title: Lenalidomide and prednisone for myelofibrosis: Eastern Cooperative Oncology Group (ECOG) phase 2 trial E4903.
abstract: 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.
authors.affiliation: Mayo Clinic, Scottsdale, AZ, USA. mesa.ruben@mayo.edu
authors.forename: Ruben A
authors.initials: RA
authors.lastname: Mesa
authors.forename: Xiaopan
authors.initials: X
authors.lastname: Yao
authors.forename: Larry D
authors.initials: LD
authors.lastname: Cripe
authors.forename: Chin Yang
authors.initials: CY
authors.lastname: Li
authors.forename: Mark
authors.initials: M
authors.lastname: Litzow
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Paietta
authors.forename: Jacob M
authors.initials: JM
authors.lastname: Rowe
authors.forename: Ayalew
authors.initials: A
authors.lastname: Tefferi
authors.forename: Martin S
authors.initials: MS
authors.lastname: Tallman
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols; D005500:Follow-Up Studies; D006801:Humans; D000077269:Lenalidomide; D011241:Prednisone / Q000009:adverse effects / Q000627:therapeutic use*; D055728:Primary Myelofibrosis / Q000188:drug therapy*; D013792:Thalidomide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000970:Antineoplastic Agents; D013792:Thalidomide; D000077269:Lenalidomide; D011241:Prednisone