Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer: safety analysis of FRESCO-2.

ABSTRACT:

Background

Fruquintinib is a highly selective, oral inhibitor of all 3 VEGF receptors. The global, randomized, double-blind phase 3 FRESCO-2 trial (NCT04322539) met its primary endpoint demonstrating significantly improved overall survival in patients with refractory metastatic colorectal cancer (mCRC) who received fruquintinib plus best supportive care (BSC) versus placebo plus BSC. Here we report detailed safety data from FRESCO-2 including an analysis of treatment-related adverse events of special interest (AESIs).

Patients and methods

Patients with mCRC eligible for FRESCO-2 had received all standard chemotherapies and prior anti-VEGF and anti-EGFR therapies if indicated, and displayed progression on, or intolerance to, TAS-102 and/or regorafenib. Prespecified AESIs base

SUBMITTER: Eng C 

PROVIDER: S-EPMC11957243 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature