Postoperative Hepatic Arterial Infusion With Oxaliplatin After Surgery of Four or More Colorectal Liver Metastases: A Randomized Phase II Trial

PURPOSE: To evaluate the efficacy and safety of adjuvant hepatic arterial infusion (HAI) of oxaliplatin combined with intravenous (IV) fluorouracil/leucovorin (LV5FU2) after curative-intent surgery of ≥4 colorectal liver metastases (CRLM). METHODS: Patients with an Eastern Cooperative Oncology Group performance status 0-1, who underwent resection or ablation of ≥4 CRLM after preoperative IV chemotherapy were enrolled. Patients were randomly assigned (1:1) to receive adjuvant oxaliplatin via HAI (HAI group, n = 50) or IV infusion (IV group, n = 49), both combined with IV LV5FU2 for at least 3 months. The primary end point was hepatic recurrence-free survival (h-RFS). Secondary end points included RFS, overall survival (OS), safety, and feasibility. RESULTS: = .75). CONCLUSION: Adjuvant oxaliplatin HAI plus LV5FU2 improves h-RFS after curative-intent surgery of CRLM in high-risk patients, with an acceptable safety profile. These results support further evaluation in a phase III trial.

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Publication Details

Journal
Journal of Clinical Oncology
Published
2026-04-22
DOI
https://doi.org/10.1200/jco-25-01737
Primary Topic
Hepatocellular Carcinoma Treatment and Prognosis
Type
article
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article

Postoperative Hepatic Arterial Infusion With Oxaliplatin After Surgery of Four or More Colorectal Liver Metastases: A Randomized Phase II Trial

F Quenet, Fabrice Muscari, Julien Taı̈eb, Maximiliano Gelli et al.
Journal of Clinical Oncology
Hepatocellular Carcinoma Treatment and Prognosis
article

Postoperative Hepatic Arterial Infusion With Oxaliplatin After Surgery of Four or More Colorectal Liver Metastases: A Randomized Phase II Trial

F Quenet, Fabrice Muscari, Julien Taı̈eb, Maximiliano Gelli, David Tougeron, Thomas Aparicio, Hélène Senellart, Astrid Lièvre, Yann Touchefeu, Amani Asnacios Lecerf, Marie-Laure Tanguy, Thierry De Baere, Jacques Ewald, Jean-Marc Regimbeau, Valerie Boige, Diane Goéré, Lambros Tselikas, René Adam, David Malka, Charles Mastier, Guillaume Passot
article en

Abstract

PURPOSE: To evaluate the efficacy and safety of adjuvant hepatic arterial infusion (HAI) of oxaliplatin combined with intravenous (IV) fluorouracil/leucovorin (LV5FU2) after curative-intent surgery of ≥4 colorectal liver metastases (CRLM). METHODS: Patients with an Eastern Cooperative Oncology Group performance status 0-1, who underwent resection or ablation of ≥4 CRLM after preoperative IV chemotherapy were enrolled. Patients were randomly assigned (1:1) to receive adjuvant oxaliplatin via HAI (HAI group, n = 50) or IV infusion (IV group, n = 49), both combined with IV LV5FU2 for at least 3 months. The primary end point was hepatic recurrence-free survival (h-RFS). Secondary end points included RFS, overall survival (OS), safety, and feasibility. RESULTS: = .75). CONCLUSION: Adjuvant oxaliplatin HAI plus LV5FU2 improves h-RFS after curative-intent surgery of CRLM in high-risk patients, with an acceptable safety profile. These results support further evaluation in a phase III trial.

Journal of Clinical Oncology
Inserm (FR), Université Paris Cité (FR), Université Paris-Saclay (FR), Institut Gustave Roussy (FR), Saint Louis University Hospital (US), Centre Hospitalier Universitaire de Nantes (FR), Université Rennes 2 (FR), Université de Poitiers (FR), Institute Mutualiste Montsouris (FR), La Ligue Contre le Cancer (FR), Centre Hospitalier Universitaire Amiens-Picardie (FR), Assistance Publique – Hôpitaux de Paris (FR), Centre Léon Bérard (FR), Institut de Cancérologie de l'Ouest (FR), Hôpital Européen (FR), Hôpital Lyon Sud (FR), Hôpital Rangueil (FR), Institut de Recherche en Cancérologie de Montpellier (FR), Hôpital Saint-Louis (FR), Institut Paoli-Calmettes (FR), Hôpital Paul-Brousse (FR), Université de Rennes (FR), Institut Curie (FR)
Good health and well-being
Openalex Percentile: Top 26%
Hepatocellular Carcinoma Treatment and Prognosis
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