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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.


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

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Publications

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.

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]

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