Survival with nal-IRI (liposomal irinotecan) plus 5-fluorouracil and leucovorin versus 5-fluorouracil and leucovorin in per-protocol and non-per-protocol populations of NAPOLI-1: Expanded analysis of a global phase 3 trial

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, Richard A. Hubner

研究成果: Article同行評審

12 引文 斯高帕斯(Scopus)

摘要

Background: In 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 methods: The 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. Results: For 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). Conclusion: A statistically significant survival advantage was observed with nal-IRI+5-FU/LV vs 5-FU/LV in the PP patient population.

原文English
頁(從 - 到)71-78
頁數8
期刊European Journal of Cancer
105
DOIs
出版狀態Published - 2018 十二月

All Science Journal Classification (ASJC) codes

  • 腫瘤科
  • 癌症研究

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