4, the incidence of hypothyroidism reported as an adverse event was 2.6% in the CYRAMZA plus FOLFIRI treated patients and 0.9% in the placebo plus FOLFIRI treated patients.Embryofetal Toxicity Based on its mechanism of action, CYRAMZA can cause fetal harm when administered to pregnant women. Animal models link angiogenesis, VEGF and VEGF Receptor 2 (VEGFR2) to critical aspects of female reproduction, embryofetal development, and postnatal development. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with CYRAMZA and for at 3 least months after the last dose of CYRAMZA.

ADVERSE REACTIONSClinical Trials ExperienceBecause 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.Safety data are presented from two randomized, placebo controlled clinical trials in which patients received CYRAMZA: Study 1, a randomized (2:1), double-blind, clinical trial in which 351 patients received either CYRAMZA 8 mg/kg intravenously every two weeks or placebo every two weeks and Study 2, a double-blind, randomized (1:1) clinical trial in which 656 patients received paclitaxel 80 mg/m2 on days 1, 8, and 15 of each 28-day cycle plus either CYRAMZA 8 mg/kg intravenously every two weeks or placebo every two weeks. Both trials excluded patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2 or greater, uncontrolled hypertension, major surgery within 28 days, or patients receiving chronic anti-platelet therapy other than once daily aspirin. Study 1 excluded patients with bilirubin ≥1.5 mg/dL and Study 2 excluded patients with bilirubin >1.5 times the upper limit of normal.CYRAMZA Administered as a Single Agent Among 236 patients who received CYRAMZA (safety population) in Study 1, median age was 60 years, 28% were women, 76% were White, and 16% were Asian. Patients in Study 1 received a median of 4 doses of CYRAMZA; the median duration of exposure was 8 weeks, and 32 (14% of 236) patients received CYRAMZA for at least six months.

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In Study 1, the most common adverse reactions (all grades) observed in CYRAMZA-treated patients at a rate of ≥10% and ≥2% higher than placebo were hypertension and diarrhea. The most common serious adverse events with CYRAMZA were

anemia (3.8%) and intestinal obstruction (2.1%). Red blood cell transfusions were given to 11% of CYRAMZA-treated patients versus 8.7% of patients who received placebo.

Table 1: Adverse Reactions Occurring at Incidence Rate ≥5% and a ≥2% Difference Between Arms in Patients Receiving CYRAMZA in Study 1

Adverse Reactions (MedDRA)a

System Organ Class

CYRAMZA (8 mg/kg)N=236

PlaceboN=115

All Grades(Frequency %)

Grade 3-4(Frequency %)

All Grades(Frequency %)

Grade 3-4(Frequency %)

Gastrointestinal Disorders Diarrhea 14 1 9 2

Metabolism and Nutrition Disorders Hyponatremia 6 3 2 1

Nervous System Disorders Headache 9 0 3 0

Vascular Disorders Hypertension 16 8 8 3

aMedDRA Version 15.0.

Clinically relevant adverse reactions reported in ≥1% and <5% of CYRAMZA-treated patients in Study 1 were: neutropenia (4.7% CYRAMZA versus 0.9% placebo), epistaxis (4.7% CYRAMZA versus 0.9% placebo), rash (4.2% CYRAMZA versus 1.7% placebo), intestinal obstruction (2.1% CYRAMZA versus 0% placebo), and arterial thromboembolic events (1.7% CYRAMZA versus 0% placebo).Across clinical trials of CYRAMZA administered as a single agent, clinically relevant adverse reactions (including Grade ≥3) reported in CYRAMZA-treated patients included proteinuria, gastrointestinal perforation, and infusion-related reactions. In Study 1, according to laboratory assessment, 8% of CYRAMZA-treated patients developed proteinuria versus 3% of placebo-treated patients. Two patients discontinued CYRAMZA due to proteinuria. The rate of gastrointestinal perforation in Study 1 was 0.8% and the rate of infusion-related reactions was 0.4%.

CYRAMZA Administered in Combination with Paclitaxel Among 327 patients who received CYRAMZA (safety population) in Study 2, median age was 60 years, 31% were women, 63% were White, and 33% were Asian. Patients in Study 2 received a median of 9 doses of CYRAMZA; the median duration of exposure was 18 weeks, and 93 (28% of 327) patients received CYRAMZA for at least six months.In Study 2, the most common adverse reactions (all grades) observed in patients treated with CYRAMZA plus paclitaxel at a rate of ≥30% and ≥2% higher than placebo plus paclitaxel were fatigue, neutropenia, diarrhea, and epistaxis. The most common serious adverse events with CYRAMZA plus paclitaxel were neutropenia (3.7%) and febrile neutropenia (2.4%); 19% of patients treated with CYRAMZA plus paclitaxel received granulocyte colony-stimulating factors. Adverse reactions resulting in discontinuation of any component of the CYRAMZA plus paclitaxel combination in 2% or more patients in Study 2 were neutropenia (4%) and thrombocytopenia (3%).

Table 2: Adverse Reactions Occurring at Incidence Rate ≥5% and a ≥2% Difference Between Arms in PatientsReceiving CYRAMZA plus Paclitaxel in Study 2

Adverse Reactions (MedDRA) System Organ Class

CYRAMZA plus Paclitaxel(N=327)

Placebo plus Paclitaxel(N=329)

All Grades(Frequency %)

Grade ≥3(Frequency %)

All Grades(Frequency %)

Grade ≥3(Frequency %)

Blood and Lymphatic System DisordersNeutropenia 54 41 31 19

Thrombocytopenia 13 2 6 2

Gastrointestinal DisordersDiarrhea 32 4 23 2

Gastrointestinal hemorrhage events 10 4 6 2

Stomatitis 20 1 7 1

General Disorders and Administration Site Disorders

Fatigue/Asthenia 57 12 44 6

Peripheral edema 25 2 14 1

Metabolism and Nutrition Disorders

Hypoalbuminemia 11 1 5 1

Renal and Urinary Disorders

Proteinuria 17 1 6 0

Respiratory, Thoracic, and Mediastinal Disorders

Epistaxis 31 0 7 0

Vascular Disorder

Hypertension 25 15 6 3

Clinically relevant adverse reactions reported in ≥1% and <5% of the CYRAMZA plus paclitaxel treated patients in Study 2 were sepsis (3.1% CYRAMZA plus paclitaxel versus 1.8% placebo plus paclitaxel) and gastrointestinal perforations (1.2% CYRAMZA plus paclitaxel versus 0.3% for placebo plus paclitaxel).ImmunogenicityAs with all therapeutic proteins, there is the potential for immunogenicity. In 23 clinical trials, 86/2890 (3.0%) of CYRAMZA-treated patients tested positive for treatment-emergent anti-ramucirumab antibodies by an enzyme-linked immunosorbent assay (ELISA). Neutralizing antibodies were detected in 14 of

the 86 patients who tested positive for treatment-emergent anti-ramucirumab antibodies.The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to CYRAMZA with the incidences of antibodies to other products may be misleading.

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CYRAMZA® (ramucirumab) injectionBRIEF SUMMARY: For complete safety, please consult the full Prescribing Information.

WARNING: HEMORRHAGE, GASTROINTESTINAL PERFORATION, AND IMPAIRED WOUND HEALING

Hemorrhage: CYRAMZA increased the risk of hemorrhage and gastrointestinal hemorrhage, including severe and sometimes fatal hemorrhagic events. Permanently discontinue CYRAMZA in patients who experience severe bleeding.

Gastrointestinal Perforation: CYRAMZA can increase the risk of gastrointestinal perforation, a potentially fatal event. Permanently discontinue CYRAMZA in patients who experience a gastrointestinal perforation.

Impaired Wound Healing: Impaired wound healing can occur with antibodies inhibiting the VEGF pathway. Discontinue CYRAMZA therapy in patients with impaired wound healing. Withhold CYRAMZA prior to surgery and discontinue CYRAMZA if a patient develops wound healing complications.

INDICATIONS AND USAGEGastric CancerCYRAMZA as a single agent, or in combination with paclitaxel, is indicated for the treatment of patients with advanced or metastatic, gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.

CONTRAINDICATIONSNone.

WARNINGS AND PRECAUTIONSHemorrhageCYRAMZA increased the risk of hemorrhage and gastrointestinal hemorrhage, including severe and sometimes fatal hemorrhagic events. In Study 1, the incidence of severe bleeding was 3.4% for CYRAMZA and 2.6% for placebo. In Study 2, the incidence of severe bleeding was 4.3% for CYRAMZA plus paclitaxel and 2.4% for placebo plus paclitaxel. Patients with gastric cancer receiving nonsteroid anti-inflammatory drugs (NSAIDs) were excluded from enrollment in Studies 1 and 2; therefore, the risk of gastric hemorrhage in CYRAMZA-treated patients with gastric tumors receiving NSAIDs is unknown. In Study 3, the incidence of severe bleeding was 2.4% for CYRAMZA plus docetaxel and 2.3% for placebo plus docetaxel. Patients with NSCLC receiving therapeutic anticoagulation or chronic therapy with NSAIDS or other antiplatelet therapy other than once daily aspirin or with radiographic evidence of major airway or blood vessel invasion or intratumor cavitation were excluded from Study 3; therefore the risk of pulmonary hemorrhage in these groups of patients is unknown. In Study 4, the incidence of severe bleeding was 2.5% for CYRAMZA plus FOLFIRI and 1.7% for placebo plus FOLFIRI. Permanently discontinue CYRAMZA in patients who experience severe bleeding.Arterial Thromboembolic EventsSerious, sometimes fatal, arterial thromboembolic events (ATEs) including myocardial infarction, cardiac arrest, cerebrovascular accident, and cerebral ischemia occurred in clinical trials including 1.7% of 236 patients who received CYRAMZA as a single agent for gastric cancer in Study 1. Permanently discontinue CYRAMZA in patients who experience a severe ATE.HypertensionAn increased incidence of severe hypertension occurred in patients receiving CYRAMZA as a single agent (8%) as compared to placebo (3%) and in patients receiving CYRAMZA plus paclitaxel (15%) as compared to placebo plus paclitaxel (3%), in patients receiving CYRAMZA plus docetaxel (6%) as compared to placebo plus docetaxel (2%), and in patients receiving CYRAMZA plus FOLFIRI (11%) as compared to placebo plus FOLFIRI (3%). Control hypertension prior to initiating treatment with CYRAMZA. Monitor blood pressure every two weeks or more frequently as indicated during treatment. Temporarily suspend CYRAMZA for severe hypertension until medically controlled. Permanently discontinue CYRAMZA if medically significant hypertension cannot be controlled with antihypertensive therapy or in patients with hypertensive crisis or hypertensive encephalopathy.Infusion-Related ReactionsPrior to the institution of premedication recommendations across clinical trials of CYRAMZA, infusion-related reactions (IRRs) occurred in 6 out of 37 patients (16%), including two severe events. The majority of IRRs across trials occurred during or following a first or second CYRAMZA infusion. Symptoms of IRRs included rigors/tremors, back pain/spasms, chest pain and/or tightness, chills, flushing, dyspnea, wheezing, hypoxia, and paresthesia. In severe cases, symptoms included bronchospasm, supraventricular tachycardia, and hypotension. Monitor patients during the infusion for signs and symptoms of IRRs in a setting with available resuscitation equipment. Immediately and permanently discontinue CYRAMZA for Grade 3 or 4 IRRs.

Gastrointestinal PerforationsCYRAMZA is an antiangiogenic therapy that can increase the risk of gastrointestinal perforation, a potentially fatal event. Four of 570 patients (0.7%) who received CYRAMZA as a single agent in clinical trials experienced gastrointestinal perforation. In Study 2, the incidence of gastrointestinal perforations was also increased in patients that received CYRAMZA plus paclitaxel (1.2%) as compared to patients receiving placebo plus paclitaxel (0.3%). In Study 3, the incidence of gastrointestinal perforation was 1% for CYRAMZA plus docetaxel and 0.3% for placebo plus docetaxel. In Study 4, the incidence of gastrointestinal perforation was 1.7% for CYRAMZA plus FOLFIRI and 0.6% for placebo plus FOLFIRI. Permanently discontinue CYRAMZA in patients who experience a gastrointestinal perforation.Impaired Wound HealingImpaired wound healing can occur with antibodies inhibiting the VEGF pathway. CYRAMZA has not been studied in patients with serious or non-healing wounds. CYRAMZA, an antiangiogenic therapy, has the potential to adversely affect wound healing. Withhold CYRAMZA prior to surgery. Resume following the surgical intervention based on clinical judgment of adequate wound healing. If a patient develops wound healing complications during therapy, discontinue CYRAMZA until the wound is fully healed.Clinical Deterioration in Patients with Child-Pugh B or C CirrhosisClinical deterioration, manifested by new onset or worsening encephalopathy, ascites, or hepatorenal syndrome was reported in patients with Child-Pugh B or C cirrhosis who received single-agent CYRAMZA. Use CYRAMZA in patients with Child-Pugh B or C cirrhosis only if the potential benefits of treatment are judged to outweigh the risks of clinical deterioration.Reversible Posterior Leukoencephalopathy Syndrome Reversible Posterior Leukoencephalopathy Syndrome (RPLS) has been reported with a rate of <0.1% in clinical studies with CYRAMZA. Confirm the diagnosis of RPLS with MRI and discontinue CYRAMZA in patients who develop RPLS. Symptoms may resolve or improve within days, although some patients with RPLS can experience ongoing neurologic sequelae or death.Proteinuria Including Nephrotic Syndrome In Study 4, severe proteinuria occurred more frequently in patients treated with CYRAMZA plus FOLFIRI compared to patients receiving placebo plus FOLFIRI. Severe proteinuria was reported in 3% of patients treated with CYRAMZA plus FOLFIRI (including 3 cases [0.6%] of nephrotic syndrome) compared to 0.2% of patients treated with placebo plus FOLFIRI. Monitor proteinuria by urine dipstick and/or urinary protein creatinine ratio for the development of worsening of proteinuria during CYRAMZA therapy. Withhold CYRAMZA for urine protein levels that are 2 or more grams over 24 hours. Reinitiate CYRAMZA at a reduced dose once the urine protein level returns to less than 2 grams over 24 hours. Permanently discontinue CYRAMZA for urine protein levels greater than 3 grams over 24 hours or in the setting of nephrotic syndrome.Thyroid Dysfunction Monitor thyroid function during treatment with CYRAMZA. In Study 4, the incidence of hypothyroidism reported as an adverse event was 2.6% in the CYRAMZA plus FOLFIRI treated patients and 0.9% in the placebo plus FOLFIRI treated patients.Embryofetal Toxicity Based on its mechanism of action, CYRAMZA can cause fetal harm when administered to pregnant women. Animal models link angiogenesis, VEGF and VEGF Receptor 2 (VEGFR2) to critical aspects of female reproduction, embryofetal development, and postnatal development. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with CYRAMZA and for at 3 least months after the last dose of CYRAMZA.

ADVERSE REACTIONSClinical Trials ExperienceBecause 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.Safety data are presented from two randomized, placebo controlled clinical trials in which patients received CYRAMZA: Study 1, a randomized (2:1), double-blind, clinical trial in which 351 patients received either CYRAMZA 8 mg/kg intravenously every two weeks or placebo every two weeks and Study 2, a double-blind, randomized (1:1) clinical trial in which 656 patients received paclitaxel 80 mg/m2 on days 1, 8, and 15 of each 28-day cycle plus either CYRAMZA 8 mg/kg intravenously every two weeks or placebo every two weeks. Both trials excluded patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2 or greater, uncontrolled hypertension, major surgery within 28 days, or patients receiving chronic anti-platelet therapy other than once daily aspirin. Study 1 excluded patients with bilirubin ≥1.5 mg/dL and Study 2 excluded patients with bilirubin >1.5 times the upper limit of normal.CYRAMZA Administered as a Single Agent Among 236 patients who received CYRAMZA (safety population) in Study 1, median age was 60 years, 28% were women, 76% were White, and 16% were Asian. Patients in Study 1 received a median of 4 doses of CYRAMZA; the median duration of exposure was 8 weeks, and 32 (14% of 236) patients received CYRAMZA for at least six months.

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In Study 1, the most common adverse reactions (all grades) observed in CYRAMZA-treated patients at a rate of ≥10% and ≥2% higher than placebo were hypertension and diarrhea. The most common serious adverse events with CYRAMZA were

anemia (3.8%) and intestinal obstruction (2.1%). Red blood cell transfusions were given to 11% of CYRAMZA-treated patients versus 8.7% of patients who received placebo.

Table 1: Adverse Reactions Occurring at Incidence Rate ≥5% and a ≥2% Difference Between Arms in Patients Receiving CYRAMZA in Study 1

Adverse Reactions (MedDRA)a

System Organ Class

CYRAMZA (8 mg/kg)N=236

PlaceboN=115

All Grades(Frequency %)

Grade 3-4(Frequency %)

All Grades(Frequency %)

Grade 3-4(Frequency %)

Gastrointestinal Disorders Diarrhea 14 1 9 2

Metabolism and Nutrition Disorders Hyponatremia 6 3 2 1

Nervous System Disorders Headache 9 0 3 0

Vascular Disorders Hypertension 16 8 8 3

aMedDRA Version 15.0.

Clinically relevant adverse reactions reported in ≥1% and <5% of CYRAMZA-treated patients in Study 1 were: neutropenia (4.7% CYRAMZA versus 0.9% placebo), epistaxis (4.7% CYRAMZA versus 0.9% placebo), rash (4.2% CYRAMZA versus 1.7% placebo), intestinal obstruction (2.1% CYRAMZA versus 0% placebo), and arterial thromboembolic events (1.7% CYRAMZA versus 0% placebo).Across clinical trials of CYRAMZA administered as a single agent, clinically relevant adverse reactions (including Grade ≥3) reported in CYRAMZA-treated patients included proteinuria, gastrointestinal perforation, and infusion-related reactions. In Study 1, according to laboratory assessment, 8% of CYRAMZA-treated patients developed proteinuria versus 3% of placebo-treated patients. Two patients discontinued CYRAMZA due to proteinuria. The rate of gastrointestinal perforation in Study 1 was 0.8% and the rate of infusion-related reactions was 0.4%.

CYRAMZA Administered in Combination with Paclitaxel Among 327 patients who received CYRAMZA (safety population) in Study 2, median age was 60 years, 31% were women, 63% were White, and 33% were Asian. Patients in Study 2 received a median of 9 doses of CYRAMZA; the median duration of exposure was 18 weeks, and 93 (28% of 327) patients received CYRAMZA for at least six months.In Study 2, the most common adverse reactions (all grades) observed in patients treated with CYRAMZA plus paclitaxel at a rate of ≥30% and ≥2% higher than placebo plus paclitaxel were fatigue, neutropenia, diarrhea, and epistaxis. The most common serious adverse events with CYRAMZA plus paclitaxel were neutropenia (3.7%) and febrile neutropenia (2.4%); 19% of patients treated with CYRAMZA plus paclitaxel received granulocyte colony-stimulating factors. Adverse reactions resulting in discontinuation of any component of the CYRAMZA plus paclitaxel combination in 2% or more patients in Study 2 were neutropenia (4%) and thrombocytopenia (3%).

Table 2: Adverse Reactions Occurring at Incidence Rate ≥5% and a ≥2% Difference Between Arms in PatientsReceiving CYRAMZA plus Paclitaxel in Study 2

Adverse Reactions (MedDRA) System Organ Class

CYRAMZA plus Paclitaxel(N=327)

Placebo plus Paclitaxel(N=329)

All Grades(Frequency %)

Grade ≥3(Frequency %)

All Grades(Frequency %)

Grade ≥3(Frequency %)

Blood and Lymphatic System DisordersNeutropenia 54 41 31 19

Thrombocytopenia 13 2 6 2

Gastrointestinal DisordersDiarrhea 32 4 23 2

Gastrointestinal hemorrhage events 10 4 6 2

Stomatitis 20 1 7 1

General Disorders and Administration Site Disorders

Fatigue/Asthenia 57 12 44 6

Peripheral edema 25 2 14 1

Metabolism and Nutrition Disorders

Hypoalbuminemia 11 1 5 1

Renal and Urinary Disorders

Proteinuria 17 1 6 0

Respiratory, Thoracic, and Mediastinal Disorders

Epistaxis 31 0 7 0

Vascular Disorder

Hypertension 25 15 6 3

Clinically relevant adverse reactions reported in ≥1% and <5% of the CYRAMZA plus paclitaxel treated patients in Study 2 were sepsis (3.1% CYRAMZA plus paclitaxel versus 1.8% placebo plus paclitaxel) and gastrointestinal perforations (1.2% CYRAMZA plus paclitaxel versus 0.3% for placebo plus paclitaxel).ImmunogenicityAs with all therapeutic proteins, there is the potential for immunogenicity. In 23 clinical trials, 86/2890 (3.0%) of CYRAMZA-treated patients tested positive for treatment-emergent anti-ramucirumab antibodies by an enzyme-linked immunosorbent assay (ELISA). Neutralizing antibodies were detected in 14 of

the 86 patients who tested positive for treatment-emergent anti-ramucirumab antibodies.The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to CYRAMZA with the incidences of antibodies to other products may be misleading.

16 FCS The Magazine

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DRUG INTERACTIONSNo pharmacokinetic interactions were observed between ramucirumab and paclitaxel.

USE IN SPECIFIC POPULATIONSPregnancyRisk SummaryBased on its mechanism of action, CYRAMZA can cause fetal harm. Animal models link angiogenesis, VEGF and VEGF Receptor 2 (VEGFR2) to critical aspects of female reproduction, embryofetal development, and postnatal development. There are no available data on CYRAMZA in pregnant women to inform any drug-associated risks. No animal studies have been conducted to evaluate the effect of ramucirumab on reproduction and fetal development. The background risk of major birth defects and miscarriage for the indicated populations are unknown. In the U.S. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Advise pregnant women of the potential risk to a fetus.Animal DataNo animal studies have been specifically conducted to evaluate the effect of ramucirumab on reproduction and fetal development. In mice, loss of the VEGFR2 gene resulted in embryofetal death and these fetuses lacked organized blood vessels and blood islands in the yolk sac. In other models, VEGFR2 signaling was associated with development and maintenance of endometrial and placental vascular function, successful blastocyst implantation, maternal and feto-placental vascular differentiation, and development during early pregnancy in rodents and non-human primates. Disruption of VEGF signaling has also been associated with developmental anomalies including poor development of the cranial region, forelimbs, forebrain, heart, and blood vessels.LactationRisk SummaryThere is no information on the presence of ramucirumab in human milk, the effects on the breast-fed infant, or the effects on milk production. Human IgG is present in human milk, but published data suggest that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts. Because of the potential risk for serious adverse reactions in nursing infants from ramucirumab, advise women that breastfeeding is not recommended during treatment with CYRAMZA.Females and Males of Reproductive PotentialContraceptionFemalesBased on its mechanism of action, CYRAMZA can cause fetal harm. Advise females of reproductive potential to use effective contraception while receiving CYRAMZA and for at least 3 months after the last dose of CYRAMZA.InfertilityFemalesAdvise females of reproductive potential that based on animal data CYRAMZA may impair fertility.Pediatric UseThe safety and effectiveness of CYRAMZA in pediatric patients have not been established. In animal studies, effects on epiphyseal growth plates were identified. In cynomolgus monkeys, anatomical pathology revealed adverse effects on the epiphyseal growth plate (thickening and osteochondropathy) at all doses tested (5-50 mg/kg). Ramucirumab exposure at the lowest weekly dose tested in the cynomolgus monkey was 0.2 times the exposure in humans at the recommended dose of ramucirumab as a single agent.Geriatric UseOf the 563 CYRAMZA-treated patients in two randomized gastric cancer clinical studies, 36% were 65 and over, while 7% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Renal ImpairmentNo dose adjustment is recommended for patients with renal impairment based on population pharmacokinetic analysis.Hepatic ImpairmentNo dose adjustment is recommended for patients with mild (total bilirubin within upper limit of normal [ULN] and aspartate aminotransferase [AST] >ULN, or total bilirubin >1.0-1.5 times ULN and any AST) or moderate (total bilirubin >1.5-3.0 times ULN and any AST) hepatic impairment based on population pharmacokinetic analysis. Clinical deterioration was reported in patients with Child-Pugh B or C cirrhosis who received single-agent CYRAMZA.

DOSAGE AND ADMINISTRATION

Do not administer CYRAMZA as an intravenous push or bolus.

Recommended Dose and ScheduleThe recommended dose of CYRAMZA either as a single agent or in combination with weekly paclitaxel is 8 mg/kg every 2 weeks administered as an intravenous infusion over 60 minutes. Continue CYRAMZA until disease progression or unacceptable toxicity. When given in combination, administer CYRAMZA prior to administration of paclitaxel.PremedicationPrior to each CYRAMZA infusion, premedicate all patients with an intravenous histamine H1 antagonist (e.g., diphenhydramine hydrochloride). For patients who have experienced a Grade 1 or 2 infusion-related reaction, also premedicate with dexamethasone (or equivalent) and acetaminophen prior to each CYRAMZA infusion.Dose ModificationsInfusion-Related Reactions (IRR)• Reduce the infusion rate of CYRAMZA by 50% for Grade 1 or 2 IRRs.• Permanently discontinue CYRAMZA for Grade 3 or 4 IRRs.Hypertension• Interrupt CYRAMZA for severe hypertension until controlled with medical

management.• Permanently discontinue CYRAMZA for severe hypertension that cannot be

controlled with antihypertensive therapy.Proteinuria• Interrupt CYRAMZA for urine protein levels ≥2 g/24 hours. Reinitiate treatment

at a reduced dose of 6 mg/kg every 2 weeks once the urine protein level returns to <2 g/24 hours. If the protein level ≥2 g/24 hours reoccurs, interrupt CYRAMZA and reduce the dose to 5 mg/kg every 2 weeks once the urine protein level returns to <2 g/24 hours.

• Permanently discontinue CYRAMZA for urine protein level >3 g/24 hours or in the setting of nephrotic syndrome.

Wound Healing Complications• Interrupt CYRAMZA prior to scheduled surgery until the wound is fully healed.Arterial Thromboembolic Events, Gastrointestinal Perforation, or Grade 3 or 4 Bleeding• Permanently discontinue CYRAMZA.

For toxicities related to paclitaxel, refer to the current prescribing information.

PATIENT COUNSELING INFORMATION• Hemorrhage: Advise patients that CYRAMZA can cause severe bleeding. Advise patients to contact their health care provider for bleeding or symptoms of bleeding including lightheadedness]. • Arterial thromboembolic events: Advise patients of an increased risk of an arterial thromboembolic event. • Hypertension: Advise patients to undergo routine blood pressure monitoring and to contact their health care provider if blood pressure is elevated or if symptoms from hypertension occur including severe headache, lightheadedness, or neurologic symptoms. • Gastrointestinal perforations: Advise patients to notify their health care provider for severe diarrhea, vomiting, or severe abdominal pain. • Impaired wound healing: Advise patients that CYRAMZA has the potential to impair wound healing. Instruct patients not to undergo surgery without first discussing this potential risk with their health care provider. • Pregnancy and fetal harm: Advise females of reproductive potential of the potential risk for maintaining pregnancy, risk to the fetus, and risk to postnatal newborn and infant development and to use effective contraception during CYRAMZA therapy and for at least 3 months following the last dose of CYRAMZA. • Lactation: Advise patients not to breastfeed during CYRAMZA treatment. • Infertility: Advise females of reproductive potential regarding potential infertility effects of CYRAMZA

Additional information can be found at www.CYRAMZAHCP.com.

Eli Lilly and Company, Indianapolis, IN 46285, USACopyright © 2015, Eli Lilly and Company. All rights reserved.

RB-G HCP BS 29APR2015

Spring 2016 17CYRAMZA® (ramucirumab) injection RB-G HCP BS 29APR2015 CYRAMZA® (ramucirumab) injection RB-G HCP BS 29APR2015

CYRAMZA RB-G HCP BS 29APR2015 - 7 x 10 PRINTER VERSION 3 OF 3

DRUG INTERACTIONSNo pharmacokinetic interactions were observed between ramucirumab and paclitaxel.

USE IN SPECIFIC POPULATIONSPregnancyRisk SummaryBased on its mechanism of action, CYRAMZA can cause fetal harm. Animal models link angiogenesis, VEGF and VEGF Receptor 2 (VEGFR2) to critical aspects of female reproduction, embryofetal development, and postnatal development. There are no available data on CYRAMZA in pregnant women to inform any drug-associated risks. No animal studies have been conducted to evaluate the effect of ramucirumab on reproduction and fetal development. The background risk of major birth defects and miscarriage for the indicated populations are unknown. In the U.S. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Advise pregnant women of the potential risk to a fetus.Animal DataNo animal studies have been specifically conducted to evaluate the effect of ramucirumab on reproduction and fetal development. In mice, loss of the VEGFR2 gene resulted in embryofetal death and these fetuses lacked organized blood vessels and blood islands in the yolk sac. In other models, VEGFR2 signaling was associated with development and maintenance of endometrial and placental vascular function, successful blastocyst implantation, maternal and feto-placental vascular differentiation, and development during early pregnancy in rodents and non-human primates. Disruption of VEGF signaling has also been associated with developmental anomalies including poor development of the cranial region, forelimbs, forebrain, heart, and blood vessels.LactationRisk SummaryThere is no information on the presence of ramucirumab in human milk, the effects on the breast-fed infant, or the effects on milk production. Human IgG is present in human milk, but published data suggest that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts. Because of the potential risk for serious adverse reactions in nursing infants from ramucirumab, advise women that breastfeeding is not recommended during treatment with CYRAMZA.Females and Males of Reproductive PotentialContraceptionFemalesBased on its mechanism of action, CYRAMZA can cause fetal harm. Advise females of reproductive potential to use effective contraception while receiving CYRAMZA and for at least 3 months after the last dose of CYRAMZA.InfertilityFemalesAdvise females of reproductive potential that based on animal data CYRAMZA may impair fertility.Pediatric UseThe safety and effectiveness of CYRAMZA in pediatric patients have not been established. In animal studies, effects on epiphyseal growth plates were identified. In cynomolgus monkeys, anatomical pathology revealed adverse effects on the epiphyseal growth plate (thickening and osteochondropathy) at all doses tested (5-50 mg/kg). Ramucirumab exposure at the lowest weekly dose tested in the cynomolgus monkey was 0.2 times the exposure in humans at the recommended dose of ramucirumab as a single agent.Geriatric UseOf the 563 CYRAMZA-treated patients in two randomized gastric cancer clinical studies, 36% were 65 and over, while 7% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Renal ImpairmentNo dose adjustment is recommended for patients with renal impairment based on population pharmacokinetic analysis.Hepatic ImpairmentNo dose adjustment is recommended for patients with mild (total bilirubin within upper limit of normal [ULN] and aspartate aminotransferase [AST] >ULN, or total bilirubin >1.0-1.5 times ULN and any AST) or moderate (total bilirubin >1.5-3.0 times ULN and any AST) hepatic impairment based on population pharmacokinetic analysis. Clinical deterioration was reported in patients with Child-Pugh B or C cirrhosis who received single-agent CYRAMZA.

DOSAGE AND ADMINISTRATION

Do not administer CYRAMZA as an intravenous push or bolus.

Recommended Dose and ScheduleThe recommended dose of CYRAMZA either as a single agent or in combination with weekly paclitaxel is 8 mg/kg every 2 weeks administered as an intravenous infusion over 60 minutes. Continue CYRAMZA until disease progression or unacceptable toxicity. When given in combination, administer CYRAMZA prior to administration of paclitaxel.PremedicationPrior to each CYRAMZA infusion, premedicate all patients with an intravenous histamine H1 antagonist (e.g., diphenhydramine hydrochloride). For patients who have experienced a Grade 1 or 2 infusion-related reaction, also premedicate with dexamethasone (or equivalent) and acetaminophen prior to each CYRAMZA infusion.Dose ModificationsInfusion-Related Reactions (IRR)• Reduce the infusion rate of CYRAMZA by 50% for Grade 1 or 2 IRRs.• Permanently discontinue CYRAMZA for Grade 3 or 4 IRRs.Hypertension• Interrupt CYRAMZA for severe hypertension until controlled with medical

management.• Permanently discontinue CYRAMZA for severe hypertension that cannot be

controlled with antihypertensive therapy.Proteinuria• Interrupt CYRAMZA for urine protein levels ≥2 g/24 hours. Reinitiate treatment

at a reduced dose of 6 mg/kg every 2 weeks once the urine protein level returns to <2 g/24 hours. If the protein level ≥2 g/24 hours reoccurs, interrupt CYRAMZA and reduce the dose to 5 mg/kg every 2 weeks once the urine protein level returns to <2 g/24 hours.

• Permanently discontinue CYRAMZA for urine protein level >3 g/24 hours or in the setting of nephrotic syndrome.

Wound Healing Complications• Interrupt CYRAMZA prior to scheduled surgery until the wound is fully healed.Arterial Thromboembolic Events, Gastrointestinal Perforation, or Grade 3 or 4 Bleeding• Permanently discontinue CYRAMZA.

For toxicities related to paclitaxel, refer to the current prescribing information.

PATIENT COUNSELING INFORMATION• Hemorrhage: Advise patients that CYRAMZA can cause severe bleeding. Advise patients to contact their health care provider for bleeding or symptoms of bleeding including lightheadedness]. • Arterial thromboembolic events: Advise patients of an increased risk of an arterial thromboembolic event. • Hypertension: Advise patients to undergo routine blood pressure monitoring and to contact their health care provider if blood pressure is elevated or if symptoms from hypertension occur including severe headache, lightheadedness, or neurologic symptoms. • Gastrointestinal perforations: Advise patients to notify their health care provider for severe diarrhea, vomiting, or severe abdominal pain. • Impaired wound healing: Advise patients that CYRAMZA has the potential to impair wound healing. Instruct patients not to undergo surgery without first discussing this potential risk with their health care provider. • Pregnancy and fetal harm: Advise females of reproductive potential of the potential risk for maintaining pregnancy, risk to the fetus, and risk to postnatal newborn and infant development and to use effective contraception during CYRAMZA therapy and for at least 3 months following the last dose of CYRAMZA. • Lactation: Advise patients not to breastfeed during CYRAMZA treatment. • Infertility: Advise females of reproductive potential regarding potential infertility effects of CYRAMZA

Additional information can be found at www.CYRAMZAHCP.com.

Eli Lilly and Company, Indianapolis, IN 46285, USACopyright © 2015, Eli Lilly and Company. All rights reserved.

RB-G HCP BS 29APR2015

As life-changing events go, it was prodigious

Richard Brown, a 20-year-old student at the

University of Rochester, came home to New York City for a weekend visit with his family. He had planned to have dinner with his older sister Wendy that evening in 1975, but first he went to his aunt’s house, which was right next door to the home where his parents, Hungarian immigrants, had raised him. When he got there, his aunt was crying because his brother-in-law had called to say that Wendy had been killed in a car accident.

“I had to go next door to my parents’ house and tell them their 24-year-old daughter had died. It was the hardest thing I’ve ever done in my life,” said Brown. “It had a significant impact on my life. … I realized the frailty of human existence. I became a much more serious person and wanted to make something meaningful with my life. I guess you could say my childhood ended as a result of this tragedy,” recalled Brown. “My mother had always said that when she and my dad got old my sister would take care of them. I said to myself ‘Well, this is my responsibility now,’ and I took that responsibility seriously. … I grew up fast.”

Brown returned to college and earned his degree in social psychology, but still pondered his future. “I was publishing an article with a professor on a research project. I asked him what I should do in way of a profession. He suggested either teaching or getting an MBA in organizational behavior. I chose to go for an MBA as part of a scholarship package I received from Boston University,” he said. But after several months in graduate school he soon realized he “needed more in my life than being in business,” he said.

“I went through a period of despondency. I was living in the back bay of Boston and would walk along the Charles River and see Massachusetts General Hospital daily. This put the notion of medicine in my head. After much soul searching I recognized I could have meaning in my life by going to medical school,” said Brown. He completed his MBA and worked on pre-med courses concurrently. Following the advice of his professor, he applied and was accepted to the University of Vermont College of Medicine.

For his internship and residency in internal medicine, Brown went to the University of Minnesota in Minneapolis, where he briefly considered becoming a gastroenterologist. “But I eventually realized what I was really interested in was hematology, so I changed my plans and accepted a fellowship in hematology and oncology at New York University,” Brown said. “It was time to get back home to New York.”

And “back home” is where he met Pam—with whom he soon will celebrate his 26th wedding anniversary—on a blind date. “As

soon as I saw her that was it! I had just met the woman I was going to marry,” Brown remembered, his voice still rising with first-crush excitement. “Our first date was on Nov. 22, 1988, and I asked her to marry me on Feb. 4. We hadn’t even met each other’s families, but we both knew it was meant to be. We were married the following December.”

On the way to honeymoon in Grand Cayman, the newlyweds had a stopover in Tampa. “My wife’s friend’s mother lived in Longboat Key and we had some time to kill. We took a ride down here and said ‘Wow! This is really nice. We could live here!’” he said.

Brown remains “very, very happy with our decision” to move to Sarasota and accept a job with Oncology/Hematology Consultants, where he worked from 1991 until 2014, when the practice was acquired by Florida Cancer Specialists. Brown said he and his partners “realized the changes that were occurring in medicine and that we were better off joining a larger, stronger group. … In retrospect, it was a very good decision.”

Brown works exclusively in FCS’ downtown Sarasota office on Golf Street. And, when he is not seeing patients in his office, he is making rounds at Sarasota Memorial Hospital, where he “has been on just about every single committee you can be,” said Brown, 59. He currently is director of Cancer Care Services and is serving on several active committees; he also has been chief of staff and physician of the year at SMH.

The Browns are adjusting to becoming empty-nesters. Their daughters, Sammy, 21, and Jordan, 19, both are communications majors and attend the University of Florida and the University of Michigan, respectively. “Pam has more time to pursue her volunteer activities, but my time is still taken up mostly by my job and hospital responsibilities,” said Brown.

However, the couple is taking steps of different sort as they plan for the future. “We’ve taken up dance lessons. When it comes time for my daughters’ weddings, I don’t want to embarrass myself. I’m starting now because it may take me a long time to learn” Brown laughed.

But the dances Brown is more familiar with are touchdown celebrations at Raymond James Stadium, where he is a longtime Tampa Bay Buccaneers season ticket holder. “I go to every single game and I have great seats,” said Brown, who has been an honorary team captain and participated in a pre-game coin toss when the Bucs played division rival New Orleans Saints.

But on Mondays, Brown is back in his clinic “to provide the care and meet the needs of each individual I face,” he said. As is inherent in his speciality, sometimes that means delivering bad news, a circumstance he first faced as a grieving college kid.

“I always try to understand what they are going through. That makes me a better doctor,” said Brown. “It never gets easier, and hopefully it never will.”

Reprinted with the permission of Tampa Bay Medical News (TampaBayMedicalNews.com)

Finding a meaningful lifeTragedy shaped the future for Richard Brown, M.D. BY JEFF wEBB

Feature

18 FCS The Magazine

Spring 2016 19

can-do attitudeQuiet Leader Commands Respect BY ZANDRA wOLFGRAM

arah Cevallos has enjoyed a meteoric rise to the executive ranks of Florida Cancer Specialists & Research Institute (FCS), since she joined in 2008, but this steady super star is glad her job as Chief Revenue Cycle Officer keeps her behind the scenes and out of the spotlight.

Cevallos has a formal education and a professional background making for an impressive resume. She holds a Bachelor of Science degree in Business Management from Nova Southeastern University and an MBA from Western Governors University with a concentration in Healthcare Management. In addition to her work with FCS, she serves as Clinical Practice Committee Member for the Florida Association of Clinical Oncology (FLASCO).

But it just may be her other full-time job as a mother to Cameron, 14, and Leah, 9, that provided this Naples, Florida, native with the motivation and drive necessary to reinvent her life after being laid off from a job as a contract negotiator for a private home builder. She was thus driven to find and forge a path in the competitive and challenging world of healthcare administration.

“I started a family when I was very young so I didn’t have the opportunity to concentrate on one thing at a time, so I said ‘I need a college education, a job, and I have to be a mother’, so I did it. This gave me the foundation to understand no matter how long the days end up being and how challenging the work may be, as a mother, your ‘why’ can get you through most anything,” this Cevallos said during a recent interview from her corporate office in Fort Myers. “I always said I was going to be a role model for my children, and I always want my children to see it is possible to achieve success despite the circumstances you are given.”

And deliver she does. As Chief Revenue Cycle Officer, she is responsible for providing strategic leadership and direction for all revenue cycle responsibilities for the FCS physician network. In this role, she oversees all patient financial services, billing, collections, payment posting, and refunds. She is also responsible for managing payer partnerships and credentialing. Though her list of responsibilities is long, for this executive, Sarah’s ultimate focus of everyone who works with her including her four direct reports comprising of Christy Banach, Melissa Chandler, Krista

Dommes, and Nicole Picazio — is always the patient.“Although we don’t see patients on a day-to-day basis, we’re behind

the scenes helping with their financial and insurance needs so they can focus on their health and getting better,” she says. “In the end, we’re all here for the same reason and that is to make sure the patient gets access to the best care,” she says.

Cevallos eagerly applies her “Let’s do this” mentality to resolve any challenge whether personal or professional, but she contends it’s not just her determination that has helped her climb the rungs of success. This go-getter says her success was not just from her hard work but also because FCS is an organization that has a culture for continued growth. “I’m really blessed to be brought into a company where they saw my business intellect and gave me a chance,” she says.

CEO Brad Prechtl became a mentor to Cevallos and, over several years, shared key corporate lessons.

“He taught me the basics of the business, which I was able to apply in my day-to-day workload, so I could then understand how decisions affected outcomes and see how the underlying puzzle pieces fit together,” Cevallos says.

Once Cevallos understood how the “company’s wheels turned” she was motivated to learn even more. She headed back to school for her master’s degree in healthcare administration while working full time at FCS and that education she credits is what “took my career to the next level.”

FCS’ investment in Cevallos has been a win-win.“Sarah has consistently demonstrated leadership qualities that have

earned the respect of her peers and the employees in the departments she oversees,” says Prechtl. “Over the past eight years at FCS, she has developed a strong track record for achieving strategic improvements within her areas of responsibility. We rely on leaders like Sarah to contribute to our success.”

Continued success for this executive is a sure pay off, especially if she can continue to shine in the shadows. “I like being in the background and behind the scenes and being able to make things run smoothly,” she says. “I don’t need the limelight. Being in the back office is the right fit for me.”

aDMINISTraTIvE SPoTlIghT

20 FCS The Magazine

D r. Paresh Patel is a man in motion. In the middle of explaining complex cancer treatment, he pulls out his personal cell phone to schedule a patient for the radiologic procedure she suddenly needs. You see,

his patient developed a complication during her FCS visit. She needed immediate relief, and it was the end of the day. Without a call from doctor to doctor, she would have ended up in the queue for a callback.

It’s this personal attention that hallmarks the Tallahassee practice of FCS.

Patel is one of three doctors who run the two locations in Florida’s capital city. All three are similarly devoted to patient care—and comfort. Doctors Viralkumar Bhanderi and Scott Tetreault are Patel’s colleagues at FCS Tallahassee, and they work as a unified team to oversee the dual-office practice.

Tetreault focuses on administrative duties for the practice, while also testing advanced treatments for melanoma and other cancers. His FCS career biography includes board certifications in Medical Oncology, Hematology, Internal Medicine and Palliative Medicine. He was

close-knit teamTallahassee physicians provide personal touch while pioneering advances BY TISHA CREwS KELLER

oFFICE SPoTlIghT

Spring 2016 21

awarded the Rhone Poulenc Fellowship Award in 1998 for Breast Cancer Research. Other honors include selection by his peers in 2003 as Doctor of the Year, the Goldman Award for contributions to the cancer community in 2009 and selection by the Consumer Research Council as one of “America’s Top Oncologists” every year since 2006.

Widely published in the scientific literature, Tetreault is an investigator in more than 50 clinical trials. He is a member of the American Society of Clinical Oncology, the American College of Physicians and was recently granted the honor of being selected as a Fellow of the Royal Society of Medicine (United Kingdom). Currently, Tetreault is the only FCS physician working on a clinical trial involving promising treatment for advanced melanomas.

Patel focuses on research administration at FCS Tallahassee. Currently, he oversees FCS trials involving lymphoma, lung cancer (two trials), breast cancer, low-grade lymphoma, melanoma and more.

During a one-year chief medical residency, Patel’s leadership and natural gift for teaching shined brightly. He was an assistant professor at Virginia Commonwealth University for several years. It was at this time that Dr. Patel gravitated toward his true calling and decided to pursue a Hospice and Palliative Care Fellowship, followed by a Hematology and Oncology Fellowship. He is board certified in Medical Oncology, Hematology, Internal Medicine and Hospice and Palliative Care.

In addition to his impressive resume, during his residency Patel developed the unique ability to perform intrathecal chemotherapy—delivering chemotherapy drugs directly into the cerebrospinal fluid surrounding the brain and spinal cord—without the (normally required) aid of fluoroscopy in a hospital setting. His specialized training and ability saves time and money for both patient and doctor. Patel uses this technique to successfully treat lymphomas, leukemias and advanced breast cancer that has metastasized into the meninges.

Bhanderi is board certified in Internal Medicine and Oncology. He began his practice 13 years ago and did his internship, residency and fellowship at Shands Hospital at the University of Florida in Gainesville. He treats oncology and hematology patients at both FCS

locations in Tallahassee and helps manage both offices as part of the collaborative management trio.

Practice administrator/office manager Debra Mabry points out that each Tallahassee FCS office seems to have its own personality. In a “capital city that’s really a small town,” the average patient age in Tallahassee is much younger than other FCS offices because there is not much of a seasonal population in North Florida.

“The Tallahassee North location is the one that’s serene, calm, quiet,” she explains. “The Tallahassee East location is more lively, with patients that have lots of pep.”

Mabry works hard to keep her staff of 25 administrative and clinical professionals well coordinated. She also makes sure that patients have an inviting and comfortable atmosphere in the FCS clinics. Every detail, from soothing style to an enabled, service-focused staff, is part of Mabry’s master plan.

She arranged for a local art dealer to provide an array of beautiful works by local artists for the walls of both offices. Patients love the inspirational images—and the artists enjoy giving back (and showing off) their work. The display changes throughout the year and is one of the more inspirational aspects of FCS Tallahassee.

The practice gives back to the community in many ways, including partnerships with the Joanna Francis Living Well Foundation, which provides money to patients for ancillary needs including makeup, gas cards, wigs, prostheses, and other cancer treatment and comfort items. In addition, the local American Cancer Society chapter, the Leukemia & Lymphoma Society, Relay for Life, Springtime Tallahassee, and other causes receive support from the FCS Tallahassee staff.

Like all FCS locations, patient-centered service is at the heart of what they do.

Patel describes his practice’s mission in simple terms: “Cancer treatment has come a long way,” he explains. “Used to be the main goal was just to live longer. Now, it’s quality of life that’s most important, in addition to extending life. We are focused on the quality and the quantity.”

22 FCS The Magazine

FCSevents

1. corPorAte PArtner, celgene corPorAtion, AWArds fcs foundAtion $75,000

Celgene Corporation presented a check for $75,000 as the “Presenting Sponsor of FCS Foundation Events” for 2016:•Time to Remember Gala in Naples–April 16, 2016•Palm Beach Art Event–May 5, 2016•50 shades of Pink–Oct. 8, 2016•Golf Event in Orlando-Oct. 30, 2016

Pictured (L-R): Terri Gagliardi–FCS Foundation Development & Event Coordinator; Michael Eddy–Hematology Oncology Consultant–Celgene Corporation; Kim Wyar–Hematology Oncology Consultant–Celgene Corporation; al Vance–FCS Foundation Executive Director; Jessica McIntyre–FCS Foundation Client Services Manager; Dan Leber–Sr. District Sales Manager–Celgene Corporation

2. stAying fit!FCS employees taking a break get a workout in at Orange Theory Fitness, including CEO Brad Prechtl and Chief Revenue Cycle Officer Sarah Cevallos.3. fcs oPerAtionAl excellence AWArd WinnersCongratulations to the following recipients of the 2015 Operational Excellence Award!Sandra Santiago, Olga Maderas, Kim Hanrahan, Nisali Rosario-Santiago, Mayra Gil, Danielle Lewandwoski, Michelle Roski, Allen Bergemann, Wanda Ruth, Michelle Yoder, Camilo Rodriquez, Chrystal Wynn, Esther McKay, Jaclyn Donley, Paula Zuluga, Ashley Pate, Lisa Flores, Rebecca Strahan, Patricia Leduc, Lori Stroud, Katie Kaiser

1.

3.

2.

Spring 2016 23

FCSevents

4. celeBrAting 5 yeArs At fcsFCS would like to recognize and thank Flor Uscanga for her five years of service with Florida Cancer Specialists at the Bradenton East Office!Pictured (L-R): Flor Uscanga and Vice President of Practice Operations Jeff Rubin5. A toAst to celeBrAte the oPening of the

diAgnostic clinic in lArgoPictured (L-R): Denise McAllister, NP; Dr Bergier; Jude Blackenship, office manager; Bree Waiters, MA

4.

6b.

6a.

5.

6A. And 6B. “Pink” PAlM trAn BusFCS partnered with the South Florida Affiliate of Susan G. Komen and Palm Tran on their “Pink Bus” to promote breast cancer awareness. FCS physicians were featured on a new bus wrap that was used during the month of January with an estimated weekly viewing of 100,000. The bus was staged at the Race For the Cure event on January 31.Pictured (L-R) on the bus: Dr. Raymond, Dr. Vattigunta and Dr. McKeen

24 FCS The Magazine

FCSevents

8.

9.

7.

7. AdvocAting rAdio iMMunotherAPyDr. Jennifer Cultrera presented at a meeting, with Chairman Stephen G. Burns and Commissioner William C. Ostendorff of the US Nuclear Regulatory Commission, regarding ‘Authorized User Status For Beta Emitter Administration – Setting Appropriate Training and Experience Requirements’ in Washington, D.C. in late January. The team is advocating for more realistic training requirements to allow medical oncologists/hematologists to deliver alpha and beta emitting targeted therapies to their patients.Pictured (L-R): Dr. Allen Yang, CFA (Spectrum Pharmaceuticals); Former Senator Joseph I. Lieberman (Kasowitz, Benson, Torres, & Friedman); Avi Oler, Esq. (Spectrum Pharmaceuticals); Brian Carey Esq. (Foley & Hoag); Michael Guastella, Executive Director of CORAR; and Dr. Jennifer Cultrera

8. ugly sWeAter contest Winners–dccPictured (L-R): Mary Carn, PSS ; John Dorr, FH Regional Chief Medical Physicist; Sabrina Maldonado, PSS9. Jfk excellence AWArd WinnersPictured (L-R): Todd Schonherz, COO; Dr. Shachar Peles; Camilo Rodriguez (Regional Clinic Pharmacy Trainer); Dr. Elizabeth Byron; Megan Scott, ARNP; Lois Brown (Regional Director )

Spring 2016 25

11b.

12.

11a.

10a. 10b.

10a. and 10b. fcs MArketing teAM Building event in Mount dorA, flA10a. (L-R): Front Row: Sandy Brooks, Rhonda Webster, Rebecca

Appelbaum, Leslie Jaye, Val Vance, Julie Anning, JoLynn Wright, Monica Clark, Lynn Clemens Back Row: Brett Hipsley, Maria Ramos-Person, Irene Nathanson, Shelly Glenn, Terri Gagliardi, Danielle Spears

10b. Lynn Clemens, Leslie Jaye, Sandy Brooks, Julie Anning, Terri Gagliardi, Danielle Spears, Irene Nathanson, JoLynn Wright, Maria Ramos-Person, Rhonda Webster, Shelly Glenn, Val Vance, Rebecca Appelbaum, Brett Hipsley and Monica Clark

11a. and 11b. insAne inflAtABle 5k in sArAsotAThe 1st Region 2 team building event in Sarasota was a great success. There were 58 participants and $290 was raised for the FCS Foundation. Thank you to the Region 2 physicians who contributed toward sponsorship of the team.

12. cfM teAM Building fun At fArris And foster’s chocolAte MAkers in orlAndo

Pictured (L-R):Front Row: Christy Banach, Joshua Olivero, Tesha Rivera, Barbara Kraemer, Cabrina Adams, Sarah Cevallos, Bandith (Loe) PhaengsavanhBack Row: Jana Palmer, Sydney Ward, Jackie LeBoeuf, Maureen Richardson, Carmen Tortarelli, Serena Dragotta

FCSevents

Submit your recent event photos to FCS Marketing at marketing@FLCancer.com.

West Palm Beach Art & Jewelry AuctionThursday, May 5, 2016 | 6 – 9 pm EmKo Art Gallery | 2119 South Dixie Highway West Palm Beach, FL 33401Foundation.FLCancer.com/WPBArt

50 Shades of Awesome PinkSaturday, October 8, 2016 | 6 pmGrand Hyatt Tampa | 2900 Bayport Drive, Tampa, FL 33607Foundation.FLCancer.com/50-Shades-of-Pink

Hope “Fore” the HolidaysSunday, October 30, 2016 | 11:30 amRitz Carlton Golf Club | 4048 Central Florida Parkway Orlando, FL 32837Foundation.FLCancer.com/Hope-Fore-the-Holidays-2

Wine Women & ShoesThursday, November 17, 2016 | 5:30 – 9:30 pmWestin Lake Mary | 2974 International Parkway Lake Mary, FL 32746Foundation.FLCancer.com/WWS2016

Party Under the Stars Saturday, January 28, 2017 | Time TBDLakewood Ranch location TBD

For information or to donate, please call (941) 677.7181 or visit Foundation.FLCancer.comFlorida Cancer Specialists is a 501 (c) (3) non-profit organization.

5202 Paylor Lane, Sarasota, FL 34240

Save2016 CALENDAR of EVENTSDatesthe

Spring 2016 27

SAVE THE DATE | APRIL 14-15, 2016

The Community Oncology Conference is going back to Orlando to an exciting new venue at Universal Orlando Resort!

The Community Oncology Conference will be held on Thursday and Friday, April 14–15, 2016 at the Loews Royal Pacific Resort (a Universal Orlando resort), 6300 Hollywood Way, Orlando, FL 32819.

Loews Royal Pacific Resort at Universal Orlando6300 Hollywood Way, Orlando, FL 32819

INNOVATION IN CANCER CAREMoving from Theory to Practice

Feature

cigna partnership for care managementBY TISHA CREwS KELLER

at Florida Cancer Specialists, innovation is the name of the game. That’s especially true when it comes to patient care. The nexus of compassionate patient services and streamlined, efficient, sensible practice is the sweet spot

that really excited Jeremy Behling and Don Champlain.Behling is the Vice President of Operations and Practice Innovation

at FCS. Champlain is the Senior Manager of Care Management Services—an RN with more than 20 years of experience in care management. Along with FCS COO Todd Schonherz, they have created the new FCS Care Management Program that will soon be rolled out across the FCS family of facilities.

The traditional care model for oncology has been buy/bill—buy a drug, bill a drug. The care management model shifts to a more holistic approach, adding a human touch—and human connection—between the patient and his/her course of treatment.

Statistics show that 19 percent of the total cancer patient cost of care is associated with hospitalizations; so, by eliminating just one hospitalization through a follow-up and heading-off approach, FCS can reduce patient discomfort and save time and money for everyone.

A major goal is to reduce one-day hospitalizations, including observations and ER visits for treatment-related complications and side effects, such as nausea.

The care management program puts processes in place to have oncology-certified nurses interact with patients via telephone to

recognize early signs of infection, complications, pain management needs and the like. This reduces the need for office/hospital visits for things including oxygen assistance and antibiotics.

In addition, these RNs will follow up with patients immediately after treatment through survivorship. Making sure survivors continue medication and fulfill recommended periodic scans is also an important role FCS can play in continuing cancer care.

A key benefit of the program is that care management nurses are able to assist patients with actually utilizing their insurance benefit to the fullest. It can be hard to get through to an insurance carrier, but the RN has direct access to the insurance case manager. If patients require something, the nurse looks at the best way to obtain whatever is needed for the patient under their insurance. This allows patients to understand benefits and know what is allowed through their program.

To staff the program, FCS will hire employees well suited to the care management approach with the typical ratio being one nurse to 200 active patients.

Behling anticipates that this will become a standard part of care for FCS. The ultimate goal is to treat patients in a better, more cost-effective way. Onsite staff will be able to handle the patients in front of them, instead of fielding emergency phone calls in between patients.

Currently, the care management program is in effect for fully insured Cigna and Millennium patients, and Behling sees it expanding to Medicare and other employers and insurance carriers shortly.

28 FCS The Magazine

Spring 2016 29

Bond BuilderNurse practitioner’s own story helps her connect with patientsBY ZANDRA wOLFGRAM

W hen nurse practitioner Lori Padden, RN, BSN, OCN, says, “I know” to her Florida Cancer Specialist & Research Institute (FCS) oncology patients, she really does. Though most are not

aware of it, this steadfast 57-year-old Midwesterner is a two-time survivor of cancer. Yet Padden’s personal cancer journey story is something of a “secret weapon” she shares only when necessary with those who need it most.

“If someone has lost hope and is giving up and if I think it will help, then I will let them know that I do know where they are coming from, how bad they feel and how difficult it is,” she says with a hint of her Western Pennsylvania upbringing lacing her vowels.

On the day we spoke, the Naples West treatment room was one of those days. The chart of Padden’s breast cancer patient read a lot like her own—she was just one year younger, had the same stage and was on the same treatment regimen. But, she didn’t have one thing: Padden’s fighting spirit … at least not yet.

“She said ‘I can’t do this; it’s not worth it,’ so I told her my story …”

After Padden talked with her, the patient took her treatment, got back on her anti-nausea medicine, ate some crackers, relaxed and in a couple of hours was feeling much better. Once again, Padden’s personal story had come to the rescue.

Though she feels she was “called” to nursing, Padden credits her own fight with cancer for leading her into oncology. But, it didn’t start there. She began her career in a small ER at Naples Community Hospital. She gained still more experience in Collier County as a nurse in Immokalee, a small south Florida town originally occupied by the Calusa Indians and, centuries later, the Seminoles. When the swamps were drained in the region, agriculture became the dominant industry. The town of 15,000 swelled to 45,000 migrants during the growing season.

“They were poor. No one could pay their bills, but they still

needed our care,” Padden says.When Padden was diagnosed with breast cancer at the age of 45

while head nurse at Naples Urgent Care, it was her turn to receive some help. “After I got my treatment, I felt oncology was where I belonged,” she says. “It definitely was not “treat ‘em and street ‘em” as we used to say in the ER. It’s a long-term commitment.”

Padden and her team treat an average of 50 to 60 patients a day, 10 hours a day, four days a week in FCS’s 45-chair treatment room. She is proud to be an integral part of a six-member nursing team, each with an average tenure of 10 years with FCS. They provide support and manage treatment for patients of all four physicians at the largest of FCS’s four Naples’ locations.

Teamwork is essential to give quality care, but perhaps even more so in the winter. It’s not uncommon for the regular patient load to double. Though this influx of seasonal “snowbird” patients comes with high expectations for their “vacation treatments,” this compassionate caregiver takes it all in stride.

“FCS is a community cancer center, so you try to make them feel comfortable around other people,” she says. “Our patients often learn coping skills from their fellow patients. And sometimes they make lifelong friends, because they share the bond of cancer.”

Forming a bond is something Padden does well. She and two other cancer “survivor friends” formed a support group in Naples, her home for 28 years. They are called Breast Friends. The group grew to about 20 members just by word of mouth. A decade later, they still gather monthly in area restaurants. Padden—who loves to thrift shop, garden and jog—attends when she can. But, many days she is busy building bonds and skill sets of nurses new to the FCS family.

She leads training sessions and teaches “the way of FCS” to new hires after mergers. If anyone needs encouragement, like her cancer patients, she let’s them know she was once in their shoes.

“I tell them, ‘I was once where you are now and I know,’” she says.

NurSE SPoTlIghT

30 FCS The Magazine

The FCS Foundation fulfills a unique purpose for cancer patients who are struggling to pay their everyday living expenses. Imagine cancer patients who can’t make car payments leaving them without transportation to their physician’s office; or patients who can’t pay mortgage or rent and are facing eviction while they are fighting for their lives. The Foundation pays for non-medical expenses such as mortgage, rent, utilities, car payments, etc., so that patients can concentrate on recovering from cancer.

What Separates the FCS Foundation from Similar Charities?What truly separates the FCS Foundation from similar charities is that Florida Cancer Specialists pays for all salaries and overhead for the Foundation, which means that 100% of all donations go directly to help cancer patients in need! The FCS Foundation provides help for the entire family, as well, by relieving some of the stress cancer patients and family members face on a daily basis.

Please call (941) 677.7181 or visit Foundation.FLCancer.com for more information or to donate.

5202 Paylor Lane, Sarasota, FL 34240

Thank You for Your Continued Support of the FCS Foundation!

Spring 2016 31

Q&A Profileget to know your doctor

he likes bluegrass and catching wavesDr. Raul Storey-Rojas answers some of our questions

One food I never learned to eat is…

I love hot dogs but I’ve never quite managed to eat them the “appropriate” way, or at least that’s what I’m told when I ask for silverware. I’ve gotten laughed at which tells me I am not the expert.

Favorite entertainer?

A little bit of everything, my taste is very diverse. I can go from Pearl Jam to Andrea Boccelli and back to Matisyahu. Love to go to concerts, especially here in Florida where the weather is always good to be out.

Quentin Tarantino or David O. Russell?

If I had to choose, it would be David Russell because Tarantino’s movies are not particularly appealing to me; however, I am wondering if Pedro Almodovar is an option? Love his work because it’s different and he is very good at bringing up touchy social topics.

Walk in the woods or a stroll on the beach?

For sure, stroll on the beach. It’s something that takes me back to my childhood in Venezuela; the beach feels like home. If the waves are breaking more than a stroll, I’ll grab my paddleboard and catch some waves.

Rock ‘n’ roll or blue grass?

Blue grass in honor of my alma mater University of Louisville. I had minimal exposure before arriving in Louisville for my fellowship. I have to say that thing grows on you, and it totally became part of me.

The last book you read for fun?

Love in the Time of Cholera by Gabriel Garcia Marquez

One of my most prized possessions is…

my family.

One childhood blunder that I never have been able to forget is the time I…

took money from my mom’s purse without asking. I felt very ashamed afterwards and worst when they caught me. That taught me a great lesson and I never took anything that wasn’t mine ever again. This incident gave a new value to the importance of honesty. I’m not proud but I am glad I learned that lesson.

I wish that I had more time to…

ride horses, surf and run. I am very fond of sports and they are an essential element to my wellness. Before private practice, it was easier to take off. It is sometimes hard to keep a balance especially when my ADHD kicks in, which is often, lol.

The best advice I ever received from my parents was…

work hard and go the extra mile, it always pays off. This has been with me through my whole life, including school and my training. It is a premise that has helped me keep going in the hardest of times, through all the long nights, board testing, and calls taken especially during training when we are learning the ropes. Today, it is something that I continue to apply and realize has led me to a successful practice, building relationships with

patients and feeling happy with what I have accomplished.

If I were to write a book, the lead sentence might be…

in the words of Johnnie Walker, “Keep Walking” and in mine Never Stop Dreaming.

It sounds irrational, but I truly am afraid of…

heights! I’ll ski, I’ll hike, I’ll ride bicycles, horses, surf, anything … no sky diving for me though lol … and in my medical beginnings I was afraid of blood, oddly enough later becoming a hematologist.

I have had a lot of good mentors, but the best was…

throughout my life I have had a lot of amazing people who have mentored me and guided me in different aspects of life however the first people who come to mind are Dr. Luis T. Campos and Dr. Damian Laber. They both shaped the oncologist I am today. I will always be grateful for their guidance and for believing in me.

Once in a while, people will surprise you in the best of ways. I remember when…

it is always great when patients surprise me with a word or an act of kindness. I have fond memories of my rural rotations in Venezuela during med school, people there had very little to give, but did it with a lot of love. For example, the fisherman of the town would bring us fresh fish at the end of the day in gratitude for our service, the lady who cooked “arepas” always dropped by with a few for us to eat and people would bring freshly picked fruits to the clinic. It was a very good time, and I had the opportunity to live in a community where I learned about the real riches of life.

For me, a great day at work is one that includes…

the phrase …”you are on REMISSION.”

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For more information on a specific location, please visit FLCancer.com.

Spring 2016 33

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 e-mail to FCS Marketing at marketing@FLCancer.com.

i have been a patient of Dr. Rubin’s for many years. In that

time, I have had cause to avail myself of the services of most of your staff. They are all excellent, and I have never had any reason to complain. While you do not always get the same nurse or technician, they are all excellent.

In particular today, I would like to let you know how important Bill Grass is to me. He has been a constant I can depend on. I feared I would lose him when he moved out of state, but thanks to video conferencing, this did not happen. Bill is so knowledgeable and

knows my history. He has the ability to be empathic so that I feel comfortable in speaking with him about anything that is bothering me medically. Even when I just need to vent, he will allow it, and I feel validated even though there is nothing to be done. In my 10-year struggle to survive Stage IV breast cancer, there have been many ups and downs. Dr. Rubin has kept me alive, and I do not in any way want to undermine this fact. However, I do not feel comfortable taking up too much of his time. That is where Bill comes in. I know I will be able to tell him about anything I may have forgotten to tell Dr. Rubin or thought might not be that important. I am never made to feel like I am imposing on his time when I speak to Bill. His pleasant demeanor allows for open communication.

I hope I will never lose Bill Grass a part of Dr. Rubin’s team. He is invaluable to me and the role he plays could not be replaced.

Very truly yours,“A patient in Bonita Springs”

I just completed a two-month infusion protocol at the Tampa Cancer Center location on Martin Luther King Blvd. According to the doctors, the Ritauxin infusion treatments will eliminate the Non-Hodgkin’s lymphoma (stomach cancer).

I write to you because I was overwhelmed with a “culture of caring” at the Florida Cancer Center here in Tampa. Dr. Christopher George, his NP assistant, Lisa Laches, and everyone I came into contact with, exhibited a friendly, caring attitude. From the front desk reception to

the lab nurses, to the infusion nurses and even the business checkout personnel … all were not only professional in their duties, but had a cheerful demeanor in doing their jobs. I witnessed some very sick people being cared for by unbelievable caring TCC employees.

I do hope you will pass on my appreciation to the TCC facility employees who went out of their way to successfully treat this grateful patient.

“A patient of the Tampa Cancer Center”

FCSpatient letters

Mark Rubinbill Grass

34 FCS The Magazine

immunotherapyChanging the Landscape of Oncology TreatmentBY KATIE GOODMAN, DIRECTOR OF RESEARCH; MANISH PATEL, M.D.; JUDY wANG, M.D.

We have all witnessed the advancements made in the field of immuno-oncology that have changed the way we practice. Because of the successful results

from numerous trials, drugs such as Pembrolizumab (Keytruda) and Nivolumab (Opdivo) have recently been approved for NSCLC, melanoma and renal cell cancer. The trials that studied these PD-1 inhibitors have paved the way for other therapies involving PD-L1 inhibitors and promising immune targets, such as IDO, OX40, LAG3 and TNF. In conjunction with our colleagues at SCRI in Nashville, the practice has been involved in many of the clinical trials that eventually led to the approval of a wide range of new drugs, including immunotherapies. As many of you can attest, the clinical benefits our patients have experienced while on these immunotherapies have been rewarding to witness. The tolerability of these therapies is encouraging and the combination trials that have been formed as a result can change the way we practice oncology.

The practice and our patients have the unique opportunity to gain access to numerous clinical trials that involve immunotherapies. This sets us apart from most outpatient oncology clinics and on level with many major academic centers that have large clinic trial programs. Our continued involvement with these trials has and will lead to more trials involving other promising immunotherapies. We have the advantage of becoming comfortable with the administration and management of these therapies through the clinical trials, while yielding encouraging responses for our patients. Currently within our Phase I Drug Development Unit (DDU), we have several immunotherapy trials that could be possible for your patients. The timing of the slots is variable, but we’d be happy to investigate the possibilities for each patient, as the trials evolve. Shown below is a current listing of immunotherapy-based trials performed within the DDU:

MEL41 – PD-L1 inhibitor as triplet therapy with a BRAF inhibitor (Vemurafenib) and a MEK inhibitor (Cobimetinib) for first line metastatic BRAF mutated melanoma

RM 312 – PD-L1 inhibitor as monotherapy for select solid tumor types, including metastatic gastric and urothelial cancers

RM 376 – PD-L1 inhibitor in combination with an

oral IDO inhibitor, blocking a known pathway that suppresses T cell function, for NSCLC, HNSCC and melanoma

RM 316 – Nivolumab in combination with PEG-IL10, blocking anti-inflammatory cytokine and upregulating T cell recruitment, for NSCLC, RCC and melanoma

RM406 – PD-L1 inhibitor in combination with either an oral CXCR2 inhibitor, blocking recruitment of tumor-protective mesenchymal-derived stem cells, or an infusional STAT3 inhibitor, blocking a known pathway for cancer stem cells, for HNSCC

RM412 – PD-L1 inhibitor in combination with an oral WEE1 inhibitor, blocking a potent DNA cell cycle checkpoint thereby promoting aberrant DNA subject to apoptosis, for solid tumors

In addition to the DDU trials, there are Phase II/III trials open in various regions that involve PD-L1 inhibitors. These include several trials for NSCLC with PD-L1 inhibitors, such as LUN282, LUN298, LUN308 and LUN299. Some of these trials provide the unique opportunity to provide immunotherapy in the adjuvant and first line metastatic setting. There is also the BRE258 trial with a PD-L1 inhibitor given with Abraxane in the first line setting for triple negative breast cancer, MULTI04 with a PD-L1/2 inhibitor in gastric/GEJ/bladder CA and GU127 with a PD-L1 inhibitor in renal cell.

Our group is quite fortunate to have access to these interesting and possible practice changing immunotherapy trials. The patients in Florida should be made aware of these opportunities. As always, the better we enroll to these trials, the more opportunities we have to gain access to other promising immunotherapies in the future. This field is certainly moving quickly.

Judy Wang, M.D.

Manish Patel, M.D.

Katie Goodman, RN, bSN, CCRP

rESEarCh SPoTlIghT

Spring 2016 35

latest generation in Bone scansNew Technology Aids in Cancer Detection, MonitoringBY LEVESTER JONES JR., C.N.M.T., B.S., DIRECTOR OF RADIOLOGY AND JEFF ESHAM, MBA, RTT, VICE PRESIDENT OF RADIATION & RADIOLOGY

molecular Imaging’s most underutilized resource for assessing altered osteogenic activity is the 18F-Sodium

Fluoride (NaF) PET/CT bone scan. Multiple published studies from experts including Evan-Sapir, Siegel and Schirrmeister have demonstrated NaF PET/CT’s superiority over conventional bone imaging in detecting early bone reaction when small bone marrow metastases are present.

NaF PET/CT differentiates the presence or absence of systemic disease and, unlike conventional planar imaging, can detect both lytic and blastic lesions. This highly sensitive test is a preferable alternative to traditional bone scans. Since CMS approved coverage of 18F-NaF PET/CT bone scans through the National Oncologic PET Registry (NOPR) for Medicare beneficiaries with known or suspected cancer, many of our FCS physicians have taken advantage of this cutting-edge technology by utilizing it to detect and monitor their patients with metastatic bone cancer in prostate, breast, lung and other prevalent cancers associated with high incidences of bone metastases.

The NOPR has prospectively assessed the impact of PET with NaF PET/CT on the intended management of patients with known or suspected osseous metastases in several studies. One study monitoring the treatment response to systemic therapies consisted of 2,217 patients (68% prostate, 17% breast, 6% lung and 8% other cancers) and showed a 40% change in management associated with NaF PET/CT. In patients with prior NaF Pet/CT scans for comparison, 79% continued with current therapy when scans showed no change or a decrease or absence of osseous metastases. Treating physicians switched therapy in 59% of patients after scans showed evidence of new or progressive metastases.

Although the physiological basis of F18 NaF and 99mTc MDP, HDP are similar, there are a number of advantages associated with NaF.

The minimal protein binding and rapid blood pool clearance with NaF, when compared to 99mTc based products, offers superior bone to background ratios with

little residual retention in the soft tissues and kidneys. These attributes allow for superior image quality and faster injection to scan time resulting in faster report turnaround times as well as patient convenience.

Additionally, the NaF PET/CT scan is significantly more accurate with improvements in both specificity and sensitivity so clinical decisions based on the results of the procedure are more likely to be accurate. The NaF’s PET/CT bone scan combines the power of a PET’s high spatial resolution with the anatomical correlation and tomographic nature of the CT, leading to an improvement in sensitivity of 20%-40% and specificity of approximately 40% when compared to traditional planar imaging.

Sodium Fluoride Bone PET/CT scans offer many advantageous features versus conventional bone scans; the superior pharmacokinetics combined with the higher spatial and contrast resolution of the PET/CT scanner yield a more confident identification and classification of systemic bone disease and may eliminate the need for additional procedures, thus decreasing radiation exposure. In addition, patients may be offered a more expedient pathway to treatment and better quality of life in addition to cost savings.

Conventional bone scan: 30mCi 99mtc MDP

PET/CT bone scan: 10mCi F18NaF

Levester Jones Jr., C.N.M.T., b.S.

Jeff Esham, Mba, RTT

raDIology SPoTlIghT

36 FCS The Magazine

Spring 2016 37

at 15, he was already smitten by Valeria, his high school sweetheart—and computer engineering. He was, after all, tinkering with medical software already as a teenager.

He kept the girl, but after five years of writing medical software in his homeland of Brazil, Lucio Navarro Gordan, M.D.—who grew up in a family of physicians—thought something was missing.

human interaction.“I realized my passion was caring for patients one-to-one and

applying new knowledge and concepts to help people,” the 46-year-old physician reflects.

Today after joining Florida Cancer Specialists & Research Institute’s (FCS) Gainesville medical team six years ago, this medical oncologist/hematologist is thrilled to be able to do both.

And after his residency in internal medicine at the University of Iowa, he and Valeria (his bride of 21 years) ventured south to the University of Florida, where he completed his fellowship and she earned a master’s degree and later joined the faculty in the Restorative Dental Sciences Department as director of practice-based research.

Listing the many “extracurricular” responsibilities Gordan has, in addition to his role as an oncologist/hematologist, would spill off more than a page. “If I had to rank them in order of importance and time spent, I would say the Executive Board, Information Technology and Quality Committee, then Compliance Committee …” he continues down the line via telephone interview as he makes the three-and-a-half-hour drive from Gainesville to Sarasota for a board meeting.

Gordan remains active in clinical research and has received numerous awards for his work, as well as being published in such prestigious journals as Oncologist, Leukemia & Lymphoma, and the Journal of Clinical Oncology. In addition to his professional achievements, he provides sponsorship for the academic studies of approximately 30 children through Compassion International worldwide, and is a strong supporter of several charitable organizations, including Doctors Without Borders, Gainesville’s Hippodrome Theater and the Florida Cancer Specialists Foundation.

With leadership responsibilities, 40 patients a day, a new 48,000-square-foot medical facility about to open and the Community Oncology Alliance (COA) conference (April 14-15 in

Orlando) to co-chair, not to mention a busy working wife and an active 11-year-old daughter to tend to, balancing his very full plate requires an advanced level of dexterity.

“It’s a dynamic up and down and can be tricky,” he confesses adding with a soft laugh. “My wife and I are very organized.”

And this compassionate physician wouldn’t have it any other way.“Even if I were to take a break, I’d probably do the very same thing

again … I just love what I do; it’s a part of me,” he says.Exploring the world by traveling the globe also is a big part of who

all the Gordans are as a family.“We have been to 60 countries on five continents,” Gordan says.

“We love being outdoors, music, sports, but travel is number one,” adds Valeria, a hands-on crafter, who especially loves going “off road” to explore the local culture.

Bringing the family on one another’s business trips is one way this active couple carves out quality time and feeds their travel bug.

“We are always on the go, but we are happy,” he says.Gordan is also very proud to play a part in the oncology field during

what he says is one of the most “dynamic” times in medical history.Though the fast, forward movement in oncology can seem

“overwhelming,” even for a self-confessed research and data junkie, this award-winning, highly lauded medical expert says his success is due to “staying on top of things” by reading several medical papers and journals every day and also to his dedicated team of highly skilled nurses, administrators and fellow doctors.

Valeria says her husband’s personality and demeanor serves him well as a physician.

“He’s a gentle person with a calm way of looking at life,” she says admiringly. “He has great emotional intelligence and treats his patients with respect … and the many cards and gifts he receives show they appreciate that about him.”

His colleagues agree. Gordan has been honored with a host of awards over the years, including the prestigious Frist Humanitarian Award in 2013. According to Ward Boston, President and CEO of the North Florida Medical Center, where Gordan has practiced for nearly 20 years, Frist recipients are “living examples of patient-centered care and of going above and beyond for their community.”

above and BeyondPhysician Combines Passions for Research and Patients BY ZANDRA wOLFGRAM

DoCTor SPoTlIghT

38 FCS The Magazine

BY MICHAEL DIAZ, M.D.Florida Society of Clinical Oncology PresidentCommunity Oncology Alliance SecretaryFCS Director of Patient Advocacy

F lorida Cancer Specialists advocates for our community oncology patients nationally, recognizing that a great deal of health care policy is determined by the Medicare system and our elected officials in Washington. As the

Director of Patient Advocacy, with the guidance of our Executive Management team and Executive Board, my role is to coordinate efforts and our resources with Community Oncology Alliance

(COA), a national advocacy organization for community oncology patients and practices, located in Washington.

COA has been heavily involved in pursuing site payment parity, correction of unintended consequences of legislation and evolution of the oncology care delivery system. Privately owned community oncology practices are in a crisis in this country for a multitude of reasons. In 2004, 86 percent of oncology care was provided in a community oncology clinic with the balance occurring in hospital-owned outpatient clinics. In 2014, 55 percent of oncology care was given in a community oncology clinic, with 45 percent given in a hospital-owned outpatient clinic.

Recent studies have shown that the same care given in a hospital-owned outpatient oncology clinic costs Medicare (and thus society) 50 percent more compared to a community oncology clinic. The reasons for the shift of care to hospital-owned outpatient clinics are primarily due to decreased reimbursement for chemotherapy medications (in some settings the medication is reimbursed less than the cost of the medication) and increased reimbursement for the exact same care in a hospital-owned clinic compared to a private practice clinic.

We have successfully passed legislation that limits economic reimbursement of future hospital-owned clinics to that of community practice clinics. This step can save oncology patients and society 50 percent of outpatient clinic care costs for Medicare patients alone. Reduction of site payment differences will not go away and will continue to evolve in the years to come.

We are attempting to have the Prompt Pay Bill (HR 696) and the Sequestration Relief Bill (HR 1416) passed to fix unintended consequences of legislation that decreases reimbursement for Medicare Part B medications to less than the cost to the practice for several medications for some clinics.

We are attempting to pass legislation (HR 1934) that will implement an Oncology Demonstration Project based on the Oncology Medical Home, which has been demonstrated to decrease the cost of cancer care by 20 percent in a CMMI project that involved several practices across the county. This will ensure and improve the quality and value of care we provide our patients.

All of these efforts are focused on ensuring high quality, affordable, accessible oncology care for our patients that is close to their homes.

in pursuit of parityPatients are at center of public policy advocacy work

what's on your radar?the radar screen

Dr. Michael Diaz with COa Executive Director Ted Okron.

Spring 2016 39

Join us on Cinco de Mayo for

SAVE THE DATE

Thursday, May 5, 20166pm – 9pm

EmKo Art Gallery | 2119 South Dixie Highway West Palm Beach, FL 33401

west Palm Beach Art&JewelryAuction

to benefit

For More Information and to Register for the Event: Foundation.FLCancer.com/WPBArt

For Partners Direct Ledger, please contact Terri Gagliardi at TGagliardi@FLCancer.com or call 941.677.7192.

$50 per person (pre-event) | $75 at door

Includes heavy hors d’oeuvres and open bar (beer, wine and margaritas)

• Stunning photography provided by Dr. Stan Winokur and Mary Jane Zapp

• One-of-a-kind jewelry by

Visit NINLARO-hcp.com to learn more

Takeda Oncology and are registered trademarks of Takeda Pharmaceutical Company Limited.NINLARO is a registered trademark of Millennium Pharmaceuticals, Inc.

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