Safety and efficacy of sunitinib in patients from Latin America: subanalysis of an expanded access trial in metastatic renal cell carcinoma.

ABSTRACT:

Background

Sunitinib is an approved treatment for metastatic renal cell carcinoma (mRCC). The safety profile and efficacy of sunitinib were confirmed in a global expanded access trial (ClinicalTrials.gov identifier: NCT00130897). This report presents a subanalysis of the final trial data from patients in Latin America.

Methods

Treatment-naïve or previously treated mRCC patients aged ≥18 years received oral sunitinib at a starting dose of 50 mg/day on a 4-weeks-on/2-weeks-off schedule. Treatment continued until disease progression, unacceptable toxicity, or withdrawal of consent. Safety was assessed regularly, and tumor measurements were scheduled per local practice (using Response Evaluation Criteria in Solid Tumors).

Results

In total, 348 patients from Latin America

SUBMITTER: Barrios CH 

PROVIDER: S-EPMC5045222 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature