Long-term Safety of Sunitinib in Metastatic Renal Cell Carcinoma.

ABSTRACT:

Background

Metastatic renal cell carcinoma (mRCC) patients receiving first-line sunitinib typically survive >2 yr, with chronic treatment sometimes extending to ≥6 yr.

Objective

To analyze long-term safety with sunitinib in mRCC patients.

Design, setting, and participants

Data were pooled from 5739 patients in nine trials, comprising seven phase II studies, a phase III study, and an expanded-access trial in various treatment settings (e.g., cytokine refractory or treatment-naïve).

Outcome measurements and statistical analysis

Interval and cumulative time-period analyses evaluated the incidence of treatment-related adverse events (TRAEs) for up to 6 yr, in the overall population and in those with long-term (≥2 yr) sunitinib treatment.

Results and limitations<

SUBMITTER: Porta C 

PROVIDER: S-EPMC5032140 | biostudies-literature | 2016 Feb

REPOSITORIES: biostudies-literature