TAILOR Trial: FOLFOX Plus Cetuximab in RAS Wild-Type Colorectal Cancer
Posted: Monday, November 26, 2018
According to the phase III TAILOR trial, published in the Journal of Clinical Oncology, cetuximab plus leucovorin, fluorouracil, and oxaliplatin (FOLFOX) seems to be effective and safe in the first-line treatment of patients with RAS wild-type metastatic colorectal cancer. The trial met its objectives and relevant clinical endpoints, according to the investigators.
“To our knowledge, the TAILOR trial is the first randomized, multicenter, phase III study of the addition of cetuximab to first-line FOLFOX prospectively choosing a RAS (wild-type) population and thus providing confirmative data for the efficacy and safety of cetuximab plus FOLFOX versus FOLFOX alone,” wrote Shukui Qin, MD, PhD, of the People’s Liberation Army 81 Hospital in China, and colleagues.
A total of 393 Chinese patients with RAS wild-type metastatic colorectal cancer were included in the study. Participants were randomly assigned 1:1 to receive either FOLFOX-4 or FOLFOX-4 plus cetuximab.
When compared with patients receiving FOLFOX-4 alone, those who received FOLFOX-4 plus cetuximab experienced a longer median progression-free survival time (9.2 months vs. 7.4 months; hazard ratio = 0.69) as well as a longer median overall survival time (20.7 months versus 17.8 months; hazard ratio = 0.76). In addition, the overall response rate was higher for patients who received cetuximab than for those who did not (61.1% vs. 39.5%). No new or unexpected safety findings were observed.