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Chemotherapy (doublet or triplet) plus targeted therapy by RAS status as conversion therapy in colorectal cancer patients with initially unresectable liver-only metastases. The UNICANCER PRODIGE-14 randomised clinical trial

2022; Springer Nature; Volume: 126; Issue: 9 Linguagem: Inglês

10.1038/s41416-021-01644-y

1532-1827

Marc Ychou, Michel Rivoire, Simon Thézenas, Rosine Guimbaud, François Ghiringhelli, Anne Mercier-Blas, Laurent Mineur, Éric François, Faïza Khemissa, Marion Chauvenet, Réza Kianmanesh, Marianne Fonck, Philippe Houyau, Thomas Aparicio, Marie‐Pierre Galais, Franck Audemar, Éric Assenat, Evelyne Lopez‐Crapez, C. Jouffroy, Antoine Adenis, René Adam, Olivier Bouché,

Pancreatic and Hepatic Oncology Research

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.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.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.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.