國家衛生研究院 NHRI:Item 3990099045/11825
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    题名: NAPOLI-1 phase III trial outcomes by prior surgery, and disease stage, in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC)
    作者: Mercade, TM;Bodoky, G;Siveke, J;Lee, KH;Chen, J;Mirakhur, B;Dean, A;Chen, LT;de Jong, F
    贡献者: National Institute of Cancer Research
    摘要: Background: The NAPOLI-1 phase 3 trial (NCT01494506) reported significantly increased median OS with nal-IRI+5-FU/LV vs 5-FU/LV (6.1 mo vs 4.2 mo; HR = 0.67; p = 0.012) in mPDAC patients who progressed after gemcitabine-based therapy. We report subgroup analysis outcomes in NAPOLI-1 patients who had undergone prior surgery and by disease stage at diagnosis. Methods: This post-hoc analysis investigated outcomes with or without prior surgery, and by disease stage at diagnosis (stage IIA, IIB, or III, vs IV). P values are descriptive. Results: In the NAPOLI-1 trial, OS and PFS were increased in ITT patients who had undergone prior surgery compared to those who did not (Table). In patients with prior surgery receiving nal-IRI+5-FU/LV (n = 40), OS and PFS were increased vs 5-FU/LV (n = 43) (HR = 0.84 and 0.72). Patients without prior surgery had significantly increased OS and PFS with nal-IRI+5-FU/LV (n = 77) vs 5-FU/LV (n = 76) (HR = 0.56, p = 0.003 and HR = 0.47, p < 0.001). OS was significantly increased in ITT patients with disease stages IIA (n = 36, HR = 0.59, p = 0.013), IIB (n = 77, 0.54, <0.001), and III (n = 75, 0.57, <0.001) vs stage IV (n = 213). A consistent OS increase was also seen in patients treated with nal-IRI+5-FU/LV: stage IIA (HR = 0.63, ns) stage IIB (HR = 0.50, p = 0.024) and stage III (HR = 0.43, p = 0.021) vs stage IV. Conclusions: OS and PFS were increased in ITT patients who had undergone surgery prior to trial inclusion. Patients treated with nal-IRI+5-FU/LV showed a consistent increase in OS and PFS vs 5-FU/LV. ITT patients with stages IIA, IIB, and III had significantly improved OS vs those with stage IV disease. Treatment with nal-IRI+5-FU/LV showed a survival benefit across disease stages IIA, IIB, and III, vs stage IV. Limited patient numbers should be taken into consideration when interpreting these findings.
    日期: 2018-10
    關聯: Annals of Oncology. 2018 Oct;29(Suppl. 8):Meeting Abstract 733P.
    Link to: https://doi.org/10.1093/annonc/mdy282.116
    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:000459277301312
    Cited Times(Scopus): https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85081532861
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