A randomised phase II trial of selumetinib vs selumetinib plus temsirolimus for soft-tissue sarcomas.

ABSTRACT:

Background

The MEK inhibitor, selumetinib, suppresses soft-tissue sarcoma (STS) cell proliferation in vitro. Mammalian target of rapamycin inhibitors possess modest activity against STS; however, resistance develops via MAPK pathway feedback activation. The combination of selumetinib and temsirolimus synergistically inhibits STS cell line growth. Therefore, a randomized phase II trial of selumetinib vs selumetinib plus temsirolimus was conducted.

Methods

Seventy-one adults with advanced STS who received ⩽ 2 prior chemotherapeutics were randomized to selumetinib 75 mg p.o. bid and allowed to crossover upon progression, or to selumetinib 50 mg p.o. bid plus temsirolimus 20 mg i.v. weekly, with primary endpoint of progression-free survival (PFS).

Results

There was no dif

SUBMITTER: Eroglu Z 

PROVIDER: S-EPMC4430716 | biostudies-literature | 2015 May

REPOSITORIES: biostudies-literature