• Li-Tzong Chen, Jens T Siveke, Andrea Wang-Gillam, Chung-Pin Li, György Bodoky, Andrew P Dean, Yan-Shen Shan, Gayle S Jameson, Teresa Macarulla, Kyung-Hun Lee, David Cunningham, Jean-Frédéric Blanc, Chang-Fang Chiu, Gilberto Schwartsmann, Fadi S Braiteh, Khalid Mamlouk, Bruce Belanger, Floris A de Jong, and Richard A Hubner.
• National Institute of Cancer Research, National Health Research Institutes (NHRI), 367 Sheng-Li Road, Tainan 704, Taiwan; Department of Internal Medicine, National Cheng Kung University Hospital, National Cheng Kung University, No. 138, Sheng-Li Road, Tainan 704, Taiwan. Electronic address: leochen@nhri.org.tw.
• Eur. J. Cancer. 2018 Dec 1; 105: 71-78.

BackgroundIn the phase 3 randomised NAPOLI-1 clinical study, a 45% increase in median overall survival (OS) was shown with liposomal irinotecan, 5-fluorouracil and leucovorin (nal-IRI+5-FU/LV) versus 5-FU/LV in patients with metastatic pancreatic cancer progressing after gemcitabine-based therapy. Here, we report data from a pre-specified, expanded analysis of outcomes in the per-protocol (PP) population.Materials And MethodsThe PP population comprised patients receiving ≥80% of planned treatment during the first 6 weeks, with no major protocol violations. A post-hoc analysis of the non-PP population was also performed.ResultsFor PP patients, median OS was 8.9 (95% confidence interval: 6.4-10.5) months with nal-IRI+5-FU/LV (n = 66) vs 5.1 (4.0-7.2) months with 5-FU/LV (n = 71; unstratified hazard ratio [HR] 0.57, p = 0.011). For non-PP patients, it was 4.4 (3.3-5.3) months with nal-IRI+5-FU/LV (n = 51) vs 2.8 (1.7-3.2) months with 5-FU/LV (n = 48; unstratified HR 0.64, p = 0.0648).ConclusionA statistically significant survival advantage was observed with nal-IRI+5-FU/LV vs 5-FU/LV in the PP patient population.Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

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