Lenalidomide and prednisone for myelofibrosis: Eastern Cooperative Oncology Group (ECOG) phase 2 trial E4903 Journal Article
| Authors: | Mesa, R. A.; Yao, X.; Cripe, L. D.; Li, C. Y.; Litzow, M.; Paietta, E.; Rowe, J. M.; Tefferi, A.; Tallman, M. S. |
| Article 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. Lenalidomide and prednisone for myelofibrosis evaluated through a multicenteredcooperative group mechanism is only modestly active and myelosuppresive. This study was registered at http:// clinicaltrials.gov as NCT00227591. © 2010 by The American Society of Hematology. |
| Keywords: | adult; clinical article; treatment response; aged; myelofibrosis; lenalidomide; prednisone; clinical trial; neutropenia; diarrhea; drug dose reduction; drug withdrawal; treatment duration; follow up; low drug dose; multiple cycle treatment; neutrophil count; anemia; bone marrow suppression; heart disease; thrombocytopenia; hemoglobin; hemoglobin blood level; angiogenesis; aspartate aminotransferase blood level; hyperglycemia; hypoxia; aspartate aminotransferase; bilirubin; multicenter study; thrombosis; splenomegaly; patient compliance; thrombocyte count; liver disease; bilirubin blood level; bone marrow examination; spleen size |
| Journal Title: | Blood |
| Volume: | 116 |
| Issue: | 22 |
| ISSN: | 0006-4971 |
| Publisher: | American Society of Hematology |
| Date Published: | 2010-11-25 |
| Start Page: | 4436 |
| End Page: | 4438 |
| Language: | English |
| DOI: | 10.1182/blood-2010-05-287417 |
| PROVIDER: | scopus |
| PMCID: | PMC2996111 |
| PUBMED: | 20651074 |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 3" - "Export Date: 20 April 2011" - "CODEN: BLOOA" - "Source: Scopus" |
