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633.O1.8 Myelodysplastic Syndromes: Clinical Studies: Genetic and Epigenetic Targets

Monday, December 8, 2008: 7:00 AM-9:00 AM
304-306-308 - South (Moscone Center)
Moderators:
Azra Raza, MD and Rena Buckstein, MD, FRCPC
7:00 AM
Final Results from a Phase I Combination Study of Lenalidomide and Azacitidine in Patients with Higher-Risk Myelodysplastic Syndromes (MDS)

Mikkael A. Sekeres, MD, MS1, Alan F. List, MD2, David Cuthbertson3*, Ronald Paquette, MD4, Deborah Latham, R.N.1*, Manual Afable, R.N.1*, Katarina Paulic1*, Thomas P. Loughran Jr., MD5 and Jaroslaw P. Maciejewski, MD, PhD6

1Hematologic Oncology and Blood Disorders R35, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH
2H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL
3Pediatric Epidemiology Center, University of South Florida, Tampa, FL
4University of California, Los Angeles, Los Angeles, CA
5Penn State Cancer Institute - H072, Hershey, PA
6Hematologic Oncology and Blood Disorders, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH

7:15 AM
Oral (po) and Intravenous (iv) Clofarabine for Patients (pts) with Myelodysplastic Syndrome (MDS)

Stefan Faderl1, Guillermo Garcia-Manero1*, Farhad Ravandi1*, Gautam Borthakur1*, Zeev Estrov1*, Deborah A. Thomas1*, Varsha Gandhi2*, William Plunkett1*, Anna Byrd1*, Monica Kwari1* and Hagop M. Kantarjian1*

1M.D. Anderson Cancer Center, Houston, TX
2U.T. M.D. Anderson Cancer Center, Houston, TX

7:30 AM
Maintenance Treatment with 5-Azacitidine for Patients with High Risk Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia Following MDS (MDS-AML) in Complete Remission (CR) after Induction Chemotherapy

Michael Grövdal1, Rasheed Khan1*, Anni Aggerholm2*, Petar Antunovic3*, Jan Astermark4*, Per Bernell5*, Lena-Maria Engström6*, Lars Kjeldsen7*, Olle Linder8*, Lars Nilsson9*, Anna Olsson10*, Jonas Wallvik11*, Jon Magnus Tangen12*, Gunnar Öberg13*, Sten Eirik Jacobsen9*, Anna Porwit14*, Peter Hokland2 and Eva Hellström-Lindberg1*

1Karolinska Institutet/Karolinska University Hospital Huddinge, Stockholm, Sweden
2Aarhus University Hospital, Aarhus, Denmark
3Linköping University Hospital, Linköping, Sweden
4Malmö University Hospital (MAS), Malmö, Sweden
5Karolinska University Hospital Solna, Stockholm, Sweden
6University Hospital of Norrland (NUS), Umeå, Sweden
7Rigshospitalet, Copenhagen, Denmark
8Örebro University Hospital, Örebro, Sweden
9Lund University Hospital, Lund, Sweden
10Sahlgrenska University Hospital, Gothenburg, Sweden
11Sundsvall Hospital, Sundsvall, Sweden
12Ullevål University Hospital, Oslo, Sweden
13Uppsala Academic Hospital, Uppsala, Sweden
14Department of Pathology, Stockholm, Sweden

7:45 AM
Effect of Romiplostim in Patients (pts) with Low or Intermediate Risk Myelodysplastic Syndrome (MDS) Receiving Azacytidine

Hagop Kantarjian, MD1*, Frank Giles, MD2*, Peter Greenberg, MD3, Ronald Paquette, MD4, Eunice Wang, MD5*, Janice Gabrilove, MD6, Guillermo Garcia-Manero, MD1, Julie Gray7*, Kuolung Hu, PhD7* and Janet Franklin, MD, MPH7

1Leukemia Department, University of Texas MD Anderson Cancer Center, Houston, TX
2Cancer Therapy & Research Center, University of Texas Health Science Center, San Antonio, TX
3Stanford University Cancer Center, Stanford, CA
4University of California, Los Angeles, Los Angeles, CA
5Roswell Park Cancer Institute, Division of Hematologic Oncology, Buffalo, NY
6Mount Sinai School of Medicine, New York, NY
7Amgen Inc., Thousand Oaks, CA

8:00 AM
High Resolution Molecular Analysis of 5q- Syndrome Patients at Diagnosis and Following Lenalidomide Therapy

Azim M Mohamedali, PhD*, Nicholas Lea, PhD*, Natalie Twine, MSc*, Joop Gaken, PhD*, Rajani Chelliah, MSc*, Nigel Westwood, PhD, CSci, FIBMS* and Ghulam J Mufti, FRCP, FRCPath

Dept. of Haematological Medicine, Kings College London, London, United Kingdom

8:15 AM
Low Dose Decitabine Versus Best Supportive Care in Elderly Patients with Intermediate or High Risk MDS Not Eligible for Intensive Chemotherapy: Final Results of the Randomized Phase III Study (06011) of the EORTC Leukemia and German MDS Study Groups

Pierre Wijermans1, Stefan Suciu2, Liliana Baila2*, Uwe Platzbecker3, Aristoteles Giagounidis3, Dominik Selleslag3, Boris Labar3, Helmut Salih3, Filip Beeldens2*, Petra Muus3, Theo de Witte3* and Michael Lübbert, MD, PhD4*

1Dept of Hematology, Haga Hospital, The Hague, Netherlands
2EORTC Leukemia Group, Brussels, Belgium
3on behalf of EORTC or German MDS study Group
4Medical Center, University of Freiburg, Freiburg, Germany

8:30 AM
The Effects of Continued Azacitidine (AZA) Treatment Cycles on Response in Higher-Risk Patients (Pts) with Myelodysplastic Syndromes (MDS)

Lewis R. Silverman, MD1*, Pierre Fenaux, MD, PhD2*, Ghulam J Mufti, MBBS, DM, FRCP, FRCPath3, Valeria Santini, MD4*, Eva Hellström-Lindberg, MD, PhD5*, Norbert Gattermann, MD6, Guillermo Sanz, MD, PhD7, Alan F. List, MD8, Steven D. Gore, MD9, John F Seymour, MBBS, PhD, FRACP10*, Jay Backstrom, MD, MPH11*, David McKenzie, MS11* and C. L. Beach, PharmD11*

1Division of Hematology, Mount Sinai School of Medicine, New York, NY
2Hôpital Avicenne/ Université Paris 13, Bobigny, France
3Department of Haematological Medicine, Kings College London, London, United Kingdom
4Hematology, Azienda Ospedaliera Careggi, Firenze, Italy
5Karolinska University Hospital, Stockholm, Sweden
6Heinrich-Heine-University, Düsseldorf, Germany
7Dept. of Hematology, Hospital Universitario La Fe, Valencia, Spain
8H Lee Moffitt Cancer Center and Research Institute, Tampa, FL
9The Sidney Kimmel Comprehensive Cancer Ctr. at Johns Hopkins, Baltimore, MD
10Dept of Haematology, Peter MacCallum Cancer Institute, Victoria, Australia
11Celgene, Overland Park, KS

8:45 AM
Randomized Phase II Study of Combined Epigenetic Therapy: Decitabine Vs. Decitabine and Valproic Acid in MDS and AML

Jean-Pierre Issa1, Ryan Castoro1*, Farhad Ravandi-Kashani1*, Stefan Faderl1*, Xuelin Huang1*, Elihu Estey2*, Gautam Borthakur1, Gail Morris1*, Guillermo Garcia-Manero1* and Hagop M Kantarjian1*

1The University of Texas M. D. Anderson Cancer Center, Houston, TX
2University of Washington, Seattle, WA

*signifies non-member of ASH