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New Protocol – Durvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer

New Protocol – Durvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer
Study:
  • Double-blind, placebo-controlled, phase 3 study
  • Untreated unresectable or metastatic biliary tract cancer
  • Gemcitabine – cisplatin plus Durvalumab (341) or placebo (344)
Efficacy:
  • 24 month OS: 24.9% vs. 10.4%
  • ORR: 26.7% vs. 18.7%
  • mPFS: 7.2 mos vs. 5.7 mos (HR:0.75, P=0.001)
  • DOR: 7.3 mos vs. 5.8 mos
Safety:
  • Any grade AEs: 99.4% vs 98.8%, anemia:48.2%-44.7%, nausea: 40.2%-34.2, neutropenia:31.7%-31%
  • Grade ≥3 AEs: 75.7% vs 77.8%
  • Deaths due to adverse events: 3.6% vs 4.1%
  • Immune-mediated AEs: 12.7% – 4.7%

NEJM Evid 2022; 1 (8)

Do-Youn Oh, Aiwu Ruth He, Shukui Qin, M.D. et al. Durvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer

https://doi.org/10.1056/EVIDoa2200015

Reviewed by Hasan Çağrı Yıldırım, MD on Sep 27, 2022

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