Decitabine in patients with myelodysplastic syndromes: A multi-center, open-label, dose comparison trial.

ABSTRACT:

Background

The hypomethylating agent decitabine is the standard therapy for intermediate or high risk myelodysplastic syndrome (MDS).

Methods

In this trial, 191 adult patients with intermediate/high risk MDS (IPSS score ≥ 0.5) randomly received decitabine using a standard regimen (20 mg/m² /day for 5 consecutive days; n = 94) or an extended regimen with lower daily dose (12 mg/m² /day for 8 consecutive days; n = 97) every 4 weeks, for a total of 4 cycles.

Results

The median follow-up was 14 months (range 2-36). The primary end point of overall response rate in the intent-to-treat analysis was 41.5% and 38.1% in the standard and extended dosing arms, respectively (p = 0.660). Complete remission and marrow complete remission also did not differ bet

SUBMITTER: Liu H 

PROVIDER: S-EPMC10358210 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature