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.

Authors

Yu Sunakawa, Manabu Shiozawa, Takanori Watanabe, Hirofumi Ota, Hisateru Yasui, Taichi Yabuno, Mitsuyoshi Tei, Mitsugu Kochi, Dai Manaka, Hisatsugu Ohori, Tatsuro Yamaguchi, Tamotsu Sagawa, Masahito Kotaka, Yutaro Kubota, Takashi Sekikawa, Masato Nakamura, Masahiro Takeuchi, Wataru Ichikawa, Masashi Fujii, Akihito Tsuji

Published in

Journal of clinical oncology : official journal of the American Society of Clinical Oncology. Pages JCO2600355. Aug 27, 2026. Epub Aug 27, 2026.

Abstract

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.

PMID:
42659588
Bibliographic data and abstract were imported from PubMed on 28 Aug 2026.

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