Fluropyrimidine single agent or doublet chemotherapy as second line treatment in advanced biliary tract cancer.

Abstract

Fluoropyrimidine (FP) plus platinum chemotherapy has been recently established as a second-line (L2) preferred option in advanced biliary tract cancer (aBTC) (ABC-06 phase III trial). However, the overall survival (OS) benefit was limited and comparison with FP monotherapy was not available. Our aim was to assess the OS of patients treated with a FP monotherapy compared to a doublet with irinotecan or platinum in L2. We performed a retrospective analysis of two large multicenter prospective cohorts: a French cohort (28 centers) and an Italian cohort (9 centers). All consecutive patients with aBTC receiving FP-based L2 after gemcitabine plus cisplatin/gemcitabine plus oxaliplatin L1 between 2003 and 2016 were included. A subgroup analysis according to performance status (PS) and an exploratory analysis according to platinum sensitivity in L1 were planned. In the French cohort (n = 351), no significant OS difference was observed between the FP monotherapy and doublet groups (median OS: 5.6 vs 6.8 months, P = .65). Stratification on Eastern Cooperative Oncology Group (ECOG) PS showed similar results in PS 0-1 and 2. Median OS was not different between FP monotherapy, platinum- and irinotecan-based doublets (5.6 vs 7.1 vs 6.7 months, P = .68). Similar findings were observed in the Italian cohort (n = 174) and in the sensitivity analysis in pooled cohorts (n = 525). No L2 regimen seemed superior over others in the platinum resistant/refractory or sensitive subgroups. Our results suggest that FP monotherapy is as active as FP doublets in aBTC in L2, regardless of the patient PS and country, and could be a therapeutic option in this setting.

• Authors: Cindy Neuzillet, Andrea Casadei-Gardini, Bertrand Brieau, Caterina Vivaldi, Giovanni Brandi, David Tougeron, Roberto Filippi, Angélique Vienot, Nicola Silvestris, Anne-Laure Pointet, Sara Lonardi, Benoît Rousseau, Mario Scartozzi, Laetitia Dahan, Giuseppe Aprile, Samuel Le Sourd, Ludovic Evesque, Aurélia Meurisse, Astrid Lièvre, Dewi Vernerey, AGEO (Association des Gastro-Entérologues Oncologues) Investigators, GICO (Italian Group of Cholangiocarcinoma) Investigators
• Journal: International journal of cancer (Int J Cancer) Vol. 147 Issue 11 Pg. 3177-3188 (12 01 2020) ISSN: 1097-0215 [Electronic] United States
• PMID: 32525595 (Publication Type: Comparative Study, Journal Article, Multicenter Study)
• Copyright: © 2020 UICC.

Chemical References

• Pyrimidines
• Platinum
• Capecitabine
• Irinotecan
• Fluorouracil

Topics

• Aged
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, therapeutic use)
• Bile Duct Neoplasms (drug therapy)
• Capecitabine (administration & dosage, therapeutic use)
• Female
• Fluorouracil (administration & dosage, therapeutic use)
• France
• Humans
• Irinotecan (administration & dosage, therapeutic use)
• Italy
• Male
• Middle Aged
• Platinum (administration & dosage, therapeutic use)
• Prospective Studies
• Pyrimidines (administration & dosage, therapeutic use)
• Retrospective Studies
• Survival Analysis
• Treatment Outcome