Cetuximab plus FOLFOX-4 safe, effective in metastatic colorectal cancer
Treatment with cetuximab plus FOLFOX-4 appeared safe and effective among patients with RAS wild-type metastatic colorectal cancer, data from the randomized, multicenter phase 3 TAILOR trial showed.
“There were no new or unexpected safety findings; the safety profile of cetuximab (Erbitux, Eli Lilly) plus FOLFOX-4 was similar to that observed in prior randomized clinical trials,” Shukui Qin, MD, PhD, of East Hospital of Tongji University in Shanghai, China, and colleagues wrote. “Thus, the TAILOR study provides robust evidence for clinical practice regarding cetuximab in combination with FOLFOX-4 as a standard-of-care first-line treatment for patients with RAS wild-type metastatic colorectal cancer.”
Cetuximab in combination with chemotherapy is a standard-of-care first-line treatment for RAS wild-type metastatic colorectal cancer; however, the efficacy of cetuximab plus FOLFOX has never been evaluated in a randomized phase 3 trial.
The study included 393 patients (median age, 56 years; 266 men) in China with RAS wild-type metastatic colorectal cancer. Researchers assigned patients 1:1 to FOLFOX-4 (with or without cetuximab.
PFS served as the primary endpoint. Secondary endpoints included OS, overall response rate, safety and tolerability.
Researchers reported a median PFS of 9.2 months in the cetuximab plus FOLFOX-4 arm compared with 7.4 months in the FOLFOX-4 alone arm (HR = 0.69; 95% CI, 0.54-0.89).
Median OS — after 300 events — was 20.7 months in the combination arm vs. 17.8 months in the FOLFOX-4 alone arm (HR = 0.76; 95% CI, 0.61-0.96).
The ORR was 61.1% with cetuximab and FOLFOX-4 vs. 39.5% with FOLFOX-4 alone (OR = 2.41; 95% CI, 1.61-3.61).
Serious adverse events occurred among 19.1% of those in the cetuximab arm vs. 13.1% in the FOLFOX-4 alone arm. Sixteen percent of patients assigned cetuximab discontinued treatment due to adverse events. There were no deaths specifically associated with cetuximab, according to the researchers.
“There were no major differences between our observations and those previously reported from analogous pivotal trials in metastatic colorectal cancer that enrolled predominantly white patients,” the researchers wrote. – by Jennifer Southall
Disclosures: Qin reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.