We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness...

32
FCS FOUNDATION EVENTS  » SPOTLIGHT ON OCALA OFFICE   » RADAR SCREEN Winter 2014 THE MAGAZINE INSIDE Medicine Runs In This Family Drs. Vasundhara and Meera Iyengar

Transcript of We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness...

Page 1: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

FCSfoundation events » spotlight on ocala office  » RadaR scReen

Winter 2014

THE MAGAZINE

INSIDE

Medicine Runs In This Family

Drs. Vasundhara and Meera Iyengar

Page 2: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

We Support the Health of your PracticeWith the Same Dedication that You Support Your Patients

Your number one priority is the health of your patients. With the changing healthcare landscape, our number one priority is the business health of your practice.

Dedicated exclusively to the viability of community oncology, ION Solutions provides contracting, technology, education and advocacy support that ensures you have the tools to run your practice both efficiently and effectively. With the practice support of ION Solutions, you can navigate this changing environment and focus on providing quality care for your patients.

To learn how ION Solutions enables community oncology practices to improve operational efficiency, financial performance and quality of care, contact your Strategic Account Manager or visit IONonline.com.

To experience ION Solutions advocacy support, visit ourcommunitycounts.org.

Page 3: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

Winter 2014 3

winter 2014contents

Dear Colleagues,

“What gets measured gets improved.” – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class”

Almost a year ago, with support from Brad Prechtl, Dr. Bill Harwin and the executive board, we began working in earnest on our Operational Excellence Program. The overarching goal of this program is to deliver superior service to our patients through a committed focus on improving quality, productivity and efficiency.

One of the key components of this program was the development and implementation of our Operational

Excellence Playbook. This playbook was developed by our clinical and administrative leaders from each of the regions along with support from our central service teams. It consists of more than 80 best practices or standard operating procedures categorized by functional area that are used by our team members on a daily basis.

During the latter part of this quarter, small teams will be visiting each office to assess the adoption and implementation of our best practices. As part of this process, we will be rewarding and recognizing offices with the highest adoption and assessment scores. As with any good playbook, it will remain dynamic as we continue to measure and work to improve upon our results.

Looking forward we plan to continue to expand the Operational Excellence Program through the development of a formal customer experience program. This will include customer service training for all of our team members to enhance our patient experience and working collaboratively with human resources to improve our employee engagement across the organization.

We hope that you are beginning to see the results of countless hours of hard work by our team. If you have questions or suggestions for our program, please feel free to email me directly.

Thank you all for the continued support of our Operational Excellence Program.

Todd SchonherzChief Operating Officer

Message from

Todd Schonherz, COOPhySICIan leadeRShIP

President 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 finAnciAl officer libby Slater

chief oPerAting officer tODD SCHONHerz

generAl counsel tOm Clark

chief MArketing & sAles officer SHelly GleNN

chief huMAn resources officer SHarON Dill

senior vice President, rAdiAtion/rAdiology And PArtnershiP services

eD merCaDO

vice President of revenue cycle SaraH CeVallOS

vice President of clinic finAnciAl services CHriStiNa SieVert

SenIOR ManageMenTJeremy beHliNG

Jeff eSHam tara ruSka

Jeffrey rubiNray bailey

lOiS brOWNmelODy CHaNG

DaViD CurryriCH DySON

miCHael eSSikiNGa GONzalezkatie GOODmaN

CHriStOpHer HOuSer Sue kearNey

lOiS pOelDeNiCe VeatCH

SamaNtHa WatkiNS

FCSTHE MAGAZINE

editor'sletter

Produced By

in PArtnershiP With

in this issue dePaRTMenTS 13 foundation events

16 update on integrative medicine

22 Shelly Glenn, Chief marketing & Sales Officer

24 Sue kearney, Director of Compliance

30 the radar Screen

SPOTlIghT 18 Doctor Spotlight:

Dr. marilyn raymond

20 Nurse Spotlight: Sean bliss

28 Office Spotlight: Ocala

FeaTuRe10 profile: Drs. meera and

Vasundhara iyengar

Page 4: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

Doctor anD nurse spotlight This supplemenT is sponsored and co-developed by millennium: The TaKeda oncoloGy company. parTicipanTs received compensaTion For Their Time and inpuT.

What is your treatment strategy for patients with previously untreated multiple myeloma?I try to divide patients into two basic groups: individuals who are candidates for high-dose chemotherapy and autologous transplants and those patients who are not eligible for transplant. These categories will influence my treatment decision. There is now a multitude of drugs and treatment options available and therefore an even greater number of possible treatment combinations. This multitude of combinations allows many patients to achieve improved outcomes with an appropriate treatment strategy. Our job as oncologists is really to make sure that we find the most appropriate treatment plan for each particular patient. That is why we really want to sit down and think about our approach as to optimize treatment sequencing throughout the continuum of care.

How long do you typically treat your patients with VELCADE® (bortezomib)-based therapy?My goal is to try and stay within the parameters of the VISTA trial where the study population was representative of what I see in day-to-day practice in south Florida.

Warnings and precautions (continued on subsequent pages)▼ Peripheral neuropathy, including severe cases, may occur. Patients should be monitored for symptoms and managed with dose modification or

discontinuation. Patients with preexisting symptoms may experience worsening peripheral neuropathy (including ≥Grade 3). Starting with VELCADE subcutaneously may be considered for patients who either have preexisting or are at high risk for peripheral neuropathy.

▼ Hypotension: Caution should be used when treating patients receiving antihypertensives, those with a history of syncope, and those who are dehydrated.

The VISTA trial was a randomized, open-label, international phase 3 trial (N=682) evaluating the efficacy and safety of VELCADE (bortezomib) administered intravenously in combination with melphalan plus prednisone (MP) vs MP in previously untreated multiple myeloma. After progressive disease was established, all patients were eligible to receive subsequent therapies. The primary endpoint was TTP. Secondary endpoints were CR, ORR, PFS, and OS.

shachar peles, Md West Palm Beach, JFK

What do you tell your patients when preparing for 1 year of VELCADE?Usually, one of the first questions you get from patients when they’re diagnosed with multiple myeloma is, “Doctor, I have kind of resigned myself to the fact that I need chemotherapy. How long am I going to be on it?” And every patient is hoping that you are going to say, “Oh, just three or four months,” but I tell him or her, “You are going to be on treatment for a while. In fact, my intention is to keep you on therapy for one year.” This may be hard for the patient to hear and that is why I think it is so important to sit with them and review the data from the VISTA trial together. I tell them the reason I am doing this is because this was the duration of therapy used in the VISTA trial.

VISTA trial results: 1-year (50 weeks) median of VELCADE delivered a >1-year median sustained overall survival (OS) advantage in combination with MP vs MP alone for previously untreated multiple myeloma

• Median OS of 56.4 vs 43.1 months, respectively; HR=0.695 (95% CI, 0.57-0.85); p<0.05

• Results were achieved using VELCADE twice-weekly followed by weekly dosing for a median of 50 weeks (54 weeks planned)1

For patients with previously untreated multiple myeloma, I plan to treat for one year with VELCADE-based therapy. Our electronic medical records (EMR) system at Florida Cancer helps me achieve my goal of staying within the parameters of the VISTA trial. All of Florida Cancer uses the same EMR. Typically, when you select a regimen in the EMR, it has a reference to the publication of the clinical trial, in this case VISTA, so you know to be consistent with the way the regimen was administered in the trial as it was published.

How would you characterize the safety profile of VELCADE over the course of 1 year?At the beginning of treatment, I explain to my patients that the toxicity profile of VELCADE is something that oncologists have become very familiar with because we have been using the drug for a while. I explain the most common adverse reactions with my patients so they feel prepared and confident. These include thrombocytopenia, neutropenia, peripheral neuropathy, nausea, diarrhea, neuralgia, anemia, and leukopenia. It’s also important for patients to be aware that serious adverse reactions may also occur.2

Multiple myeloma is currently considered an incurable disease. However, with the advent of novel

treatment approaches, many patients can now achieve improved outcomes. Millennium: The Takeda Oncology

Company had the opportunity to speak with Shachar Peles, MD, Maen Abdelkarim Hussein, MD, and Diane

Cope, PhD, ARNP, from Florida Cancer Specialists and Research Institute to learn about their treatment

approach and experience with 1 year of VELCADE (bortezomib)-based therapy in the treatment of

patients with previously untreated multiple myeloma.

Find out why your peers plan for 1 year of VELCADE® (bortezomib)

In combination with melphalan+prednisone (MP) for previously untreated multiple myeloma

indication: VELCADE is indicated for the treatment of patients with multiple myeloma.

contraindications: VELCADE is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol, including anaphylactic reactions. VELCADE is contraindicated for intrathecal administration. Fatal events have occurred with intrathecal administration of VELCADE.

please see important safety information on subsequent pages and Brief summary for VeLcade adjacent to this advertisement.

Photography by Liz Linder.

VISTA trial safety experience:

• In the VISTA trial studying VELCADE+MP (n=340) vs MP alone (n=337), the most common adverse reactions (ARs) were thrombocytopenia (48% vs 42%), neutropenia (47% vs 42%), peripheral neuropathy (PN) (46% vs 1%), nausea (39% vs 21%), diarrhea (35% vs 6%), neuralgia (34% vs <1%), anemia (32% vs 46%), and leukopenia (32% vs 28%)

• A total of 25% of patients in the treatment group receiving VELCADE+MP experienced serious ARs vs 18% in the treatment group receiving MP. The most commonly reported serious ARs with VELCADE+MP vs MP alone included pneumonia (5% vs 4%), diarrhea (4% vs 0%), thrombocytopenia (3% vs 1%), vomiting (3% vs <1%), nausea (2% vs <1%), anemia (2% vs 2%), herpes zoster (2% vs <1%), and dehydration (2% vs <1%)2

VEL214CDNY6136_FCS_Q_and_A_Ad_r19_FSU.indd 1-2 11/11/14 2:13 PM

Page 5: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

Doctor anD nurse spotlight This supplemenT is sponsored and co-developed by millennium: The TaKeda oncoloGy company. parTicipanTs received compensaTion For Their Time and inpuT.

What is your treatment strategy for patients with previously untreated multiple myeloma?I try to divide patients into two basic groups: individuals who are candidates for high-dose chemotherapy and autologous transplants and those patients who are not eligible for transplant. These categories will influence my treatment decision. There is now a multitude of drugs and treatment options available and therefore an even greater number of possible treatment combinations. This multitude of combinations allows many patients to achieve improved outcomes with an appropriate treatment strategy. Our job as oncologists is really to make sure that we find the most appropriate treatment plan for each particular patient. That is why we really want to sit down and think about our approach as to optimize treatment sequencing throughout the continuum of care.

How long do you typically treat your patients with VELCADE® (bortezomib)-based therapy?My goal is to try and stay within the parameters of the VISTA trial where the study population was representative of what I see in day-to-day practice in south Florida.

Warnings and precautions (continued on subsequent pages)▼ Peripheral neuropathy, including severe cases, may occur. Patients should be monitored for symptoms and managed with dose modification or

discontinuation. Patients with preexisting symptoms may experience worsening peripheral neuropathy (including ≥Grade 3). Starting with VELCADE subcutaneously may be considered for patients who either have preexisting or are at high risk for peripheral neuropathy.

▼ Hypotension: Caution should be used when treating patients receiving antihypertensives, those with a history of syncope, and those who are dehydrated.

The VISTA trial was a randomized, open-label, international phase 3 trial (N=682) evaluating the efficacy and safety of VELCADE (bortezomib) administered intravenously in combination with melphalan plus prednisone (MP) vs MP in previously untreated multiple myeloma. After progressive disease was established, all patients were eligible to receive subsequent therapies. The primary endpoint was TTP. Secondary endpoints were CR, ORR, PFS, and OS.

shachar peles, Md West Palm Beach, JFK

What do you tell your patients when preparing for 1 year of VELCADE?Usually, one of the first questions you get from patients when they’re diagnosed with multiple myeloma is, “Doctor, I have kind of resigned myself to the fact that I need chemotherapy. How long am I going to be on it?” And every patient is hoping that you are going to say, “Oh, just three or four months,” but I tell him or her, “You are going to be on treatment for a while. In fact, my intention is to keep you on therapy for one year.” This may be hard for the patient to hear and that is why I think it is so important to sit with them and review the data from the VISTA trial together. I tell them the reason I am doing this is because this was the duration of therapy used in the VISTA trial.

VISTA trial results: 1-year (50 weeks) median of VELCADE delivered a >1-year median sustained overall survival (OS) advantage in combination with MP vs MP alone for previously untreated multiple myeloma

• Median OS of 56.4 vs 43.1 months, respectively; HR=0.695 (95% CI, 0.57-0.85); p<0.05

• Results were achieved using VELCADE twice-weekly followed by weekly dosing for a median of 50 weeks (54 weeks planned)1

For patients with previously untreated multiple myeloma, I plan to treat for one year with VELCADE-based therapy. Our electronic medical records (EMR) system at Florida Cancer helps me achieve my goal of staying within the parameters of the VISTA trial. All of Florida Cancer uses the same EMR. Typically, when you select a regimen in the EMR, it has a reference to the publication of the clinical trial, in this case VISTA, so you know to be consistent with the way the regimen was administered in the trial as it was published.

How would you characterize the safety profile of VELCADE over the course of 1 year?At the beginning of treatment, I explain to my patients that the toxicity profile of VELCADE is something that oncologists have become very familiar with because we have been using the drug for a while. I explain the most common adverse reactions with my patients so they feel prepared and confident. These include thrombocytopenia, neutropenia, peripheral neuropathy, nausea, diarrhea, neuralgia, anemia, and leukopenia. It’s also important for patients to be aware that serious adverse reactions may also occur.2

Multiple myeloma is currently considered an incurable disease. However, with the advent of novel

treatment approaches, many patients can now achieve improved outcomes. Millennium: The Takeda Oncology

Company had the opportunity to speak with Shachar Peles, MD, Maen Abdelkarim Hussein, MD, and Diane

Cope, PhD, ARNP, from Florida Cancer Specialists and Research Institute to learn about their treatment

approach and experience with 1 year of VELCADE (bortezomib)-based therapy in the treatment of

patients with previously untreated multiple myeloma.

Find out why your peers plan for 1 year of VELCADE® (bortezomib)

In combination with melphalan+prednisone (MP) for previously untreated multiple myeloma

indication: VELCADE is indicated for the treatment of patients with multiple myeloma.

contraindications: VELCADE is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol, including anaphylactic reactions. VELCADE is contraindicated for intrathecal administration. Fatal events have occurred with intrathecal administration of VELCADE.

please see important safety information on subsequent pages and Brief summary for VeLcade adjacent to this advertisement.

Photography by Liz Linder.

VISTA trial safety experience:

• In the VISTA trial studying VELCADE+MP (n=340) vs MP alone (n=337), the most common adverse reactions (ARs) were thrombocytopenia (48% vs 42%), neutropenia (47% vs 42%), peripheral neuropathy (PN) (46% vs 1%), nausea (39% vs 21%), diarrhea (35% vs 6%), neuralgia (34% vs <1%), anemia (32% vs 46%), and leukopenia (32% vs 28%)

• A total of 25% of patients in the treatment group receiving VELCADE+MP experienced serious ARs vs 18% in the treatment group receiving MP. The most commonly reported serious ARs with VELCADE+MP vs MP alone included pneumonia (5% vs 4%), diarrhea (4% vs 0%), thrombocytopenia (3% vs 1%), vomiting (3% vs <1%), nausea (2% vs <1%), anemia (2% vs 2%), herpes zoster (2% vs <1%), and dehydration (2% vs <1%)2

VEL214CDNY6136_FCS_Q_and_A_Ad_r19_FSU.indd 1-2 11/11/14 2:13 PM

Page 6: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

DOCTOR AND NURSE SPOTLIGHT This suPPLemenT is sPonsored and co-deveLoPed By miLLennium: The TaKeda oncoLoGy comPany. ParTiciPanTs received comPensaTion For Their Time and inPuT.

What is your approach to the treatment of patients with previously untreated multiple myeloma?Multiple myeloma is a complex, incurable disease, requiring a long-term treatment strategy. I tell my patients that with an appropriate treatment sequence, we now can better treat across the multiple periods of response and remission.3-5 This is important because patients with multiple myeloma typically experience their best response and longest remission following initial therapy.

Upon relapse, subsequent therapies typically deliver poorer outcomes. That is why I implement a long-term treatment strategy from the start.

What is the typical length of treatment with VELCADE® (bortezomib)-based therapy?

Based on the results of the VISTA clinical trial, I aim to treat my patients with VELCADE (bortezomib) for one year or until we reach a tolerability threshold. The VISTA trial demonstrated that a 50-week median, or about one year of VELCADE-based therapy, delivered a greater than one-year median overall survival advantage over MP for patients with previously untreated multiple myeloma who are ineligible for transplant. I believe that starting with one year of therapy is imperative as the clinical evidence also indicates that at the three-year median follow-up, VELCADE-based therapy provided an overall survival benefi t that was not regained with subsequent therapies. Of the 69% of MP patients who received subsequent therapies, 50% received VELCADE or a VELCADE-containing regimen.1

Also, in my clinical experience, while some patients respond early to treatment, others may respond later. In the VISTA trial, of the 238 patients achieving a response, 42% were complete responders and of that, 28% of the CRs were achieved after 24 weeks of therapy.6 This is the information that I provide to patients when we discuss the length of therapy. The evidence is important for building strong patient morale when it comes to the duration of treatment.

What evidence supports your decision to use subcutaneous VELCADE?

I typically treat my patients with multiple myeloma with subcutaneous VELCADE. This decision is based on the results of the subcutaneous vs intravenous VELCADE trial,‡ which demonstrated consistent safety and effi cacy results between the two administration routes. The trial shows us that subcutaneous VELCADE demonstrated consistent overall and complete response rates compared with intravenous VELCADE. In addition to similar response rates, subcutaneous VELCADE also demonstrated a

Warnings and precautions (continued on subsequent pages)▼ Thrombocytopenia/Neutropenia: Manage with dose and/or schedule modifi cations. Complete blood counts should be monitored frequently during

treatment. There have been reports of gastrointestinal and intracerebral hemorrhage. Support with transfusions and supportive care, according to published guidelines.

▼ Tumor lysis syndrome: Closely monitor patients with high tumor burden and take appropriate precautions.

Maen abdelkarim Hussein, MdTavares, Villages East, Leesburg, Ocala

difference in incidence of peripheral neuropathy; even the incidence of grade three or greater peripheral neuropathy was also different. In general, safety data were similar for the subcutaneous and intravenous treatment groups.

I think that subcutaneous VELCADE should be considered for patients with preexisting or those at high risk for peripheral neuropathy.

How do you set treatment expectations about the full duration of VELCADE-based therapy with your patients?I like to spend time explaining treatment decisions to my patients. There are some patients who say, “Well, you are the doctor, just do whatever you want,” but I think all patients should be involved in decision-making and be a part of the team that treats their cancer. It’s actually easier to treat patients when they are more involved. They help to identify and alert you about certain side effects so our medical team can manage them sooner rather than later.

After discussing treatment options and determining if VELCADE-based therapy is appropriate for the patient, I like to set very clear expectations when it comes to the duration of treatment. I tell my patients upfront that this is not just a two- to three-month therapy and to plan on treatment for one year with VELCADE for an overall survival advantage. Again, this is supported by clinical evidence from the VISTA trial where the one-year median survival advantage over MP was achieved with VELCADE twice weekly followed by weekly dosing for about one year (54 weeks). My patients plan to come to the offi ce twice a week, following the dosing schedule of the VISTA trial, and they fi nd this relieving. They like the transition to weekly dosing, and I think that’s an advantage that you don’t have with a lot of therapies.

‡ SUBCUTANEOUS VS IV TRIAL: a non-inferiority, phase 3, randomized (2:1), open-label trial that compared the effi cacy and safety of VELCADE administered subcutaneously (n=148) with VELCADE administered intravenously (n=74) in patients with relapsed multiple myeloma. Patients who did not obtain a CR after 4 cycles were allowed oral dexamethasone. The primary endpoint was ORR at 4 cycles. Secondary endpoints included response rate at 8 cycles, median TTP and PFS (months), 1-year OS, and safety.

§ The incidence of serious ARs was similar in the subcutaneous and IV treatment groups (20% vs 19%). The most commonly reported serious ARs in the subcutaneous treatment group were pneumonia and pyrexia (2% each); in the IV treatment group, pneumonia, diarrhea, and peripheral sensory neuropathy (3% each).

Subcutaneous vs IV trial results:• ORRs with subcutaneous and IV VELCADE were 43% and

42% and CR rates were 7% and 8%, respectively

• Incidence of PN with subcutaneous vs IV VELCADE: all grades, 37% and 50%; grade ≥3 PN, 6% vs 15%, respectively

• In the phase 3 study of VELCADE administered subcutaneously vs intravenously in relapsed multiple myeloma, safety data were similar between the 2 treatment groups. The most commonly reported ARs were PN (37% vs 50%), thrombocytopenia (30% vs 34%), neutropenia (23% vs 27%), and neuralgia (23% vs 23%), respectively§

Would you consider retreating your multiple myeloma patients with VELCADE® (bortezomib) at relapse?Oncologists really want to get the most out of every drug we have available and if the drug is well tolerated you don’t want to give up on it too soon because eventually you will run out of options. If my patient responded to prior VELCADE (bortezomib) therapy and relapsed at least six months after completing that therapy, I would retreat. I would start the patient at the last tolerated dose. This decision is based on the results of the RETRIEVE trial,* which studied patients who previously had at least a partial response on a VELCADE-based regimen and relapsed at or beyond six months after completion of that regimen. Retreatment with VELCADE demonstrated an additional benefi t and did not result in cumulative toxicity.

Warnings and precautions (continued on subsequent pages)▼ Cardiac toxicity, including acute development or exacerbation of congestive heart failure and new onset of decreased left ventricular ejection fraction, has

occurred. Isolated cases of QT-interval prolongation have been reported. Patients with risk factors for, or existing, heart disease should be closely monitored.▼ Pulmonary toxicity: Acute respiratory distress syndrome (ARDS) and acute diffuse infi ltrative pulmonary disease of unknown etiology have occurred

(sometimes fatal). Pulmonary hypertension, in the absence of left heart failure or signifi cant pulmonary disease, has been reported. In the event of new or worsening cardiopulmonary symptoms, consider interrupting VELCADE until a prompt and comprehensive diagnostic evaluation is conducted.

▼ Posterior reversible encephalopathy syndrome has occurred. Consider MRI imaging for onset of visual or neurological symptoms; discontinue VELCADE if suspected.

▼ Gastrointestinal toxicity, including nausea, diarrhea, constipation, and vomiting, has occurred and may require use of antiemetic and antidiarrheal medications or fl uid replacement. Interrupt VELCADE for severe symptoms.

please see important safety information on subsequent pages and Brief summary for VeLcade adjacent to this advertisement.

* retrieVe triaL: a single arm, open-label study that evaluated the effi cacy and safety of retreatment with IV VELCADE (N=130). Patients with multiple myeloma who had previously achieved ≥PR on a VELCADE-containing regimen (median of 2 prior lines of therapy [range: 1-7]) and progressed ≥6 months after completing that regimen were retreated with IV VELCADE±dexamethasone. Patients received VELCADE on days 1, 4, 8, and 11 q 3 weeks for 24 weeks. The primary endpoint was best confi rmed response to treatment as assessed by European Group for Blood and Marrow Transplantation criteria. The secondary endpoints were DOR and safety.

†One patient achieved a CR and 49 patients achieved a PR.

Dexamethasone was administered in combination with VELCADE to 83 patients in cycle 1 with an additional 11 patients receiving dexamethasone during the course of VELCADE retreatment.

I tell my patients that in the VISTA trial, 1-year (50 weeks) median of VELCADE- based therapy delivered a greater than 1-year median sustained overall survival advantage.

RETRIEVE trial results:• Retreatment with VELCADE demonstrated a 6.5-month

median duration of response (all responders [CR+PR]; n=50; range: 0.6 to 19.3 months)

• VELCADE treatment may be started at the last tolerated dose(±dexamethasone). Patients should receive VELCADE on days 1, 4, 8, and 11 q 3 weeks for a maximum of 24 weeks

• ORR: 38.5% (N=130; 95% CI, 30.1-47.4)†

• The most common adverse drug reaction was thrombocytopenia, which occurred in 52% of patients (grade ≥3: 24%). PN was experienced by 28% of patients (grade ≥3: 6%)

• The incidence of serious ARs was 12.3%; the most commonly reported serious ARs were thrombocytopenia (3.8%), diarrhea (2.3%), and herpes zoster and pneumonia (1.5% each)

• In the RETRIEVE trial, ARs leading to discontinuation occurred in 13% of patients and included PN (5%) and diarrhea (3%)

• Two deaths (2%) considered to be VELCADE-related occurred within 30 days of the last VELCADE dose; one in a patient with cerebrovascular accident and one in a patient with sepsis

VEL214CDNY6136_FCS_Q_and_A_Ad_r19_FSU.indd 3-4 11/11/14 2:13 PM

Page 7: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

DOCTOR AND NURSE SPOTLIGHT This suPPLemenT is sPonsored and co-deveLoPed By miLLennium: The TaKeda oncoLoGy comPany. ParTiciPanTs received comPensaTion For Their Time and inPuT.

What is your approach to the treatment of patients with previously untreated multiple myeloma?Multiple myeloma is a complex, incurable disease, requiring a long-term treatment strategy. I tell my patients that with an appropriate treatment sequence, we now can better treat across the multiple periods of response and remission.3-5 This is important because patients with multiple myeloma typically experience their best response and longest remission following initial therapy.

Upon relapse, subsequent therapies typically deliver poorer outcomes. That is why I implement a long-term treatment strategy from the start.

What is the typical length of treatment with VELCADE® (bortezomib)-based therapy?

Based on the results of the VISTA clinical trial, I aim to treat my patients with VELCADE (bortezomib) for one year or until we reach a tolerability threshold. The VISTA trial demonstrated that a 50-week median, or about one year of VELCADE-based therapy, delivered a greater than one-year median overall survival advantage over MP for patients with previously untreated multiple myeloma who are ineligible for transplant. I believe that starting with one year of therapy is imperative as the clinical evidence also indicates that at the three-year median follow-up, VELCADE-based therapy provided an overall survival benefi t that was not regained with subsequent therapies. Of the 69% of MP patients who received subsequent therapies, 50% received VELCADE or a VELCADE-containing regimen.1

Also, in my clinical experience, while some patients respond early to treatment, others may respond later. In the VISTA trial, of the 238 patients achieving a response, 42% were complete responders and of that, 28% of the CRs were achieved after 24 weeks of therapy.6 This is the information that I provide to patients when we discuss the length of therapy. The evidence is important for building strong patient morale when it comes to the duration of treatment.

What evidence supports your decision to use subcutaneous VELCADE?

I typically treat my patients with multiple myeloma with subcutaneous VELCADE. This decision is based on the results of the subcutaneous vs intravenous VELCADE trial,‡ which demonstrated consistent safety and effi cacy results between the two administration routes. The trial shows us that subcutaneous VELCADE demonstrated consistent overall and complete response rates compared with intravenous VELCADE. In addition to similar response rates, subcutaneous VELCADE also demonstrated a

Warnings and precautions (continued on subsequent pages)▼ Thrombocytopenia/Neutropenia: Manage with dose and/or schedule modifi cations. Complete blood counts should be monitored frequently during

treatment. There have been reports of gastrointestinal and intracerebral hemorrhage. Support with transfusions and supportive care, according to published guidelines.

▼ Tumor lysis syndrome: Closely monitor patients with high tumor burden and take appropriate precautions.

Maen abdelkarim Hussein, MdTavares, Villages East, Leesburg, Ocala

difference in incidence of peripheral neuropathy; even the incidence of grade three or greater peripheral neuropathy was also different. In general, safety data were similar for the subcutaneous and intravenous treatment groups.

I think that subcutaneous VELCADE should be considered for patients with preexisting or those at high risk for peripheral neuropathy.

How do you set treatment expectations about the full duration of VELCADE-based therapy with your patients?I like to spend time explaining treatment decisions to my patients. There are some patients who say, “Well, you are the doctor, just do whatever you want,” but I think all patients should be involved in decision-making and be a part of the team that treats their cancer. It’s actually easier to treat patients when they are more involved. They help to identify and alert you about certain side effects so our medical team can manage them sooner rather than later.

After discussing treatment options and determining if VELCADE-based therapy is appropriate for the patient, I like to set very clear expectations when it comes to the duration of treatment. I tell my patients upfront that this is not just a two- to three-month therapy and to plan on treatment for one year with VELCADE for an overall survival advantage. Again, this is supported by clinical evidence from the VISTA trial where the one-year median survival advantage over MP was achieved with VELCADE twice weekly followed by weekly dosing for about one year (54 weeks). My patients plan to come to the offi ce twice a week, following the dosing schedule of the VISTA trial, and they fi nd this relieving. They like the transition to weekly dosing, and I think that’s an advantage that you don’t have with a lot of therapies.

‡ SUBCUTANEOUS VS IV TRIAL: a non-inferiority, phase 3, randomized (2:1), open-label trial that compared the effi cacy and safety of VELCADE administered subcutaneously (n=148) with VELCADE administered intravenously (n=74) in patients with relapsed multiple myeloma. Patients who did not obtain a CR after 4 cycles were allowed oral dexamethasone. The primary endpoint was ORR at 4 cycles. Secondary endpoints included response rate at 8 cycles, median TTP and PFS (months), 1-year OS, and safety.

§ The incidence of serious ARs was similar in the subcutaneous and IV treatment groups (20% vs 19%). The most commonly reported serious ARs in the subcutaneous treatment group were pneumonia and pyrexia (2% each); in the IV treatment group, pneumonia, diarrhea, and peripheral sensory neuropathy (3% each).

Subcutaneous vs IV trial results:• ORRs with subcutaneous and IV VELCADE were 43% and

42% and CR rates were 7% and 8%, respectively

• Incidence of PN with subcutaneous vs IV VELCADE: all grades, 37% and 50%; grade ≥3 PN, 6% vs 15%, respectively

• In the phase 3 study of VELCADE administered subcutaneously vs intravenously in relapsed multiple myeloma, safety data were similar between the 2 treatment groups. The most commonly reported ARs were PN (37% vs 50%), thrombocytopenia (30% vs 34%), neutropenia (23% vs 27%), and neuralgia (23% vs 23%), respectively§

Would you consider retreating your multiple myeloma patients with VELCADE® (bortezomib) at relapse?Oncologists really want to get the most out of every drug we have available and if the drug is well tolerated you don’t want to give up on it too soon because eventually you will run out of options. If my patient responded to prior VELCADE (bortezomib) therapy and relapsed at least six months after completing that therapy, I would retreat. I would start the patient at the last tolerated dose. This decision is based on the results of the RETRIEVE trial,* which studied patients who previously had at least a partial response on a VELCADE-based regimen and relapsed at or beyond six months after completion of that regimen. Retreatment with VELCADE demonstrated an additional benefi t and did not result in cumulative toxicity.

Warnings and precautions (continued on subsequent pages)▼ Cardiac toxicity, including acute development or exacerbation of congestive heart failure and new onset of decreased left ventricular ejection fraction, has

occurred. Isolated cases of QT-interval prolongation have been reported. Patients with risk factors for, or existing, heart disease should be closely monitored.▼ Pulmonary toxicity: Acute respiratory distress syndrome (ARDS) and acute diffuse infi ltrative pulmonary disease of unknown etiology have occurred

(sometimes fatal). Pulmonary hypertension, in the absence of left heart failure or signifi cant pulmonary disease, has been reported. In the event of new or worsening cardiopulmonary symptoms, consider interrupting VELCADE until a prompt and comprehensive diagnostic evaluation is conducted.

▼ Posterior reversible encephalopathy syndrome has occurred. Consider MRI imaging for onset of visual or neurological symptoms; discontinue VELCADE if suspected.

▼ Gastrointestinal toxicity, including nausea, diarrhea, constipation, and vomiting, has occurred and may require use of antiemetic and antidiarrheal medications or fl uid replacement. Interrupt VELCADE for severe symptoms.

please see important safety information on subsequent pages and Brief summary for VeLcade adjacent to this advertisement.

* retrieVe triaL: a single arm, open-label study that evaluated the effi cacy and safety of retreatment with IV VELCADE (N=130). Patients with multiple myeloma who had previously achieved ≥PR on a VELCADE-containing regimen (median of 2 prior lines of therapy [range: 1-7]) and progressed ≥6 months after completing that regimen were retreated with IV VELCADE±dexamethasone. Patients received VELCADE on days 1, 4, 8, and 11 q 3 weeks for 24 weeks. The primary endpoint was best confi rmed response to treatment as assessed by European Group for Blood and Marrow Transplantation criteria. The secondary endpoints were DOR and safety.

†One patient achieved a CR and 49 patients achieved a PR.

Dexamethasone was administered in combination with VELCADE to 83 patients in cycle 1 with an additional 11 patients receiving dexamethasone during the course of VELCADE retreatment.

I tell my patients that in the VISTA trial, 1-year (50 weeks) median of VELCADE- based therapy delivered a greater than 1-year median sustained overall survival advantage.

RETRIEVE trial results:• Retreatment with VELCADE demonstrated a 6.5-month

median duration of response (all responders [CR+PR]; n=50; range: 0.6 to 19.3 months)

• VELCADE treatment may be started at the last tolerated dose(±dexamethasone). Patients should receive VELCADE on days 1, 4, 8, and 11 q 3 weeks for a maximum of 24 weeks

• ORR: 38.5% (N=130; 95% CI, 30.1-47.4)†

• The most common adverse drug reaction was thrombocytopenia, which occurred in 52% of patients (grade ≥3: 24%). PN was experienced by 28% of patients (grade ≥3: 6%)

• The incidence of serious ARs was 12.3%; the most commonly reported serious ARs were thrombocytopenia (3.8%), diarrhea (2.3%), and herpes zoster and pneumonia (1.5% each)

• In the RETRIEVE trial, ARs leading to discontinuation occurred in 13% of patients and included PN (5%) and diarrhea (3%)

• Two deaths (2%) considered to be VELCADE-related occurred within 30 days of the last VELCADE dose; one in a patient with cerebrovascular accident and one in a patient with sepsis

VEL214CDNY6136_FCS_Q_and_A_Ad_r19_FSU.indd 3-4 11/11/14 2:13 PM

Page 8: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

Doctor anD nurse spotlight This supplemenT is sponsored and co-developed by millennium: The TaKeda oncoloGy company. parTicipanTs received compensaTion For Their Time and inpuT. Doctor anD nurse spotlight

VELCADE, MILLENNIUM and are registered trademarks of Millennium Pharmaceuticals, Inc. Other trademarks are property of their respective owners.

Millennium Pharmaceuticals, Inc., Cambridge, MA 02139 Copyright © 2014, Millennium Pharmaceuticals, Inc.All rights reserved. Printed in USA V-14-0367 12/14

Warnings and precautions (continued)▼ Hepatic toxicity: Monitor hepatic enzymes during treatment. Upon

occurrence, interrupt therapy with VELCADE to assess reversibility.▼ Embryo-fetal risk: Women should avoid breast-feeding or becoming

pregnant while on VELCADE.▼ Patients with diabetes may require close monitoring and adjustment

of the antidiabetic medications.

drug interactions: Closely monitor patients receiving VELCADE in combination with strong CYP3A4 inhibitors. Avoid concomitant use of strong CYP3A4 inducers.

adVerse reactions▼ Previously untreated multiple myeloma (MM): In the phase 3 study of VELCADE administered intravenously with melphalan and prednisone (MP) vs MP

alone, the most commonly reported adverse reactions (ARs) were thrombocytopenia (48% vs 42%), neutropenia (47% vs 42%), peripheral neuropathy (46% vs 1%), nausea (39% vs 21%), diarrhea (35% vs 6%), neuralgia (34% vs <1%), anemia (32% vs 46%), and leukopenia (32% vs 28%).

▼ Relapsed MM: In the phase 3 study of VELCADE administered intravenously vs dexamethasone, the most commonly reported ARs were nausea (52% vs 9%), diarrhea (52% vs 11%), fatigue (39% vs 25%), peripheral neuropathies (35% vs 4%), thrombocytopenia (33% vs 3%), constipation (30% vs 8%), vomiting (29% vs 3%), and anorexia (21% vs 2%). The most commonly reported serious ARs were diarrhea (3%), dehydration, herpes zoster, pyrexia, nausea, vomiting, dyspnea, and thrombocytopenia (2% each) in the VELCADE treatment group and pneumonia (4%), hyperglycemia (3%), pyrexia, and psychotic disorder (2% each) in the dexamethasone treatment group.

▼ Relapsed MM subcutaneous vs IV: In the phase 3 study of VELCADE administered subcutaneously vs intravenously in relapsed MM, safety data were similar between the two treatment groups. The most commonly reported ARs in the subcutaneous vs IV treatment groups were peripheral neuropathy (37% vs 50%) and thrombocytopenia (30% vs 34%). The incidence of serious ARs was similar in the subcutaneous treatment group (20%) and the IV treatment group (19%). The most commonly reported serious ARs were pneumonia and pyrexia (each 2%) in the subcutaneous treatment group and pneumonia, diarrhea, and peripheral sensory neuropathy (each 3%) in the IV treatment group.

please see important safety information throughout and Brief summary for VeLcade adjacent to this advertisement.

diane cope, phd, arnp Fort Myers-Summerlin

How do you monitor and manage patients to help them remain on therapy?Patients are anxious and sometimes afraid at first, so the more information you can tell them, the better prepared they feel, especially in preparing for one year of VELCADE® (bortezomib)-based therapy. Communicate with your patients and relay any adverse reaction-related information with the rest of the healthcare team. There are dose modification strategies that may help patients who experience peripheral neuropathy, hematologic and nonhematologic toxicities, and hepatic impairment. These management strategies are available to help patients remain on therapy. Millennium also has excellent resources for our VELCADE (bortezomib) patients. I encourage our nurses to contact our local Millennium clinical nurse educator or oncology sales specialist for additional resources. They can also find helpful tools on the VELCADE Nurse Portal at VELCADE-hcp.com/rn/.

What is your experience with VELCADE-associated peripheral neuropathy?I make sure to continually assess patients for a number of adverse

reactions including peripheral neuropathy, which is a common clinical symptom we see with VELCADE use. Peripheral neuropathy is a common adverse reaction with VELCADE (46% in the VISTA trial) and is predominantly sensory; however, cases of severe sensory and motor peripheral neuropathy have been reported. It is also important to mention that the onset of peripheral neuropathy plateaued at about 24 weeks of therapy in the VISTA trial. In fact, of the patients who experienced PN, 91% experienced onset by week 24.7 I usually ask my patients a series of questions to assess the peripheral neuropathy; for example, his or her ability to write, button shirts, use utensils. It helps me to assess their limitations with peripheral neuropathy. Treatment-emergent peripheral neuropathy may be manageable and reversible with VELCADE dose modifications. Early detection and management of peripheral neuropathy may help patients stay on VELCADE. For patients with preexisting, or at high risk for, peripheral neuropathy, subcutaneous VELCADE should be considered. Patients with preexisting severe neuropathy should be treated with VELCADE only after a careful risk-benefit assessment has been performed.

• In patients treated with VELCADE+MP, 47% of patients experienced treatment-emergent PN, including 13% with grade ≥37

• 11% of patients discontinued treatment with VELCADE due to PN and continued MP; 3% of patients discontinued treatment with VELCADE+MP due to PN7

references: 1. Mateos M-V, Richardson PG, Schlag R, et al. Bortezomib plus melphalan and prednisone compared with melphalan and prednisone in previously untreated multiple myeloma: updated follow-up and impact of subsequent therapy in the phase III VISTA trial. J Clin Oncol. 2010;28(13):2259-2266. 2. Data on file 48, Millennium Pharmaceuticals, Inc. 3. Durie BGM. Multiple myeloma: cancer of the bone marrow. International Myeloma Foundation. http://myeloma.org/pdfs/CR2011-Eng_b1.pdf. Accessed October 9, 2013. 4. Mohty B, EI-Cheikh J, Yakoub-Agha I, Avet-Loiseau H, Moreau P, Mohty M. Treatment strategies in relapsed and refractory multiple myeloma: a focus on drug sequencing and ‘retreatment’ approaches in the era of novel agents. Leukemia. 2012;26(1):73-85. 5. Heeg B, van Agthoven M, Liwing J, et al. Optimal treatment sequencing in multiple myeloma: an exploratory modeling approach [abstract 3046]. Poster presented at: 52nd ASH® Annual Meeting and Exposition; December 4-7, 2010; Orlando, FL. 6. Harousseau J-L, Palumbo A, Richardson PG, et al. Superior outcomes associated with complete response in newly diagnosed multiple myeloma patients treated with nonintensive therapy: analysis of the phase 3 VISTA study of bortezomib plus melphalan-prednisone versus melphalan-prednisone. Blood. 2010;116(19):3743-3750. 7. Dimopoulos MA, Mateos M-V, Richardson PG. Risk factors for, and reversibility of, peripheral neuropathy associated with bortezomib-melphalan-prednisone in newly diagnosed patients with multiple myeloma: subanalysis of the phase 3 VISTA study. Eur J Haematol. 2011;86(1):23-31.

This suPPLemenT is sPonsored and co-deveLoPed By miLLennium: The TaKeda oncoLoGy comPany. ParTiciPanTs received comPensaTion For Their Time and inPuT. DOCTOR AND NURSE SPOTLIGHT

Brief Summary

INDICATIONS:VELCADE® (bortezomib) for Injection is indicated for the treatment of patients with multiple myeloma. VELCADE for Injection is indicated for the treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy.

CONTRAINDICATIONS: VELCADE is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol, including anaphylactic reactions. VELCADE is contraindicated for intrathecal administration. Fatal events have occurred with intrathecal administration of VELCADE.

WARNINGS AND PRECAUTIONS: Peripheral Neuropathy: VELCADE treatment causes a peripheral neuropathy that is predominantly sensory; however, cases of severe sensory and motor peripheral neuropathy have been reported. Patients with pre-existing symptoms (numbness, pain, or a burning feeling in the feet or hands) and/or signs of peripheral neuropathy may experience worsening peripheral neuropathy (including ≥Grade 3) during treatment with VELCADE. Patients should be monitored for symptoms of neuropathy, such as a burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, neuropathic pain or weakness. In the Phase 3 relapsed multiple myeloma trial comparing VELCADE subcutaneous vs intravenous, the incidence of Grade ≥2 peripheral neuropathy events was 24% for subcutaneous and 39% for intravenous. Grade ≥3 peripheral neuropathy occurred in 6% of patients in the subcutaneous treatment group, compared with 15% in the intravenous treatment group. Starting VELCADE subcutaneously may be considered for patients with pre-existing or at high risk of peripheral neuropathy.Patients experiencing new or worsening peripheral neuropathy during VELCADE therapy may require a decrease in the dose and/or a less dose-intense schedule. In the VELCADE vs dexamethasone phase 3 relapsed multiple myeloma study, improvement in or resolution of peripheral neuropathy was reported in 48% of patients with ≥Grade 2 peripheral neuropathy following dose adjustment or interruption. Improvement in or resolution of peripheral neuropathy was reported in 73% of patients who discontinued due to Grade 2 neuropathy or who had ≥Grade 3 peripheral neuropathy in the phase 2 multiple myeloma studies. The long-term outcome of peripheral neuropathy has not been studied in mantle cell lymphoma.Hypotension: The incidence of hypotension (postural, orthostatic, and hypotension NOS) was 8%. These events are observed throughout therapy. Caution should be used when treating patients with a history of syncope, patients receiving medications known to be associated with hypotension, and patients who are dehydrated. Management of orthostatic/postural hypotension may include adjustment of antihypertensive medications, hydration, and administration of mineralocorticoids and/or sympathomimetics.Cardiac Toxicity: Acute development or exacerbation of congestive heart failure and new onset of decreased left ventricular ejection fraction have occurred during VELCADE therapy, including reports in patients with no risk factors for decreased left ventricular ejection fraction. Patients with risk factors for, or existing, heart disease should be closely monitored. In the relapsed multiple myeloma study of VELCADE vs dexamethasone, the incidence of any treatment-related cardiac disorder was 8% and 5% in the VELCADE and dexamethasone groups, respectively. The incidence of adverse reactions suggestive of heart failure (acute pulmonary edema, pulmonary edema, cardiac failure, congestive cardiac failure, cardiogenic shock) was ≤1% for each individual reaction in the VELCADE group. In the dexamethasone group, the incidence was ≤1% for cardiac failure and congestive cardiac failure; there were no reported reactions of acute pulmonary edema, pulmonary edema, or cardiogenic shock. There have been isolated cases of QT-interval prolongation in clinical studies; causality has not been established.Pulmonary Toxicity: Acute Respiratory Distress Syndrome (ARDS) and acute diffuse infiltrative pulmonary disease of unknown etiology, such as pneumonitis, interstitial pneumonia, and lung infiltration have occurred in patients receiving VELCADE. Some of these events have been fatal. In a clinical trial, the first two patients given high-dose cytarabine (2 g/m2 per day) by continuous infusion with daunorubicin and VELCADE for relapsed acute myelogenous leukemia died of ARDS early in the course of therapy. There have been reports of pulmonary hypertension associated with VELCADE administration in the absence of left heart failure or significant pulmonary disease. In the event of new or worsening cardiopulmonary symptoms, consider interrupting VELCADE until a prompt, comprehensive, diagnostic evaluation is conducted.Posterior Reversible Encephalopathy Syndrome (PRES): Posterior Reversible Encephalopathy Syndrome (PRES; formerly termed Reversible Posterior Leukoencephalopathy Syndrome (RPLS)) has occurred in patients receiving VELCADE. PRES is a rare, reversible, neurological disorder, which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances. Brain imaging, preferably MRI (Magnetic Resonance Imaging), is used to confirm the diagnosis. In patients developing PRES, discontinue VELCADE. The safety of reinitiating VELCADE therapy in patients previously experiencing PRES is not known.Gastrointestinal Toxicity: VELCADE treatment can cause nausea, diarrhea, constipation, and vomiting, sometimes requiring use of antiemetic and antidiarrheal medications. Ileus can occur. Fluid and electrolyte replacement should be administered to prevent dehydration. Interrupt VELCADE for severe symptoms.Thrombocytopenia/Neutropenia: VELCADE is associated with thrombocytopenia and neutropenia that follow a cyclical pattern, with nadirs occurring following the last dose of each cycle and typically recovering prior to initiation of the subsequent cycle. The cyclical pattern of platelet and neutrophil decreases and recovery remained consistent over the 8 cycles of twice-weekly dosing, and there was no evidence of cumulative thrombocytopenia or neutropenia. The mean platelet count nadir measured was approximately 40% of baseline. The severity of thrombocytopenia was related to pretreatment platelet count. In the relapsed multiple myeloma study of VELCADE vs dexamethasone, the incidence of bleeding (≥Grade 3) was 2% on the VELCADE arm and <1% on the dexamethasone arm. Complete blood counts (CBC) should be monitored frequently during treatment with VELCADE. Platelet counts should be monitored prior to each dose of VELCADE. Patients experiencing thrombocytopenia may require change in the dose and schedule of VELCADE. Gastrointestinal and intracerebral hemorrhage has been reported in association with VELCADE. Transfusions may be considered. Tumor Lysis Syndrome: Tumor lysis syndrome has been reported with VELCADE therapy. Patients at risk of tumor lysis syndrome are those with high tumor burden prior to treatment. Monitor patients closely and take appropriate precautions.Hepatic Toxicity: Cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions. Other reported hepatic reactions include hepatitis, increases in liver enzymes, and hyperbilirubinemia. Interrupt VELCADE therapy to assess reversibility. There is limited re-challenge information in these patients.

Embryo-fetal: Pregnancy Category D. Women of reproductive potential should avoid becoming pregnant while being treated with VELCADE. Bortezomib administered to rabbits during organogenesis at a dose approximately 0.5 times the clinical dose of 1.3 mg/m2 based on body surface area caused post-implantation loss and a decreased number of live fetuses.

ADVERSE EVENT DATA: Safety data from phase 2 and 3 studies of single-agent VELCADE 1.3 mg/m2/dose administered intravenously twice weekly for 2 weeks followed by a 10-day rest period in 1163 patients with previously-treated multiple myeloma (N=1008) and previously-treated mantle cell lymphoma (N=155) were integrated and tabulated. In these studies, the safety profile of VELCADE was similar in patients with multiple myeloma and mantle cell lymphoma.In the integrated analysis, the most commonly reported (≥10%) adverse reactions were nausea (49%), diarrhea NOS (46%), fatigue (41%), peripheral neuropathies NEC (38%), thrombocytopenia (32%), vomiting NOS (28%), constipation (25%), pyrexia (21%), anorexia (20%), anemia NOS (18%), headache NOS (15%), neutropenia (15%), rash NOS (13%), paresthesia (13%), dizziness (excl vertigo 11%), and weakness (11%). Eleven percent (11%) of patients experienced at least 1 episode of ≥Grade 4 toxicity, most commonly thrombocytopenia (4%) and neutropenia (2%). A total of 26% of patients experienced a serious adverse reaction during the studies. The most commonly reported serious adverse reactions included diarrhea, vomiting, and pyrexia (3% each), nausea, dehydration, and thrombocytopenia (2% each), and pneumonia, dyspnea, peripheral neuropathies NEC, and herpes zoster (1% each).In the phase 3 VELCADE+melphalan and prednisone study in previously untreated multiple myeloma, the safety profile of VELCADE administered intravenously in combination with melphalan/prednisone is consistent with the known safety profiles of both VELCADE and melphalan/prednisone. The most commonly reported adverse reactions in this study (VELCADE+melphalan/prednisone vs melphalan/prednisone) were thrombocytopenia (48% vs 42%), neutropenia (47% vs 42%), peripheral neuropathy (46% vs 1%), nausea (39% vs 21%), diarrhea (35% vs 6%), neuralgia (34% vs <1%), anemia (32% vs 46%), leukopenia (32% vs 28%), vomiting (26% vs 12%), fatigue (25% vs 14%), lymphopenia (23% vs 15%), constipation (23% vs 4%), anorexia (19% vs 6%), asthenia (16% vs 7%), pyrexia (16% vs 6%), paresthesia (12% vs 1%), herpes zoster (11% vs 3%), rash (11% vs 2%), abdominal pain upper (10% vs 6%), and insomnia (10% vs 6%).In the phase 3 VELCADE subcutaneous vs intravenous study in relapsed multiple myeloma, safety data were similar between the two treatment groups. The most commonly reported adverse reactions in this study were peripheral neuropathy NEC (37% vs 50%), thrombocytopenia (30% vs 34%), neutropenia (23% vs 27%), neuralgia (23% vs 23%), anemia (19% vs 23%), diarrhea (19% vs 28%), leukopenia (18% vs 20%), nausea (16% vs 14%), pyrexia (12% vs 8%), vomiting (9% vs 11%), asthenia (7% vs 16%), and fatigue (7% vs 15%). The incidence of serious adverse reactions was similar for the subcutaneous treatment group (20%) and the intravenous treatment group (19%). The most commonly reported SARs were pneumonia and pyrexia (2% each) in the subcutaneous treatment group and pneumonia, diarrhea, and peripheral sensory neuropathy (3% each) in the intravenous treatment group.

DRUG INTERACTIONS: Bortezomib is a substrate of cytochrome P450 enzyme 3A4, 2C19 and 1A2. Co-administration of ketoconazole, a strong CYP3A4 inhibitor, increased the exposure of bortezomib by 35% in 12 patients. Monitor patients for signs of bortezomib toxicity and consider a bortezomib dose reduction if bortezomib must be given in combination with strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir). Co-administration of omeprazole, a strong inhibitor of CYP2C19, had no effect on the exposure of bortezomib in 17 patients. Co-administration of rifampin, a strong CYP3A4 inducer, is expected to decrease the exposure of bortezomib by at least 45%. Because the drug interaction study (n=6) was not designed to exert the maximum effect of rifampin on bortezomib PK, decreases greater than 45% may occur. Efficacy may be reduced when VELCADE is used in combination with strong CYP3A4 inducers; therefore, concomitant use of strong CYP3A4 inducers is not recommended in patients receiving VELCADE. St. John’s wort (Hypericum perforatum) may decrease bortezomib exposure unpredictably and should be avoided. Co-administration of dexamethasone, a weak CYP3A4 inducer, had no effect on the exposure of bortezomib in 7 patients. Co-administration of melphalan-prednisone increased the exposure of bortezomib by 17% in 21 patients. However, this increase is unlikely to be clinically relevant.

USE IN SPECIFIC POPULATIONS:Nursing Mothers: It is not known whether bortezomib is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from VELCADE, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.Pediatric Use: The safety and effectiveness of VELCADE in children has not been established.Geriatric Use: No overall differences in safety or effectiveness were observed between patients ≥age 65 and younger patients receiving VELCADE; but greater sensitivity of some older individuals cannot be ruled out.Patients with Renal Impairment: The pharmacokinetics of VELCADE are not influenced by the degree of renal impairment. Therefore, dosing adjustments of VELCADE are not necessary for patients with renal insufficiency. Since dialysis may reduce VELCADE concentrations, VELCADE should be administered after the dialysis procedure. For information concerning dosing of melphalan in patients with renal impairment, see manufacturer’s prescribing information.Patients with Hepatic Impairment: The exposure of bortezomib is increased in patients with moderate and severe hepatic impairment. Starting dose should be reduced in those patients.Patients with Diabetes: During clinical trials, hypoglycemia and hyperglycemia were reported in diabetic patients receiving oral hypoglycemics. Patients on oral antidiabetic agents receiving VELCADE treatment may require close monitoring of their blood glucose levels and adjustment of the dose of their antidiabetic medication.

Please see full Prescribing Information for VELCADE at VELCADEHCP.com.

VELCADE, MILLENNIUM and are registered trademarks of Millennium Pharmaceuticals, Inc. Other trademarks are property of their respective owners.Millennium Pharmaceuticals, Inc., Cambridge, MA 02139 Copyright © 2013, Millennium Pharmaceuticals, Inc. All rights reserved. Printed in USA

S:7”

S:10”

VELC3X0043_A_Velcade_BS_7x10_r3.indd 1 8/27/13 4:54 PM

V-12-0306a 6/14

VEL214CDNY6136_FCS_Q_and_A_Ad_r19_FSU.indd 5-6 11/11/14 2:13 PM

Page 9: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

Doctor anD nurse spotlight This supplemenT is sponsored and co-developed by millennium: The TaKeda oncoloGy company. parTicipanTs received compensaTion For Their Time and inpuT. Doctor anD nurse spotlight

VELCADE, MILLENNIUM and are registered trademarks of Millennium Pharmaceuticals, Inc. Other trademarks are property of their respective owners.

Millennium Pharmaceuticals, Inc., Cambridge, MA 02139 Copyright © 2014, Millennium Pharmaceuticals, Inc.All rights reserved. Printed in USA V-14-0367 12/14

Warnings and precautions (continued)▼ Hepatic toxicity: Monitor hepatic enzymes during treatment. Upon

occurrence, interrupt therapy with VELCADE to assess reversibility.▼ Embryo-fetal risk: Women should avoid breast-feeding or becoming

pregnant while on VELCADE.▼ Patients with diabetes may require close monitoring and adjustment

of the antidiabetic medications.

drug interactions: Closely monitor patients receiving VELCADE in combination with strong CYP3A4 inhibitors. Avoid concomitant use of strong CYP3A4 inducers.

adVerse reactions▼ Previously untreated multiple myeloma (MM): In the phase 3 study of VELCADE administered intravenously with melphalan and prednisone (MP) vs MP

alone, the most commonly reported adverse reactions (ARs) were thrombocytopenia (48% vs 42%), neutropenia (47% vs 42%), peripheral neuropathy (46% vs 1%), nausea (39% vs 21%), diarrhea (35% vs 6%), neuralgia (34% vs <1%), anemia (32% vs 46%), and leukopenia (32% vs 28%).

▼ Relapsed MM: In the phase 3 study of VELCADE administered intravenously vs dexamethasone, the most commonly reported ARs were nausea (52% vs 9%), diarrhea (52% vs 11%), fatigue (39% vs 25%), peripheral neuropathies (35% vs 4%), thrombocytopenia (33% vs 3%), constipation (30% vs 8%), vomiting (29% vs 3%), and anorexia (21% vs 2%). The most commonly reported serious ARs were diarrhea (3%), dehydration, herpes zoster, pyrexia, nausea, vomiting, dyspnea, and thrombocytopenia (2% each) in the VELCADE treatment group and pneumonia (4%), hyperglycemia (3%), pyrexia, and psychotic disorder (2% each) in the dexamethasone treatment group.

▼ Relapsed MM subcutaneous vs IV: In the phase 3 study of VELCADE administered subcutaneously vs intravenously in relapsed MM, safety data were similar between the two treatment groups. The most commonly reported ARs in the subcutaneous vs IV treatment groups were peripheral neuropathy (37% vs 50%) and thrombocytopenia (30% vs 34%). The incidence of serious ARs was similar in the subcutaneous treatment group (20%) and the IV treatment group (19%). The most commonly reported serious ARs were pneumonia and pyrexia (each 2%) in the subcutaneous treatment group and pneumonia, diarrhea, and peripheral sensory neuropathy (each 3%) in the IV treatment group.

please see important safety information throughout and Brief summary for VeLcade adjacent to this advertisement.

diane cope, phd, arnp Fort Myers-Summerlin

How do you monitor and manage patients to help them remain on therapy?Patients are anxious and sometimes afraid at first, so the more information you can tell them, the better prepared they feel, especially in preparing for one year of VELCADE® (bortezomib)-based therapy. Communicate with your patients and relay any adverse reaction-related information with the rest of the healthcare team. There are dose modification strategies that may help patients who experience peripheral neuropathy, hematologic and nonhematologic toxicities, and hepatic impairment. These management strategies are available to help patients remain on therapy. Millennium also has excellent resources for our VELCADE (bortezomib) patients. I encourage our nurses to contact our local Millennium clinical nurse educator or oncology sales specialist for additional resources. They can also find helpful tools on the VELCADE Nurse Portal at VELCADE-hcp.com/rn/.

What is your experience with VELCADE-associated peripheral neuropathy?I make sure to continually assess patients for a number of adverse

reactions including peripheral neuropathy, which is a common clinical symptom we see with VELCADE use. Peripheral neuropathy is a common adverse reaction with VELCADE (46% in the VISTA trial) and is predominantly sensory; however, cases of severe sensory and motor peripheral neuropathy have been reported. It is also important to mention that the onset of peripheral neuropathy plateaued at about 24 weeks of therapy in the VISTA trial. In fact, of the patients who experienced PN, 91% experienced onset by week 24.7 I usually ask my patients a series of questions to assess the peripheral neuropathy; for example, his or her ability to write, button shirts, use utensils. It helps me to assess their limitations with peripheral neuropathy. Treatment-emergent peripheral neuropathy may be manageable and reversible with VELCADE dose modifications. Early detection and management of peripheral neuropathy may help patients stay on VELCADE. For patients with preexisting, or at high risk for, peripheral neuropathy, subcutaneous VELCADE should be considered. Patients with preexisting severe neuropathy should be treated with VELCADE only after a careful risk-benefit assessment has been performed.

• In patients treated with VELCADE+MP, 47% of patients experienced treatment-emergent PN, including 13% with grade ≥37

• 11% of patients discontinued treatment with VELCADE due to PN and continued MP; 3% of patients discontinued treatment with VELCADE+MP due to PN7

references: 1. Mateos M-V, Richardson PG, Schlag R, et al. Bortezomib plus melphalan and prednisone compared with melphalan and prednisone in previously untreated multiple myeloma: updated follow-up and impact of subsequent therapy in the phase III VISTA trial. J Clin Oncol. 2010;28(13):2259-2266. 2. Data on file 48, Millennium Pharmaceuticals, Inc. 3. Durie BGM. Multiple myeloma: cancer of the bone marrow. International Myeloma Foundation. http://myeloma.org/pdfs/CR2011-Eng_b1.pdf. Accessed October 9, 2013. 4. Mohty B, EI-Cheikh J, Yakoub-Agha I, Avet-Loiseau H, Moreau P, Mohty M. Treatment strategies in relapsed and refractory multiple myeloma: a focus on drug sequencing and ‘retreatment’ approaches in the era of novel agents. Leukemia. 2012;26(1):73-85. 5. Heeg B, van Agthoven M, Liwing J, et al. Optimal treatment sequencing in multiple myeloma: an exploratory modeling approach [abstract 3046]. Poster presented at: 52nd ASH® Annual Meeting and Exposition; December 4-7, 2010; Orlando, FL. 6. Harousseau J-L, Palumbo A, Richardson PG, et al. Superior outcomes associated with complete response in newly diagnosed multiple myeloma patients treated with nonintensive therapy: analysis of the phase 3 VISTA study of bortezomib plus melphalan-prednisone versus melphalan-prednisone. Blood. 2010;116(19):3743-3750. 7. Dimopoulos MA, Mateos M-V, Richardson PG. Risk factors for, and reversibility of, peripheral neuropathy associated with bortezomib-melphalan-prednisone in newly diagnosed patients with multiple myeloma: subanalysis of the phase 3 VISTA study. Eur J Haematol. 2011;86(1):23-31.

This suPPLemenT is sPonsored and co-deveLoPed By miLLennium: The TaKeda oncoLoGy comPany. ParTiciPanTs received comPensaTion For Their Time and inPuT. DOCTOR AND NURSE SPOTLIGHT

Brief Summary

INDICATIONS:VELCADE® (bortezomib) for Injection is indicated for the treatment of patients with multiple myeloma. VELCADE for Injection is indicated for the treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy.

CONTRAINDICATIONS: VELCADE is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol, including anaphylactic reactions. VELCADE is contraindicated for intrathecal administration. Fatal events have occurred with intrathecal administration of VELCADE.

WARNINGS AND PRECAUTIONS: Peripheral Neuropathy: VELCADE treatment causes a peripheral neuropathy that is predominantly sensory; however, cases of severe sensory and motor peripheral neuropathy have been reported. Patients with pre-existing symptoms (numbness, pain, or a burning feeling in the feet or hands) and/or signs of peripheral neuropathy may experience worsening peripheral neuropathy (including ≥Grade 3) during treatment with VELCADE. Patients should be monitored for symptoms of neuropathy, such as a burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, neuropathic pain or weakness. In the Phase 3 relapsed multiple myeloma trial comparing VELCADE subcutaneous vs intravenous, the incidence of Grade ≥2 peripheral neuropathy events was 24% for subcutaneous and 39% for intravenous. Grade ≥3 peripheral neuropathy occurred in 6% of patients in the subcutaneous treatment group, compared with 15% in the intravenous treatment group. Starting VELCADE subcutaneously may be considered for patients with pre-existing or at high risk of peripheral neuropathy.Patients experiencing new or worsening peripheral neuropathy during VELCADE therapy may require a decrease in the dose and/or a less dose-intense schedule. In the VELCADE vs dexamethasone phase 3 relapsed multiple myeloma study, improvement in or resolution of peripheral neuropathy was reported in 48% of patients with ≥Grade 2 peripheral neuropathy following dose adjustment or interruption. Improvement in or resolution of peripheral neuropathy was reported in 73% of patients who discontinued due to Grade 2 neuropathy or who had ≥Grade 3 peripheral neuropathy in the phase 2 multiple myeloma studies. The long-term outcome of peripheral neuropathy has not been studied in mantle cell lymphoma.Hypotension: The incidence of hypotension (postural, orthostatic, and hypotension NOS) was 8%. These events are observed throughout therapy. Caution should be used when treating patients with a history of syncope, patients receiving medications known to be associated with hypotension, and patients who are dehydrated. Management of orthostatic/postural hypotension may include adjustment of antihypertensive medications, hydration, and administration of mineralocorticoids and/or sympathomimetics.Cardiac Toxicity: Acute development or exacerbation of congestive heart failure and new onset of decreased left ventricular ejection fraction have occurred during VELCADE therapy, including reports in patients with no risk factors for decreased left ventricular ejection fraction. Patients with risk factors for, or existing, heart disease should be closely monitored. In the relapsed multiple myeloma study of VELCADE vs dexamethasone, the incidence of any treatment-related cardiac disorder was 8% and 5% in the VELCADE and dexamethasone groups, respectively. The incidence of adverse reactions suggestive of heart failure (acute pulmonary edema, pulmonary edema, cardiac failure, congestive cardiac failure, cardiogenic shock) was ≤1% for each individual reaction in the VELCADE group. In the dexamethasone group, the incidence was ≤1% for cardiac failure and congestive cardiac failure; there were no reported reactions of acute pulmonary edema, pulmonary edema, or cardiogenic shock. There have been isolated cases of QT-interval prolongation in clinical studies; causality has not been established.Pulmonary Toxicity: Acute Respiratory Distress Syndrome (ARDS) and acute diffuse infiltrative pulmonary disease of unknown etiology, such as pneumonitis, interstitial pneumonia, and lung infiltration have occurred in patients receiving VELCADE. Some of these events have been fatal. In a clinical trial, the first two patients given high-dose cytarabine (2 g/m2 per day) by continuous infusion with daunorubicin and VELCADE for relapsed acute myelogenous leukemia died of ARDS early in the course of therapy. There have been reports of pulmonary hypertension associated with VELCADE administration in the absence of left heart failure or significant pulmonary disease. In the event of new or worsening cardiopulmonary symptoms, consider interrupting VELCADE until a prompt, comprehensive, diagnostic evaluation is conducted.Posterior Reversible Encephalopathy Syndrome (PRES): Posterior Reversible Encephalopathy Syndrome (PRES; formerly termed Reversible Posterior Leukoencephalopathy Syndrome (RPLS)) has occurred in patients receiving VELCADE. PRES is a rare, reversible, neurological disorder, which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances. Brain imaging, preferably MRI (Magnetic Resonance Imaging), is used to confirm the diagnosis. In patients developing PRES, discontinue VELCADE. The safety of reinitiating VELCADE therapy in patients previously experiencing PRES is not known.Gastrointestinal Toxicity: VELCADE treatment can cause nausea, diarrhea, constipation, and vomiting, sometimes requiring use of antiemetic and antidiarrheal medications. Ileus can occur. Fluid and electrolyte replacement should be administered to prevent dehydration. Interrupt VELCADE for severe symptoms.Thrombocytopenia/Neutropenia: VELCADE is associated with thrombocytopenia and neutropenia that follow a cyclical pattern, with nadirs occurring following the last dose of each cycle and typically recovering prior to initiation of the subsequent cycle. The cyclical pattern of platelet and neutrophil decreases and recovery remained consistent over the 8 cycles of twice-weekly dosing, and there was no evidence of cumulative thrombocytopenia or neutropenia. The mean platelet count nadir measured was approximately 40% of baseline. The severity of thrombocytopenia was related to pretreatment platelet count. In the relapsed multiple myeloma study of VELCADE vs dexamethasone, the incidence of bleeding (≥Grade 3) was 2% on the VELCADE arm and <1% on the dexamethasone arm. Complete blood counts (CBC) should be monitored frequently during treatment with VELCADE. Platelet counts should be monitored prior to each dose of VELCADE. Patients experiencing thrombocytopenia may require change in the dose and schedule of VELCADE. Gastrointestinal and intracerebral hemorrhage has been reported in association with VELCADE. Transfusions may be considered. Tumor Lysis Syndrome: Tumor lysis syndrome has been reported with VELCADE therapy. Patients at risk of tumor lysis syndrome are those with high tumor burden prior to treatment. Monitor patients closely and take appropriate precautions.Hepatic Toxicity: Cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions. Other reported hepatic reactions include hepatitis, increases in liver enzymes, and hyperbilirubinemia. Interrupt VELCADE therapy to assess reversibility. There is limited re-challenge information in these patients.

Embryo-fetal: Pregnancy Category D. Women of reproductive potential should avoid becoming pregnant while being treated with VELCADE. Bortezomib administered to rabbits during organogenesis at a dose approximately 0.5 times the clinical dose of 1.3 mg/m2 based on body surface area caused post-implantation loss and a decreased number of live fetuses.

ADVERSE EVENT DATA: Safety data from phase 2 and 3 studies of single-agent VELCADE 1.3 mg/m2/dose administered intravenously twice weekly for 2 weeks followed by a 10-day rest period in 1163 patients with previously-treated multiple myeloma (N=1008) and previously-treated mantle cell lymphoma (N=155) were integrated and tabulated. In these studies, the safety profile of VELCADE was similar in patients with multiple myeloma and mantle cell lymphoma.In the integrated analysis, the most commonly reported (≥10%) adverse reactions were nausea (49%), diarrhea NOS (46%), fatigue (41%), peripheral neuropathies NEC (38%), thrombocytopenia (32%), vomiting NOS (28%), constipation (25%), pyrexia (21%), anorexia (20%), anemia NOS (18%), headache NOS (15%), neutropenia (15%), rash NOS (13%), paresthesia (13%), dizziness (excl vertigo 11%), and weakness (11%). Eleven percent (11%) of patients experienced at least 1 episode of ≥Grade 4 toxicity, most commonly thrombocytopenia (4%) and neutropenia (2%). A total of 26% of patients experienced a serious adverse reaction during the studies. The most commonly reported serious adverse reactions included diarrhea, vomiting, and pyrexia (3% each), nausea, dehydration, and thrombocytopenia (2% each), and pneumonia, dyspnea, peripheral neuropathies NEC, and herpes zoster (1% each).In the phase 3 VELCADE+melphalan and prednisone study in previously untreated multiple myeloma, the safety profile of VELCADE administered intravenously in combination with melphalan/prednisone is consistent with the known safety profiles of both VELCADE and melphalan/prednisone. The most commonly reported adverse reactions in this study (VELCADE+melphalan/prednisone vs melphalan/prednisone) were thrombocytopenia (48% vs 42%), neutropenia (47% vs 42%), peripheral neuropathy (46% vs 1%), nausea (39% vs 21%), diarrhea (35% vs 6%), neuralgia (34% vs <1%), anemia (32% vs 46%), leukopenia (32% vs 28%), vomiting (26% vs 12%), fatigue (25% vs 14%), lymphopenia (23% vs 15%), constipation (23% vs 4%), anorexia (19% vs 6%), asthenia (16% vs 7%), pyrexia (16% vs 6%), paresthesia (12% vs 1%), herpes zoster (11% vs 3%), rash (11% vs 2%), abdominal pain upper (10% vs 6%), and insomnia (10% vs 6%).In the phase 3 VELCADE subcutaneous vs intravenous study in relapsed multiple myeloma, safety data were similar between the two treatment groups. The most commonly reported adverse reactions in this study were peripheral neuropathy NEC (37% vs 50%), thrombocytopenia (30% vs 34%), neutropenia (23% vs 27%), neuralgia (23% vs 23%), anemia (19% vs 23%), diarrhea (19% vs 28%), leukopenia (18% vs 20%), nausea (16% vs 14%), pyrexia (12% vs 8%), vomiting (9% vs 11%), asthenia (7% vs 16%), and fatigue (7% vs 15%). The incidence of serious adverse reactions was similar for the subcutaneous treatment group (20%) and the intravenous treatment group (19%). The most commonly reported SARs were pneumonia and pyrexia (2% each) in the subcutaneous treatment group and pneumonia, diarrhea, and peripheral sensory neuropathy (3% each) in the intravenous treatment group.

DRUG INTERACTIONS: Bortezomib is a substrate of cytochrome P450 enzyme 3A4, 2C19 and 1A2. Co-administration of ketoconazole, a strong CYP3A4 inhibitor, increased the exposure of bortezomib by 35% in 12 patients. Monitor patients for signs of bortezomib toxicity and consider a bortezomib dose reduction if bortezomib must be given in combination with strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir). Co-administration of omeprazole, a strong inhibitor of CYP2C19, had no effect on the exposure of bortezomib in 17 patients. Co-administration of rifampin, a strong CYP3A4 inducer, is expected to decrease the exposure of bortezomib by at least 45%. Because the drug interaction study (n=6) was not designed to exert the maximum effect of rifampin on bortezomib PK, decreases greater than 45% may occur. Efficacy may be reduced when VELCADE is used in combination with strong CYP3A4 inducers; therefore, concomitant use of strong CYP3A4 inducers is not recommended in patients receiving VELCADE. St. John’s wort (Hypericum perforatum) may decrease bortezomib exposure unpredictably and should be avoided. Co-administration of dexamethasone, a weak CYP3A4 inducer, had no effect on the exposure of bortezomib in 7 patients. Co-administration of melphalan-prednisone increased the exposure of bortezomib by 17% in 21 patients. However, this increase is unlikely to be clinically relevant.

USE IN SPECIFIC POPULATIONS:Nursing Mothers: It is not known whether bortezomib is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from VELCADE, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.Pediatric Use: The safety and effectiveness of VELCADE in children has not been established.Geriatric Use: No overall differences in safety or effectiveness were observed between patients ≥age 65 and younger patients receiving VELCADE; but greater sensitivity of some older individuals cannot be ruled out.Patients with Renal Impairment: The pharmacokinetics of VELCADE are not influenced by the degree of renal impairment. Therefore, dosing adjustments of VELCADE are not necessary for patients with renal insufficiency. Since dialysis may reduce VELCADE concentrations, VELCADE should be administered after the dialysis procedure. For information concerning dosing of melphalan in patients with renal impairment, see manufacturer’s prescribing information.Patients with Hepatic Impairment: The exposure of bortezomib is increased in patients with moderate and severe hepatic impairment. Starting dose should be reduced in those patients.Patients with Diabetes: During clinical trials, hypoglycemia and hyperglycemia were reported in diabetic patients receiving oral hypoglycemics. Patients on oral antidiabetic agents receiving VELCADE treatment may require close monitoring of their blood glucose levels and adjustment of the dose of their antidiabetic medication.

Please see full Prescribing Information for VELCADE at VELCADEHCP.com.

VELCADE, MILLENNIUM and are registered trademarks of Millennium Pharmaceuticals, Inc. Other trademarks are property of their respective owners.Millennium Pharmaceuticals, Inc., Cambridge, MA 02139 Copyright © 2013, Millennium Pharmaceuticals, Inc. All rights reserved. Printed in USA

S:7”

S:10”

VELC3X0043_A_Velcade_BS_7x10_r3.indd 1 8/27/13 4:54 PM

V-12-0306a 6/14

VEL214CDNY6136_FCS_Q_and_A_Ad_r19_FSU.indd 5-6 11/11/14 2:13 PM

Page 10: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

10 FCS The Magazine

Medicine Runs In This FamilyMother and daughter team up to heal cancer patientsBy Lynda BeLcher

When it comes to establishing a close working relationship among colleagues, it takes time to build a certain level of personal and professional trust — unless you are related to the colleague in question, as is the case for Drs. Vasundhara and Meera Iyengar.

The mother-daughter duo has both followed career paths that have led them to Florida Cancer Specialists & Research Institute (FCS), working out of the Orlando-area offices. Dr. Vasundhara Iyengar practices at the Clermont, Altamonte Springs and Villages East offices, while Dr. Meera Iyengar sees patients at the Clermont and Orlando Downtown locations.

Medicine does run in the family. However, following in her mother’s footsteps was not initially Meera’s chosen path.

“I started out majoring in business and didn’t really feel passionate about it,” Meera said. “Obviously, medicine has always been a part of my life, so when I found I wanted to make the switch to something else, that was the obvious choice.”

Both women say that they didn’t set out for a career in hematology/oncology. As residents, they tried different areas of medicine, and both found that this was an area that spoke to them. By the time she graduated and was trying to determine her career direction, Meera had heard great things about FCS from her mother and found an opportunity to join the team.

ProFIle

Page 11: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

Winter 2014 11

Page 12: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

12 FCS The Magazine

“I knew I wanted to be close to home,” Meera said. “My mother enjoyed working with FCS and talked about what a great organization this is, so I was excited to have the opportunity to join as well.”

Following in her mother’s footsteps has paid off professionally for Meera. An accomplished doctor in her own right, she already has made quite an impact in the field. Meera has been published in the International Journal of Radiation Oncology, the Journal of Surgical Research and the Journal of Pediatric Surgery. In addition, she has led presentations on targeted therapies in lung cancer and is a past recipient of the University of Florida College of Medicine’s Creativity Award and Scholarship and the Society of Rhode Island Clinical Oncologists Fellows Oncology Grant.

As the pair sometimes works out of the Clermont office together, this allows Meera to consult her mother, as needed, on cases from a colleague’s perspective.

“When you are seeking advice on a patient from a fellow colleague, you want to know that is someone that you trust, and so not only respecting my mother on a professional level as an excellent doctor but also having that personal trust with her is so helpful,” Meera said.

Despite their professional and personal closeness, however, Vasu says it has been easy to keep their work and home life separate.

“When we are at work, I look at Meera like any other colleague,” Vasundhara said. “After hours, we have our personal relationship. Even though we work together, we

are ultimately mother and daughter and really good friends.”

Both have personal pursuits in which they support one another unequivocally. For instance, Meera is fluent in four languages: Spanish, Kannada, Tamil and English, and enjoys spending time volunteering, cooking and traveling.

In addition, Meera is in the process of learning the art of Indian classical singing and dance. This is something she has picked up from her mother, who performs and teaches classes on Carnatic vocal, which is the classical music style of southern India. Vasundhara learned Carnatic vocal from her father at age three and has been performing for many years, with her most recent concert held in August at a local Hindu temple. She has

performed at concerts around the U.S., as well as in the United Kingdom and Canada, and her singing has earned her a number of awards. It is a personal endeavor in which her daughter supports her wholeheartedly.

“To hear her perform is an amazing experience because she puts so much of herself into each performance,” Meera said. “And knowing that she is so accomplished in so many ways, from her singing talent to the professional respect she gets as a doctor, I am just constantly learning from her and enjoying my time with her — both at work and at home.” n

ProFIle

I knew I wanted to be close to home,” Meera said. “My mother enjoyed working with FCS and talked about what a great organization this is, so I was excited to have the opportunity to join as well.”

— Dr. Meera Iyengar

Page 13: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

Winter 2014 13

foundationevents

Rowdy Rauder 2014 MAy 16, 2014 Amanda Moore, Alexis Simpson and Tamer Morghem of Tallahassee competed for FCS in the Rowdy Rauder extreme endurance race.

Julie Eason 5K sePt. 28 2014

Above Left: (L to R) John Dambrauskas, 4th place finisher for the men, from Nurse on Call in Volusia County; Dana Dambrauskas, 1st place finisher for women, PT for Nurse on Call; and Jimmy Spears, 2nd place overall, husband of Danielle Spears, Lake County liaison. The run is held in memory of Julie Eason, an attorney in Oviedo who lost her battle with cancer in 2012.Above Right: (L to R ) Maria Langhorst, Office Manager (ODT); Ralph Gousse, MD; Rhonda Webster, Lead Physician Liaison; and Danielle Spears, Lead Physician Liaison.

Page 14: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

14 FCS The Magazine

foundationevents

Open House nov. 6, 2014

An open house was held to welcome Dr. Andres Soriano, Hematologist/Oncologist at Florida Cancer Specialists, and Dr. Tyler Hollen, Radiation Oncologist at 21st Century Oncology. Dr. Soriano has offices in Englewood and Venice Health Park. Dr. Hollen, the newest member to join 21st Century Oncology, sees patients at 21st Century Englewood and Sarasota locations. The reception was well attended by local Englewood Physicians.Above left: (L to R) Gary Bartlett, PA; Dr. Steven Porter, 21C; Dr. Tyler Hollen, 21C; Dr. Todd Chace; Dr. Julian Gershon; Dr. Andres Soriano; Dr. Dale Lakomy, 21st Century.Above Right: Carol King-Murphy, Patient Oncology Navigator 21st Century Oncology, and Dr. Pedro Casanova, Englewood General Practitioner.

Liaison Retreat 

nov. 10, 2014After a meeting on 11/10/14, coaching and training to improve their skills, the Physician Liaisons had a team building event at TreeUmph in Bradenton, FL.Front row: (L to R) Danielle Spears, Lead Physician Liaison; Rhonda Webster, Physician Liaison; Rebecca Appelbaum, Physician Liaison; Maria Ramos-Person, Lead Physician Liaison.Row two: (L to R) Monica Clark, Physician Liaison;Lisa Hrenko, Physician Liaison; Shelly Glenn, Chief Marketing and Sales Officer; Irene Nathanson, RN, Physician Liaison;Julie Anning, RN, Physician Liaison.Row three: (L to R) Lynn Clemens, Marketing Coordinator; Sandy Brooks, Physician Liaison.

Page 15: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

Winter 2014 15

foundationevents

Clinical Summit oct. 25, 2014

Dr. Bill Harwin, FCS President, is recognized for his commitment over the past 30 years.

Page 16: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

16 FCS The Magazine

expanding Integrative MedicineFCS partners with research nurse to better understand benefits of acupunctureBy Lynda BeLcher

Integrative medicine is an important part of a successful cancer treatment program. From good

nutrition to general well-being, it is important that the patient is strong enough to sustain during traditional therapies and continue to get better afterward.

This is the driving purpose behind Florida Cancer Specialists & Research Institute’s (FCS) integrative medicine program, which has grown by leaps and bounds since its inception. The program, headed up Dr. Nuruddin Jooma and nurse Sarah Boses, RN, working out of the Pinellas and Hillsborough County FCS offices, has added a number of resources in recent months that enable it to better serve patients.

Perhaps the most significant change is the partnership that FCS now has with a research nurse from the University of

South Florida to better understand the role that acupuncture might play in patients experiencing lasting side effects from chemotherapy treatments.

“This is the most exciting thing we are doing right now,” Boses said. “This is the next level of credibility in terms of integrative medicine because of the research element.”

Boses happened upon this partnership through a conversation with a presenter at an integrative oncology event. The conversation

steered toward the presenter’s research in neuropathy and, from there, evolved into potential research regarding acupuncture and neuropathy, which is a common chemo-related side effect.

“We’ve found that chemotherapy side effects can sometimes be long lasting, with patients sometimes two years out of the

Page 17: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

Winter 2014 17

treatment and still dealing with issues like neuropathy,” Boses said. “Some patients take prescription medications that may or may not help; we’ve found that among those patients incorporating integrative therapies like acupuncture, almost all report some improvement, and many report significant improvements.”

In addition to the research partnership, the program has expanded in a number of other ways as well. Several FCS regions now have a dietitian in place to work with patients on nutritional habits that might enhance treatment. Nutritional management services can include anything from what to eat during treatment to tube-feeding management and everything in between. This is a service that was previously referred outside of FCS, sometimes even to competing medical practitioners.

“It’s amazing to be able to provide those services in-house when a patient is already coming in to see the doctor,” Boses said.

In addition, massage therapists work through the program to help patients relax when they are in the office. They visit each of the chemo rooms to give patients 15-minute massages during treatment. Patients also have the option to join yoga sessions, which are offered twice monthly among the various offices, giving patients an opportunity to go at least once a week.

“We try to make it so that the patients are able to take advantage of services as often as possible,” Boses said.

Because of the support Jooma, Boses and the rest of the integrative services team has received from within FCS, they anticipate that the program will continue to grow, responding to patient needs as those needs evolve.

“So much of the growth of the integrative program has been driven by the genuine interest of our physicians, and this will continue to be what sets us apart from others,” Boses said. n

Page 18: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

DoCTor SPoTlIghT

18 FCS The Magazine

dr. Marilyn Raymond is Still asking the ‘Why’ QuestionsBy Zandra WoLfgram

When she was 16, in spite of her best friend’s positive prognosis, Marilyn Raymond couldn’t help but wonder why her young friend beat the odds of cancer . . . and lived.

“When she didn’t die, I wanted to know why someone who was supposed to be terminal survived . . . and why more people can’t survive it,” she recalls.

Thirty-some years later, that curious teenager — who is now married with two children — is board certified in oncology and internal medicine, and has been a practicing oncologist for 16 years. In June 2013, her practice merged with Florida Cancer Specialists & Research Institute (FCS). Raymond now works with 16 other physicians to see patients at the West Palm Beach and Wellington offices.

You could say that her work as clinical instructor during her residency at the University of Alabama at Birmingham (UAB) and her current role as FCS’ primary investigator for clinical research at the West Palm Beach location are indicative of someone with a natural curiosity. But, this modest physician would probably deny it.

“I don’t think I’m any more curious than anyone else,” Raymond says. “I am not a researcher. I am just a doctor who sees her patients.”

Ivonne Abreu, RN, has worked with Raymond since 1999. Abreu started as her secretary and, after going back to school, was rehired on Raymond’s team as a registered nurse.

“She is an extremely caring and compassionate person, and I think that is key to being in oncology,” Abreu said. “On top of that, she’s extremely smart, makes a point to keep up to date on technology and medication, and tries very hard to be aware and ‘be there.’”

Page 19: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

Winter 2014 19

And, with 20 to 25 patients a day, Raymond has plenty of opportunity to make a difference. The only thing she doesn’t seem to mind getting credit for is being a “people person.” But when it comes to her patients, Raymond prefers to do more listening than talking.

“I try to give them opportunities to tell me what they’re going through,” she says. “And I try to really hear what they’re saying in order to help them.”

Since her undergraduate days at the University of Georgia and residency time at UAB, Raymond has been particularly intrigued with the study of genetics. For Raymond — who deals with all cancers, but specializes in breast cancer — the development of new drugs, new discoveries and an increase of targeted treatment are both exciting and hopeful.

“I find the field of genetics amazing. The ways they are able to find that people who have malfunctioning tumor suppressor genes are more prone to certain cancer types . . . to me it’s amazing to be able to offer somebody that has that family history the answer. So that they can know, ‘I have this gene and it causes 80 percent chance of breast cancer and 35 percent of this other cancer and if I watch those two areas, I probably will live a normal life expectancy instead of feeling doomed,’ because their grandmother, mother and great-aunt died of cancer at a young age.”

Raymond is encouraged to see gene testing becoming more mainstream.

“With people like Angelina Jolie and Christina Applegate coming out and saying, ‘I have a gene that causes breast cancer and that’s why I had a bilateral mastectomy,’ now patients are aware of gene tests and are asking about them,” she says. She hopes that with more interest in gene testing and newer drugs, the demand will eventually reduce the expense, making such tests even more accessible.

As a breast cancer specialist, Raymond has seen firsthand the trend toward targeted drug therapy.

“Over the past 10 years, the drugs now are no longer just, ‘Here is a drug for breast cancer.’ It’s ‘Here is a new drug, but it’s only for HER2 positive breast cancer,’ or ‘Here’s a drug that’s only for triple-negative breast cancer.’ They are much more targeted now,” she explains.

The fact that the numbers are improving every year is why oncology is rewarding for Raymond. She says targeted drugs are improving the longevity of patients with metastatic breast cancer and improving the cure rate for those with curable cancers, such as adjuvant treatment of breast cancer.

“You can never say never, but the cure rate is up to 75 percent,” she says.

Keeping in mind the big picture and framing things from a positive view is essential for Raymond.

“I saw a lady today who is 42 and newly diagnosed, and she cried the whole visit, but it’s nice to be able to reassure her for her Stage I cancer that the chance of being cured is excellent,” she says.

For Raymond, it’s OK that oncology gets personal.

“It really goes back to liking and caring about the patient as a human being,” she says. “You do think about them after the day is over. You ask, ‘Did I do everything? Did I turn over every rock? Did I investigate every avenue for that person?’”

Now doesn’t that sound like a curious, caring oncologist who is still asking, “Why?” n

Page 20: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

nurSe SPoTlIghT

20 FCS The Magazine

a Bliss-ful FitA Fascination for Science and Passion for People Makes Nursing a Natural for This Seasoned PractitionerBy Zandra WoLfgram

What’s in a name? For 32 years, her joy has been a job that has allowed her to “teach, help, care for and empower” thousands of patients. She is grateful for

a career path that has teamed her with the same physician, Richard Brown, M.D., for 18 years — more years than her first marriage, she jokes.

And for this Sarasota ARNP/AOCN, her new married name truly reflects her current state of mind: Meet Shawn Bliss.

The Schenectady, N.Y., native grew up living in bustling big cities such as Pittsburgh, Boston and Chicago. In 1987, she ventured south from Illinois seeking the comfort of a warmer climate, but her life wasn’t always filled with Florida sunshine. For nearly seven years, she raised her two daughters as a single mother while working full time in oncology nursing and earning her Master of Science degree in nursing at the University of South

Florida. Today, she has been remarried for 12 years to Jeff Bliss — “a person who cooks like a chef,” so she quips, “It has literally been bliss ever since.”

Coming from a “family of science people” — her father is an engineer and her sister a scientist — Bliss knew she would follow suit.

“I love science,” she says. “I started as a chemical engineer, but I realized while I was in school that I really liked patient and personal interaction and decided to pursue nursing, which is a perfect fit for me.”

Finding oncology was another good fit. In 1985, while working in Chicago as a floor nurse at McNeal Hospital, she was sent to a chemotherapy training class at Rush Presbyterian Hospital.

“I really fell in love with oncology at that point,” she recalls.

Page 21: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

Winter 2014 21

Putting her passion for science into action, Bliss helped develop the genetic testing program at Sarasota Memorial Hospital, where she worked as an oncology nurse, and also helped develop the breast cancer treatment program at the Breast Health Center in Sarasota. She joined Florida Cancer Specialists & Research Institute (FCS) in 1996 and, as a member of the Oncology Nursing Society, was tapped to be a trainer for its chemotherapy certification class, which she taught at various FCS locations for five years.

For nearly two decades, Bliss has enjoyed a successful partnership with Brown, who is treated like a member of her family, going to ballgames with her husband and joining the family for dinner.

“We work hand-in-hand and look out for each other while we focus on doing the right thing for our patients,” she says. Being on the same wavelength is important to Bliss, because the Sarasota office is large and busy. Each team of six physicians averages about 25 to 30 patients a day.

Though it’s hectic hard work, after nearly three decades in oncology, Bliss is still moved by her patients.

“Being in oncology is to be humbled by people,” she says. “They are in a life-and-death situation, and it just blows me away when they take time to give me a compliment. Every day, it’s just . . . wow. It sounds hokey, but it’s true. People just amaze me.”

Though there are never enough hours in the day to do all she’d like to, for Bliss, being a good nurse means much more than having a good bedside manner.

“It’s so multifaceted — there is the physical, but also psychosocial, whatever is going on at home, and then the financial piece, how they can afford their medicine. So there is a lot to it,” she explains.

When she needs to “regroup” herself, you can find Bliss training for half-marathons, reading, meditating or at home entertaining family and friends.

“Because of Jeff’s cooking, our house is the one everyone comes to,” she says with a laugh.

Despite being a veteran caregiver — or maybe because of it — Bliss somehow exudes the wide-eyed, passionate enthusiasm of someone new on the job. Perhaps it’s her steadfast belief that every day provides an opportunity to make a difference and learn something new. And, every time she “pays it forward” is a day she is living her life philosophy.

“If you extend yourself — be kind to the next person, with a nice smile, pat on the arm, a nice anything — you may be amazed at how you’ve touched that person, who may very well be having a really bad day,” she says.

At the risk of sounding corny, this nurse practitioner says helping people is simply what makes her happy.

“Part of my impetus to get up every morning is to do something good,” she says. What comes around goes around. And, when it comes to Bliss, that’s a very good thing. n

Page 22: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

22 FCS The Magazine

Physician liaison ProgramBy Lynda BeLcher

a lthough Florida Cancer Specialists and Research Institute (FCS) is the largest independent, privately held

medical oncology/hematology practice in the U.S., our group continues to achieve new milestones and treat more cancer patients in Florida year after year – in spite of the increasing number of challenges community oncology practices are facing.

In addition to preeminent physicians, outstanding nurses and clinicians, dedicated employees and FCS’s sterling reputation, we have an incredible team of physician liaisons who help support our growth by developing relationships with referring physicians in scores of communities, both large and small, across the state. Led by Chief Marketing and Sales Officer Shelly Glenn, the FCS physician liaisons play a significant role in growing our practice and advancing our reputation throughout Florida.

Glenn joined FCS in 2012, and immediately set about enhancing and implementing a goal-driven liaison program, which strives to work with local current and prospective referral physicians to identify areas of opportunity in the process of referring patients to FCS. The liaisons are responsible for networking with referral physicians in the communities in which FCS has a presence and identifying what needs the company must meet in order to retain, grow and secure these coveted referrals.

Given her extensive experience in both marketing and sales, Glenn is a seasoned leader who has the necessary perspective to prioritize goals, align and leverage sales and marketing functions to produce results for the company.

Moreover, Glenn has a personal dedication to cancer awareness and education that manifests itself through her involvement in several key associations and cancer awareness organizations, including serving on the Board of Directors of the Florida Cancer Specialists Foundation, Jack & Jill Late Stage Cancer Foundation, and as both Legislative Committee Member and Chair of the Marketing & Communications Committee for the Florida Society of

Clinical Oncology (FLASCO). She was 2013 Co-Chair of American Cancer Society’s Making Strides Against Breast Cancer in Sarasota/Manatee and was named the 2014 Leukemia & Lymphoma Society’s Woman of the Year.

In addition to her role overseeing the marketing team and the FCS Foundation, Glenn manages 10 full-time physician liaisons with a keen understanding of just how important her team is to the company’s success.

“When it comes to the physician liaisons, they are truly the boots on the ground,” she said. “They are the face of FCS when it comes to referrals to each office and they are very motivated. All of our liaisons are working weekends and/or outside of the typical workday, attending evening continuing medical education (CME) programs, educational and networking initiatives and coordinating events and meetings. They understand that they always need to have a positive demeanor and remain professional in their interactions, despite being pulled in so many directions.”

The physician liaisons develop relationships with referring doctors and their staff members with a goal of bridging the gap between referral physician offices and the FCS physicians.

Page 23: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

Winter 2014 23

When there is hesitation from a physician’s office, the liaisons are charged with finding out why that physician is not referring to FCS and what strategy might be necessary for that specific office. The needs of each community vary, depending on location, demographics and specialties. The liaisons must have a working knowledge of the factors that bring patient referrals to FCS.

“The goal of the physician liaison program is to serve as the intermediary between referring physicians’ offices and the FCS physicians and their respective offices,” Glenn said. “Almost every FCS physician has strong existing relationships with referring physicians. However, when someone is unhappy or blocking referrals, it is the job of the physician liaison to identify physician needs and immediately convey this feedback to the regional director, office manager and FCS physician and ensure that those needs are addressed efficiently and appropriately.”

Managing this team demands attention to detail and stringent organizational skills. It also requires a substantial investment of time required from Glenn. She holds a conference call every Monday morning with the entire team to review productivity and activities from the prior week and talk through any challenges uncovered during the previous week. Along with the lead physician liaisons, every six to eight weeks, she goes on a ride-along with individual team members to observe them in the field and determine potential areas of opportunity and identify additional support tools needed. Glenn also holds one-on-one phone conferences each Friday to talk through individual areas of opportunity and to receive updates. The entire team meets together once a month and reviews best practices for the liaisons. Vendors and other organizations that can share advances in technology or medical innovations also are invited to attend the monthly meetings to help make the team more knowledgeable about cancer care and what FCS does—and should—offer.

“What we have observed, unofficially, is that more than 90 percent of patients come directly from referral physicians,” Glenn said. “What our team does can really drive results in a variety of ways. For instance, one of our liaisons initially

identified CME programs that we could offer at no cost. Our FCS physicians can speak or moderate an important clinical topic with prospective referral physicians in attendance. Our physician liaisons who have implemented these CME events have seen 15 to 60 physicians attend these programs and subsequently our referrals have increased from the attendees.”

Glenn remains focused on elevating the skills of the team and aligning best practices. “We want to ensure that our FCS physicians continue to be perceived as the experts they truly are,” she said. “We aren’t really selling as much as we are educating referral physicians. The liaisons are facilitating dialogues about our patient-centric physicians who are committed to providing the best care and communication in an environment with the latest technology and personalized care in each of the communities that we serve and in which we live. More than that, our amazing and dedicated physician liaisons provide me an opportunity to see them grow, learn and bring a measureable ROI to each of their physicians. Through their experiences, I also grow and learn so much from each of them.”

Physician Liaison TeamFront row: (L to R) Lisa Hrenko, Physician Liaison, Rebecca Appelbaum, Physician Liaison, Irene Nathanson, RN, Physician LiaisonBack row: (L to R) Lynn Clemens, Marketing Coordinator, Julie Anning, RN - Physician Liaison, Rhonda Webster, Physician Liaison, Monica Clark, Physician Liaison, Danielle Spears, Lead Physician Liaison, Maria Ramos-Person, Lead Physician Liaison, Shelly Glenn, Chief Marketing & Sales Officer, Sandy Brooks, Physician Liaison

Page 24: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

24 FCS The Magazine

Sue Kearney Walks the lineBy Zandra WoLfgram

growing up in Derby Line, a small town in northern Vermont, offered a unique perspective for Sue Kearney. Her backyard was in the U.S. while the front yard was in Canada. Today, as director of compliance and ancillary services for Florida Cancer Specialists & Research Institute (FCS), having

her feet in more than one place at a time is all part of “walking the line.”

In Dec. 1998, Kearney — now a 35-year veteran of the health care industry — gave up her job of 16 years as a certified clinical research associate at Fletcher Allen Health Care at the University of Vermont and happily traded cold snow for warm Florida sunshine to make a new life with her husband, Peter.

In January of the following year, she saw an opening at FCS in Fort Myers. Fast-forward 15 years, and Kearney still can’t believe all that FCS has accomplished. When she started, there were about eight offices, and today there are 10 times that many.

“I love working for FCS. One of the best parts for me is the continued growth and dramatic expansion, keeping it very challenging,” she says.

Kearney’s core job is to manage the organization’s adherence to its compliance plan and practice policies. Her responsibilities include legal adherence, HIPAA, coding, auditing and transcription. And like Johnny Cash’s song says, it’s her job to ensure that all 170-plus FCS physicians are walking in lockstep.

“I really have a zero percent error goal,” she says. “I want every doctor to comply, because all it takes is one. We are very large, so we have to make sure every single physician is compliant, because we can’t pick and choose who they are going to audit.”

Page 25: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

Winter 2014 25

Page 26: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

26 FCS The Magazine

And, just one small stumble can mean a big financial hit to the company. Kearney explains that at the crux of a medical billing audit is documentation provided by each physician that ensures “you gave the right dose of the right drug for the right reason.” Kearney says auditors often cast a big net on the most expensive drugs and then dig very deep. If it turns up that 20 percent of the medical charts they review are coded incorrectly, then FCS can expect to have 20 percent of its insurance-claim revenue withheld.

With big dollars and FCS’ reputation at stake each day, Kearney’s strategy is to get to the front of the line.

“We have saved millions of dollars being proactive and staying one step ahead,” she says. She closely monitors what

the auditors are looking at and implements best practices to be sure FCS stays on the right path.

There is no roadmap for many of the projects Kearney is tapped to do and that is fine with her.

“I was in an executive meeting and someone brought up mobile PET/CT scanners. Dr. Harwin (FCS’ President) said, ‘Sue, you need to make that happen.’” She didn’t know anything about them at the time, but after boning up and surrounding herself with a team of industry experts, in less than one year FCS rolled out the first mobile PET/CT scanner.

“I literally had tears in my eyes when that first one pulled into our Broadway office,” she says.

Page 27: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

Winter 2014 27

This past year, Kearney devoted a great deal of time to several new projects and programs at the new Central Lab location. Kearney has been instrumental in helping the lab grow its testing to 6 million tests a year. The more testing the lab can do internally, the greater the financial upside for FCS. Recently, the lab even added an extra day to its schedule so it can run tests six days a week.

This year, one of Kearney’s goals has been to incorporate FISH (fluorescent in situ hybridization) in the FCS pathology lab — a cytogenetic technique used to detect and localize the presence or absence of specific DNA sequences on chromosomes.

“We started with flow cytometry three years ago, a year ago we added morphology, and now FISH. We’ve come a long way,” Kearney says. Seeing something come to fruition is one of the most satisfying aspects of her job. “I am very driven to complete a project. I can’t stand things not completed, it just makes my hair hurt.”

Though she most enjoys the time she gets to spend in the Central Lab — because, like her, it is fast-paced, productive and interesting — she also enjoys spending time in the clinics, working directly with patients. Though it’s her job to handle 25 to 30 complaints and issues each week, she relishes the challenge.

“When you answer that phone call, you have no idea what to anticipate on the other end,” she says. “When it comes to patient complaints, they usually just want someone to listen. If I can make them feel better after a 15-minute phone call, they feel better . . . and so do I!”

Over her four-decade career journey, Kearney has been asked to step into some big shoes. How does she fill them? She says her secret is putting first things first.

“I know how to prioritize, and I understand that things change moment to moment,” she says. To keep up, she utilizes lists and calendars. “I love crossing things off when they are done.” And just like Johnny Cash, this high-energy executive will continue to “keep my eyes wide open all the time.” n

When you answer that phone call, you have no idea what to anticipate on the other end,” she says. “When it comes to patient complaints, they usually just want someone to listen. If I can make them feel better after a 15-minute phone call, they feel better . . . and so do I!”

— Sue Kearney

Page 28: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

28 FCS The Magazine

The new Ocala Office is Off and RunningFCS’ Ocala office is racing for a cure…quite literally.By Zandra WoLfgram

Situated within about 40 square miles in North Central Florida,

Ocala, home to one of the newest FCS offices, is about a 90-minute drive from the Gulf coast, the Atlantic coast and Orlando attractions. Historians say the area was first settled by Spanish explorers in 1539. Ocala is named for a Timucua historical village and is believed to mean “big hammock.”

In 1846, modern Ocala developed around its fort site. The first horse farms began forming in Florida in the 1940s. As luck would have it, in 1956 a thoroughbred named Needles was the first Florida thoroughbred to win the Kentucky Derby. Twenty years later, Affirmed won the Triple Crown, cinching the area’s title of “horse capital of the world.” Today, Marion County boasts 1,200 horse farms across 77,000 acres of lush “Kentucky bluegrass,” with 900 of those farms being home to thoroughbreds. From this billion-dollar industry, nearly $7 million funnels into Marion County coffers each year.

But horses are not the only things fast-paced here. Since the 1970s, Ocala has enjoyed some of the highest growth for a city of its size. In just 25 years, the population exploded by 150,000. Visitors attracted by the artesian springs flowing

from the Silver Springs and Silver River allowed the area to claim being one of Florida’s first tourist destinations. Today, visitors still flock to Silver Springs State Park and the Ocala National Forest, the second largest national forest in the state.

Perhaps a winning horse named Needles was fortuitous. The medical industry is the second largest employer in the area. The Florida Cancer Specialists & Research Institute (FCS) Ocala office opened in June 2014. Placed in the heart of Deerwood Plaza with several other clinics and offices, FCS is part of a health care hub serving nearly 57,000 residents.

Led by Dr. Patrick Acevedo, Dr. Maen Abdelkarim Hussein and Dr. Vipul Patel, the Ocala office opened as a FCS facility on June 2. Office manager Rachel Lefkowitz, originally from South

oFFICe SPoTlIghT

Page 29: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

Winter 2014 29

Florida, is a 10-year veteran of the health care industry who has lived in Ocala for the past six years. Having operated the Inverness FCS office, she transferred to Ocala to help that location get up and running and now oversees the day-to-day operations of both.

The Ocala staff has already become a close-knit team of eight who see between 10 and 15 patients each day. Max Gibbons, who has worked in the front office since it opened, says having a small office has its advantages for patients.

“We are all familiar with our patients and know them on a first-name basis,” he says.

Though the office stays busy, Lefkowitz says it is the comfortable atmosphere and friendly staffers who come

to work with a smile that give the office a welcoming atmosphere and what Gibbons describes as “a good vibe.”

Lefkowitz seconds that, saying, “Our first priority is making sure all of our patients receive top-of-the-line care. After all, they are why we are all here.” And with that, she politely ends the interview so she can giver her full attention to a patient.

Like the thoroughbreds raised nearby, the FCS Ocala office is in good form. Its tight team knows that when you train well and put your best foot forward, you are sure to come out a winner. n

We are all familiar with our patients and know them on a first-name basis.”

— Max gIbbonS

Page 30: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

30 FCS The Magazine

the radar screen

ASCO at 100 Miles an Hour By Scott tetreauLt

So, has ASCO lost its appeal? Sure, it is less of a nerd fest than ASH but still mostly a noisy waste of time.

Well, I’ve got you covered. Join me on a little trip, at high speed, through the ASCO abstracts that you need to know now, in the clinic, today. Buckle up for safety, and remember we are professionals on a closed course, do not try this at home.

BreAst cAncerTo preserve fertility in young women during adjuvant chemo, use goserelin. Only 20 percent on shots had failed ovaries at two years versus 45 percent and many more pregnancies. (POEMS study, Abstract LBA505)

Lapatinib plus Herceptin in adjuvant treat-ment was a bust. The combo had previously looked better in neoadjuvant but just forget it. (ALTTO LBA4)

You need to digest SOFT and TEXT for yourself, but personally, I am ablating the ovaries in young high-risk women and using aromasin.

ovAriAn cAncerA non-chemo approach of cediranib plus olaparib reduced risk of recurrence to only 48 percent compared to 80 percent for chemo. Stay tuned for this one. (Abstract LBA 5500 J. Liu, Late Breaking)

For second line therapy in platinum resistant patients, taxol plus pazopanib was better than taxol. (Abstract 5503)

MyeloMAContinuous treatment for this chronic blood cancer is much better than just picking a treatment duration out of a hat. Continuous is better for progression free interval and better for overall survival at four years. (Abstract 8515 Palumbo)

Transplant costs 72k per year of life saved. They considered this cost effective for eligible patients. (Abstract 8517)

non-hodgkin’s lyMPhoMAReplace R-CHOP??!! Maybe. Swap out the vincristine for velcade (VRCAP) and the early data looks better. Again, R-CHOP has been down by a few touchdowns before and has always come back to win, but looks promising, and we all know vincristine is worthless. (Abstract 8500 Cavalli)

Greatest trial name ever: SEXIE. They gave high-dose Rirtuxan-CHOP versus standard and lo and behold, the men did better with the high-octane fuel but the women did not. Soon we will be dosing Rituxan differently in men and women. (Abstract 8501)

The next attack on R-CHOP is R squared CHOP. R-CHOP plus revlimid in diffuse large cell. This was very promising at two years and Celgene is a very skilled company at getting the FDA to see things their way. (Abstract 8520)

ProstAte cAncerCHAARTED topped the charts here: For men walking in the urologists door with aggressive untreated stage 4 prostate cancer, the urologist should start Lupron, but then he should do something that he has never done before: send the patient directly to Florida Cancer Specialists to consider starting taxotere chemo, too. I told a few urologists this and they looked at me like I was speaking Chinese. This one may take some time. (Abstract 5008)

BlAdder cAncerPD-L1 strategies WILL be important in this disease, and soon. This drug, MPDL 3280A is a winner but the cancer must express PD-L1. (Abstract 5011)

renAl cell cAncerPD-L1 strategies also will be very important in this disease, too. This one was nivolumab. It was way too toxic with pazopanib but was OK with sutent. (Abstract 5010)

colon cAncerThe LEAP study was presented and it was a mish mash of FOLFOX and FOLFIRI

and Avastin and Cetuximab. There was no real difference but the headline is that for all patients the average survival was 30 months!

rectAl cAncerOxaliplatinum in adjuvant colon has been criticized lately, at least in some patient populations, but in rectal it really seems to make a difference when compared to 5-FU alone. So, FOLFOX for adjuvant rectal. (Abstract 3502)

heAd And neckThis is pretty big actually. Ghi and friends showed that induction chemo with TPF was way better. Now, I know, last year two trials, PARADIGM and DECIDE were reported and they did not show any survival benefit to induction but the profession is moving toward a risk-adapted approach to curative therapy and the NCCN guidelines just moved induction (neoadjuvant if you prefer) therapy to a category 2A recommendation. I like induction therapy in select patients—it “gets them started” when there are delays from other docs and dental issues and it gives the patient the opportunity to see results right away while they gain our trust. It’s not for everyone and Hi Dose Cis times three during XRT is still the category 1 option but not every patient is identical, right? (Abstract 6004)

lung cAncerPD-L1 will be important here, too. Rizvi reported a progression free survival of 37 weeks on average, which is pretty impressive. (Abstract 8007)Nivolumab may be best of breed. (Abstract 8024)

MelAnoMANivolumab again. (Abstract 9002)As always, if I missed something that you think your friends at FCS should know about, email me at [email protected]. All the best. n

To get new biotech or novel therapies to market takes starting at

the beginning. It takes a partner with the experience, resources and

expertise to advance promising ideas into fully realized solutions. It

takes a global healthcare solutions leader dedicated to enhancing

patient care through end-to-end solutions for manufacturers,

pharmacies and providers. It takes persevering upstream and

executing downstream. It takes AmerisourceBergen. ItTakesAmerisourceBergen.com

33684-14-209018_ABC_Downstream_8.5x11_Onc_4C_r0.indd 1 11/14/14 2:14 PM

Page 31: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

To get new biotech or novel therapies to market takes starting at

the beginning. It takes a partner with the experience, resources and

expertise to advance promising ideas into fully realized solutions. It

takes a global healthcare solutions leader dedicated to enhancing

patient care through end-to-end solutions for manufacturers,

pharmacies and providers. It takes persevering upstream and

executing downstream. It takes AmerisourceBergen. ItTakesAmerisourceBergen.com

33684-14-209018_ABC_Downstream_8.5x11_Onc_4C_r0.indd 1 11/14/14 2:14 PM

Page 32: We Support the Health of your Practice · 2017-07-11 · – Robin S. Sharma, “The Greatness Guide: Powerful Secrets for Getting to World Class” Almost a year ago, with support

5202 Paylor Lane | Sarasota, FL 34240 | (855) 585-5433

Fighting cancer is a long journey. Florida Cancer Specialists Foundation helps make the road a little easier.

We deeply care about our patients and their struggles. Florida Cancer Specialists Foundation was created to help patients who need financial assistance while undergoing treatment. The Foundation allows those fighting their battle with cancer to concentrate on recovery rather than their overdue rent, mortgage, electric or water bill.

Please visit our website for ways to donate. Florida Cancer Specialists Foundation is a 501(c)(3) non-profit organization.

Foundation.FLCancer.comFoundation

A cancer diagnosis changes everything.