Second Line Chemotherapy in Biliary Tract Cancer: Outcome and Prognostic Factors.

BACKGROUND & AIMS: The prognosis of biliary tract cancer (BTC) is poor. Standard treatment for advanced BTC is a chemotherapy (CT) with gemcitabine and cisplatin. Phase-III evidence for a second line (2L) CT is lacking. We aimed to investigate the feasibility of a 2L CT, to estimate the outcome and to identify prognostic markers.

METHODS: Patients of our institution with advanced BTC between 2000 and 2015 receiving CT were included. Data were analyzed in univariate and multivariate analysis.

RESULTS: 315 and 144 patients (45.7%) received first line (1L) and 2L CT, respectively. The OS of patients receiving 2L CT was 16.67 and 9.9 months from the beginning of 1L and 2L CT, respectively. The overall response rate and the disease control rate after 3 months were 9.7% and 33.6%, respectively. Adverse events of grade 3 or more were observed in 26.1%. 1 patient died of gemcitabine -related hemolytic uremic syndrome. An age of more than 70 years was not associated with a poor outcome. In multivariate analysis, CEA levels of >3μg/L (p=0.004, HR 1.89, 95% CI 1.22, 2.91), cholinesterase levels of <5kU/L (p=0.001, HR 2.11, 95% CI 1.34, 3.31) and leukocytosis (p=0.001, HR 2.90, 95%CI 1.51, 5.56) were associated with poor survival.

CONCLUSIONS: Despite a relevant toxicity, our data suggest that 2L CT may be feasible in fit BTC patients. CEA elevation, leukocytosis and low cholinesterase levels are unfavorable prognostic markers. Results from prospective randomized trials are urgently awaited. This article is protected by copyright. All rights reserved.