Lancet Oncol: Liposome irinotecan combined with leucovorin and fluorouracil may become the second-line standard treatment for advanced biliary tract cancer!

The prognosis of advanced biliary tract cancer patients with advanced biliary tract cancer treated with gemcitabine combined with cisplatin is poor
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This study aimed to evaluate the efficacy and safety of second-line liposomal irinotecan combined with fluorouracil and leucovorin in patients with metastatic biliary cancer who progressed after gemcitabine combined with cisplatin therapy

This is a multicenter, open-label, randomized phase 2b study (NIFTY) that recruited 19-year-old histologically confirmed patients with metastatic biliary tract cancer (ECOG performance status 0 or 1 point)
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The subjects were randomly (1:1) divided into two groups and received liposomal irinotecan (70 mg/m2) combined with leucovorin (400 mg/m2) and fluorouracil (2400 mg/m2), or leucovorin and fluorouracil , Medication once every two weeks, and stratified according to the primary tumor site, surgical history and center

BICR assessment of progression-free survival

From September 5, 2018 to February 18, 2020, a total of 193 patients underwent eligibility review, of which 174 were recruited into the group: 88 were assigned to the liposomal irinotecan combined with fluorouracil and leucovorin group ( Experimental group), 86 people were divided into fluorouracil and leucovorin group (control group)
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After a median follow-up of 11.

After a median follow-up of 11.

Side reaction event

The most common grade 3-4 adverse events are neutropenia (experimental group vs control group: 24% vs 1%) and fatigue or weakness (13% vs 3%)
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In the experimental group and the control group, 37 (42%) and 21 (24%) patients had serious side effects

All in all, adding liposomal irinotecan to the regimen of leucovorin and fluorouracil can significantly prolong the progression-free survival of patients with advanced biliary tract cancer
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Liposome irinotecan combined with leucovorin and fluorouracil may be used as the standard second-line therapy for patients with advanced biliary tract cancer

The addition of liposomal irinotecan to the regimen of leucovorin and fluorouracil can significantly prolong the progression-free survival of patients with advanced biliary tract cancer

Original source:

Changhoon Yoo, et al.

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 this message