Real-life data on biliary tract cancers in France: The nested Amber study from the French ACABi GERCOR PRONOBIL retro-prospective, observational cohort.

BACKGROUND AND AIMS

To gather real-life data on biliary tract cancer (BTC) in France, an ambispective ACABi GERCOR Pronobil cohort was initiated. This nested study, Amber, utilized data from this cohort to document clinical practices in this setting.

METHODS

Inclusion criteria encompassed patients with locally advanced/metastatic BTC managed between 2019 and 2021 in nine French referral hospitals. Objectives included describing demographic and clinical data, treatments outcomes (safety and efficacy), and overall survival.

RESULTS

Of the 138 patients (median age 65 years, a balanced sex ratio) included, most displayed ECOG 0-1 (83 %), at least one comorbidity (79 %), and had intrahepatic (56 %) and metastatic (82 %) BTC. Among surgically-resected patients, 60 % received adjuvant chemotherapy, mainly capecitabine (67 %). CisGem, the primary first-line palliative chemotherapy (69 %), showed a 23 % objective response rate, a median progression-free survival of 5.3 months, and a median overall survival of 13.4 months. Second-, third-, and fourth-line were given to 75 % (FOLFOX: 35 %, targeted therapy: 14 %), 32 %, and 13 % of patients. In total, 67 % of patients had a molecular profile (IDH1 mutations and FGFR2 fusions: accounting for 21 % each in intrahepatic cholangiocarcinoma).

CONCLUSION

BTC patients were predominantly treated according to international recommendations. The obtained demographic, tumor, and molecular data were consistent with existing literature.

Informations de copyright

Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Conflict of interest MD: reports receiving research funding from AstraZeneca. EA reports receiving consulting or advisory board fees from Astra Zeneca, MSD, BMS, Roche, Servier, Incyte, AAA and receiving research funding from ROCHE, BAYER. TL reported an advisory role with Amgen, Chugai, Bristol Myers Squibb, Merck Serono, Deciphera, Pierre Fabre, Servier, Astra Zeneca, BMS, Advanced Accelerator Applications, IPSEN, Lilly and Bayer outside of the submitted work; receiving grants from LEO Pharma and Pierre Fabre outside of the submitted work. VH has participated in consulting and/or advisory boards for Amgen, Merck, Servier, MSD, Pierre Fabre, AAA, Ipsen, Deciphera. DT reports receiving consulting or advisory board fees from Astra Zeneca, Sanofi, Amgen, MSD, BMS, Roche, Servier, Pierre Fabre; receiving research funding from Pierre Fabre and Sandoz. JE: Consulting: MSD, Eisai, BMS, AstraZeneca, Bayer, Roche, Ipsen, Basilea, Merck Serono, Incyte, Servier, Beigene, Taiho, Boston Scientific; Travel expense: Amgen; Research funding (institutional): BMS, Beigene, Boston Scientific, Exeliom biosciences AD and CB: Employee at AstraZeneca AT has received personal fees from Servier, Viatris, Incyte Bioscience, BMS, Merck and grants and personal fees from AstraZeneca and MSD outside the submitted work. CN received consulting fees from Amgen, AstraZeneca, Baxter, Bristol-Myers Squibb, Fresenius Kabi, Incyte Biosciences, Merck, MSD, Mundipharma, Mylan, Novartis, Nutricia, OSE Immunotherapeutics, Pierre Fabre, Roche, Sanofi, Servier, and Viatris; grants from OSE Immunotherapeutics, AstraZeneca, Bristol-Myers Squibb, Fresenius Kabi, and Nutricia; and support for attending meetings or travel from Merck, MSD, Mylan, Viatris, OSE Immunotherapeutics, and Pierre Fabre. AB, JH, JRP, NF, AH and DV: none declared.