Assessment of the consistency and robustness of results from a multicenter trial of remission maintenance therapy for acute myeloid leukemia.

ABSTRACT:

Background

Data from a randomized multinational phase 3 trial of 320 adults with acute myeloid leukemia (AML) demonstrated that maintenance therapy with 3-week cycles of histamine dihydrochloride plus low-dose interleukin-2 (HDC/IL-2) for up to 18 months significantly improved leukemia-free survival (LFS) but lacked power to detect an overall survival (OS) difference.

Purpose

To assess the consistency of treatment benefit across patient subsets and the robustness of data with respect to trial centers and endpoints.

Methods

Forest plots were constructed with hazard ratios (HRs) of HDC/IL-2 treatment effects versus no treatment (control) for prospectively defined patient subsets. Inconsistency coefficients (I²) and interaction tests (X²) were used to detect any differen

SUBMITTER: Buyse M 

PROVIDER: S-EPMC3077323 | biostudies-literature | 2011 Mar

REPOSITORIES: biostudies-literature