Phase 2 study of lenalidomide in transfusion-dependent, low-risk, and intermediate-1-risk myelodysplastic syndromes with karyotypes other than deletion 5q Journal Article
| Authors: | Raza, A.; Reeves, J. A.; Feldman, E. J.; Dewald, G. W.; Bennett, J. M.; Deeg, H. J.; Dreisbach, L.; Schiffer, C. A.; Stone, R. M.; Greenberg, P. L.; Curtin, P. T.; Klimek, V. M.; Shammo, J. M.; Thomas, D.; Knight, R. D.; Schmidt, M.; Wride, K.; Zeldis, J. B.; List, A. F. |
| Article Title: | Phase 2 study of lenalidomide in transfusion-dependent, low-risk, and intermediate-1-risk myelodysplastic syndromes with karyotypes other than deletion 5q |
| Abstract: | Lenalidomide is approved for red blood cell (RBC) transfusion-dependent anemia due to low or intermediate-1 (int-1) risk myelodysplastic syndromes (MDSs) associated with a chromosome 5q deletion with or without additional cytogenetic abnormalities. We report results of a multicenter, phase 2 trial evaluating lenalidomide therapy for transfusion-dependent patients with low- or int-1-risk MDS without deletion 5q. Eligible patients had 50 000/mm3 or more platelets and required 2 U or more RBCs within the previous 8 weeks; 214 patients received 10 mg oral lenalidomide daily or 10 mg on days 1 to 21 of a 28-day cycle. The most common grade 3/4 adverse events were neutropenia (30%) and thrombocytopenia (25%). Using an intention-to-treat analysis, 56 (26%) patients achieved transfusion independence (TI) after a median of 4.8 weeks of treatment with a median duration of TI of 41.0 weeks. In patients who achieved TI, the median rise in hemoglobin was 32 g/L (3.2 g/dL; range, 10-98 g/L [1.0-9.8 g/dL]) from baseline. A 50% or greater reduction in transfusion requirement occurred in 37 additional patients, yielding a 43% overall rate of hematologic improvement (TI response +∥≥ 50% reduction in transfusion requirement). Lenalidomide has clinically meaningful activity in transfusion-dependent patients with low- or int-1-risk MDS who lack the deletion 5q karyotypic abnormality. This study is registered at www.clinicaltrials.gov as no. NCT00064974. © 2008 by The American Society of Hematology. |
| Keywords: | adult; treatment outcome; aged; aged, 80 and over; middle aged; major clinical study; lenalidomide; thalidomide; clinical trial; constipation; fatigue; neutropenia; diarrhea; drug dose reduction; antineoplastic agents; multiple cycle treatment; phase 2 clinical trial; anemia; nausea; thrombocytopenia; risk factors; cytogenetics; hemoglobin; deep vein thrombosis; hemoglobin blood level; pruritus; rash; myelodysplastic syndrome; multicenter study; blood transfusion; peripheral edema; thrombocyte count; chromosome deletion; erythrocyte transfusion; karyotype; karyotyping; chromosome 11q; myelodysplastic syndromes; hemopoietic growth factor; chromosome 17p; chromosome 13q; chromosome 5q; chromosomes, human, pair 5; trisomy 8; chromosome deletion 5 |
| Journal Title: | Blood |
| Volume: | 111 |
| Issue: | 1 |
| ISSN: | 0006-4971 |
| Publisher: | American Society of Hematology |
| Date Published: | 2008-01-01 |
| Start Page: | 86 |
| End Page: | 93 |
| Language: | English |
| DOI: | 10.1182/blood-2007-01-068833 |
| PUBMED: | 17893227 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 117" - "Export Date: 17 November 2011" - "CODEN: BLOOA" - "Source: Scopus" |
