ASH 2016 Annual Meeting Highlights in Myelodysplastic Syndromes

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Release Date: January 11, 2017
Expiration Date: January 11, 2018

Expected time to complete this activity as designed: 60 minutes

There are no fees for participating in or receiving credit for this online activity.

Program Overview

Health care providers, especially community-based practitioners, are challenged with attending major medical conferences, learning about new data, and understanding their relevance and potential impact on clinical practice. In this activity, participants will learn about key highlights of the most impactful and groundbreaking data in myelodysplastic syndromes (MDS), presented at the 2016 American Society of Hematology (ASH) annual meeting. Leading experts in the field of MDS will share their insights on a variety of abstracts, covering topics including, but not limited to, hypomethylating agents, immunomodulatory drugs, and new combination therapies.

Target Audience

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

Learning Objectives

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

  • Summarize the efficacy and safety data from clinical trials investigating novel therapies and treatment strategies in patients with myelodysplastic syndromes (MDS)
  • Describe expert faculty perspectives on key clinical data for novel therapies and treatment strategies in MDS

  • Recognize the potential impact of clinical trials on clinical practice and existing treatment paradigms in MDS

Agenda

The activity includes four video sections which cover the following topic areas and abstracts:

HDAC Inhibitors, Immunotherapy, and IDH2 Inhibitors – Guillermo Montalbán Bravo, MD

  • (Abstract #344) A Phase II Study Evaluating the Combination of Nivolumab (Nivo) or Ipilimumab (Ipi) with Azacitidine in Pts with Previously Treated or Untreated Myelodysplastic Syndromes (MDS)
  • (Abstract #1999) A Phase II Clinical Trial of Azacitidine and Vorinostat for Patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS) with Poor Performance Status, Comorbidities, Other Active Malignancies or Organ Dysfunction Not Eligible for Conventional Clinical Trials
  • (Abstract #3167) Combination of Oral Rigosertib and Injectable Azacitidine in Patients with Myelodysplastic Syndromes (MDS): Results from a Phase II Study
  • (Abstract #343): Enasidenib (AG-221), a Potent Oral Inhibitor of Mutant Isocitrate Dehydrogenase 2 (IDH2) Enzyme, Induces Hematologic Responses in Patients with Myelodysplastic Syndromes (MDS)

TGF-β Inhibitors, Anti-TLR-2 Antibodies, and Deaminase Inhibitors – David P. Steensma, MD, FACP

  • (Abstract #227) A Clinical Study of OPN-305, a Toll-like Receptor 2 (TLR-2) Antibody, in Patients with Lower Risk Myelodysplastic Syndromes (MDS) That Have Received Prior Hypomethylating Agent (HMA) Therapy
  • (Abstract #3168) Luspatercept Increases Hemoglobin and Reduces Transfusion Burden in Patients with Low-Intermediate Risk Myelodysplastic Syndromes (MDS): Long-Term Results from Phase 2 PACE-MDS Study
  • (Abstract #1990) Pharmacokinetics and Exposure–Response of Luspatercept in Patients with Anemia Due to Low- or Intermediate-1-Risk Myelodysplastic Syndromes (MDS): Preliminary Results from Phase 2 Studies
  • (Abstract #114) Successful Emulation of IV Decitabine Pharmacokinetics with an Oral Fixed-Dose Combination of the Oral Cytidine Deaminase Inhibitor (CDAi) E7727 with Oral Decitabine, in Subjects with Myelodysplastic Syndromes (MDS): Final Data of Phase 1 Study

Hypomethylating Agents – Guillermo Garcia-Manero, MD

  • (Abstract #347) Results of a Phase II Study of Guadecitabine (SGI-110) in Higher Risk MDS, CMML or Low Blast Count AML Patients Refractory to or Relapsing after Azacitidine (AZA) Treatment
  • (Abstract #346) Initial Results of a Phase 2 Study of Guadecitabine (SGI-110), a Novel Subcutaneous (sc) Hypomethylating Agent, for Patients with Previously Untreated Intermediate-2 or High Risk Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML)
  • (Abstract #226) A Randomized Phase II Study of Low-Dose Decitabine Versus Azacitidine in Patients with Low- or Intermediate-1-Risk Myelodysplastic Syndromes: A Report on Behalf of the MDS Clinical Research Consortium
  • (Abstract #4341) Clinical Outcomes of 420 MDS Patients Treated with 5-Azacytidine: Evaluation of Overall Survival, Duration of Treatment and Rate of Discontinuation in a Real Life Study from the Italian MDS Registry of Fondazione Italiana Sindromi Mielodisplastiche (FISM)

Immunomodulatory Drugs – Mikkael A. Sekeres, MD, MS

  • (Abstract #224) Lenalidomide with or without Erythropoietin and Granulocyte-Colony Stimulating Factor Shows Efficacy in Patients with Low and Intermediate-1 Risk Myelodysplastic Syndrome with or without Del 5q, Refractory or Unlikely to Respond to Erythropoietin. Results of a HOVON89 Phase II Randomized Multicenter Study. (EudraCT 2008-002195-10)
  • (Abstract #223) Combined Treatment with Lenalidomide (LEN) and Epoetin Alfa (EA) Is Superior to Lenalidomide Alone in Patients with Erythropoietin (Epo)-Refractory, Lower Risk (LR) Non-Deletion 5q [Del(5q)] Myelodysplastic Syndrome (MDS): Results of the E2905 Intergroup Study—an ECOG-ACRIN Cancer Research Group Study, Grant CA180820, and the National Cancer Institute of the National Institutes of Health
  • (Abstract #4322) Optimal Treatment Order of Lenalidomide and Hypomethylating Agents for Lower-Risk Myelodysplastic Syndromes: A Report on Behalf of the MDS Clinical Research Consortium
  • (Abstract #3169) Azacitidine and Lenalidomide (Combined vs Sequential Treatment) in Higher-Risk Myelodysplastic Syndromes. Long-Term Results of a Randomized Phase II Multicenter Study

Instructions for Participation and Credit

This activity is eligible for credit through January 11, 2018. 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 and CNE 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

Guillermo Garcia-Manero, MD
Professor
Chief, Section of Myelodysplastic Syndromes
Deputy Chair, Translational Research
Department of Leukemia
Division of Cancer Medicine
The University of Texas MD Anderson Cancer Center
Houston, Texas

Dr. Guillermo Garcia-Manero received his medical degree from the University of Zaragoza, Spain. He completed his clinical internship, residency, and clinical fellowship in hematology and medical oncology at Thomas Jefferson University Hospital, Philadelphia. Dr. Garcia-Manero is Professor and Chief, Section of Myelodysplastic Syndromes (MDS) and Deputy Chair of Translational Research, Department of Leukemia, Division of Cancer Medicine, at The University of Texas MD Anderson Cancer Center (UTMDACC) in Houston. In addition, he is Co-Director, DNA Methylation Core, and the endowed Dr. Kenneth B. McCredie Chair in Clinical Leukemia Research, Department of Leukemia, Division of Cancer Medicine, at UTMDACC.

Dr. Garcia-Manero is board certificated in medical oncology (hematology eligible), and internal medicine. He holds membership in the American Association for the Advancement of Science, American Society of Hematology, American Society of Clinical Oncology, American Association of Cancer Research (Chair, Scientific Review Committee), Aplastic Anemia and International Myelodysplastic Syndromes Foundation (Steering Committee/Medical Advisory Board), American Medical Association (AMA) Foundation, Society of Hematologic Oncology, and the European Hematology Association. In addition, he is an editor/journal reviewer for numerous peer-reviewed publications. Dr. Garcia-Manero has written more than 800 abstracts, invited articles, and editorials in scientific journals, and is the Principal Investigator in several MDS studies.

Guillermo Montalbán Bravo, MD
Clinical Fellow in Leukemia
Department of Leukemia
The University of Texas MD Anderson Cancer Center
Houston, Texas

Dr. Guillermo Montalbán Bravo received his medical training at Autonomous University of Madrid. He continued his postgraduate training in Molecular Oncology at CNIO Spanish National Center on Investigational Oncology, and clinical fellowship and training in hematology and hemotherapy at University Hospital La Paz, Madrid, Spain. He is a Clinical Fellow in Leukemia, Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.

Dr. Montalbán Bravo holds professional memberships in the Society of Hematological Oncology (SOHO), Spanish Hematology and Hemotherapy Association (SEHH), Spanish Thrombosis and Hemostasis Association (SETH), and the Spanish Association of Fundamental and Clinical Bioethics (AEBFC). He has authored/co-authored journal articles and book chapters on myelodysplastic syndromes and acute myeloid leukemia.

Mikkael A. Sekeres, MD, MS
Professor of Medicine
Director, Leukemia Program
Vice Chair for Clinical Research
Cleveland Clinic
Cleveland, Ohio

Dr. Mikkael Sekeres earned a medical degree and a master’s degree in clinical epidemiology from the University of Pennsylvania School of Medicine. He completed his postgraduate training at Harvard University, finishing an internal medicine residency at Massachusetts General Hospital, and a fellowship in hematology-oncology at the Dana-Farber Cancer Institute in Boston. Dr. Sekeres is Professor of Medicine, Director of the Leukemia Program, and Vice Chair for Clinical Research at the Cleveland Clinic Taussig Cancer Institute. In addition, he is Deputy Associate Director for Clinical Research of the Case Comprehensive Cancer Center in Ohio.

Dr. Sekeres chaired the Oncologic Drugs Advisory Committee of the FDA and is co-chair of the medical advisory board of the Aplastic Anemia and Myelodysplastic Syndromes (MDS) International Foundation. He is a member of the American Society of Hematology, the American Society of Clinical Oncology, and the Southwest Oncology Group—Leukemia Committee. Dr. Sekeres is an invited speaker at numerous meetings, grand rounds, and conferences. He is the author/co-author of hundreds of abstracts published in Blood, Journal of Clinical Oncology, Nature Genetics, Journal of the National Cancer Institute, PLoS One, Cancer, Haematologica, and Leukemia. He is also the co-author of six books, editor-in-chief of the ASH Clinical News magazine, is on the editorial board of several journals, and is an essayist for The New York Times and Huffington Post. Dr. Sekeres’ current research focuses on patients with MDS and older adults with acute myeloid leukemia, and he has been the national primary study investigator on several phase I/II trials. 

David P. Steensma, MD, FACP
Associate Professor of Medicine
Harvard Medical School
Senior Physician
Dana-Farber Cancer Institute
Boston, Massachusetts

Dr. David Steensma received his medical degree from the University of Chicago’s Pritzker School of Medicine. He completed an internal medicine internship and residency, and a combined hematology-oncology fellowship in the Mayo Graduate School of Medicine in Rochester, Minnesota. Dr. Steensma is an Associate Professor of Medicine at Harvard Medical School, a Senior Physician in the Division of Hematological Malignancies at Dana-Farber Cancer Institute, and a consulting physician at Brigham & Women’s Hospital, Boston, Massachusetts.

Following completion of his formal training, Dr. Steensma spent several years as a visiting research scholar in the Molecular Haematology Unit of the Weatherall Institute of Molecular Medicine, Oxford, England, investigating the molecular genetics of myelodysplastic syndromes. He joined the consulting staff of the Mayo Clinic in Rochester, Minnesota as a clinician-investigator in the Division of Hematology, and served as the Associate Fellowship Program Director for Hematology and Associate Professor in the Mayo Clinic College of Medicine.

Dr. Steensma is board certified by the American Board of Internal Medicine in internal medicine, hematology, and medical oncology. He is a fellow of the American College of Physicians, has served as education chair for the annual meeting of the American Society of Hematology (ASH), editor of several ASH publications, and a section editor of the Journal of Clinical Oncology. He has written more than 300 publications in peer-reviewed journals including The New England Journal of Medicine, Nature Genetics, Blood, Lancet, Journal of Clinical Oncology, and Leukemia. Dr. Steensma’s primary clinical and research focus is myelodysplastic syndromes, and he also maintains an active interest in marrow failure syndromes.

Accreditation

MediCom CME CREDIT
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Designation Statement: MediCom Worldwide, Inc. designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credit™. 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 1.0 contact hour of Continuing Education Credit. Universal Activity Number: 827-0000-17-135-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 login/registration on the home page of this site.
MediCom NURSING CREDIT
Accreditation Statement: MediCom Worldwide, Inc., 101 Washington Street, Morrisville, PA 19067 is approved by the California Board of Registered Nursing, Provider Number CEP11380. MediCom designates this CNE activity for 1.0 contact hour. Program Number: 17-135-050

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 in 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. Guillermo Garcia-Manero has disclosed no relevant financial relationships.

Dr. Guillermo Montalbán Bravo has disclosed no relevant financial relationships.

Dr. Mikkael Sekeres has received honoraria related to formal advisory activities from Celgene Corporation.

Dr. David Steensma has received honoraria as a consultant from Akebia Therapeutics, Amgen Inc., Celgene Corporation, Janssen Pharmaceuticals, Inc., Novartis AG, and Takeda Oncology. He owns significant holdings in ARIAD Pharmaceuticals, Inc.

Planning Committee Disclosures

The individuals listed below from MediCom Worldwide, Inc. reported the following for this activity: Joan Meyer, RN, MHA, Executive Director, and Patrick Brooks, PharmD, 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.

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

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