Long-Term Survival Outcomes of Modified-FOLFOXIRI Plus Cetuximab Versus Bevacizumab in RAS / BRAF Wild-Type Metastatic Colorectal Cancer: Final Analysis of the DEEPER Trial

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The randomized phase II DEEPER trial (jRCTs061180022) previously reported superior depth of response with modified 5-fluorouracil, leucovorin, oxaliplatin and irinotecan (m-FOLFOXIRI) plus cetuximab versus bevacizumab in patients with RAS wild-type metastatic colorectal cancer (mCRC). Here, we report updated final survival outcomes and exploratory subgroup analyses focusing on RAS / BRAF wild-type and left-sided tumors. Final overall survival (OS) and progression-free survival (PFS) were analyzed in the per-protocol set (PPS) with exploratory subgroup analyses according to the presence of liver-limited disease and sex, using extended follow-up data. There were no differences in PFS and OS in the PPS. In patients with RAS / BRAF wild-type and left-sided tumors, median PFS was longer with cetuximab than with bevacizumab (14.8 v 11.9 months; hazard ratio [HR], 0.71 [95% CI, 0.52 to 0.97]; P = .029). The median OS was 50.2 months for cetuximab and 40.2 months for bevacizumab (HR, 0.74 [95% CI, 0.53 to 1.05]). In the exploratory analyses, cetuximab-based therapy was associated with longer OS in male patients (HR, 0.59; P = .016) and in patients with extrahepatic disease (HR, 0.60; P = .014). In conclusion, the DEEPER trial suggests that m-FOLFOXIRI plus cetuximab achieves superior tumor shrinkage and may be associated with favorable outcomes in selected patients with RAS / BRAF wild-type and left-sided mCRC, with exploratory signals of benefit in male patients and those with extrahepatic disease.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.