Phase III trial of everolimus in metastatic renal cell carcinoma: subgroup analysis of Japanese patients from RECORD-1.

ABSTRACT:

Objective

To assess the efficacy and safety of everolimus in Japanese patients with metastatic renal cell carcinoma.

Methods

A subgroup analysis of the pivotal Phase III, randomized, double-blind, placebo-controlled trial of everolimus 10 mg/day in patients with disease progression after treatment with sorafenib, sunitinib or both assessed outcomes in Japanese participants. Results were compared with those for the overall study population.

Results

The final trial analysis included 24 Japanese patients (everolimus, n= 15; placebo, n = 9). Median progression-free survival in the Japanese subpopulation was 5.75 months (95% confidence interval, 4.90 months to not reached) with everolimus and 3.61 months (95% confidence interval, 1.91-9.03 months) with placebo (hazard rati

SUBMITTER: Tsukamoto T 

PROVIDER: S-EPMC3012894 | biostudies-literature | 2011 Jan

REPOSITORIES: biostudies-literature