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5-azacitidine prolongs overall survival in patients with myelodysplastic syndrome - systematic review and meta-analysis.

Author(s): Gurion R, Vidal L, Gafter-Gvili A, Belnik Y, Yeshurun M, Raanani P, Shpilberg O

Affiliation(s): Davidoff Cancer Center, Beilinson Hospital, Rabin Medical Center.

Publication date & source: 2009-09-22, Haematologica., [Epub ahead of print]

Background Hypomethylating agents have recently been shown to improve the outcome of patients with myelodysplastic syndrome (MDS). Meta-analysis and systematic review of randomized controlled trials comparing treatment with hypomethylating agents to conventional care, e.g., best supportive care or chemotherapy, in MDS patients was carried out. DESIGN AND METHODS: Outcomes assessed were: overall survival (OS), time to transformation or death, overall response rate and toxicity. Hazard ratios (HR) with 95% confidence intervals (CIs) were estimated and pooled for time to event data. For dichotomous data, relative risks (RR) were estimated and pooled. RESULTS: Four trials including 952 patients examined the effect of 5-azacitidine and decitabine. Treatment with hypomethylating agents significantly improved OS (HR 0.66, 95% CI 0.55-0.80, 3 trials) and time to transformation or death (HR 0.69, 95% CI 0.58-0.82, 4 trials). In a subgroup analysis per type of drug, these benefits could be shown for 5-azacitidine but not for decitabine. Both agents favorably influenced response rates. A higher rate of grade 3/4 adverse events was observed with their use. Conclusions Since 5-azacitidine prolongs overall survival and time to transformation or death it should be highly considered in the treatment of high risk MDS patients. Further studies are needed to establish the exact role of decitabine compared to 5-azacitidine in these patients.

Page last updated: 2009-10-20

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