Liposomal irinotecan plus fluorouracil and leucovorin versus fluorouracil and leucovorin for metastatic biliary tract cancer after progression on gemcitabine plus cisplatin (NIFTY): a multicentre, open-label, randomised, phase 2b study
In a Korean trial, adding liposomal irinotecan to fluorouracil held second-line bile duct and gallbladder cancer still for about seven months rather than six weeks, at the cost of more low blood counts.
Overview
NIFTY randomised 174 patients at five South Korean academic centres between September 2018 and February 2020 to liposomal irinotecan 70 mg/m2 with fluorouracil and leucovorin, or fluorouracil and leucovorin alone, every two weeks. Median progression-free survival by blinded independent central review was 7.1 months (95 percent CI 3.6 to 8.8) against 1.4 months (1.2 to 1.5); hazard ratio 0.56 (0.39 to 0.81), p=0.0019. Grade 3 to 4 neutropenia occurred in 24 versus 1 percent and serious adverse events in 42 versus 24 percent, with no treatment-related deaths.
- Median progression-free survival 7.1 vs 1.4 months; hazard ratio 0.56 (95 percent CI 0.39 to 0.81), p=0.0019.
- Grade 3 to 4 neutropenia 24 vs 1 percent; serious adverse events 42 vs 24 percent.
A positive randomised phase 2 that the German NALIRICC trial failed to reproduce; guidelines list the regimen as an option, and the disagreement is a reminder that single-country phase 2 results in biliary cancer need replication.
- Phase 2b with a progression-free survival endpoint, not survival.
- Not reproduced by NALIRICC (2024).
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