國家衛生研究院 NHRI:Item 3990099045/9635

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Please use this identifier to cite or link to this item: http://ir.nhri.org.tw/handle/3990099045/9635

Title:	Expanded analyses of NAPOLI-1: Phase 3 study of nal-IRI (MM-398), with or without 5-fluorouracil (5FU) and leucovorin (LV), versus 5-fluorouracil and leucovorin (5FU/LV), in metastatic pancreatic cancer (mPAC) previously treated with gemcitabine-based therapy
Authors:	Siveke, JT;Chen, LT;Von Hoff, DD;Li, CP;Wang-Gillam, A;Bodoky, G;Dean, A;Shan, YS;Jameson, G;Macarulla, T;Lee, KH;Cunningham, D;Blanc, JF;Hubner, RA;Chiu, CF;Schwartsmann, G;Braiteh, F;Moyo, V;Belanger, B;Bayever, E
Contributors:	National Institute of Cancer Research
Abstract:	Question: Nal-IRI is a nanoliposomal encapsulated formulation of irinotecan. OS in the ITT population was significantly longer with nal-IRI+5FU/LV (n = 117) vs 5FU/LV (n = 119) (median OS was 6.1 m vs 4.2 m; unstratified HR = 0.67, log-rank test p = 0.012). Most frequent grade 3+ AEs included neutropenia, fatigue and GI-effects. Thes e expanded, pre-specified analyses have been presented. Methods: Patients with mPAC (n = 417) previously treated with gemcitabine-based therapy, were randomized 1:1:1 to receive: Nal-IRI (120 mg/m 2 ; IV 90 min) q3w; 5FU (2,000 mg/m 2 ; 24 h) + LV (200 mg/m 2 ; 30 min) ×4w followed by 2w rest; or combination of nal-IRI (80 mg/m 2 ; IV 90 min) prior to 5FU (2,400 mg/m 2 ; 46h) + LV (400 mg/m 2 ; 30min) q2w. Primary endpoint was OS. The ITT population included all randomized patients; the Per Protocol (PP) population included patients who received ≥80% of the target dose in the first 6 weeks and did not violate any in/ exclusion criteria. Results: Analysis of the PP populations confirmed the favorable OS of the combination nal-IRI+5FU/LV, which was also reflected by the PFS, ORR and CA19-9 levels. Median OS in the PP population for nal-IRI+5FU/ LV-arm was 8.9 m (n = 66) vs 5.1 m (n = 71) for 5FU/LV (unstratified HR = 0.57, log-rank test p = 0.011). The nal-IRI monotherapy arm did not show a statistically significant OS improvement over 5FU/LV. Analysis of subgroups, based on pretreatment characteristics including stage at diagnosis, time since initial histological diagnosis, prior lines of therapy, time since last prior therapy, and CA19-9, favored OS for the nal-IRI+5FU/ LV arm. Conclusions: Expanded analysis of the PP population and sensitivity analyses support the favorability of nal-IRI+5FU/LV over 5FU/LV, with amanageable safety profile.
Date:	2016-02
Relation:	Oncology Research and Treatment. 2016 Feb;39(Suppl. 1):170.
Link to:	http://dx.doi.org/10.1159/000444354
JIF/Ranking 2023:	http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=2296-5270&DestApp=IC2JCR
Cited Times(WOS):	https://www.webofscience.com/wos/woscc/full-record/WOS:000371353700553
Appears in Collections:	[Li-Tzong Chen] Conference Papers/Meeting Abstract

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