Qin S, et al. - In prospectively selected patients with RAS wild-type (wt) metastatic colorectal cancer (mCRC), researchers sought to confirm the safety and effectiveness of first-line cetuximab plus leucovorin, fluorouracil, and oxaliplatin (FOLFOX) vs FOLFOX alone in the TAILOR trial, which is the first randomized, multicenter, phase 3 study addressing this topic. This investigation met all its objectives and pertinent clinical end points and confirmed that, for patients with RAS wt mCRC, cetuximab plus FOLFOX is an efficacious standard-of-care first-line treatment regimen.

Methods

• In the TAILOR trial, which was an open-label, randomized (1:1), multicenter, phase 3 trial, researchers compared FOLFOX-4 with or without cetuximab in RAS wt (KRAS/NRAS, exons 2 to 4) mCRC patients from China.
• They focused on progression-free survival time (primary end point) as well as on overall survival time, overall response rate, and safety and tolerability (secondary end points).

Results

• Adding cetuximab to FOLFOX-4 vs FOLFOX-4 alone resulted in significant improvement in the primary end point of progression-free survival time (hazard ratio, 0.69; 95% CI, 0.54 to 0.89; P=.004; median, 9.2 v 7.4 months, respectively), and the secondary end points of overall survival time (current assessment after 300 events: hazard ratio, 0.76; 95% CI, 0.61 to 0.96; P=.02; median, 20.7 v 17.8 months, respectively) and overall response rate (odds ratio, 2.41; 95% CI, 1.61 to 3.61; P < .001; 61.1% v 39.5%, respectively) in the modified intent-to-treat population of 393 patients with RAS wt mCRC.
• Good tolerability of the treatment was evident, and there were no new or unexpected safety findings.