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| Title: | Updated overall survival (OS) analysis of NAPOLI-1: Phase 3 study of nanoliposomal irinotecan (nal-IRI, MM-398), with or without 5-fluorouracil and leucovorin (5-FU/LV), vs 5-FU/LV in metastatic pancreatic cancer (mPAC) previously treated with gemcitabine |
| Authors: | 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;Siveke, JT;Braiteh, FS;Moyo, VM;Belanger, B;Bayever, E;Von Hoff, DD;Chen, LT |
| Contributors: | National Institute of Cancer Research |
| Abstract: | Background: NAPOLI-1 is a global, randomized Phase 3 study evaluating nal-IRI—a nanoliposomal irinotecan—with or without 5-FU/LV vs 5-FU/LV in 417 mPAC patients previously treated with gem-based therapy. Primary survival analysis was based on 313 events. nal-IRI+5-FU/LV significantly improved OS (primary endpoint), 6.1 months (mo) vs 4.2 mo; with 5-FU/LV (unstratified hazard ratio [HR] = 0.67; P = 0.012). The primary endpoint was supported by improved progression-free survival, time to treatment failure, objective response and CA19-9 response rates, and manageable toxicities. An updated analysis of OS, 6- and 12-month-survival estimates, and safety is presented. Methods: The updated descriptive analysis of OS, based on 378 events (25 May 2015), includes data from all randomized patients across the 3 arms. The final OS analysis will also be presented. Results: After 378 OS events, nal-IRI+5-FU/LV (n = 117) retained an OS advantage relative to 5-FU/LV (n = 119): 6.2 mo (95% confidence interval [CI], 4.8–8.4) vs 4.2 mo (95% CI, 3.3–5.3) with an unstratified HR of 0.75 (P = 0.0417). In contrast, there was no OS advantage with nal-IRI monotherapy (n = 151) vs 5-FU/LV (n = 149): 4.9 mo [95% CI, 4.2–5.6] vs 4.2 mo [95% CI, 3.6–4.9], HR = 1.08; P = 0.5. Six-month survival estimates were 53% (95% CI, 44–62%) for nal-IRI+5-FU/LV vs 38% (95% CI, 29–47%) for 5-FU/LV; 12-month survival estimates were 26% (95% CI, 18–35%) for nal-IRI+5-FU/LV vs 16% (95% CI, 10–24%) for 5-FU/LV. With events in nearly all patients, the OS curves converge at ~20 mo with 19 patients (16.2%) surviving beyond 20 mo. This is a reason for attenuation of the HR estimate and unstratified log rank p-value. The most common ≥ grade 3 adverse events occurring at a ≥ 2% incidence in nal-IRI-containing arms were neutropenia, diarrhea, vomiting, and fatigue. Conclusions: In an updated analysis, the median OS benefit for nal-IRI+5-FU/LV over 5-FU/LV was maintained with a similar safety profile. nal-IRI+5-FU/LV may be a new standard of care for mPAC patients previously treated with gem-based therapy. |
| Date: | 2016-05 |
| Relation: | Journal of Clinical Oncology. 2016 May;34(15, Suppl.):Meeting Abstract 4126. |
| Link to: | http://dx.doi.org/10.1200/JCO.2016.34.15_suppl.4126 |
| JIF/Ranking 2023: | http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0732-183X&DestApp=IC2JCR |
| Cited Times(WOS): | https://www.webofscience.com/wos/woscc/full-record/WOS:000404665406090 |
| Appears in Collections: | [陳立宗] 會議論文/會議摘要
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