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Extended survival and reduced risk of AML progression in erythroid-responsive lenalidomide-treated patients with lower-risk del(5q) MDS.

List AF1, Bennett JM2, Sekeres MA3, Skikne B4, Fu T4, Shammo JM5, Nimer SD6, Knight RD4, Giagounidis A7; MDS-003 Study Investigators.

Leukemia. 2014 ;28(5):1033-40.

 

1Department of Malignant Hematology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.and

2Departments of Oncology and Pathology, James P. Wilmot Cancer Center, Rochester, NY, USA.and

3Leukemia Program, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH, USA.and

4Celgene Corporation, Summit, NJ, USA.and

5Rush University Medical Center, Chicago, IL, USA.and

6Molecular Pharmacology and Chemistry Program, Sloan-Kettering Institute, New York, NY, USA.and

7Clinic for Oncology, Hematology and Palliative Medicine, Marien Hospital, Düsseldorf, Germany.

 

Abstract

 Lenalidomide is the approved treatment for patients with red blood cell (RBC) transfusion-dependent lower-risk myelodysplastic syndromes (MDS) and chromosome 5q deletion (del(5q)). We report the long-term outcomes (median follow-up 3.2 years) in patients treated with lenalidomide in the MDS-003 trial. RBC transfusion independence (TI) ≥ 8 weeks was achieved in 97 of 148 treated patients (65.5%), with a median response duration of 2.2 years. Partial or complete cytogenetic response was achieved by 63 of 88 evaluable patients (71.6%). Median overall survival (OS) was longer in patients achieving RBC-TI ≥ 8 weeks (4.3 vs 2.0 years in non-responders; P<0.0001) or cytogenetic response (4.9 vs 3.1 years in non-responders; P=0.010). Time to acute myeloid leukemia (AML)  progression was longer in patients achieving RBC-TI ≥ 8 weeks or any cytogenetic response versus non-responders (P=0.001 and P=0.0002, respectively). In a landmark multivariate analysis, RBC-TI ≥ 8 weeks was associated with prolonged OS (P<0.001) and a trend toward reduced  relative  risk of AML progression (P=0.080). Among these lower-risk MDS patients with del(5q), lenalidomide was associated with prolonged RBC-TI and cytogenetic responses, which were linked to improved OS and reduced risk of AML progression.

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red blood cell (RBC) transfusion-dependent lower-risk myelodysplastic syndromes (MDS)