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http://ir.nhri.org.tw/handle/3990099045/10107
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| Title: | Effects of nanoliposomal irinotecan (nal-IRI;MM-398) +/- 5-Fluorouracil and leucavorin (5-FU/LV) on quality of life (QoL) in NAPOLI-1: A phase 3 study in patients (pts) with metastatic pancreatic adenocarcinoma (mPAC) previously treated with gemcitabine-b |
| Authors: | Siveke, JT;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;Hubner, R |
| Contributors: | National Institute of Cancer Research |
| Abstract: | Introduction: Here we report QoL results from the NAPOLI-1 trial: a randomized phase 3 study of nal-IRI plus 5-FU/LV vs 5FU/LV in pts with mPDAC previously treated with gemcitabine-based therapy. Methods: QoL was assessed using the EORTC-QLQ-C30, which includes functional and symptom scales, and a global health and QoL scale. Pts completed the questionnaire at treatment start, every 6 weeks (wks), and 30 days post-follow-up visit. Pts who provided baseline and ≥1 subse quent assessment were included. Linear transformations were applied to raw scores to produce reported scores in the 0-100 range. Pts were classified as improved (≥10% increase in scale of breadth at a post-baseline time point and remained above baseline for ≥6 wks), worsened (did not meet improvement criteria and died, or had ≥10% decrease from baseline in scale of breadth at a post-baseline time point), or stable (did not meet criteria for improvement or worsening) for each subscale. Pairwise treatment group comparisons on response classification were performed for each subscale and adjusted for multiplicity to control false discovery rate at 0.05 level for the 15 comparisons. Results: 154 pts were included in the analysis; 69% (49/71) in the nalIRI+5-FU/LV group and 53% (44/83) in the 5-FU/LV group had evaluable data at 12 wks. At baseline, median Global Health Status scores were near the midpoint of the scoring range, median Functional Scale scores were high, and Symptom Scale scores were low, with baseline values similar between groups. The observed median change in score at 12 wks was 0 for both treatment groups for Global Health Status and for the following subscale scores: role functioning, emotional functioning, cognitive functioning, social functioning, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhoea, and financial difficultie s. For subscale scores where the median change was not 0 (nal-IRI+5-FU/LV: physical functioning and fatigue), the between-group differences were not substantial. There were no significant differences in the proportion of pts classified as improved, worsened, or stable between the treatment groups. Across subscales, adjusted P values for the comparisons were >0.05 (NS). Conclusion: While limited by pt numbers, in this analysis nal-IRI+5-FU/LV-treated pts tended to maintain baseline QoL over 12 wks. There were no significant differences versus 5-FU/LV-treated pts in QoL response despite the addition of a second cytotoxic agent. |
| Date: | 2016-10 |
| Relation: | Oncology Research and Treatment. 2016 Oct;39(Suppl. 3):259. |
| Link to: | http://dx.doi.org/10.1159/000449050 |
| 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:000385691300646 |
| Appears in Collections: | [陳立宗] 會議論文/會議摘要
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| ISI000385691300646.pdf | | 76Kb | Adobe PDF | 482 | View/Open |
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