Efficacy and Safety of Gemcitabine Plus Cisplatin Chemotherapy for Advanced Biliary Tract Cancer: A Retrospective Study

ABSTRACT Background The ABC-02 trial demonstrated a statistically significant survival benefit associated with the addition of cisplatin to gemcitabine for advanced biliary tract cancer (BTC). Purpose To determine the efficacy and safety of gemcitabine plus cisplatin (GC) chemo-therapy for advanced BTC. Patients and methods From April 2010 to January 2012, 12 advanced BTC patients were received cisplatin (25 mg/m2) followed by gemcitabine (1000 mg/m2 on days 1 and 8, every 3 weeks) in our hospital. Results Eleven patients received GC for first-line therapy and one for third-line therapy. Eleven patients were evaluated. CR/PR/SD/PD were 0% (0/12)/50% (6/12)/41.6% (5/12)/0% (0/12), respectively. Response rate (RR) was 50% (6 of 12) and disease control rate (DCR) was 92% (11 of 12). The median progression-free survival (PFS) and the median overall survival (OS) were 8.2 and 13.0 months, respectively. Grade 3 or higher adverse events occurred in 10 patients (83%), including one who died of gastrointestinal bleeding as grade 5. All patients required a reduction in dose and/or a delayed administration. Conclusion The adverse events of GC were severe, but GC for BTC in our hospital was equal to or more effective than in the ABC-02 trial.