Lenalidomide and prednisone for myelofibrosis: Eastern Cooperative Oncology Group (ECOG) phase 2 trial E4903

A multicenter Eastern Cooperative Group (ECOG) phase 2 trial assessed whether adding prednisone to lenalidomide would improve previously reported responses in persons with myelofibrosis (MF). Forty-eight subjects with anemia (42 evaluable) received lenalidomide, 10 mg/d, with a 3-month low-dose pred...

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Bibliographic Details
Published in:Blood 2010-11, Vol.116 (22), p.4436-4438
Main Authors: Mesa, Ruben A., Yao, Xiaopan, Cripe, Larry D., Li, Chin Yang, Litzow, Mark, Paietta, Elisabeth, Rowe, Jacob M., Tefferi, Ayalew, Tallman, Martin S.
Format: Article
Language:English
Subjects:
Antineoplastic Agents - adverse effects
Antineoplastic Agents - therapeutic use
Antineoplastic Combined Chemotherapy Protocols
Biological and medical sciences
Clinical Trials and Observations
Follow-Up Studies
Hematologic and hematopoietic diseases
Humans
Lenalidomide
Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis
Medical sciences
Prednisone - adverse effects
Prednisone - therapeutic use
Primary Myelofibrosis - drug therapy
Thalidomide - adverse effects
Thalidomide - analogs & derivatives
Thalidomide - therapeutic use
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Summary:A multicenter Eastern Cooperative Group (ECOG) phase 2 trial assessed whether adding prednisone to lenalidomide would improve previously reported responses in persons with myelofibrosis (MF). Forty-eight subjects with anemia (42 evaluable) received lenalidomide, 10 mg/d, with a 3-month low-dose prednisone taper. Ten subjects received 3 months, and 25 received 6 months of therapy. Myelosuppression was the main toxicity with 88% with ≥ grade 3 hematologic toxicity and 45% ≥ grade 3 nonhematologic toxicity. There were responses in 10 subjects (23%) using the International Working Group for Myelofibrosis Research and Treatment (IWG-MRT)–defined clinical improvement of anemia in 8 (19%) and/or decreased spleen size in 4 (10%). Serial bone marrow analysis showed no resolution of disease-related fibrosis or angiogenesis. With a median follow-up of 2.3 years, 23 subjects are alive. Lenali-domide and prednisone for myelofibro-sis evaluated through a multicentered-cooperative group mechanism is only modestly active and myelosuppre-sive. This study was registered at http://clinicaltrials.gov as NCT00227591.
ISSN:0006-4971
1528-0020
DOI:10.1182/blood-2010-05-287417