Emerging Therapies and Clinical Trials: What’s on the Horizon?

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Release Date: May 12, 2015
Expiration Date: May 12, 2016

Expected time to complete this activity as designed: 30 minutes
There are no fees for participating in or receiving credit for this online activity.

Program Overview

The myelodysplastic syndromes (MDS) represent myeloid clonal hemopathies with relatively heterogeneous spectrums of presentation. The primary clinical challenges that arise as a consequence of these hematologic stem cell disorders are the appropriate management of comorbidities that arise from cytopenias such as bleeding and infection which can lead to mortality, in addition to attentive monitoring for the development of secondary acute myeloid leukemia (AML), an aggressive hematologic malignancy that occurs in approximately a third of patients. With only some 13,000 people in the United States diagnosed annually with MDS, community-based clinicians see relatively few patients with this disorder in their practice but require significant skill sets to effectively manage this disease spectrum. MDS is rare in people younger than 40, with the vast majority of patients presenting over the age of 60. Consequently, effective management is often complicated by advanced age (median at diagnosis, 70-75 years), the presence of pre-existing non-hematologic comorbidities, and the inability of many of these older patients to tolerate certain intensive forms of therapy. Also of concern, when this illness progresses to AML, these patients experience lower response rates to standard therapies than those who develop de novo AML. Practice essentials include the early and appropriate diagnosis and risk assessment of MDS with subsequent development of personalized management plans that incorporate strategies tailored to each individual patient’s treatment goals and needs. Recent developments in the understanding of the genetic expression markers that are associated with poor prognosis hold promise that future therapeutic management will be tailored more specifically to address the biologic and molecular mechanisms driving an individual patient’s MDS with the goal of eradicating MDS clones. Indeed, recent insights from pre-clinical and clinical investigations have led to a period of accelerated discovery and therapeutic development that may provide new treatment options for MDS patients to more effectively address various specific MDS presentations while determining the optimal uses and benefits of available agents such as lenalidomide in select patient populations.

Join world-leading Managing MDS team experts Stuart Goldberg, MD, associate clinical professor of medicine at the John Theurer Cancer Center in Hackensack, New Jersey, and Azra Raza, MD, professor of medicine and director of the MDS Center at Columbia University in New York, New York, in a lively and frank practice-oriented discussion centered on two common real-world presentations of elderly MDS patients, one with low-risk disease and one with high-risk disease, and how they were evaluated and managed according to the most current clinical evidence for today’s approaches to disease management. Drs. Goldberg and Raza also explore what is new on the horizon for MDS management after each of these cases, including strategies that are undergoing clinical investigations to address outstanding clinical uncertainties and barriers to improved patient outcomes for low- and high-risk disease patients with a discussion of the trial results which either impact your practice today or have the potential to do so in the near future according to data that has been recently reported at scientific meetings including the American Society of Hematology (ASH) annual meeting.

Target Audience

This activity is designed for physicians, pharmacists, physician assistants, and other health care professionals who have an interest in enhancing their clinical skills in MDS.

Learning Objectives

Upon completion of this educational activity, participants should be able to:

  • Recognize current and emerging therapeutic strategies for elderly low- and high-risk MDS patients and associated clinical trial findings which either impact your MDS practice today, or may do so in the near future
  • Identify current clinical uncertainties and barriers to improved outcomes for elderly MDS patients
  • Relate new and emerging approaches to evaluating an individual MDS patient’s disease which may facilitate more effective personalized therapy

Agenda

Emerging Therapies and Clinical Trials: What’s on the Horizon? – Stuart Goldberg, MD, and Azra Raza, MD

Instructions for Participation and Credit

This activity is eligible for credit through May 12, 2016. After this date, this activity will expire and no further credit will be awarded.

  1. Read the target audience, learning objectives, and faculty disclosures.
  2. You may be asked to complete a short pre-test before accessing the educational content. This must be completed in order to move forward in the activity.
  3. Complete the educational content as designed.
  4. Complete the post-test. To receive a certificate, you must receive a passing score of 70%.
  5. Complete the activity evaluation survey to provide feedback and information useful for future programming.
  6. Certificates for CME credit may be printed immediately after successfully completing the post-test and activity evaluation. Pharmacist credit will be uploaded to CPE Monitor 4 weeks following receipt of a completed, qualified form.

Faculty Biographies

Stuart L. Goldberg, MD
Chief, Division of Leukemia
John Theurer Cancer Center
Hackensack, New Jersey

Dr. Stuart Goldberg received his medical degree from Pennsylvania State University, Milton S. Hershey Medical Center. He completed his internal medicine residency and his hematology-oncology fellowship at George Washington University Medical Center. He also completed a bone marrow transplantation fellowship at Fred Hutchinson Cancer Research Center. Dr. Goldberg is chief, Division of Leukemia, John Theurer Cancer Center in Hackensack, New Jersey.

Dr. Goldberg specializes in medical oncology and leukemia, and is board certified in medical oncology, hematology and internal medicine. He is a member of the American College of Physicians, American Society of Blood and Marrow Transplantation, American Society of Hematology, American Society of Clinical Oncology, Eastern Cooperative Oncology Group, Southwest Oncology Group, and the Myelodysplastic Foundation, among others. Dr. Goldberg specializes in treating all types of leukemia and myelodysplastic syndromes with a variety of treatment modalities, including chemotherapy and stem cell transplantation.

Azra Raza, MD
Professor of Medicine
Director, MDS Center
Columbia University Medical Center
New York, New York

Dr. Azra Raza completed her medical education in Pakistan, training in internal medicine at the University of Maryland, Franklin Square Hospital, and Georgetown/VA Medical Center in Washington, DC, followed by her fellowship in medical oncology at Roswell Park Cancer Institute in Buffalo, New York. She is currently the director of the MDS Center at Columbia University in New York City.

Dr. Raza serves on numerous national and international panels as a reviewer, consultant, and advisor, and is well known internationally for several landmark observations related to the biology and treatment of MDS. She has published the results of her laboratory research and clinical trials in prestigious, peer-reviewed journals such as The New England Journal of Medicine, Nature, Blood, PloS Med, PloS One, Cancer, Cancer Research, British Journal of Hematology, Leukemia, and Leukemia Research.

During her career, Dr. Raza has established a highly productive translational myelodysplastic syndromes (MDS) research program which includes a tissue repository containing more than 50,000 samples from MDS patients. She belongs to that rare group of investigators who are adept at both basic and clinical research. Her basic research is therapy-driven and is marked by her tireless efforts to move the advances in the laboratory to the bedside with alacrity for the improvement of treatment outcome of MDS patients.

Accreditation

MediCom CME CREDIT
Accreditation Statement: MediCom Worldwide, Inc. is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
Designation Statement: MediCom Worldwide, Inc. designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
ACPE CPE CREDIT
MediCom Worldwide, Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This activity is acceptable for 0.5 contact hours of Continuing Education Credit. Universal Activity Number: 827-0000-15-019-H01-P. Knowledge-based CPE activity.

In order for CPE Monitor to authenticate credit, pharmacists/technicians must provide their e-Profile ID number from NABP and date of birth (in MMDD format) when registering for a CPE program. Please make sure to provide this information in your Member Profile accessed through the Member Center on the home page of this site.

Disclosure

As an organization accredited by the Accreditation Council for Continuing Medical Education (ACCME), Accreditation Council for Pharmacy Education (ACPE) and California State Board of Registered Nursing, MediCom Worldwide, Inc. requires everyone who is a position to control the content of an educational activity to disclose all relevant financial relationships with any commercial interest. The ACCME defines “relevant financial relationships” as financial relationships in any amount, occurring within the past 12 months, including financial relationships of a spouse or life partner, that could create a conflict of interest. Accordingly, the following disclosures were made.

Faculty Disclosures

Dr. Stuart Goldberg has received honoraria related to speakers’ bureau activities from ARIAD, Bristol-Myers Squibb Company, and Novartis. He has received grant support related to research activities from ARIAD, Bristol-Myers Squibb, Novartis, and Pfizer Inc. Dr. Goldberg has been employed by COTA (Cancer Outcomes Tracking Analysis).

Dr. Azra Raza has received honoraria related to the development of educational materials from Novartis AG and speakers’ bureau activities from Genoptix–a Novartis Company.

Planning Committee Disclosures

The individuals listed below from MediCom Worldwide, Inc. reported the following for this activity: Joan Meyer, RN, MHA, executive director, and Eugene R. Tombler, PhD, FACME, medical director, oncology have no relevant financial relationships.

Peer Reviewer Disclosure

In accordance with MediCom Worldwide, Inc. policy, all content is reviewed by external independent peer reviewers for balance, objectivity and commercial bias. The peer reviewers have no relevant financial relationships to disclose.

Off-Label Disclosures/Investigational Disclosures

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The opinions expressed in the educational activity are those of the faculty. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings. Further, attendees/participants should appraise the information presented critically and are encouraged to consult appropriate resources for any product or device mentioned in this program.

Dr. Goldberg and Dr. Raza have indicated that they do not intend to discuss off-label uses of drugs, mechanical devices, biologics or diagnostics approved by the US Food and Drug Administration (FDA) for use in the US.

Dr. Goldberg and Dr. Raza have indicated that they do not intend to discuss investigational drugs, mechanical devices, biologics or diagnostics not approved by the FDA for use in the US.

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If you have any questions or concerns regarding this activity, please contact MediCom Worldwide, Inc. at 1-800-408-4242 or email us at info@managingmds.com.

Provided by MediCom Worldwide, Inc.
This activity is supported by an educational grant from Celgene Corporation.

©2015 MediCom Worldwide, Inc., 101 Washington St., Morrisville, PA 19067, 800-408-4242.
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Managing MDS would like to recognize and thank Celgene Corporation for their educational support of ManagingMDS.com

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