Randomized Trial of Irinotecan and Cetuximab With or Without Vemurafenib in BRAF-Mutant Metastatic Colorectal Cancer (SWOG S1406).

ABSTRACT:

Purpose

BRAF^V600E mutations are rarely associated with objective responses to the BRAF inhibitor vemurafenib in patients with metastatic colorectal cancer (CRC). Blockade of BRAF^V600E by vemurafenib causes feedback upregulation of EGFR, whose signaling activities can be impeded by cetuximab.

Methods

One hundred six patients with BRAF^V600E-mutated metastatic CRC previously treated with one or two regimens were randomly assigned to irinotecan and cetuximab with or without vemurafenib (960 mg PO twice daily).

Results

Progression-free survival, the primary end point, was improved with the addition of vemurafenib (hazard ratio, 0.50, P = .001). The response rate was 17% versus 4% (P =

SUBMITTER: Kopetz S 

PROVIDER: S-EPMC8462593 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature