ABC-02: cisplatin plus gemcitabine versus gemcitabine alone for biliary tract cancer
Adding cisplatin to gemcitabine lengthened survival by more than three months in advanced bile duct and gallbladder cancer without extra serious toxicity, establishing the chemotherapy standard for the disease.
Overview
Phase 3 trial of 410 patients with locally advanced or metastatic cholangiocarcinoma, gallbladder or ampullary cancer randomised to cisplatin plus gemcitabine or gemcitabine alone for up to 24 weeks.
Median overall survival was 11.7 versus 8.1 months (hazard ratio 0.64) and progression-free survival 8.0 versus 5.0 months, with similar rates of grade 3 to 4 adverse events.
- Median overall survival 11.7 vs 8.1 months; hazard ratio 0.64.
- Median progression-free survival 8.0 vs 5.0 months.
Gemcitabine-cisplatin is the backbone of first-line treatment for advanced biliary tract cancer, now combined with durvalumab or pembrolizumab.
- Treatment was capped at eight cycles.
- Heterogeneous population across biliary sites.
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