Effect of First-Line Chemotherapy Combined With Cetuximab or Bevacizumab on Overall Survival in Patients With KRAS Wild-Type Advanced or Metastatic Colorectal Cancer

JAMA, Journal Year: 2017, Volume and Issue: 317(23), P. 2392 - 2392

Published: June 20, 2017

Importance

Combining biologic monoclonal antibodies with chemotherapeutic cytotoxic drugs provides clinical benefit to patients advanced or metastatic colorectal cancer, but the optimal choice of initial therapy in previously untreated is unknown.

Objective

To determine if addition cetuximab vs bevacizumab combination leucovorin, fluorouracil, and oxaliplatin (mFOLFOX6) regimen irinotecan (FOLFIRI) superior as first-line metastaticKRASwild-type (wt) cancer.

Design, Setting, Participants

Patients (≥18 years) enrolled at community academic centers throughout National Clinical Trials Network United States Canada (November 2005-March 2012) cancer whose tumors wereKRASwt chose take either mFOLFOX6 FOLFIRI chemotherapy were randomized receive (n = 578) 559). The last date follow-up was December 15, 2015.

Interventions

Cetuximab combined chosen by treating physician patient.

Main Outcomes Measures

primary end point overall survival. Secondary objectives included progression-free survival response rate, site-reported confirmed unconfirmed complete partial response.

Results

Among 1137 (median age, 59 years; 440 [39%] women), 1074 (94%) met eligibility criteria. As 2015, median for 263 surviving 47.4 months (range, 0-110.7 months), 82% (938 1137) experienced disease progression. 30.0 cetuximab-chemotherapy group 29.0 bevacizumab-chemotherapy a stratified hazard ratio (HR) 0.88 (95% CI, 0.77-1.01;P .08). 10.5 10.6 HR 0.95 0.84-1.08;P .45). Response rates not significantly different, 59.6% 55.2% bevacizumab, respectively (difference, 4.4%, 95% 1.0%-9.0%,P .13).

Conclusions Relevance

withKRASwt there no significant difference between treatment.

Trial Registration

clinicaltrials.gov identifier:NCT00265850

Language: Английский