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 analysed in univariate and multivariate analysis.


RESULTS
Three-hundred and fifteen 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%. One patient died of gemcitabine-related haemolytic uraemic syndrome. Age of more than 70 years was not associated with a poor outcome. In multivariate analysis, CEA levels of >3 µg/L (P = 0.004, hazard ratio [HR] 1.89, 95% CI 1.22, 2.91), cholinesterase (CHE) levels of <5 kU/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 CHE levels are unfavourable prognostic markers. Results from prospective randomized trials are urgently awaited.
['Schweitzer|Nora|N|0000-0002-4687-3582', 'Kirstein|Martha M|MM|0000-0001-9415-4083', 'Kratzel|Anna-Maria|AM|', 'Mederacke|Young-Seon|YS|', 'Fischer|Mareike|M|', 'Manns|Michael P|MP|', 'Vogel|Arndt|A|']
D000368:Aged D000369:Aged, 80 and over D000971:Antineoplastic Combined Chemotherapy Protocols D001661:Biliary Tract Neoplasms D018281:Cholangiocarcinoma D002945:Cisplatin D002986:Clinical Trials as Topic D003841:Deoxycytidine D005260:Female D005706:Gallbladder Neoplasms D006801:Humans D008297:Male D008875:Middle Aged D015999:Multivariate Analysis D011379:Prognosis D011446:Prospective Studies D016019:Survival Analysis D016896:Treatment Outcome
chemotherapy biliary tract cancer cholangiocarcinoma second line