Gemcitabine plus cisplatin (GC) is acknowledged as standard chemotherapy for advanced biliary tract cancer (BTC). Few studies have been conducted to identify the prognostic factors in patients receiving this therapy. The purpose of this study was to identify and validate predictive factors of outcome in patients with advanced BTC receiving GC therapy.
The data of 307 patients with advanced BTC who received GC as the first-line chemotherapy at our institution from January 2007 to June 2017 were reviewed retrospectively. All patients were randomly assigned to the investigation and validation datasets at the ratio of 2:1. Multivariate analysis was conducted to identify the prognostic factors in the investigation dataset (n = 205) and the patients were classified, according to the prognostic factors, into three risk groups, that is, groups with a good, intermediate and poor prognosis. This classification was then applied to the validation dataset (n = 102).
The median overall survival (OS) and 1-year survival rate in the investigation dataset were 13.0 months (95% confidence interval, 11.0-13.9) and 54.7% respectively. Multivariate analysis identified the performance status, pretreatment serum lactate dehydrogenase level and pretreatment neutrophil-to-lymphocyte ratio as independent predictive factors of the OS. The patients were classified into three groups according to the identified prognostic factors, and the outcomes were found to differ significantly among the three groups (p < 0.01). When this classification was applied to the validation dataset, the OS was found to differ significantly among the three risk groups (p < 0.05).
This study identified three predictive factors of outcome, which allowed patients of advanced BTC receiving GC therapy to be classified into three risk groups.
Clinical trial identification
Legal entity responsible for the study
Principal Investigator: Masafumi Ikeda, M.D.
Has not received any funding.
H. Takahashi: Research funding: Bayer Pharmaceutical, Bristol-Myers Squibb; Honoraria: Taiho Pharmaceutical. I. Ohno: Honoraria: Taiho Pharmaceutical, Merck Serono. M. Ikeda: Research fundings: Bayer Yakuhin, Kyowa Hakko Kirin, Yakult, Taiho Pharmaceutical, Eli Lilly Japan, Ono Pharmaceutical, Eisai, AstraZeneca, Zeria Pharmaceutical, Baxter, Chugai Pharmaceutical, Bristol Myers Sqiibb, Merck Serono, Kowa, Nano Carrier, ASLAN Pharmaceuticals; Honoraria: Novartis Pharma, Bayer Yakuhin, Bristol-Myers Squibb, Abbott Japan, Eisai, Eli Lilly Japan, Taiho Pharmaceutical, Chugai Pharmaceutical, Daiichi-Sankyo, Yakult, Otsuka Pharmaceutical, and Nobelpharma. All other authors have declared no conflicts of interest.