國家衛生研究院 NHRI:Item 3990099045/10402

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Title:	Effects of nal-IRI (MM-398) +/- 5-fluorouracil on quality of life (QoL) of patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) previously treated with gemcitabine based therapy: Results from NAPOLI-1
Authors:	Hubner, R;Cubillo, A;Blanc, JF;Melisi, D;von Hoff, DD;Wang-Gillam, A;Chen, LT;Becker, C;Mamlouk, K;Belanger, B;Yang, Y;de Jong, F;Siveke, JT
Contributors:	National Institute of Cancer Research
Abstract:	Background: The randomized phase 3 NAPOLI-1 study showed that nal-IRI + 5-fluorouracil/leucovorin (5-FU/LV) significantly improved overall survival vs 5-FU/LV (6.1 vs 4.2 months; unstratified hazard ratio 0.67; P = 0.012) in patients with mPDAC previously treated with gemcitabine-based therapy (Wang-Gillam et al., Lancet 2016). QoL was a secondary end point of NAPOLI-1. Methods: Patients were to complete the European Organization for Research and Treatment of Cancer quality-of-life core questionnaire (EORTC-QLQ-C30) at baseline, every 6 weeks, and 30 days after follow-up visit. The population analyzed included patients with a baseline and ≥1 post-baseline assessment. In a responder analysis, patients were classified as improved (≥10% improvement from baseline score maintained for ≥6 weeks), worsened (did not meet improvement criteria and died or had ≥10% worsening from baseline score), or stable (not improved or worsened) for each subscale. Pairwise treatment arm comparisons on response classification were performed for each subscale using Cochran-Mantel-Haenszel testing adjusted for multiplicity with a Benjamini-Hochberg correction. Results: Of 154 evaluable patients in this population, 69% (49/71) of patients in the nal-IRI + 5-FU/LV arm and 53% (44/83) in the 5-FU/LV arm had data at 12 weeks. Median baseline scores for Global Health Status (GHS), Functional and Symptom Scales were similar between arms. The median change in score at 12 weeks was 0 for both treatment arms for GHS and for all Functional and Symptom Scales except for physical functioning and fatigue. The between-arm differences for physical functioning and fatigue were not substantial. Also, there were no significant between-arm differences in the proportion of improved, worsened, or stable patients. Conclusions: In NAPOLI-1, nal-IRI + 5-FU/LV–treated patients with data through 12 weeks tended to maintain their baseline QoL over the period, and no significant differences versus the 5-FU/LV–treated patients were observed. Study results are limited by the small number of patients and variability in QoL subscale scores.
Date:	2016-12
Relation:	Annals of Oncology. 2016 Dec;27(Suppl. 9):Meeting Abstract 242P.
Link to:	http://dx.doi.org/10.1093/annonc/mdw582.00210.1093/annonc/mdw582.023
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:000393980600240
Appears in Collections:	[Li-Tzong Chen] Conference Papers/Meeting Abstract

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