Gemcitabine plus S-1 yielded noninferior overall survival (OS) outcomes compared with gemcitabine plus cisplatin among patients with advanced biliary tract cancer (BTC), according to research being presented at the 2018 Gastrointestinal Cancers Symposium in San Francisco, California.
For this phase 3 study, researchers enrolled 354 chemotherapy-naive patients with recurrent or unresectable biliary tract adenocarcinoma and randomly assigned them to receive gemcitabine 1 g/m2 plus cisplatin 25 mg/m2 or gemcitabine 1 g/m2 plus S-1 60, 80, or 100 mg/day.
Patients in the cisplatin arm had a median OS of 13.4 months vs 15.1 months among patients in the S-1 arm (hazard ratio [HR], 0.95; 90% CI, 0.78-1.15; P =.046 for non-inferiority).
Median progression-free survival (PFS) was 5.8 months and 6.8 months among patients in the cisplatin and S-1 arms, respectively, (HR, 0.86; 95% CI, 0.70-1.07); the response rates were 32.4% and 29.8%, respectively.
The study arms had similar rates of adverse events, with 34.7% of patients in the cisplatin arm and 31.2% of patients in the S-1 arm reporting clinically relevant events.
The authors concluded that “[gemcitabine plus S-1] demonstrated noninferiority to [gemcitabine plus cisplatin] in OS with good tolerability and was considered as a new convenient option of standard of care without hydration for advanced BTC.”
Morizane C, Okusaka T, Mizusawa J, et al. Randomized phase III study of gemcitabine plus S-1 combination therapy versus gemcitabine plus cisplatin combination therapy in advanced biliary tract cancer: a Japan Clinical Oncology Group study (JCOG1113, FUGA-BT). Oral presentation at: 2018 Gastrointestinal Cancers Symposium; January 18-20, 2018; San Francisco, CA.