Treatment outcomes of gemcitabine alone versus gemcitabine plus platinum for advanced biliary tract cancer: A Korean cancer study group retrospective analysis

Purpose: ABC-02 trial of gemcitabine plus cisplatin combination showed prolongation of overall survival in biliary tract cancer (BTC) patients. In this multicenter retrospective study, we evaluated the treatment outcome of gemcitabine combined with platinum (GP) compared to that of gemcitabine (G) alone in Korean BTC patients. Methods: One hundred and fifty-one patients with histologically confirmed biliary tract adenocarcinoma were enrolled at nine institutions between July 2003 and May 2011, including 100 treated with GP and 51 treated with G. Results: With a median follow-up of 7.7 months (range 0.4-38.3 months), the median overall survival (OS) was 12.4 months [95 % confidence interval (CI) 9.4-15.6 months] of the G group, which was not significantly different for the median OS of 11.0 months (95 % CI 9.7-12.3 months) of the GP group (p = 0.599). The median progression-free survival (PFS) was 3.9 months (95 % CI 0.8-7.0 months) in the G group and 3.3 months (95 % CI 2.6-4.0 months) in the GP group (p = 0.504). Overall response rates (ORR) were 18.8 % in G group and 23.9 % in GP group (p = 0.485). Conclusions: There was no significant difference in ORR, PFS, or OS for patients between the G group and the GP group, which was different from the ABC-02 trial. Therefore, gemcitabine monotherapy and GP combination are both effective regimens for Korean BTC patients.