Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): a phase 3, open-label, randomised, controlled trial
The UK trial that showed a second chemotherapy, FOLFOX, helps people with advanced bile duct or gallbladder cancer live about a month longer on average once gemcitabine and cisplatin stop working, with one in four alive at a year instead of one in nine.
Overview
ABC-06 randomised 162 patients at 20 UK sites between March 2014 and January 2018, after progression on cisplatin and gemcitabine, to active symptom control with or without FOLFOX for up to 12 cycles. Median overall survival was 6.2 months (95 percent CI 5.4 to 7.6) with FOLFOX against 5.3 months (4.1 to 5.8); adjusted hazard ratio 0.69 (0.50 to 0.97), p=0.031. Survival at 6 and 12 months was 50.6 and 25.9 percent with FOLFOX against 35.5 and 11.4 percent. Grade 3 to 5 adverse events occurred in 69 versus 52 percent, with three chemotherapy-related deaths.
- Median overall survival 6.2 vs 5.3 months; adjusted hazard ratio 0.69 (95 percent CI 0.50 to 0.97), p=0.031.
- Overall survival at 12 months 25.9 vs 11.4 percent; at 6 months 50.6 vs 35.5 percent.
- Grade 3 to 5 adverse events 69 vs 52 percent; three chemotherapy-related deaths.
FOLFOX became the guideline second-line option for gallbladder cancer on this trial. The gain is real but small, which is why later-line care now starts with a search for a HER2 or other targetable alteration.
- Open-label trial with a symptom-control comparator.
- Gallbladder and ampullary cancers were included but not analysed as separate populations in the abstract.
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