3 years ago

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

Publication date: December 2018

Source: European Journal of Cancer, Volume 105

Author(s): 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


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.


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).


A statistically significant survival advantage was observed with nal-IRI+5-FU/LV vs 5-FU/LV in the PP patient population.

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