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.