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 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.
Mesa
Ruben A
RA
Mayo Clinic, Scottsdale, AZ, USA. mesa.ruben@mayo.edu
Yao
Xiaopan
X
Cripe
Larry D
LD
Li
Chin Yang
CY
Litzow
Mark
M
Paietta
Elisabeth
E
Rowe
Jacob M
JM
Tefferi
Ayalew
A
Tallman
Martin S
MS
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
D000970:Antineoplastic Agents; D013792:Thalidomide; D000077269:Lenalidomide; D011241:Prednisone