國家衛生研究院 NHRI:Item 3990099045/10401

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Title:	Final results of NAPOLI-1: A phase 3 study of nal-IRI (MM-398) +/- 5-fluorouracil and leucovorin (5-FU/LV) vs 5-FU/LV in metastatic pancreatic cancer (mPAC) previously treated with gemcitabine-based therapy
Authors:	Chen, LT;Wang-Gillam, A;Li, CP;Bodoky, G;Dean, A;Shan, YS;Jameson, GS;Macarulla, T;Lee, KH;Cunningham, D;Blanc, JF;Hubner, R;Chiu, CF;Schwartsmann, G;Braiteh, F;Belanger, B;Bayever, E;de Jong, F;von Hoff, DD;Siveke, JT
Contributors:	National Institute of Cancer Research
Abstract:	Background: nal-IRI, a liposomal formulation of irinotecan, plus 5-FU/LV is approved in the US for patients (pts) with mPAC previously treated with gemcitabine-based therapy. Primary analysis (data cutoff, Feb 14, 2014) of the NAPOLI-1 trial (NCT01494506) showed that, after 313 events, nal-IRI + 5-FU/LV significantly improved median overall survival (OS) vs 5-FU/LV (6.1 vs 4.2 mo; HR 0.67; 95% CI 0.49-0.92; P = 0.012; Wang-Gillam et al, Lancet. 2016). Here we report the final analysis of NAPOLI-1 (data cutoff, Nov 16, 2015). Methods: 417 pts were randomly assigned to nal-IRI 70 mg/m2 (equivalent to 80 mg/m2 irinotecan HCl trihydrate salt) + 5-FU/LV 2400/400 mg/m2 q2w (n = 117), nal-IRI 100 mg/m2 (equivalent to 120 mg/m2 irinotecan HCl trihydrate salt) q3w (n = 151), or 5-FU/LV 2000/200 mg/m2 weekly for weeks 1-4 q6w (n = 149). Log-rank P values are 2-sided. Results: After 382 events, median OS was improved with nal-IRI + 5-FU/LV vs 5-FU/LV (6.2 vs 4.2 mo; HR 0.75; 95% CI 0.57-0.99; P = 0.038), but not for nal-IRI vs 5-FU/LV (4.9 vs 4.2 mo; HR 1.07; 95% CI 0.84-1.36; P = 0.567). Kaplan-Meier estimates of OS for nal-IRI + 5-FU/LV and 5-FU/LV, respectively, were 53% and 38% at 6 mo, and 26% and 16% at 12 mo. Median progression-free survival was longer for nal-IRI + 5-FU/LV vs 5-FU/LV (3.1 vs 1.5 mo; HR 0.57; 95% CI 0.43-0.76; P . Conclusion:Final results from NAPOLI-1 continue to show OS benefit for nal-IRI + 5-FU/LV vs 5-FU/LV. No new safety concerns were identified. nal-IRI + 5-FU/LV provides a new treatment option for pts with mPAC previously treated with gemcitabine-based therapy.
Date:	2016-10
Relation:	Annals of Oncology. 2016 Oct;27(Suppl. 6):Meeting Abstract 622PD.
Link to:	http://dx.doi.org/10.1093/annonc/mdw371.14
JIF/Ranking 2023:	http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0923-7534&DestApp=IC2JCR
Cited Times(WOS):	https://www.webofscience.com/wos/woscc/full-record/WOS:000393912500628
Cited Times(Scopus):	https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85081651932
Appears in Collections:	[Li-Tzong Chen] Conference Papers/Meeting Abstract

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