Ontology highlight
ABSTRACT: Background
Colorectal cancer (CRC) patients have a better prognosis if metastases are resectable. Initially, unresectable liver-only metastases can be converted to resectable with chemotherapy plus a targeted therapy. We assessed which of chemotherapy doublet (2-CTx) or triplet (3-CTx), combined with targeted therapy by RAS status, would be better in this setting.Methods
PRODIGE 14 was an open-label, multicenter, randomised Phase 2 trial. CRC patients with initially defined unresectable liver-only metastases received either, 2-CTx (FOLFOX or FOLFIRI) or 3-CTx (FOLFIRINOX), plus bevacizumab/cetuximab by RAS status. The primary endpoint was to increase the R0/R1 liver-resection rate from 50 to 70% with the 3-CTx.Results
Patients (n = 256) were mainly men with an ECOG PS of 0, and a median age of 60 years. In total, 109 patients (42.6%) had RAS-mutated tumours. After a median follow-up of 45.6 months, the R0/R1 liver-resection rate was 56.9% (95% CI: 48-66) with the 3-CTx versus 48.4% (95% CI: 39-57) with the 2-CTx (P = 0.17). Median overall survival was 43.4 months with 3-CTx versus 40 months with 2-CTx.Conclusion
We failed to increase from 50 to 70% the R0/R1 liver-resection rate with the use of 3-CTx combined with bevacizumab or cetuximab by RAS status in CRC patients with initially unresectable liver metastases.
SUBMITTER: Ychou M
PROVIDER: S-EPMC9042909 | biostudies-literature | 2022 May
REPOSITORIES: biostudies-literature
Ychou Marc M Rivoire Michel M Thezenas Simon S Guimbaud Rosine R Ghiringhelli Francois F Mercier-Blas Anne A Mineur Laurent L Francois Eric E Khemissa Faiza F Chauvenet Marion M Kianmanesh Reza R Fonck Marianne M Houyau Philippe P Aparicio Thomas T Galais Marie-Pierre MP Audemar Franck F Assenat Eric E Lopez-Crapez Evelyne E Jouffroy Claire C Adenis Antoine A Adam René R Bouché Olivier O
British journal of cancer 20220106 9
<h4>Background</h4>Colorectal cancer (CRC) patients have a better prognosis if metastases are resectable. Initially, unresectable liver-only metastases can be converted to resectable with chemotherapy plus a targeted therapy. We assessed which of chemotherapy doublet (2-CTx) or triplet (3-CTx), combined with targeted therapy by RAS status, would be better in this setting.<h4>Methods</h4>PRODIGE 14 was an open-label, multicenter, randomised Phase 2 trial. CRC patients with initially defined unres ...[more]