Altai Protocol Library

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New Indication: Liposomal Irinotecan Plus Fluorouracil and Leucovorin for Patients with Previously Treated Metastatic Biliary Tract Cancer

New Indication: Liposomal Irinotecan Plus Fluorouracil and Leucovorin for Patients with Previously Treated Metastatic Biliary Tract Cancer
Study:
  • Multicenter, randomized, open-label phase 2b trial (NIFTY)
  • Advanced biliary tract cancer whose disease progressed while receiving first-line gemcitabine plus cisplatin
  • nal-IRI + FU+LV (n=88) vs. FU+LV (n=86)
Efficacy:
  • mPFS: 4.2 vs. 1.7 mos, p=0.004
Safety:
  • Grade≥3 AEs: neutropenia (24% vs. 1%), fatigue (11 vs.3%)

JAMA Oncol, 2023, 23 Mar

Hyung Jaewon et al. Treatment With Liposomal Irinotecan Plus Fluorouracil and Leucovorin for Patients With Previously Treated Metastatic Biliary Tract Cancer The Phase 2b NIFTY Randomized Clinical Trial

http://doi.org/10.1001/jamaoncol.2023.0016

Reviewed by Elvin CHALABİYEV, MD on APR 17, 2023

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