國家衛生研究院 NHRI:Item 3990099045/12408
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    题名: Liposomal irinotecan + 5-FU/LV in metastatic pancreatic cancer: Subgroup analyses of patient, tumor, and previous treatment characteristics in the pivotal NAPOLI-1 trial
    作者: Macarulla Mercade, T;Chen, LT;Li, CP;Siveke, JT;Cunningham, D;Bodoky, G;Blanc, JF;Lee, KH;Dean, A;Belanger, B;Wang-Gillam, A
    贡献者: National Institute of Cancer Research
    摘要: OBJECTIVES: The NAnoliPOsomaL Irinotecan (NAPOLI-1) study (NCT01494506) was the largest global phase 3 study in a post-gemcitabine metastatic pancreatic adenocarcinoma (mPAC) population (N = 417). The subanalyses reported here investigated the prognostic effect of tumor characteristics and disease stage, prior treatment characteristics, baseline patient characteristics on survival outcomes in NAPOLI-1, and whether liposomal irinotecan (nal-IRI) + 5-fluorouracil/leucovorin (5-FU/LV) benefited patients with mPAC across subgroups. METHODS: Post hoc analyses were performed in the NAPOLI-1 population (4 across tumor characteristics and disease stage, 6 across prior treatment characteristics, and 4 across patient baseline characteristics). Survival outcomes were estimated by Kaplan-Meier analysis and patient safety data were evaluated. RESULTS: Mortality and morbidity risk was lower on nal-IRI+5-FU/LV treatment across subgroups. Exceptions were patients who had received prior nonliposomal irinotecan and those who had undergone prior Whipple procedure (overall survival hazard ratio = 1.25 and 1.23, respectively). Decreased appetite, liver metastases, and number of measurable metastatic lesions seemed to be prognostic of survival in this population. Subgroup safety data were generally comparable with those in the overall NAPOLI-1 safety population. CONCLUSIONS: A diverse population of patients with mPAC that progressed on gemcitabine-based therapy benefited from nal-IRI+5-FU/LV versus 5-FU/LV, potentially helping guide treatment decisions for challenging cases.
    日期: 2020-01
    關聯: Pancreas. 2020 Jan;49(1):62-75.
    Link to: http://dx.doi.org/10.1097/mpa.0000000000001455
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0885-3177&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000503790800006
    Cited Times(Scopus): https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85077073508
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