• This activity is Sponsored by Syntaxx Communications, Inc. and is supported through an educational grant from Amgen, Inc.. It was originally presented as a Satellite Symposium during the 2006 Annual Meeting of the American College of Clinical Pharmacy in St. Louis, Missouri.
• Estimated Time: 2 hours
• Price: $0
• Release Date: May 2007
• Expiration Date: May 31, 2008

The target audience will include clinical pharmacists, clinical pharmacy fellows, residents, and students.

Until recently, therapeutic developments in myelodysplastic syndrome (MDS) have been slow compared with that of other hematologic malignancies. New pathogenetic discoveries have led to a number of innovative therapeutic approaches.

In order to select the best treatment for an individual patient, it is important to clarify the role of licensed and established therapies as well as make a critical evaluation of the potential of new treatment options. The purpose of this program is to educate clinical pharmacists about the role of immunomodulatory drugs (eg, lenolidamide, thalidomide, antithymocyte globulin, cyclosporin A), growth factors (eg, erythropoietins, colony-stimulating factors), and epigenetic-modulating drugs (eg, azacitidine, decitabine) as treatment for MDS, the potential of these treatment options in low- and high-risk patients, and strategies for monitoring therapeutic outcomes and managing treatment-related toxicities.

After completing this program, the participant should be able to

• Develop an algorithm for treating symptomatic patients with low- or intermediate-1 risk myelodysplastic syndrome (MDS).
• Develop an algorithm for treating patients with intermediate-2 or high-risk MDS.
• Briefly describe the mechanism of action of the immunomodulatory drugs thalidomide and lenalidomide in MDS.
• Based on the results of clinical trials, describe the types of MDS patients most likely to benefit from thalidomide or lenalidomide therapy.
• List the most common grade 3 or 4 toxicities observed in clinical trials evaluating thalidomide or lenalidomide in MDS patients.
• Briefly describe the mechanism of action of the erythropoietins and granulocyte colony-stimulating factors in MDS.
• Based on the results of clinical trials, describe the types of MDS patients most likely to benefit from erythropoietin plus granulocyte colony-stimulating factor therapy.
• Briefly describe the mechanism of action of the epigenetic-modulating drugs azacitidine and decitabine in MDS.
• Based on the results of clinical trials, describe the types of MDS patients most likely to benefit from azacitidine or decitabine therapy.
• List the most common grade 3 and 4 toxicities observed in clinical trials evaluating azacitidine and decitabine in MDS patients.

Program Chair
Helen Leather, BPharm, BCPS
Clinical Pharmacy Specialist, BMT/Leukemia
Shands Hospital at the University of Florida
Gainesville, FL

Biography
Helen Leather is a Clinical Pharmacy Specialist in bone marrow transplantation (BMT) and leukemia at Shands Hospital and a Clinical Associate Professor at the College of Pharmacy at the University of Florida in Gainesville. She received her Bachelor of Pharmacy degree from the Western Australian Institute of Technology in 1986 and her Graduate Diploma in Hospital Pharmacy with Distinction from Curtin University, also in Australia, in 1990. After working as a clinical pharmacist in hematology for several years, she completed a hematology/oncology specialty residency at Emory University Hospital in Atlanta, Georgia. Ms. Leather's primary interests are managing therapy for BMT and leukemia patients and collaborating with Dr. John Wingard to conduct outcomes research in these patients. Other areas of interest include management of antiemetic, febrile neutropenia, antiviral, antifungal, and graft-versus-host-disease treatments in hematology and BMT patients. Additionally, she has coauthored several book chapters on infections in BMT patients.
Faculty
Guillermo Garcia-Manero, MD
Associate Professor of Medicine, Leukemia
UT MD Anderson Cancer Center
Houston, TX

Biography
Guillermo Garcia-Manero graduated form the Faculty of Medicine of the University of Zaragoza in Spain. During this period, he also received training in molecular biology at the Molecular Pathology Laboratory of the Royal Free Hospital School of Medicine of the University of London in the UK. Subsequently, he became an intern and resident in the Department of Internal Medicine at Thomas Jefferson University Hospital in Philadelphia. He remained in Philadelphia as a Hematology/Oncology Fellow at the Kimmel Cancer Center and the Cardeza Foundation for Hematologic Research, also at Jefferson Medical College. After completing his fellowship in 1999, he joined the faculty of the Department of Leukemia at the University of Texas MD Anderson Cancer Center in Houston. In Houston, he has devoted his work to the care of leukemia patients and developing a leukemia translational research program that focuses on the role of epigenetic alterations in cancer and how to exploit this knowledge from a prognostic and therapeutic perspective. He is the recipient of a Research Award for Clinical Trainees from the NIH, a Career Development Award from the American Society of Clinical Oncology, and the Physician-Scientist Award from MD Anderson Cancer Center. He is an author of more than 100 publications in his field and the principal investigator of several research studies, including several phase I/II studies of epigenetic therapy in leukemia.

Laura Wiggins, PharmD, BCOP
Clinical Pharmacy Specialist, BMT/Leukemia
Shands Hospital at the University of Florida
Gainesville, FL

Biography
Laura E. Wiggins is a clinical pharmacist with the Bone Marrow Transplantation and Leukemia Service at Shands Hospital at the University of Florida. Dr. Wiggins graduated from the University of Florida College of Pharmacy and completed her oncology residency at Johns Hopkins Hospital. She has worked with both stem cell transplant and general adult oncology patients and has practiced in both academic and community-based settings. Dr. Wiggins' current practice interests include stem cell transplantation, transplant-related complications, management of acute and chronic leukemias, leukemia-related complications, and pain management.

Syntaxx Communications is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education and has designated this satellite symposium for 2.0 contact hours (0.2 CEUs) of continuing pharmacy education (UPN #299-000-07-001-H01). To obtain continuing education credit, participants must complete and return the Certificate of Attendance form provided. A statement of continuing education credit will be sent to you within 6 to 8 weeks.

In accordance with the Accreditation Council for Continuing Medical Education's Standards for Commercial Support, Syntaxx Communications requires all faculty members involved in the content development of an educational program to disclose financial relationships of any amount occurring in the last 12 months with a commercial interest in the products or services discussed in the continuing education activity. In addition, faculty members are expected to disclose discussion of an unlabeled use of a commercial product or an investigational use not yet approved for any purpose. All identified conflicts of interest are thoroughly vetted by Syntaxx Communications to ensure fair balance, scientific objectivity of studies mentioned or used as the basis for content, and appropriateness of patient care recommendations.

The following financial relationships are reported for the New Strategies for Myelodysplastic Syndromes: Immunomodulatory Drugs, Growth Factors, and Epigenetic-Modulating Drugs symposium that was originally presented on October 26, 2006 in St. Louis, Missouri.

Guillermo Garcia-Manero, MD

Dr. Garcia-Manero has received grant/research support from and is on the speakers' bureau for MGI PHARMA and the Pharmion Corporation.

Helen Leather, BPharm, BCPS

Ms. Leather is a consultant for Pfizer and Enzon, has received grant/research support from Ortho Biotech and Merck, and is on the speakers' bureau for Pfizer, Enzon, Merck, and Fujisawa.

Laura Wiggins, PharmD, BCOP

Dr. Wiggins has nothing to disclose.

This ACPE-accredited program is sponsored by Syntaxx Communications, Inc.

This continuing education activity is supported through an educational grant from Amgen, Inc.

Introduction and Overview of Current Myelodysplastic Syndrome (MDS) Guidelines
Helen Leather, BPharm, BCPS

New Strategies for MDS: Immunomodulatory Drugs
Laura Wiggins, PharmD, BCOP

New Strategies for MDS: Growth Factors
Helen Leather, BPharm, BCPS

New Strategies for MDS: Epigenetic-Modulating Drugs
Guillermo Garcia-Manero, MD

Questions & Answers

© 2006 Syntaxx Communications, Inc.

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Editorial correspondence and production questions should be addressed to Syntaxx Communications, 305 West Country Drive, Duluth, GA 30097. Telephone: 1.866.248.7005; Fax: 1.866.248.9029; e-mail: tdavidson@syntaxxcomm.com.

Syntaxx Communications assumes no responsibility for errors or omissions in this document. The faculty members participating in this symposium may discuss published and/or investigational uses of agents that are not approved by the US Food and Drug Administration. Syntaxx Communications and Amgen do not recommend the use of any agent outside of its labeled indications. The opinions expressed in this educational activity are those of the faculty and do not necessarily represent the views of Syntaxx Communications or Amgen. Participants are advised to check the appropriate medical literature and product information currently provided by the manufacturer of each drug to be administered to verify dosage, method and duration of administration, or contraindications. Pharmacists or other healthcare professionals, relying on independent experience and knowledge of patients, are responsible for determining the best treatment for a patient.

Please print the Self-Assessment and Certificate of Participation and Participant Evaluation Forms; submission instructions are provided on the Certificate of Participation Form. Completed Certificate of Participation and Participant Evaluation Forms must be submitted for participants to receive a certificate of completion for continuing education credit. Upon receipt of your forms, a certificate will be provided within 4 weeks.