Summer 2021 1
SUMMER 2021
Conquering Cancer
Personalized treatment leads
to recovery and good health
Important Safety Information
Octagam® 10% is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as
anaphylaxis, to human immunoglobulin. Octagam 10% contains trace amounts of IgA (average 106 μg/mL in a 10% solution).
It is contraindicated in IgA-deficient patients with antibodies against IgA and history of hypersensitivity. The most serious
drug-related adverse event reported with Octagam 10% treatment was a headache (0.9% of subjects). The most common
drug-related adverse reactions reported in >5% of the subjects during a clinical trial were headache, fever, and increased
heart rate.
Please see accompanying Highlights of full Prescribing Information for additional important information.
©2021. Octapharma USA Inc. All rights reserved.
Date of preparation: 5/2021. GAM10-0226-PAD
WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE
Please see accompanying Highlights of full Prescribing Information for additional important information.
■ Thrombosis may occur with immune globulin intravenous (IGIV) products, including Octagam® 10%. Risk factors
may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial
thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.
■ Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with the administration of Immune
Globulin Intravenous (Human) (IGIV) products in predisposed patients. Renal dysfunction and acute renal failure occur
more commonly in patients receiving IGIV products containing sucrose. Octagam 10% does not contain sucrose.
■ For patients at risk of thrombosis, renal dysfunction or renal failure, administer Octagam 10% at the minimum
infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and
symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
Enhancements to our FDA-approved manufacturing facilities have
yielded substantial increases in the supply of octagam 10%
Expanded Supply for the US Market
JOSEPH CANNON
Vice President, National Accounts
Joseph.Cannon@octapharma.com | 201.604.1126
Preserving
Immunoglobulin Integrity
For the treatment of adults with chronic
immune thrombocytopenic purpura (ITP)
Contact us today for pricing information.
Available Exclusively for Florida Cancer Specialists
From Oncology Supply
COPAY SUPPORT for patients
with commercial insurance
UP TO $2,500 PER YEAR
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
OCTAGAM 10% safely and effectively. See full prescribing information
for OCTAGAM 10%.
OCTAGAM 10% [Immune Globulin Intravenous (Human)]
liquid solution for intravenous administration
Initial U.S. Approval: 2014
WARNING
THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE
See full prescribing information for complete boxed warning
• Thrombosis may occur with immune globulin intravenous (IGIV)
products, including OCTAGAM 10%. Risk factors may include:
advanced age, prolonged immobilization, hypercoagulable conditions,
history of venous or arterial thrombosis, use of estrogens, indwelling
vascular catheters, hyperviscosity, and cardiovascular risk factors.
• Renal dysfunction, acute renal failure, osmotic nephropathy, and
death may occur with the administration of Immune Globulin
Intravenous (Human) (IGIV) products in predisposed patients. Renal
dysfunction and acute renal failure occur more commonly in patients
receiving IGIV products containing sucrose. OCTAGAM 10% does
not contain sucrose.
• For patients at risk of thrombosis, renal dysfunction or renal
failure, administer OCTAGAM 10% at the minimum infusion
rate practicable. Ensure adequate hydration in patients before
administration. Monitor for signs and symptoms of thrombosis and
assess blood viscosity in patients at risk for hyperviscosity.
-----------------------INDICATIONS AND USAGE------------------------------
• OCTAGAM 10% is an immune globulin intravenous (human)
liquid preparation indicated for the treatment of chronic immune
thrombocytopenic purpura (ITP) in adults.
------------------ DOSAGE AND ADMINISTRATION -------------------------
For intravenous use only.
Indication
Dose
Initial Infusion rate
Maintenance Infusion
Rate (if tolerated)
Chronic
ITP
1 g/kg daily for 2
consecutive days
1.0 mg/kg/min
(0.01 mL/kg/min)
Up to 12.0 mg/kg/min
(Up to 0.12 mL/kg/min)
• Ensure that patients with pre-existing renal insufficiency are not
volume depleted; discontinue OCTAGAM 10% if renal function
deteriorates.
• For patients at risk of renal dysfunction or thrombotic events, administer
OCTAGAM 10% at the minimum infusion rate practicable.
-----------------DOSAGE FORMS AND STRENGTHS------------------------
Solution containing 10% IgG (100 mg/mL)
------------------------- CONTRAINDICATIONS---------------------------------
• History of anaphylactic or severe systemic reactions to human
immunoglobulin
• IgA deficient patients with antibodies against IgA and a history of
hypersensitivity
-------------------WARNINGS AND PRECAUTIONS --------------------------
• IgA-deficient patients with antibodies against IgA are at greater risk
of developing severe hypersensitivity and anaphylactic reactions to
OCTAGAM 10%. Epinephrine should be available immediately to treat
any severe acute hypersensitivity reactions.
• Monitor renal function, including blood urea nitrogen and serum
creatinine, and urine output in patients at risk of developing acute
renal failure.
• Falsely elevated blood glucose readings may occur during and after the
infusion of OCTAGAM 10% with testing by some glucometers and test
strip systems.
• Hyperproteinemia, increased serum osmolarity and hyponatremia may
occur in patients receiving OCTAGAM 10%.
• Hemolysis that is either intravascular or due to enhanced red blood cell
sequestration can develop subsequent to OCTAGAM 10% treatments.
Risk factors for hemolysis include high doses and non-O-blood group.
Closely monitor patients for hemolysis and hemolytic anemia.
• Aseptic Meningitis Syndrome may occur in patients receiving
OCTAGAM 10%, especially with high doses or rapid infusion.
• Monitor patients for pulmonary adverse reactions (transfusion-related
acute lung injury (TRALI)).
• OCTAGAM 10% is made from human plasma and may contain infectious
agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease
agent.
------------------------- ADVERSE REACTIONS---------------------------------
The most common adverse reactions reported in greater than 5% of subjects
during a clinical trial were headache, fever and increased heart rate.
To report SUSPECTED ADVERSE REACTIONS, contact Octapharma
at 1-866-766-4860 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
--------------------------DRUG INTERACTIONS---------------------------------
The passive transfer of antibodies may:
Confound the results of serological testing.
Interfere with the immune response to live viral vaccines, such as measles,
mumps, and rubella.
------------------ USE IN SPECIFIC POPULATIONS--------------------------
• Pregnancy: no human or animal data. Use only if clearly needed.
• Geriatric Use: In patients over age 65 or in any person at risk of
developing renal insufficiency, do not exceed the recommended dose, and
infuse OCTAGAM 10% at the minimum infusion rate practicable.
Revised: August 2018
Drug Safety:
For all inquiries relating to drug safety, or to report adverse events, please contact our local Drug Safety Officer:
Tel: 201-604-1137 | Cell: 201-772-4546 | Fax: 201-604-1141 or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Medical Affairs:
usmedicalaffairs@octapharma.com
Tel: 888-429-4535
Reimbursement:
usreimbursement@octapharma.com
Tel: 800-554-4440 | Fax: 800-554-6744
4 FCS Magazine
DEPARTMENTS
22
People & Places
26
Foundation Update
27
From Our Patients
SPOTLIGHTS
16
Genetics Program Expansion
18
Informatics
20
Patient Advocacy
FEATURES
06
Patient Feature: Time, Distance
and Cancer: A Love Story
10
Executive Leadership Team
Welcomes New Additions
IN
THIS
ISSUE
06
22
20
16
We welcome your feedback, article suggestions
and photos (high resolution please).
Email to FCSCommunications@FLCancer.com
On the cover: Vikas Malhotra, MD, with patient
Peggy Moore; Photography by Blake Jones
Summer 2021 5
PHYSICIAN LEADERSHIP
PRESIDENT & MANAGING PHYSICIAN
LUCIO GORDAN, MD
ASSISTANT MANAGING PHYSICIAN
DIRECTOR OF PATIENT ADVOCACY
MICHAEL DIAZ, MD
MEDICAL DIRECTOR OF CLINICAL
RESEARCH OPERATIONS
GUSTAVO FONSECA, MD
PHYSICIAN DIRECTOR OF COMPLIANCE
JOSE ALEMAR, MD
PHYSICIAN DIRECTOR OF FINANCE
MAEN HUSSEIN, MD
PHYSICIAN DIRECTOR OF QUALITY
JORGE AYUB, MD
EXECUTIVE LEADERSHIP
CHIEF EXECUTIVE OFFICER
NATHAN H. WALCKER
CHIEF OPERATING OFFICER
JASON COE
CHIEF ADMINISTRATIVE OFFICER
JOYCE NELSON
CHIEF FINANCIAL OFFICER
RICH MACCLARY
CHIEF LEGAL OFFICER & GENERAL COUNSEL
NANCY ARDELL
CHIEF PROCUREMENT OFFICER
PAUL CHADWICK
CHIEF COMPLIANCE OFFICER
VALERIE EASTWOOD
PUBLISHED BY
IN PARTNERSHIP WITH
NATHAN H. WALCKER,
CHIEF EXECUTIVE OFFICER:
Our cover story in this issue of
FCS Magazine is a touching
example of the bonds that
develop between our oncologists
and their patients. With
exceptional skill and knowledge
and access to the most advanced treatments, they can
replace shock and fear with hope and healing. Stories
like these are told daily across our practice.
Information technology plays a key role in cancer
treatment and research, as well. Be sure to read about
how we are leveraging data intelligence initiatives in
the Informatics feature.
As we continuously strive to enhance the patient
experience, providing convenience and comfort as
well as operational efficiencies is essential. In the first
half of 2021, we began construction on several new
clinic locations and celebrated the opening of others.
(Details in People & Places.) These state-of-the-art
facilities are equipped with the latest technologies as
well as unique elements that foster well-being.
FCS continues to set the bar for community
oncology. This is exciting work and it takes a skilled
team. I acknowledge and thank all our FCS physicians
and team members for their unwavering commitment
to excellence and innovation, and a patient-first
approach.
LUCIO GORDAN, MD,
PRESIDENT & MANAGING
PHYSICIAN:
At FCS we are making giant leaps
forward for community oncology
as we continue to implement
advanced diagnostics, innovative
therapies and treatments.
The expansion of genetic testing capabilities in
our FCS Laboratory is a significant milestone. Next
generation sequencing enables us to correlate a
patient’s diagnosis with any mutation that was identified.
In turn, we can make better and faster decisions for our
patients, which results in better outcomes. I thank and
congratulate our skilled team members whose efforts
and expertise are bringing us many steps closer to truly
personalized medicine.
As physicians, our commitment to the wellbeing
of our patients extends beyond our clinic walls. I am
so proud of our leadership involvement in numerous
advocacy initiatives at both the state and national
levels. Two of our colleagues have gone above and
beyond in this regard. They are actively engaged in
legislative efforts to ensure that cancer patients can
easily access care in their local communities that is
affordable and of the highest quality. You’ll learn more
in our Advocacy Update.
We are proud of our ongoing successes as we strive
to improve patient outcomes and work to conquer
cancer. Thank you all for your support.
6 FCS Magazine
PATIENT FEATURE
Summer 2021 7
hen Peggy Moore was diagnosed with
pancreatic cancer early in 2020, she and
her husband, Brian, had to prepare for a
grueling fight to survive one of the most
difficult cancers of all.
Relying on their faith and the expertise of Dr. Vikas
Malhotra, a medical oncologist who practices at the FCS
Brooksville and Spring Hill locations, they never lost hope.
This was not the first time Peggy and Brian had faced a
cancer diagnosis, and they knew it would be a long battle.
They also knew their love and marriage had already conquered
time and distance, so they were prepared
to persevere.
The couple first met almost 50 years ago, when Brian was
a 26-year-old Peace Corps volunteer in Lima, Peru. Born in
Hartford, Connecticut, Peggy had moved to Peru at the age of
5 with her Peruvian father and American mother, who was the
Peace Corps office manager.
Brian recalls, “Peggy’s mother would occasionally invite
some of us volunteers for a home-cooked meal, and I
remember Peggy as a bright and attractive 14-year-old girl.
I spent several years in South America in the Corps, and I
became friends with the family. We kept in touch after we
moved back to the U.S.”
Life went on and Peggy grew up, married and started a
family in Florida. Brian remained a bachelor.
After Peggy’s husband passed away in 1998, their ongoing
friendship blossomed into a romantic relationship. The couple
dated for almost five years before then 60-year-old Brian
asked Peggy to be his bride in 2003 — 34 years and an entire
continent away from where and when they had first met.
In 2012, Peggy was diagnosed with stage 3 breast cancer
Time, Distance
and Cancer:
A Love Story
BY ELAINE GANICK
PATIENT FEATURE
PHOTO BY BLAKE JONES
8 FCS Magazine
and was referred to FCS and Dr. Malhotra. She wanted to be
treated close to home. Unsure whether a community oncology
practice would have the most advanced treatments, she sought
a second opinion from a large academic medical center over
an hour’s drive away. That second opinion concurred with
everything Dr. Malhotra had told her, and so she began
treatment at FCS.
Brian accompanied her on every visit, treatment and
follow-up appointment. By 2018, Peggy’s cancer was
in remission.
Then, early in 2020, Peggy noticed a discoloration in her
urine. When it did not clear up, Brian convinced her to see
a doctor, who referred her to a local hospital ER. There, she
underwent several tests and scans before the ER doctor told
her, “You have a tumor on your pancreas. Get your affairs in
order, you have three months to live.”
Peggy remembers the shock and fear. She and Brian
immediately called Dr. Malhotra. “Dr. Malhotra was outraged
when I told him what the ER doctor said to me,” Peggy says.
“He pointed out that the ER physician did not know my
medical history and likely was not aware of some of the most
recent breakthroughs in treating pancreatic cancer.”
Dr. Malhotra gave the couple some much-needed
reassurance and hope. He explained that because Peggy’s
tumor was located on the head of her pancreas, she had a
much better chance for survival than most patients.
He proposed aggressive chemotherapy treatment followed
by a complex surgery known as a Whipple procedure.
“We trusted him implicitly,” Peggy says. “Dr. Malhotra
was honest and direct with us. He explained the risks and the
survival rates and that he had had some success with this kind
of approach … so we put my life in his hands.” Brian adds, “I
put my life in his hands too. I waited over 30 years for Peggy,
and I wasn’t ready to lose her.”
Following chemotherapy, Peggy underwent the Whipple
surgery, which typically removes the head of the pancreas,
the first part of the small intestine, the gallbladder and the
bile duct. It is a difficult operation and can have serious risks;
however, the surgery can be lifesaving.
When the tumor was removed and biopsied, there was no
sign of cancer. Peggy’s surgeon credits the good outcome to
Dr. Malhotra’s use of a personalized chemotherapy regimen for
Peggy that reduced the cancer prior to the surgery. Brian agrees
and says, “We think his treatment plan was responsible for
Peggy’s recovery and good health.”
Today, almost a year later, Peggy is cancer-free. She gets
follow-up blood work every two weeks and goes in every six
months for a check-up to make sure everything is going well.
The couple is eager to share the advice that has helped them
navigate time, distance and cancer as they look toward the
future together. “Take it one day at a time … and don’t believe
everything you read on the internet or you’ll drive yourself
crazy,” she said. “Keep your faith, and don’t give up hope.”
“Dr. Malhotra was honest and direct with us. He explained the risks and
the survival rates and that he had had some success with this kind of
approach… so we put my life in his hands.”
Brian and Peggy Moore's
wedding day, Nov. 13, 2003.
PHOTO BY BLAKE JONES
Summer 2021 9
PATIENT FEATURE
10 FCS Magazine
GET TO KNOW
Executive Leadership Team Welcomes New Additions
s a former U.S. Navy officer,
Rich MacClary has always valued
service and excellence. In Florida
Cancer Specialists & Research
Institute (FCS), he found both. “I was
certainly aware of FCS as a highly respected
and well-branded company. It’s always
rewarding to work for a company that has a
broader mission of serving the community.”
Prior to joining the company in
February 2021, MacClary held various
leadership positions establishing strategic
direction and driving financial growth
for public and private equity-backed
companies. His healthcare experience spans
multi-site services, information technology
and electronic payments.
He held senior financial leadership
roles with Alliance Oncology, a division of
Alliance Healthcare Services, Healthcare
Holdings of America, Comdata Inc. and
Emdeon (now Change Healthcare). When
working for the U.S. Navy, he began his
career as an officer on the staff of the U.S.
Naval Nuclear Propulsion Program in
Washington, D.C.
MacClary graduated cum laude from
Duke University with an undergraduate
degree in economics and later earned an
accounting certificate from the University
of Virginia. He received an MBA from
Duke University’s Fuqua School of Business,
where he was named a Fuqua Scholar.
Having grown up in the Fort Lauderdale
area, MacClary says he was eager to return
to Florida, and he is excited to help guide
FCS through continued growth and its
next chapter.
“I am excited to be here,” he said.
“We are maturing as a company and as a
financial organization, and we are ensuring
that our foundation is strong.”
MacClary praised FCS’ resilience and
staying power in the face of the ongoing
coronavirus pandemic. “I really do think FCS
has weathered the pandemic very, very well,”
he said. “The company can be very proud
that it didn’t furlough or lay off employees.
Not many businesses can say that. While
we certainly have had our challenges, the
company has performed well.”
MacClary attributes that success to
the organization’s leadership and diverse
workforce.
“They are very, very smart people,”
he said. “We have such a broad group of
scientists and professionals working under
one roof.”
An avid outdoorsman and fisherman,
MacClary enjoys spending time with his
wife, Kristin, and their four children. He
has also served his community as a volunteer
for several Catholic organizations.
Rich MacClary
Chief Financial Officer
hen Nancy Ardell got
her first look at Florida
Cancer Specialists &
Research Institute (FCS),
she knew it was a place she wanted to be.
“The dynamic team won me over,” she
said. “Everyone I interviewed with, Dr.
Lucio Gordan, Executive Board members
and the leadership team, were all so
dedicated and committed to advancing
cancer care.”
A seasoned attorney with more than
25 years of experience in healthcare,
senior living and banking, Ardell has long
been drawn to the mission of healthcare
companies. “If you’re in healthcare (even
in a supporting role such as legal), you’re
playing a small role in changing the
trajectory of people’s lives. It’s hard not to
be motivated by that,” she said.
When she was a senior in high school,
she watched her mother start over and go
to law school — a path that eventually
led to her mother becoming a judge and
sitting on the bench for 18 years. “My
mom’s enthusiasm really sparked the idea
of my going to law school,” said Ardell,
who earned an undergraduate degree in
economics from DePauw University and
her law degree from the Chicago-Kent
College of Law.
She enjoys helping healthcare
organizations navigate the complex legal
landscape. “The exciting thing about the
field of health law is that it is constantly
changing. No week or day is the same,”
she says.
Prior to joining FCS in April, she served
as Executive Vice President and Chief
Legal Officer for Northwest Community
Healthcare, a $1.8 billion community-
based health system in the Chicago area.
Prior to that, Ardell was the Executive
Vice President and General Counsel for
Enlivant, which operates 230 assisted living
and memory care facilities across 26 states.
She has also held in-house counsel roles at
Northwestern Memorial Healthcare and
the Shirley Ryan AbilityLab in Chicago.
Since starting at FCS, Ardell has enjoyed
touring clinics and connecting with FCS
physicians and team members across the
company. “The FCS legal team is here to
serve as a trusted partner to the business
people and clinicians. Involve us early in
discussions, we are here to help,” she says.
Ardell and husband, Doug, recently
relocated from Chicago to Tampa. Their
three children, Hailey, JT and Grant, are
all in college.
“We’re having fun getting to know a
new city,” she said. “This move is a chance
for us to have a new adventure.”
Nancy Ardell
Chief Legal Officer & General Counsel
CLINICAL
2021
SAVE THE DATE:
October 22-24, 2021
Ritz Carlton Grande Lakes Orlando
4012 Central Florida Parkway, Orlando, FL 32837
For more information contact
Lynn Clemens at LClemens@FLCancer.com
FLCancer.com
INDICATIONS
TRODELVY® (sacituzumab govitecan-hziy) is a Trop-2-directed antibody
and topoisomerase inhibitor conjugate indicated for the treatment of adult
patients with:
• Unresectable locally advanced or metastatic triple-negative breast cancer
(mTNBC) who have received two or more prior systemic therapies, at least
one of them for metastatic disease.
• Locally advanced or metastatic urothelial cancer (mUC) who have previously
received a platinum-containing chemotherapy and either programmed
death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. This
indication is approved under accelerated approval based on tumor response
rate and duration of response. Continued approval for this indication
may be contingent upon verifi cation and description of clinical benefi t in
confi rmatory trials.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: NEUTROPENIA AND DIARRHEA
• Severe or life-threatening neutropenia may occur. Withhold
TRODELVY for absolute neutrophil count below 1500/mm3 or
neutropenic fever. Monitor blood cell counts periodically during
treatment. Consider G-CSF for secondary prophylaxis. Initiate anti-
infective treatment in patients with febrile neutropenia without delay.
• Severe diarrhea may occur. Monitor patients with diarrhea and
give fl uid and electrolytes as needed. Administer atropine, if not
contraindicated, for early diarrhea of any severity. At the onset of late
diarrhea, evaluate for infectious causes and, if negative, promptly
initiate loperamide. If severe diarrhea occurs, withhold TRODELVY
until resolved to ≤Grade 1 and reduce subsequent doses.
CONTRAINDICATIONS
• Severe hypersensitivity reaction to TRODELVY.
WARNINGS AND PRECAUTIONS
Neutropenia: Severe, life-threatening, or fatal neutropenia can occur and may
require dose modifi cation. Neutropenia occurred in 61% of patients treated
with TRODELVY. Grade 3-4 neutropenia occurred in 47% of patients. Febrile
neutropenia occurred in 7%. Withhold TRODELVY for absolute neutrophil
count below 1500/mm3 on Day 1 of any cycle or neutrophil count below
1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever.
Diarrhea: Diarrhea occurred in 65% of all patients treated with TRODELVY.
Grade 3-4 diarrhea occurred in 12% of patients. One patient had intestinal
perforation following diarrhea. Neutropenic colitis occurred in 0.5% of
patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when
resolved to ≤Grade 1. At onset, evaluate for infectious causes and if negative,
promptly initiate loperamide, 4 mg initially followed by 2 mg with every
episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide
12 hours after diarrhea resolves. Additional supportive measures (e.g., fl uid
and electrolyte substitution) may also be employed as clinically indicated.
Patients who exhibit an excessive cholinergic response to treatment can
receive appropriate premedication (e.g., atropine) for subsequent treatments.
Hypersensitivity and Infusion-Related Reactions: Serious
hypersensitivity reactions including life-threatening anaphylactic reactions
have occurred with TRODELVY. Severe signs and symptoms included
cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis,
and skin reactions. Hypersensitivity reactions within 24 hours of dosing
occurred in 37% of patients. Grade 3-4 hypersensitivity occurred in 2% of
patients. The incidence of hypersensitivity reactions leading to permanent
discontinuation of TRODELVY was 0.3%. The incidence of anaphylactic
reactions was 0.3%. Pre-infusion medication is recommended. Observe
patients closely for hypersensitivity and infusion-related reactions during
each infusion and for at least 30 minutes after completion of each infusion.
Medication to treat such reactions, as well as emergency equipment, should
be available for immediate use. Permanently discontinue TRODELVY for
Grade 4 infusion-related reactions.
TRODELVY, the TRODELVY logo, Gilead and the GILEAD logo are trademarks of Gilead Sciences, Inc. ©2021 Gilead Sciences, Inc. All rights reserved. 2021-US-TROU-00060 04/21
OFFER A DIFFERENT POSSIBILITY. SCAN TO VISIT TRODELVYHCP.COM.
TRODELVY attacks tumors with an antibody-drug conjugate (ADC)
that binds to Trop-2.1
Based on preclinical data. May not correlate with clinical outcomes.
A WAY IN
WITH TRODELVY
Nausea and Vomiting: Nausea occurred in 66% of all patients treated with
TRODELVY and Grade 3 nausea occurred in 4% of these patients. Vomiting
occurred in 39% of patients and Grade 3-4 vomiting occurred in 3% of
these patients. Premedicate with a two or three drug combination regimen
(e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1
receptor antagonist as well as other drugs as indicated) for prevention of
chemotherapy-induced nausea and vomiting (CINV). Withhold TRODELVY
doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional
supportive measures when resolved to Grade ≤1. Additional antiemetics and
other supportive measures may also be employed as clinically indicated. All
patients should be given take-home medications with clear instructions for
prevention and treatment of nausea and vomiting.
Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1
Activity: Patients homozygous for the uridine diphosphate-glucuronosyl
transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia,
febrile neutropenia, and anemia and may be at increased risk for other
adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia
was 67% in patients homozygous for the UGT1A1*28, 46% in patients
heterozygous for the UGT1A1*28 allele and 46% in patients homozygous for
the wild-type allele. The incidence of Grade 3-4 anemia was 25% in patients
homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the
UGT1A1*28 allele, and 11% in patients homozygous for the wild-type allele.
Closely monitor patients with known reduced UGT1A1 activity for adverse
reactions. Withhold or permanently discontinue TRODELVY based on clinical
assessment of the onset, duration and severity of the observed adverse
reactions in patients with evidence of acute early-onset or unusually severe
adverse reactions, which may indicate reduced UGT1A1 function.
Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can
cause teratogenicity and/or embryo-fetal lethality when administered to
a pregnant woman. TRODELVY contains a genotoxic component, SN-38,
and targets rapidly dividing cells. Advise pregnant women and females
of reproductive potential of the potential risk to a fetus. Advise females of
reproductive potential to use eff ective contraception during treatment with
TRODELVY and for 6 months after the last dose. Advise male patients with
female partners of reproductive potential to use eff ective contraception
during treatment with TRODELVY and for 3 months after the last dose.
ADVERSE REACTIONS
In the ASCENT study (IMMU-132-05), the most common adverse
reactions (incidence ≥25%) were fatigue, neutropenia, diarrhea, nausea,
alopecia, anemia, constipation, vomiting, abdominal pain, and decreased
appetite. The most frequent serious adverse reactions (SAR) (>1%) were
neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in
27% of patients, and 5% discontinued therapy due to adverse reactions. The
most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT
study were reduced neutrophils, leukocytes, and lymphocytes.
In the TROPHY study (IMMU-132-06), the most common adverse
reactions (incidence ≥25%) were diarrhea, fatigue, neutropenia, nausea,
any infection, alopecia, anemia, decreased appetite, constipation, vomiting,
abdominal pain, and rash. The most frequent serious adverse reactions
(SAR) (≥5%) were infection (18%), neutropenia (12%, including febrile
neutropenia in 10%), acute kidney injury (6%), urinary tract infection (6%),
and sepsis or bacteremia (5%). SAR were reported in 44% of patients, and
10% discontinued due to adverse reactions. The most common Grade 3-4
lab abnormalities (incidence ≥25%) in the TROPHY study were reduced
neutrophils, leukocytes, and lymphocytes.
DRUG INTERACTIONS
UGT1A1 Inhibitors: Concomitant administration of TRODELVY with
inhibitors of UGT1A1 may increase the incidence of adverse reactions due
to potential increase in systemic exposure to SN-38. Avoid administering
UGT1A1 inhibitors with TRODELVY.
UGT1A1 Inducers: Exposure to SN-38 may be substantially reduced
in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid
administering UGT1A1 inducers with TRODELVY.
Reference: 1. TRODELVY [package insert]. Foster City, CA: Gilead Sciences, Inc.; April 2021.
Please see Brief Summary of full Prescribing Information, including
BOXED WARNING, on the next page.
ANNOUNCING 2 NEW FDA APPROVALS FOR TRODELVY1
FOR METASTATIC TRIPLE-NEGATIVE
BREAST CANCER (mTNBC)
NEW EXPANDED INDICATION
INDICATION: TRODELVY is indicated for the treatment of
adult patients with unresectable locally advanced or mTNBC
who have received 2 or more prior systemic therapies,
at least one of them for metastatic disease.
GIVING YOU THE ABILITY
TO OFFER AN OPTION AS EARLY AS 2L
IN THE METASTATIC SETTING
In ASCENT, a phase 3 trial, ~1 out of 8 patients (13%) in the TRODELVY
group in the full population received only 1 prior line of systemic therapy
in the metastatic setting (in addition to having disease recurrence or
progression within 12 months of neoadjuvant/adjuvant systemic therapy).1
FOR METASTATIC UROTHELIAL
CANCER (mUC)
INDICATION: TRODELVY is indicated for the treatment of
adult patients with locally advanced or mUC who received a platinum-
containing chemotherapy and either programmed death receptor-1
(PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
This indication is approved under accelerated approval
based on tumor response rate and duration of response.
Continued approval for this indication may be contingent
upon verifi cation and description of clinical benefi t in
confi rmatory trials.
NEW INDICATION NOW APPROVED
TRODELVY® (sacituzumab govitecan-hziy) for injection, for intravenous use
Brief Summary of full Prescribing Information. See full Prescribing Information. Rx Only.
WARNING: NEUTROPENIA AND DIARRHEA
• Severe or life-threatening neutropenia may occur. Withhold TRODELVY for absolute neutrophil count
below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Consider
G-CSF for secondary prophylaxis. Initiate anti-infective treatment in patients with febrile neutropenia
without delay.
• Severe diarrhea may occur. Monitor patients with diarrhea and give fluid and electrolytes as needed.
Administer atropine, if not contraindicated, for early diarrhea of any severity. At the onset of late
diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea
occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses.
[See Warnings and Precautions and Dosage and Administration]
INDICATIONS AND USAGE
Also seeClinical Studies
TRODELVY (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated
for the treatment of adult patients with:
• Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior
systemic therapies, at least one of them for metastatic disease.
• Locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing
chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. This
indication is approved under accelerated approval based on tumor response rate and duration of response. Continued
approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
DOSAGE AND ADMINISTRATION
Also seeWarnings and Precautions
Do NOT substitute TRODELVY for or use with other drugs containing irinotecan or its active metabolite SN-38.
The recommended dose of TRODELVY is 10 mg/kg administered as an intravenous infusion once weekly on Days 1 and
Y Y
8 of 21-day treatment cycles. Continue treatment until disease progression or unacceptable toxicity. Do not administer
TRODELVY at doses greater than 10 mg/kg. Administer TRODELVY as an intravenous infusion only. Do not administer as an
intravenous push or bolus.
• First infusion: Administer infusion over 3 hours. Observe patients during the infusion and for at least 30 minutes
following the initial dose, for signs or symptoms of infusion-related reactions.
• Subsequent infusions
: Administer infusion over 1 to 2 hours if prior infusions were tolerated. Observe patients during the
infusion and for at least 30 minutes after infusion.
• Premedication: Prior to each dose of TRODELVY, premedication for prevention of infusion reactions and prevention of
chemotherapy-induced nausea and vomiting (CINV) is recommended. Premedicate with antipyretics, H1 and H2 blockers
prior to infusion, and corticosteroids may be used for patients who had prior infusion reactions. Premedicate with a two
or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor
antagonist, as well as other drugs as indicated).
Dose Modifications for Infusion-related Reactions: Slow or interrupt the infusion rate of TRODELVY if the patient
develops an infusion-related reaction. Permanently discontinue TRODELVY for life-threatening infusion-related reactions.
Dose Modifications for Adverse Reactions: Withhold or discontinue TRODELVY to manage adverse reactions as
described below. Do not re-escalate the TRODELVY dose after a dose reduction for adverse reactions has been made.
Severe Neutropenia
, defined as Grade 4 neutropenia ≥7 days, OR Grade 3 febrile neutropenia (absolute neutrophil count
or ANC <1000/mm3 and fever ≥38.5°C), OR at time of scheduled treatment, Grade 3-4 neutropenia which delays dosing
by 2 or 3 weeks for recovery to ≤ Grade 1:
• At first occurrence, 25% dose reduction and administer granulocyte-colony stimulating factor (G-CSF). At second
occurrence, 50% dose reduction. At third occurrence, discontinue TRODELVY.
• At time of scheduled treatment, if Grade 3-4 neutropenia occurs which delays dosing beyond 3 weeks for recovery to
≤Grade 1, discontinue TRODELVY at first occurrence.
Severe Non-Neutropenic Toxicity
y, defined as Grade 4 non-hematologic toxicity of any duration, OR any Grade 3-4 nausea,
y,y
vomiting or diarrhea due to treatment that is not controlled with antiemetics and anti-diarrheal agents, OR other Grade 3-4
non-hematologic toxicity persisting >48 hours despite optimal medical management, OR at time of scheduled treatment,
Grade 3-4 non-neutropenic hematologic or non-hematologic toxicity, which delays dose by 2 or 3 weeks for recovery to
≤Grade 1:
• At first occurrence, 25% dose reduction. At second occurrence, 50% dose reduction. At third occurrence, discontinue
TRODELVY.
• In the event of Grade 3-4 non-neutropenic hematologic or non-hematologic toxicity, which does not recover to ≤Grade 1
within 3 weeks, discontinue TRODELVY at first occurrence.
CONTRAINDICATIONS
Also seeWarnings and Precautions
TRODELVY is contraindicated in patients who have experienced a severe hypersensitivity reaction to TRODELVY.
WARNINGS AND PRECAUTIONS
Also seeBOXED WARNING, Dosage and Administration, Contraindications, Clinical Pharmacology, Nonclinical
Toxicology, andUse in Specific Populations
Neutropenia: Severe, life-threatening, or fatal neutropenia can occur in patients treated with TRODELVY. Neutropenia
occurred in 61% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 47% of patients. Febrile
neutropenia occurred in 7% of patients. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or neutrophil
count below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Dose modifications may be
required due to neutropenia.
Diarrhea:TRODELVY can cause severe diarrhea. Diarrhea occurred in 65% of all patients treated with TRODELVY. Grade 3-4
diarrhea occurred in 12% of all patients treated with TRODELVY. One patient had intestinal perforation following diarrhea.
Neutropenic colitis occurred in 0.5% of patients. Withhold TRODELVY for Grade 3-4 diarrhea at the time of scheduled
treatment administration and resume when resolved to ≤ Grade 1. At the onset of diarrhea, evaluate for infectious causes
and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a
maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g.,
fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive
cholinergic response to treatment with TRODELVY (e.g., abdominal cramping, diarrhea, salivation, etc.) can receive
appropriate premedication (e.g., atropine) for subsequent treatments.
Hypersensitivity and Infusion-Related Reactions: Serious hypersensitivity reactions including life-threatening
anaphylactic reactions have occurred with TRODELVY treatment. Severe signs and symptoms included cardiac arrest,
hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24
hours of dosing occurred in 37% of patients treated with TRODELVY. Grade 3-4 hypersensitivity occurred in 2% of patients.
The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.3%. The incidence of
anaphylactic reactions was 0.3%. Premedication for infusion reactions in patients receiving TRODELVY is recommended.
Have medications and emergency equipment to treat infusion-related reactions, including anaphylaxis, available for
immediate use when administering TRODELVY. Closely monitor patients for hypersensitivity and infusion-related reactions
during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for
Grade 4 infusion-related reactions.
Nausea and Vomiting:TRODELVY is emetogenic. Nausea occurred in 66% of all patients treated with TRODELVY. Grade 3
nausea occurred in 4% of patients. Vomiting occurred in 39% of patients. Grade 3-4 vomiting occurred in 3% of these
patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor
antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of CINV. Withhold TRODELVY
doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to
≤Grade1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients
should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.
Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the
uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile
neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of
neutropenia and anemia was analyzed in 701 patients who received TRODELVY and had UGT1A1 genotype results. The
incidence of Grade 3-4 neutropenia was 67% in patients homozygous for the UGT1A1*28 (n=87), 46% in patients
heterozygous for the UGT1A1*28 allele (n=301), and 46% in patients homozygous for the wild-type allele (n=313). The
incidence of Grade 3-4 anemia was 25% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous
for the UGT1A1*28 allele, and 11% in patients homozygous for the wild-type allele. Closely monitor patients with known
reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on onset, duration,
and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse
reactions, which may indicate reduced UGT1A1 enzyme activity.
Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal
lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets
rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise
females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after
the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during
treatment with TRODELVY and for 3 months after the last dose.
ADVERSE REACTIONS
Also seeBOXED WARNING, Warnings and Precautions, and Clinical Studies
The pooled safety population described in the Warnings and Precautions section reflect exposure to TRODELVY as a
single agent in 795 patients from three studies, IMMU-132-01, IMMU-132-05 and IMMU-132-06 which included 366
patients with mTNBC who had received prior systemic chemotherapy for advanced disease and 180 patients with mUC.
Among the 795 patients treated with TRODELVY, the median duration of treatment was 4.1 months (range: 0 to 59 months).
The most common (≥ 25%) adverse reactions were nausea (66%), diarrhea (65%), fatigue (62%), neutropenia (61%),
alopecia (45%), anemia (42%), vomiting (39%), constipation (37%), decreased appetite (34%), rash (32%) and
abdominal pain (28%).
Metastatic Triple-Negative Breast Cancer
The safety of TRODELVY was evaluated in a randomized, active-controlled, open-label trial (ASCENT, IMMU-132-05) in
patients with mTNBC who had previously received a taxane and at least two prior therapies. Patients were randomized
(1:1) to receive either TRODELVY (n=258) or single agent chemotherapy (n=224) and were treated until disease
progression or unacceptable toxicity. For patients treated with TRODELVY, the median duration of treatment was 4.4
months (range: 0 to 23 months). Serious adverse reactions occurred in 27% of patients, and those in > 1% included
neutropenia (7%), diarrhea (4%), and pneumonia (3%). Fatal adverse reactions occurred in 1.2% of patients, including
respiratory failure (0.8%) and pneumonia (0.4%). TRODELVY was permanently discontinued for adverse reactions in 5%
of patients. These adverse reactions (≥1%) were pneumonia (1%) and fatigue (1%). The most frequent (≥5%) adverse
reactions leading to a treatment interruption in 63% of patients were neutropenia (47%), diarrhea (5%), respiratory
infection (5%), and leukopenia (5%). The most frequent (>4%) adverse reactions leading to a dose reduction in 22% of
patients were neutropenia (11%) and diarrhea (5%). G-CSF was used in 44% of patients who received TRODELVY. The
most common adverse reactions (≥25%) were fatigue, neutropenia, diarrhea, nausea, alopecia, anemia, constipation,
vomiting, abdominal pain, and decreased appetite. The most common Grade 3-4 lab abnormalities (≥25%) were
decreased neutrophils (49%), decreased leukocytes (41%), and decreased lymphocytes (31%).
Locally Advanced or Metastatic Urothelial Cancer
The safety of TRODELVY was evaluated in a single-arm, open-label study (TROPHY, IMMU-132-06) in patients (n=113)
with mUC who had received previous platinum-based and anti-PD-1/PD-L1 therapy. Serious adverse reactions occurred in
44% of patients, and those in >1% included infection (18%), neutropenia (12%, including febrile neutropenia in 10%),
acute kidney injury (6%), urinary tract infection (6%), sepsis or bacteremia (5%), diarrhea (4%), anemia, venous
thromboembolism, and small intestinal obstruction (3% each), pneumonia, abdominal pain, pyrexia, and
thrombocytopenia (2% each). Fatal adverse reactions occurred in 3.6% of patients, including sepsis, respiratory failure,
epistaxis, and completed suicide. TRODELVY was permanently discontinued for adverse reactions in 10% of patients. The
most frequent of these adverse reactions was neutropenia (4%, including febrile neutropenia in 2%). The most common
adverse reactions leading to dose interruption in 52% of patients were neutropenia (27%, including febrile neutropenia
in 2%), infection (12%), and acute kidney injury (8%). The most common (>4%) adverse reactions leading to a dose
reduction in 42% of patients were neutropenia (13%, including febrile neutropenia in 3%), diarrhea (11%), fatigue (8%),
and infection (4%). G-CSF was used in 47% of patients who received TRODELVY. The most common adverse reactions
(incidence ≥25%) were diarrhea, fatigue, neutropenia, nausea, any infection, alopecia, anemia, decreased appetite,
constipation, vomiting, rash, and abdominal pain. The most common Grade 3-4 lab abnormalities (≥25%) were
decreased neutrophils (43%), decreased leukocytes (38%), and decreased lymphocytes (35%). Other clinically significant
adverse reactions (≤15%) include: peripheral neuropathy (12%), sepsis or bacteremia (9%), and pneumonia (4%).
DRUG INTERACTIONS
Also seeWarnings and PrecautionsandClinical Pharmacology
UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of
adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with
TRODELVY.
UGT1A1 Inducers: Exposure to SN-38 may be substantially reduced in patients concomitantly receiving UGT1A1 enzyme
inducers. Avoid administering UGT1A1 inducers with TRODELVY.
USE IN SPECIFIC POPULATIONS:
Also seeWarnings and Precautions, Clinical Pharmacology,and Nonclinical Toxicology
d d
Pregnancy: TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman.
There are no available data in pregnant women to inform the drug-associated risk. Advise pregnant women and females
of reproductive potential of the potential risk to a fetus.
Lactation:There is no information regarding the presence of sacituzumab govitecan-hziy or SN-38 in human milk, the
effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a
breastfed child, advise women not to breastfeed during treatment and for 1 month after the last dose of TRODELVY.
Females and Males of Reproductive Potential:Verify the pregnancy status of females of reproductive potential prior
to initiation. TRODELVY can cause fetal harm when administered to a pregnant woman. Advise females of reproductive
potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose.
Males: Advise male patients with female partners of reproductive potential to use effective contraception during
treatment with TRODELVY and for 3 months after the last dose.
Infertility: Based on findings in animals, TRODELVY may impair fertility in females of reproductive potential.
Pediatric Use: Safety and effectiveness of TRODELVY have not been established in pediatric patients.
Geriatric Use: Of the patients who received TRODELVY, 264/795 (33%) of all patients were ≥ 65 years old, and 11% were
≥75 years old. No overall differences in safety and effectiveness were observed between these patients and younger patients.
Hepatic Impairment: No adjustment to the starting dose is required when administering TRODELVY to patients with
mild hepatic impairment (bilirubin ≤ 1.5 ULN and AST/ALT < 3 ULN). The safety of TRODELVY in patients with moderate
or severe hepatic impairment has not been established, and no recommendations can be made for the starting dose in
these patients.
See PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
TRODELVY, the TRODELVY logo, GILEAD and the GILEAD logo are trademarks of Gilead Sciences, Inc. ©2021 Gilead Sciences, Inc. All rights reserved. 2021-US-TROU-00060 04/21
Our Journey.
A cancer diagnosis can feel unexpected, leaving you questioning
what to do next. But, within 72 hours*, Florida Cancer Specialists
gives you and your family the comfort of a personalized treatment
plan. Our experienced doctors and nurses provide immunotherapy,
the latest technologies from clinical trials and targeted treatment
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*All required paperwork must be provided at time of referral.
16 FCS Magazine
lorida Cancer Specialists & Research
Institute (FCS) will launch an array of new
genetic testing capabilities this summer,
ushering in some of the most personalized
patient care in the organization’s history.
Starting in July, the FCS Laboratory will expand
to provide in-house molecular testing, or next-
generation sequencing (NGS), for its oncology
patients. The effort, initiated by FCS physicians,
including Ryan Olson, MD, Medical Director of the
FCS Pathology Laboratory, was brought to fruition
under the guidance of Claudia French, FCS Vice
President of Laboratory Services & Operational
Excellence.
For French and her team, the end goal is better
and faster diagnosis and treatment planning, which
leads to more positive outcomes. Cancer is not really
a single disease but a conglomeration of thousands
or tens of thousands of individual diseases that share
the commonality of disordered cell growth. NGS
testing detects mutations in hundreds of different
genes simultaneously, thus giving a more unique
understanding of each patient’s individual diagnosis.
This information can then be used to personalize
therapy, increasing cure rates and extending lives.
“We want to make sure we can provide genetic
testing when it is needed,” French said. “Many times,
treatment decisions are made on NGS sequencing
test results and turnaround time in the commercial
labs can be over a month.”
Jennifer Gass, PhD, who completed her fellowship
training in Laboratory Genetics and Genomics,
recently joined FCS as Associate Director of the
Genetics Laboratory. She and Gina Elhammady,
MD, a molecular pathologist on the FCS Lab team,
are playing a key role in bringing these expanded
capabilities to fruition.
“When I got here, there was nothing in the lab,”
Dr. Gass recalled. “I had to start from scratch, which
has been challenging during a pandemic. A lot of the
instruments we needed were the same instruments
used in COVID-19 testing, so it’s been a challenge
… but we finally have everything and are finishing
up validations.” The new laboratory is equipped
with multiple Illumina NextSeq sequencing systems,
Hamilton robotic liquid handlers and various
supporting instruments to provide state-of-the-art
clinical NGS testing.
Initially, Gass and Dr. Elhammady, along with
three FCS technologists, will offer NGS testing on
solid tumors, hematologic malignancies and lymph
nodes, and they are aiming for a turnaround time of
10 to 15 days.
“One of the great things about having it in-house
is that we are in direct communication with the
clinicians,” Dr. Elhammady said. “We are the ones
who sign off on the original diagnosis, and so we make
the decision whether an NGS test is needed or not.”
The lab will be able to correlate the patient’s
diagnosis with any mutation that was found through
NGS testing, she added.
“Previously, physicians have told patients, ‘You
have lung cancer.’ By adding NGS, it is, ‘You have
lung cancer, with this specific mutation, in this
specific gene,’ ” Gass said. “When we know the
specific genetic alteration that person has, there may
be a therapy that actually targets that mutation.”
The new in-house NGS testing also aligns with FCS’
recent efforts to expand its genetic counseling capabilities.
FCS Genetics Counselor Cathy Marinak, AOCNP
welcomes the in-house NGS testing and sees it as a
vital tool in helping her patients understand the big-
picture implications of a single cancer diagnosis.
“It’s really rare that a genetic mutation results in
risk for only one cancer,” she said. “It just doesn’t
happen. Think about the BRCA1 mutation —
it increases risk for ovarian cancer, melanoma,
pancreatic cancer, breast cancer and prostate cancer.
It goes on and on.”
In-house NGS testing will allow physicians to
test for somatic or acquired mutations and inherited
germline mutations, to develop more comprehensive
cancer risk assessments.
“That would be done concurrently,” added
Marinak, a nurse practitioner with specialized training
in genetic counseling. “What we would ultimately love
to have is if a patient came in with a specific diagnosis,
the physician knows they can access the pancreatic
Gina Elhammady, MD
Molecular Pathologist
Claudia French
Vice President of
Laboratory Services &
Operational Excellence
Jennifer Gass, PhD
Associate Director,
Genetics Laboratory
Cathy Marinak, AOCNP
Genetics Counselor
GENETICS PROGRAM EXPANSION
Genetic Testing,
Counseling Set to Expand at FCS
BY KARI C. BARLOW
Summer 2021 17
GENETICS PROGRAM EXPANSION
panel, for instance, or the breast panel, or
melanoma panel.
“We would just make it simple — one
stop shopping.”
With those test results, Marinak can
better counsel her patients as they go
through treatment, make important
lifestyle changes, undergo preventative
surgery or explore reproductive options.
“From my perspective, I think it is just
such a privilege to work for an organization
that understands the value of the genetic
counseling piece,” Marinak said. “The FCS
physicians embrace it, and they understand
the role that it plays — not just for the
patient but also for the families.”
French agreed, adding that making
these new testing capabilities the norm will
ultimately mean better, more targeted care
for FCS patients.
“The whole field of molecular medicine is
just really exciting,” she said. “Standardization
improves quality. So as we can standardize
how our doctors order this kind of testing
and what testing they order and what profiles
they get, we are going to be able to make
better decisions for patients.”
The next-generation sequencing workflow contains four basic steps: library preparation, amplification, sequencing and data
analysis. Following preparation, the DNA and RNA sample is amplified and sequenced, allowing the geneticist or pathologist to
analyze each patient’s genetic information. Graphic courtesy of Illumina.
ARRAY GENOTYPING WORKFLOW
18 FCS Magazine
n the fictional franchise Star Trek: The Next Generation, the crew of the USS
Enterprise relies on Lt. Cmdr. Data to help navigate them to victory by using
his innate gift of leveraging data intelligence.
Similarly, Trevor Heritage, PhD, FCS Vice President of Informatics, and the
first mate of his growing crew, FCS Senior Director of Informatics Amy Ming, are
leading a mission for Florida Cancer Specialists & Research Institute (FCS).
The task for this dynamic data duo is not small. Although their mandate is far
from science fiction, it is one they relish.
Tapping into his 30-plus years of experience, Heritage oversees informatics
projects across all care settings, enabling FCS to optimize its business processes while
enhancing clinical decision support, as well as data enrichment initiatives for research
and clinical trials. Ming, a registered nurse and a former Battalion Logistics Officer
with the U.S. Army, brings a unique blend of informatics and clinical knowledge to
her role, as well as the “clinical conscience” to do the right thing for patients.
Heritage, who joined FCS in December 2020, expounds on his team’s mission to
conquer five goals:
Amy Ming
Senior Director
of Informatics
Trevor Heritage, PhD
Vice President
of Informatics
Mining Mission
BY ZANDRA WOLFGRAM
Seeking truth in data
INFORMATICS
Summer 2021 19
1. Help FCS find ways to leverage
its data to make the best possible
business and clinical decisions
“The reality throughout healthcare is that
there are numerous types and formats for
data that is captured and kept in multiple
places. Before we can use data effectively,
we must sort it and create a robust, reliable
and consistent representation. Once we
have trusted data, a huge opportunity sits
before us to ultimately deliver a high-
quality experience for both our physicians
and our patients.”
2. Using data to tell the entire
story of a patient’s health
“Although we capture a huge amount of
information about our patients and their
health, there are still more data opportunities
that can help us better understand disease
and guide care. We are especially excited
about going live with FCS’ next-generation
sequencing operations this summer. Each
patient’s cancer is different. Analyzing all the
medical information gathered will allow us
to identify specific targeted therapies for our
patients, resulting in better outcomes with
fewer side effects. Additionally, we can use a
patient’s genetic profile to quickly and more
selectively identify relevant trials that they can
participate in close to home.”
3. Looking at new ways FCS can
create value from our data
“This digital age that we all live in today
offers a wealth of opportunities for FCS
to remain at the forefront of cancer care
and research. We are able to provide our
physicians with insights into individual
patient disorders and treatment options
and the tools to make decisions to optimize
care. It also enables us to understand the
demand for cancer care in specific regions
and marry up our services to demand.
Using our clinical data and patient
response to specific therapies — what we
call “real-world data” — will influence
the standard of care and impact new drug
discovery, development programs and
clinical trials.”
4. The protection of our data
“Our patients trust FCS not only to
provide them with outstanding care
but also to guard their personal health
information. We operate according to
regulatory guidelines of protected health
information, and we also are pursuing
HITRUST certification. This will give our
patients the added confidence that FCS
goes above and beyond in ensuring the
security and meaningful use of the data
they trust us with.”
5. Up-keep of our data
“To make sure our data is healthy, we
have launched a data governance initiative
company-wide to protect, secure and
accurately gather all the information
FCS has access to. With the constant
flow of patient visits, new data coming
in constantly, new diagnostic testing
technologies, and new therapies and
guidelines, as well as new regulations, our
data environment is extremely dynamic.”
Clearly, the Informatics team’s task is
not small.
“It’s challenging, given the complexities of
healthcare, to accurately gather all relevant
patient data, analyze it and deliver those
insights across the organization,” Heritage says.
“I’m confident in our ability to accomplish this
and thrilled that FCS has not only recognized
the need, but also committed to the journey.”
INFORMATICS
“Each patient’s cancer is
different. Analyzing all
the medical information
gathered will allow
us to identify specific
targeted therapies for our
patients, resulting in better
outcomes with fewer
side effects.”
20 FCS Magazine
rs. Michael Diaz and Paresh
Patel are tireless champions
for the greater good. Both are
10-year veterans with Florida
Cancer Specialists & Research Institute
(FCS). As patient advocacy ambassadors,
they share an unwavering commitment to
ensure that cancer patients have access to
high-quality, state-of-the-art and affordable
cancer care that is close to home. Their
unwavering efforts to optimize the quality
and value of the cancer care delivery system
extend well beyond their clinic office hours.
Working in the state’s capital gives
Dr. Patel a convenient perch for his
advocacy work through the Florida Society
for Clinical Oncology (FLASCO). He is
chairman of the Legislative Committee for
FLASCO, which recently recognized him
as the 2021 Advocate of the Year.
Dr. Diaz, based in St. Petersburg, is
past president of the FLASCO board
of directors and serves as Director of
Advocacy and as Federal Legislative
Chairman. His advocacy work with the
American Society of Clinical Oncology
ASCO®’s Payment Reform Work Group
and the Community Oncology Alliance
(COA), where he is immediate past
president, allow him to work reform at
the federal level.
Together, these two physicians are
akin to “David” in the ancient parable,
standing up to healthcare insurance and big
pharma’s “Goliath” in representing patients
and community oncology providers in
legislative health issues.
We spoke with them about their
advocacy efforts and what it means to FCS
and its patients. Here are highlights:
PATIENT ADVOCACY
The Crusaders
BY ZANDRA WOLFGRAM
Champions in the fight for
quality and affordability
Michael Diaz, MD speaks at
a recent Community
Oncology Alliance
(COA) session.
FCS: WHY DO YOU CHOOSE
TO INVEST YOUR TIME IN
THIS WAY?
MD: We have to live by our ideals
and represent them. It’s important.
If we don’t, no one else is going to.
PP: It’s not everyone’s thing. The
patient drives you. Taking caring
of patients is my priority.
FCS: WHY IS THERE A NEED
FOR WHAT YOU DO?
MD: With the way society,
governmental structures and the
medical system are composed,
someone needs to represent
the patients because they’re not
informed enough to represent
themselves adequately at the table
compared to the government,