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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.
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.
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.
Shares Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, The Lancet Oncology, Biliary tract cancer (all types), Biliary tract cancer (cholangiocarcinoma) and the tag gallbladder-evidence.
Shares Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Biliary tract cancer (all types), Biliary tract cancer (cholangiocarcinoma), Gallbladder cancer and the tag gallbladder-evidence.
Shares Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Biliary tract cancer (all types), Biliary tract cancer (cholangiocarcinoma), Gallbladder cancer and the tag gallbladder-evidence.
Shares Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Biliary tract cancer (all types), Biliary tract cancer (cholangiocarcinoma), Gallbladder cancer and the tag gallbladder-evidence.
Shares Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Biliary tract cancer (all types), Biliary tract cancer (cholangiocarcinoma), Gallbladder cancer and the tag gallbladder-evidence.
Shares Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Gallbladder cancer and the tag gallbladder-evidence.
Shares Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Gallbladder cancer and the tag gallbladder-evidence.
Shares Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Gallbladder cancer and the tag gallbladder-evidence.