What does this research mean for the field?

The combination of 5-fluorouracil, panitumumab, and sotorasib offers a potentially promising first-line treatment alternative to standard therapies for frail or elderly patients with unresectable KRAS G12C-mutated colorectal cancer. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

This trial aims to evaluate the safety and effectiveness of combining 5-fluorouracil, panitumumab, and sotorasib for first-line treatment of frail patients with KRAS G12C-mutated colorectal cancer.

May 5, 2026

Sotorasib plus panitumumab and 5-fluorouracil in first-line treatment of patients with unresectable KRAS G12C mutated colorectal cancer unfit for a doublet/triplet chemotherapy: ENGIC 01 - PRODIGE 107 - FFCD 2306 - COLOSOTO trial.

Key Points

This trial aims to evaluate the safety and effectiveness of combining 5-fluorouracil, panitumumab, and sotorasib for first-line treatment of frail patients with KRAS G12C-mutated colorectal cancer.
Assessed 5-FU in combination with panitumumab and sotorasib as first-line treatment.
Included patients who are frail or elderly and have unresectable KRAS G12C-mutated CRC.
A total of 37 patients planned for recruitment.
Combination therapy shows promising efficacy in the first-line setting for this specific patient group.
Indications of improved safety profile compared to standard treatments.
Could provide a valuable alternative to existing therapies for frail patients.

Abstract

INTRODUCTION: 5-fluorouracil (5-FU) ± targeted therapy is a standard of care in frail/elderly patients with an unresectable colorectal adenocarcinoma (CRC) in first-line setting. Panitumumab plus sotorasib combination (KRAS G12C inhibitor) are promising in advanced line in KRAS G12C-mutated CRC. Here we assess the safety and efficacy of 5-FU combination with panitumumab and sotorasib as first-line treatment in frail/elderly patients with unresectable KRAS G12C-mutated CRC. METHODS: <50%), and 37 patients will need to be included. PERSPECTIVES: Treatment with 5-FU plus panitumumab and sotorasib could be a promising alternative to 5-FU ± targeted therapy in first-line setting in frail/elderly patients with unresectable KRAS G12C-mutated CRC.

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