articleThe LancetSep 11, 2023HYBRID OA

NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial

ZAZev A. WainbergDMDavide MelisiTMTeresa MacarullaRPRoberto Pazo-CidSRSreenivasa R Chandana

University of California, Los Angeles · Azienda Ospedaliera Universitaria Integrata Verona · +18 more institutions

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Abstract

BackgroundPancreatic ductal adenocarcinoma remains one of the most lethal malignancies, with few treatment options. NAPOLI 3 aimed to compare the efficacy and safety of NALIRIFOX versus nab-paclitaxel and gemcitabine as first-line therapy for metastatic pancreatic ductal adenocarcinoma (mPDAC).MethodsNAPOLI 3 was a randomised, open-label, phase 3 study conducted at 187 community and academic sites in 18 countries worldwide across Europe, North America, South America, Asia, and Australia. Patients with mPDAC and Eastern Cooperative Oncology Group performance status score 0 or 1 were randomly assigned (1:1) to receive NALIRIFOX (liposomal irinotecan 50 mg/m2, oxaliplatin 60 mg/m2, leucovorin 400 mg/m2, and…

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Topics & keywords

Topics
Keywords
  • Medicine
  • Gemcitabine
  • Internal medicine
  • Clinical endpoint
  • Population
  • Oxaliplatin
  • Oncology
  • Randomized controlled trial
UN Sustainable Development Goals
  • Good health and well-being
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