Addition of liposomal irinotecan to second-line fluorouracil-leucovorin for metastatic biliary tract cancer

The prognosis of patients with advanced biliary tract cancer who have progressed on first-line gemcitabine plus cisplatin is dismal. The multicenter randomized phase 2b NIFTY study in South Korea evaluated addition of liposomal irinotecan to second-line fluorouracil plus leucovorin for these patients. The median blinded independent central review-assessed progression-free survival was 7.1 months with liposomal irinotecan-fluorouracil-leucovorin versus 1.4 months with fluorouracil-leucovorin (HR 0.56; p=0.0019). The authors conclude that liposomal irinotecan plus fluorouracil and leucovorin could be considered a standard-of-care second-line therapy for advanced biliary tract cancer.