Resection of colorectal liver metastases with second-line aflibercept plus FOLFIRI: Results from the RESECTION prospective French cohort.
Autor: | Tougeron D; Department of Hepato-Gastroenterology, Poitiers University Hospital, Poitiers, France., Bibeau F; Department of Pathology, Besançon University Hospital, Franche-Comté University, Besançon, France., Chibaudel B; Department of Medical Oncology, French-British Hospital, Cognacq-Jay Foundation, Cancérologie Paris Ouest, Levallois-Perret, France., Kim S; Department of Medical Oncology and Clinical Investigational Center 1431, University Hospital of Besançon, Besançon, France., Nguyen T; Department of Medical Oncology, North Franch-Comté Hospital, Montbeliard, France., Phelip JM; Department of Gastroenterology, Saint-Etienne University Hospital, Saint-Priest-en-Jarez, France., Mille D; Department of Medical Oncology, Médipole de Savoie, Challes Les Eaux, France., Bouattour M; Department of Liver Oncology and Therapeutic Innovation Functional Unit, Beaujon Hospital APHP, Clichy, France., Tavan D; Department of Gastroenterology, Protestant Infirmary Clinic, Lyon, France., Rinaldi Y; Department of Hepato-Gastroenterology, Marseille European Hospital, Marseille, France., Lecomte T; Department of Hepato-Gastroenterology and Digestive Cancerology, Tours University hospital, Chambray-les-Tours, France., Perrier H; Department of Hepato-Gastroenterology, Saint Joseph Hospital, Marseille, France., Spaeth D; Department of Medical Oncology, Oncology Institute of Gentilly, Nancy, France., Caroli Bosc FX; Department of Hepato-Gastroenterology and Digestive Oncology, Angers University Hospital, Angers, France., Metges JP; Cancerology and Hematology Institute, Brest University Hospital, Brest, France., Ferec M; Department of Hepato-Gastroenterology and Department of Oncology and Hematology, Pays De Morlaix hospital, Morlaix, France., Hautefeuille V; Department of Gastroenterology and Digestive Oncology, Amiens-Picardie - North University Hospital, Amiens, France., Deslandres-Cruchant M; Department of Medical Oncology, Toulouse University Hospital, Toulouse, France., Danion J; Department of Surgery, Poitiers University Hospital, Poitiers, France., Hammel P; Department of Digestive and Medical Oncology, Paul Brousse AP-HP hospital, Paris-Saclay University, Villejuif, France., Lewin M; Department of Radiology, Paul Brousse AP-HP hospital, Paris-Saclay University, Villejuif, France., Tasu JP; Department of Diagnostic and Interventional Radiology, Poitiers University Hospital, Poitiers, France and LaTim, UMR 1011, University of Brest, Brest, France., Angelergues A; Department of Medical Oncology, Diaconesses-Croix Saint Simon hospital, Paris, France., DiFiore F; Department of Hepato-Gastroenterology, Rouen University Hospital, Rouen, France., Evrard S; Digestive Tumors Unit, Bergogné Institute and Bordeaux University, Bordeaux, France., Mansar R; Department of Pathology, Besançon University Hospital, Franche-Comté University, Besançon, France., Caillou H; Department of Statistics, Excelya Bordeaux, Floirac, France., Geffriaud-Ricouard C; Global Medical Oncology, Sanofi, Gentilly, France., Adam R; Department of Hepato-Biliary Surgery and Transplantation, AP-HP Paul Brousse Hospital, Paris-Saclay University, Villejuif, France. Electronic address: rene.adam@aphp.fr. |
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Jazyk: | angličtina |
Zdroj: | European journal of cancer (Oxford, England : 1990) [Eur J Cancer] 2024 Oct 22; Vol. 213, pp. 115082. Date of Electronic Publication: 2024 Oct 22. |
DOI: | 10.1016/j.ejca.2024.115082 |
Abstrakt: | Aim: To evaluate R0/R1 resection rate in patients with colorectal liver metastases (CLM) treated with aflibercept plus FOLFIRI after failure of a prior oxaliplatin-based regimen in daily clinical practice. Methods: This French, multicentre, prospective, observational cohort (NCT05178745) included patients with CLM (alone or predominant; up to 5 lung nodules <2 cm allowed) initiating aflibercept plus FOLFIRI every 2 weeks per physician choice. Primary endpoint was R0/R1 resection rate. Secondary endpoints included overall survival (OS), progression-free survival (PFS), radiological and pathological responses, and safety. Results: A total of 137 patients (median age 65 years, RAS/BRAF mutant 57 %/9 %) were enrolled at 22 French sites. CLM (median 4) were synchronous in 82 %, bilobar in 71 % and located in liver only in 54 %. Overall, 17 % of patients had R0/R1 resection (21 % for patients with liver-only disease). A major pathological response per Blazer score was observed in 55 % of resected patients, along with significantly longer OS (median 34.8 vs 9.1 months, p < 0.0001) and PFS (median 11.4 vs 4.9 months, p < 0.0001) compared to non-resected patients. Post-operative complications occurred in 17 % of patients (all Dindo-Clavien grade I-II) and there was no post-operative deaths. Overall, 34 % had grade ≥ 3 adverse events, mainly general health deterioration and diarrhea. Conclusions: Results suggest that aflibercept plus FOLFIRI, after failure of a prior oxaliplatin-based regimen, allows R0/R1 resection of CLM in almost 20 % of patients with a major pathological response in most cases and a median OS prolonged by more than 3-fold versus non-resected patients. Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: DT reports consultancy, advisory fees, honoraria from Servier, Pierre Fabre, Merck Serono, MSD, BMS, AZ, Roche, Sanofi; research funding from Sandoz, AstraZenenca, Servier, MSD; travel grants from Pierre Fabre, MSD, Servier, Roche. BC reports Honoraria from Amgen, Roche, Sanofi, Merck, BMS, SeqOne Genomics, Pierre Fabre and consulting or advisory fees from Bayer, BMS, MSD, Roche, Sanofi. JMP reports consultancy, advisory fees, honoraria from Servier, Pierre Fabre, Merck Serono, MSD, BMS, Astra-Zeneca, Takeda, Roche, Sanofi, Amgen. TL received honoraria for speaking or consulting role from Servier, Pierre Fabre, Merck Serono, BMS, Astra Zeneca, AAA, Sanofi, IPSEN, Novartis, CHUGAI research funding from Pierre Fabre and Leo Pharma. JPM reports from Pierre Fabre Oncologie, MSD, and Bayer. FD reports compensations for scientific expertise from Amgen, Astra Zeneca, Bayer, Incyte, Merck, MSD, BMS, Servier, Takeda, Pierre Fabre, Viatris. JD reports from Sanofi. PH received fee from SANOFI for the study. MF was invited to ASCO GI the year 2016 by Sanofi (which paid plane, hôtel and the congress). VH reports conflicts from AdAcAp, Merck, Amgen, Servier, Pierre Fabre, Ipsen, Sanofi, Esteve, Advanz, Deciphera. CGR is an employee of Sanofi. RA received honoria from Merk and Sanofi. FB, SK, TN, DM, MB, YR, HP, DS, HC, FX CB, MD, AA, SE, ML, SE and RM have no conflicts to declare. (Copyright © 2024. Published by Elsevier Ltd.) |
Databáze: | MEDLINE |
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