國家衛生研究院 NHRI:Item 3990099045/12077
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    题名: Effect of baseline carbohydrate antigen 19-9 (CA19-9) level on overall survival (OS) in NAPOLI-1: A randomized phase III study of MM-398 (nal-IRI), with or without 5-fluorouracil and leucovorin (5-FU/LV), versus 5-FU/LV in metastatic pancreatic cancer (mPAC) previously treated with gemcitabine (gem)-based therapy
    作者: Chen, LT;Siveke, JT;Wang-Gillam, A;Hubner, R;Pant, S;Dragovich, T;Chung, VM;Chang, DZ;Ross, PJ;Cooray, P;Tebbutt, NC;Franke, FA;Belanger, B;Dhindsa, N;de Jong, F;Mamlouk, K;Von Hoff, DD
    贡献者: National Institute of Cancer Research
    摘要: Background: CA19-9 correlates with response to therapy and OS in patients with mPAC. NAPOLI-1 evaluated nal-IRI, a nanoliposomal formulation of irinotecan, with or without 5-FU/LV vs 5-FU/LV in mPAC patients previously treated with gem-based therapy. nal-IRI+5-FU/LV significantly improved OS (primary endpoint) vs 5-FU/LV (6.1 mo vs 4.2 mo; unstratified hazard ratio [HR] = 0.67; P = 0.012). CA19-9 response (≥50% decline from baseline) was superior with nal-IRI+5FU/LV vs 5-FU/LV (29% vs 9%; P = 0.0006). nal-IRI alone did not show a statistical improvement in OS. Methods: Patients with baseline CA19-9 measurements were divided into quartiles to evaluate the treatment effect pattern of CA19-9 in the nal-IRI+5-FU/LV and 5-FU/LV arms. Quartile ranges were based on 404 available CA19-9 values from randomized patients (N = 417). Unstratified Cox proportional hazards regression was used to estimate HRs and 95% confidence intervals (CIs). Effect of baseline CA19-9 on OS, time to response, progression-free survival (PFS), and response were assessed. Results: Of patients randomized to receive nal-IRI+5-FU/LV (n = 117) or 5-FU/LV enrolled contemporaneously (n = 119), 218 received study drug and had a baseline CA19-9 measurement. nal-IRI+5-FU/LV had a greater treatment effect on OS and PFS with higher CA19-9 level relative to 5-FU/LV. Higher treatment termination rates occurred in both study arms with higher CA19-9 quartile, but no patterns of subsequent therapy were observed. Conclusions: In patients with mPAC previously treated with gem-based therapy, nal-IRI+5-FU/LV significantly improved OS, supported by PFS and response rate. CA19-9 serum levels can provide important information with regard to OS. Clinical trial information: NCT01494506.
    日期: 2016-05
    關聯: Journal of Clinical Oncology. 2016 May;34(15, Suppl. S):Abstract number e15740.
    Link to: http://dx.doi.org/10.1200/JCO.2016.34.15_suppl.e15740
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0732-183X&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000404665407057
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