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
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 In this ENGIC 01 – PRODIGE 107 – FFCD 2306 – COLOSOTO multicenter, open-label, prospective single-arm phase II trial, the main inclusion criteria are adult patients with unresectable locally advanced or metastatic KRAS G12C -mutated CRC, unfit for a doublet/triplet chemotherapy. All patients will receive 5-FU plus panitumumab and sotorasib in 2-week-cycles until progression or intolerance. The primary endpoint is 8-months progression-free survival (PFS). The secondary endpoints include median PFS, disease control rate, time to progression, overall survival, best objective response rate, duration of response, safety profile, quality of life and geriatric assessment. A 70% 8-months PFS is expected (H 0 <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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BibTeX
@article{grancher2026sotorasib,
title = {{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}},
author = {Adrien Grancher and Matteo Landi and Alexej Ballhausen and Rosario Vidal Tocino and Annabel Alig and Ada Taravella and Karine Le Malicot and Emilie Soularue and Claire Gallois and Meriem Guarssifi and Manon Pelkowski and Marta Beltran and Lisa Kochen and Laura Delliponti and Julien Taïeb and Javier Sastre and Dominik Paul Modest and Chiara Cremolini and Thibault Mazard and David Tougeron},
journal = {Digestive and Liver Disease},
year = {2026},
month = sep,
doi = {10.1016/j.dld.2026.04.009},
url = {https://hal.science/hal-05742222v1},
note = {CC BY},
}
RIS
TY - JOUR
TI - 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
AU - Adrien Grancher
AU - Matteo Landi
AU - Alexej Ballhausen
AU - Rosario Vidal Tocino
AU - Annabel Alig
AU - Ada Taravella
AU - Karine Le Malicot
AU - Emilie Soularue
AU - Claire Gallois
AU - Meriem Guarssifi
AU - Manon Pelkowski
AU - Marta Beltran
AU - Lisa Kochen
AU - Laura Delliponti
AU - Julien Taïeb
AU - Javier Sastre
AU - Dominik Paul Modest
AU - Chiara Cremolini
AU - Thibault Mazard
AU - David Tougeron
PY - 2026
DA - 2026/09/08
JO - Digestive and Liver Disease
DO - 10.1016/j.dld.2026.04.009
UR - https://hal.science/hal-05742222v1
AB - 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 In this ENGIC 01 – PRODIGE 107 – FFCD 2306 – COLOSOTO multicenter, open-label, prospective single-arm phase II trial, the main inclusion criteria are adult patients with unresectable locally advanced or metastatic KRAS G12C -mutated CRC, unfit for a doublet/triplet chemotherapy. All patients will receive 5-FU plus panitumumab and sotorasib in 2-week-cycles until progression or intolerance. The primary endpoint is 8-months progression-free survival (PFS). The secondary endpoints include median PFS, disease control rate, time to progression, overall survival, best objective response rate, duration of response, safety profile, quality of life and geriatric assessment. A 70% 8-months PFS is expected (H 0 <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.
SN - 1590-8658
ER -