國家衛生研究院 NHRI:Item 3990099045/10403

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Title:	Time course of selected treatment emergent adverse events (TEAEs) in 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 ther
Authors:	Hubner, RA;Chen, LT;Siveke, JT;Li, CP;Bodoky, G;Dean, A;Shan, YS;Jameson, GS;Macarulla, T;Lee, KH;Cunningham, D;Blanc, JF;Chiu, CF;Schwartsmann, G;Braiteh, F;Mamlouk, K;Belanger, B;de Jong, F;von Hoff, DD;Wang-Gillam, A
Contributors:	National Institute of Cancer Research
Abstract:	Background: Liposomal irinotecan (nal-IRI) plus 5-FU/LV is approved in the US for patients (pts) with mPAC previously treated with gemcitabine-based therapy. Primary analysis from NAPOLI-1 (NCT01494506) showed a significant median survival advantage for nal-IRI + 5-FU/LV 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). The most common TEAEs included diarrhea, vomiting, nausea, decreased appetite, fatigue, neutropenia, and anemia. Here we report incidence and prevalence of selected TEAEs over time in NAPOLI-1. Methods: Pts were randomly assigned to nal-IRI + 5-FU/LV, nal-IRI, or 5-FU/LV. In this post hoc analysis (data cutoff, Feb 14, 2014), incidence (ie, first occurrence) and prevalence (ie, first occurrence, ongoing event, or recurrence) of selected TEAEs were analyzed by treatment period (first 6 wk [period 1], second 6 wk [period 2], and beyond second 6 wk [period 3]). Denominators for percentages were the number of pts in the risk set during each period (for incidence: pts still on treatment without a previous event; for prevalence: all safety-evaluable pts). Results: 398 pts were treated with nal-IRI + 5-FU/LV (n = 117), nal-IRI (n = 147), or 5-FU/LV (n = 134). In the nal-IRI + 5-FU/LV arm, most first occurrences of neutropenia, diarrhea, nausea, and vomiting were during the first 6 wk of treatment, with incidence and severity generally decreasing thereafter (Table). Similarly, prevalence and severity were highest in the first 6 wk and tended to decrease over time. Similar trends were observed in the nal-IRI and 5-FU/LV arms. Conclusions: Neutropenia, diarrhea, nausea, and vomiting typically first occur early during the course of treatment with nal-IRI + 5-FU/LV and tend to decrease in incidence and severity thereafter.
Date:	2016-10
Relation:	Annals of Oncology. 2016 Oct;27(Suppl. 6):Meeting Abstract 693P.
Link to:	http://dx.doi.org/10.1093/annonc/mdw371.85
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:000393912500699
Cited Times(Scopus):	https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85018032900
Appears in Collections:	[Li-Tzong Chen] Conference Papers/Meeting Abstract

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