1. Prognostic factors in patients with advanced biliary tract cancer treated with first-line gemcitabine plus cisplatin: retrospective analysis of 740 patients.
- Author
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Kim, Bum, Hyung, Jaewon, Yoo, Changhoon, Kim, Kyu-pyo, Park, Seong-Joon, Lee, Sang, Park, Do, Song, Tae, Seo, Dong, Lee, Sung, Kim, Myung-Hwan, Park, Jin-hong, Cho, Hyungwoo, Ryoo, Baek-Yeol, Chang, Heung-Moon, Kim, Bum Jun, Lee, Sang Soo, Park, Do Hyun, Song, Tae Jun, and Seo, Dong Wan
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CISPLATIN , *CHOLANGIOCARCINOMA , *DRUG efficacy , *MEDICAL centers , *PROGNOSIS , *THERAPEUTICS , *ANTINEOPLASTIC agents , *GALLBLADDER tumors , *LONGITUDINAL method , *MULTIVARIATE analysis , *SEX distribution , *TREATMENT effectiveness , *RETROSPECTIVE studies , *DEOXYCYTIDINE - Abstract
Purpose: Biliary tract cancer (BTC) is a heterogeneous group of diseases comprising intrahepatic and extrahepatic cholangiocarcinoma and gallbladder cancer. Although gemcitabine plus cisplatin (GEMCIS) was established as the standard first-line chemotherapy based on the ABC-02 trial, more data are needed to define the clinical course of BTC and its prognostic factors with the standard GEMCIS treatment.Methods: Between April 2010 and June 2016, 740 patients with histologically documented cholangiocarcinoma and gallbladder cancer were treated with first-line GEMCIS in Asan Medical Center, Seoul, Korea.Results: In 389 patients with measurable disease (53%), the objective response rate was 13% (n = 50) and there was no significant difference between primary tumor sites (p = 0.45). With a median follow-up duration of 27.3 months (95% CI 24.2-30.5), the median PFS and OS were 5.2 months (95% CI 4.7-5.6) and 10.4 months (95% CI 9.6-11.2), respectively. In multivariate analysis, male gender (female versus male, hazard ratio [HR] 0.83), baseline CA 19-9 level (elevated versus normal, HR 1.31), initially metastatic disease (versus locally advanced disease, HR 1.92), poor performance status (2 versus 0-1, HR 1.45), and measurable disease by RECIST criteria (versus non-measurable, HR 1.40) were significantly associated with a poorer OS (all p < 0.05).Conclusions: Our retrospective analysis of a large number of patients in a real-world setting found comparable efficacy outcomes to the ABC-02 trial. The prognostic factors identified here may help to predict clinical outcomes and design future clinical trials for advanced BTC. [ABSTRACT FROM AUTHOR]- Published
- 2017
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