Phase 2b NIFTY trial of addition of liposomal irinotecan to second-line fluorouracil-leucovorin for metastatic biliary tract cancer

The phase 2b NIFTY trial, in five centers in South Korea, randomized patients with metastatic biliary tract cancer (mBTC) after progression on first-line gemcitabine plus cisplatin to liposomal irinotecan (nal-IRI) plus fluorouracil-leucovorin (FU-LV) or FU-LV alone. Addition of nal-IRI to FU-LV was associated with significantly improved progression-free survival by nmasked independent central radiological review (4.2 versus 1.7 months; HR 0.61; p=0.004). Additio of nal-IRI tot FU-LV also was associated with improved overall survival (8.6 versus 5.3 months; HR 0.68; p=0.02). The authrs conclude that nal-IRI plus FU-LV can be considered a second-line option for mBTC (visual abstract).