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Blood, 1 January 2008, Vol. 111, No. 1, pp. 86-93.
Prepublished online as a Blood First Edition Paper on September 24, 2007; DOI 10.1182/blood-2007-01-068833.
 Previous Article | Table of Contents | Next Article 
CLINICAL TRIALS AND OBSERVATIONS
Phase 2 study of lenalidomide in transfusion-dependent, low-risk, and intermediate-1–risk myelodysplastic syndromes with karyotypes other than deletion 5q
Azra Raza1,
James A. Reeves2,
Eric J. Feldman3,
Gordon W. Dewald4,
John M. Bennett5,
H. Joachim Deeg6,
Luke Dreisbach7,
Charles A. Schiffer8,
Richard M. Stone9,
Peter L. Greenberg10,
Peter T. Curtin11,
Virginia M. Klimek12,
Jamile M. Shammo1,
Deborah Thomas13,
Robert D. Knight14,
Michele Schmidt14,
Kenton Wride14,
Jerome B. Zeldis14, and
Alan F. List15
1 Rush University Medical Center, Chicago, IL;
2 Florida Cancer Specialists, Fort Myers;
3 Weill Medical College of Cornell University, New York, NY;
4 Mayo Clinic, Rochester, MN;
5 James P. Wilmot Cancer Center, University of Rochester Medical Center, NY;
6 Fred Hutchinson Cancer Research Center, Seattle, WA;
7 Eisenhower Medical Center, Rancho Mirage, CA;
8 Karmanos Cancer Institute, Wayne State University School of Medicine, Detroit, MI;
9 Dana-Farber Cancer Institute, Boston, MA;
10 Stanford University Medical Center, CA;
11 Oregon Health and Sciences University, Portland;
12 Memorial Sloan-Kettering Cancer Center, New York, NY;
13 M. D. Anderson Cancer Center, Houston, TX;
14 Celgene, Summit, NJ; and
15 H. Lee Moffitt Cancer Center, Tampa, FL
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
[ClinicalTrials.gov]
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