P-147 - Outcome of second-line chemotherapy (CT2) after first-line CT (CT1) with platinum plus gemcitabine in advanced biliary tract cancer (aBTC): is it wo...

Date 04 July 2015
Event WorldGI 2015
Session Posters
Topics Cytotoxic agents
Hepatobiliary Cancers
Biological therapy
Presenter L. Fornaro
Citation Annals of Oncology (2015) 26 (suppl_4): 1-100. 10.1093/annonc/mdv233
Authors L. Fornaro1, E. Vasile1, G. Brandi2, F. Leone3, D. Santini4, G. Aprile5, S. Cereda6, N. Silvestris7, M. Milella8, S. Lonardi9, C. Vivaldi1, C. Caparello1, G. Musettini1, G. Pasquini10
  • 1Istituto Toscano Tumori, Pisa/IT
  • 2University of Bologna, Bologna/IT
  • 3Department Of Medical Oncology, University of Turin Medical School, Candiolo Cancer Institute, FPO, IRCCS, Turin/IT
  • 4Università Campus Biomedico, Roma/IT
  • 5University Hospital of Udine, Udine/IT
  • 6San Raffaele Scientific Institute, Milan/IT
  • 7IRCCS Oncologico Bari, Bari/IT
  • 8Regina Elena National Cancer Institute, Rome/IT
  • 9Istituto Oncologico Veneto - IRCCS, Padova/IT
  • 10Azienda Ospedaliero Universitaria Pisana, Pisa/IT



The combination of a platinum derivative and gemcitabine has been recently set as the standard CT1 in aBTC. After progression, no established CT2 is available, and results from limited phase II trials and retrospective series suggest poor efficacy for different cytotoxic agents. We assessed the value of CT2 after a platinum-gemcitabine CT1 in aBTC by performing a systematic review of the literature.


We identified eligible studies using the Medline database and the on-line abstract datasets of the Annual Meeting of the American Society of Clinical Oncology (ASCO), the biannual European Society of Medical Oncology Congress since 2002 (ESMO) and the annual World Gastrointestinal Congress since 2006. Progression-free survival (PFS) was the primary end-point of the analysis, while overall survival (OS) and response-rate (RR) were secondary objectives.


A total of 486 patients treated with platinum-gemcitabine CT1 from 5 different studies were included in the pooled analysis. All trials reported PFS data, while OS and RR data were available for only 4 trials (441 patients) and 3 trials (390 patients), respectively. Details about the CT2 regimens used were available for 312 patients: fluoropyrimidine (5-fluorouracil or capecitabine) plus platinum (oxaliplatin or cisplatin) (n = 128), 5-fluorouracil plus irinotecan (n = 62), single-agent fluoropyrimidine (n = 39), gemcitabine plus cisplatin (n = 17), other regimens (n = 66). Median PFS with CT2 obtained by a weighted pooled analysis of the available series was 3.11 months (95% CI: 2.82-3.40). Median OS was 6.29 months (95% CI 5.59-7.00) and overall RR was 9.2%.


The current analysis confirmed the limited efficacy of CT2 after platinum-gemcitabine CT1 in unselected populations of aBTC patients. While waiting for effective biologic agents in aBTC, ongoing randomized trials should identify the optimal CT2 regimen and validate prognostic factors for individual patient management.