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Cancer Med. 2016 Jul;5(7):1694-701. doi: 10.1002/cam4.721. Epub 2016 Apr 20.

Subsequent primary malignancies and acute myelogenous leukemia transformation among myelodysplastic syndrome patients treated with or without lenalidomide.

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Department of Cancer Epidemiology, Moffitt Cancer Center, Tampa, Florida.
Department of Malignant Hematology, Moffitt Cancer Center, Tampa, Florida.
Biostatistics Shared Resource, University of New Mexico Cancer Center, Albuquerque, New Mexico.
Department of Biostatistics, Moffitt Cancer Center, Tampa, Florida.
Celgene Corporation, Summit, New Jersey.
Family Personalized Medicine Institute at Moffitt Cancer Center\M2GEN, Tampa, Florida.


The few studies that have examined rates of acute myeloid leukemia (AML) transformation in lenalidomide-treated myelodysplastic syndrome (MDS) patients have been limited to deletion 5q MDS. The association between lenalidomide and subsequent primary malignancies (SPMs) in MDS patients has not been evaluated previously. We conducted a retrospective cohort study to evaluate the risk of both SPM and AML in association with lenalidomide. A cohort of MDS patients (n = 1248) treated between 2004 and 2012 at Moffitt Cancer Center were identified, and incident cases of SPM and AML transformation were ascertained. Using a nested case-control design, MDS controls were 1:1 matched to SPM (n = 41) and AML (n = 150) cases, on age and date of MDS diagnosis, gender, follow-up time, IPSS, and del (5q). Associations between lenalidomide and (1) SPM incidence and (2) AML transformation were estimated with hazards ratios (HR) and 95% confidence intervals (CIs) in the cohort and odds ratios (OR) in the case-control analysis. SPM incidence did not differ significantly between cohort MDS patients treated with (0.7 per 100 person-years) or without lenalidomide (1.4 per 100 person-years) (HR = 1.04, 95% CI = 0.40-2.74), whereas a significantly reduced SPM risk was observed in the case-control sample (OR = 0.03, 95% CI = <0.01-0.63). Lenalidomide was not associated with AML transformation in the cohort analysis (HR = 0.75, 95% CI = 0.44-1.27) or in the case-control analyses (OR = 1.16, 95% CI = 0.52-2.56), after adjustment for potential confounders. Lenalidomide was not associated with increased risk of SPM or AML transformation in a large cohort of MDS patients mostly including nondeletion 5q MDS.


Acute myelogenous leukemia; lenalidomide; myelodysplastic syndrome; subsequent primary malignancies

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