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.
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Date
2018-12ICR Author
Author
Chen, L-T
Siveke, JT
Wang-Gillam, A
Li, C-P
Bodoky, G
Dean, AP
Shan, Y-S
Jameson, GS
Macarulla, T
Lee, K-H
Cunningham, D
Blanc, J-F
Chiu, C-F
Schwartsmann, G
Braiteh, FS
Mamlouk, K
Belanger, B
de Jong, FA
Hubner, RA
Type
Journal Article
Metadata
Show full item recordAbstract
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.
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Subject
Humans
Carcinoma, Pancreatic Ductal
Pancreatic Neoplasms
Gastrointestinal Diseases
Hematologic Diseases
Polyethylene Glycols
Fluorouracil
Leucovorin
Deoxycytidine
Antimetabolites, Antineoplastic
Antineoplastic Combined Chemotherapy Protocols
Liposomes
Proportional Hazards Models
Drug Resistance, Neoplasm
Aged
Middle Aged
Kaplan-Meier Estimate
Irinotecan
Progression-Free Survival
Research team
Medicine (RMH Smith Cunningham)
Language
eng
Date accepted
2018-09-14
License start date
2018-12
Citation
European journal of cancer (Oxford, England : 1990), 2018, 105 pp. 71 - 78