國家衛生研究院 NHRI:Item 3990099045/10715
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    题名: CA19-9 decrease and overall survival (OS) in the NAPOLI-1 trial of liposomal irinotecan (nal-IRI) +/- 5-fluorouracil and leucovorin (5FU/LV) in metastatic pancreatic ductal adenocarcinoma (mPDAC) previously treated with gemcitabine-based therapy
    作者: Chen, LT;Andrea, WG;Shan, YS;Teresa, M;Jean-Frederic, B;Richard, H;Chiu, CF;Gilberto, S;Jens, S;Marc, PJ;Bruce, B;Floris, D;Khalid, M;Daniel, V
    贡献者: National Institute of Cancer Research
    摘要: Introduction: nal-IRIþ5-FU/LV showed efficacy in a randomized phase 3 trial in mPDAC (NAPOLI-1). Decreases in CA19-9 were more common with nal-IRIþ5-FU/ LV vs 5-FU/LV, and a greater improvement in OS (primary endpoint) with nal-IRIþ5FU/LV vs 5-FU/LV was observed in patients with higher baseline CA19-9 levels. nalIRIþ5-FU/LV also significantly improved progression-free survival and objective response rate, with a manageable safety profile. Here, we present an exploratory post hoc analysis of the association ofCA19-9 decrease with OS in the final NAPOLI-1 dataset (data cutoff, November 16, 2015). Methods: In NAPOLI-1, patients with mPDAC received nal-IRIþ5-FU/LV, nal-IRI monotherapy, or 5-FU/LV. Data from all patients in the trial were pooled to assess the association ofCA19-9 decrease with OS. CA19-9 was evaluated at baseline and every 6 weeks. OS was calculated by the Kaplan-Meier method. Hazard ratios (HRs) for OS comparisons based on different thresholds for change in CA19-9 were estimated by Cox regression analysis. Of417 patients randomly assigned to treatment in NAPOLI-1, 398 received 1 dose ofstudy drug. Results: Of the 398 patients treated in the NAPOLI-1 trial, 283 (71%) had CA19-9 data at baseline and at any time post baseline up to week 12. Among these 283 patients, the estimated median OS for patients with any reduction in CA19-9 (n¼124) vs no reduction (n¼159) was 7.5 mo (95% CI, 6.7-9.4 mo) vs 5.0 mo (95% CI, 4.4-5.8 mo), with an HR of0.58 (95% CI, 0.46-0.75; P<0.0001). Similar trends were observed when 20% and 50% decreases by week 12 were considered in this exploratory analysis. Patients who achieved a ≧20% decrease in CA19-9 by week 12 (n¼97) had an estimated median OS of8.4 mo (95% CI, 7.1-10.5 mo) vs 5.1 mo (95% CI, 4.7-5.9 mo) for those patients (n¼186) who did not achieve this decrease (HR, 0.58; 95% CI, 0.450.76; P<0.0001). Patients who achieved a≧50% decrease in CA19-9 by week 12 (n¼57) had an estimated median OS of9.5 mo (95% CI, 7.5-11.7 mo) vs 5.5 mo (95% CI, 4.9-6.1 mo) for those patients (n¼226) who did not achieve this decrease (HR, 0.60; 95% CI, 0.44-0.81; P¼0.0009). Decreases in CA19-9 levels from baseline (any decrease, ≧20% decrease, or≧50% decrease) by week 12 were more frequently observed in patients treated with nal-IRIþ5-FU/LV or with nal-IRI monotherapy than with 5FU/LV (Table). Conclusion: Patients who achieved any CA19-9 decrease from baseline up to week 12, ≧20% decrease by week 12, or≧50% decrease by week 12 had significantly longer OS than patients who did not achieve these decreases. These findings in the post gemcitabine setting seem consistent with previous reports in the front-line setting. Higher proportions of patients treated with nal-IRIþ5-FU/LV vs 5-FU/LV were observed to have CA19-9 decreases.
    日期: 2017-06-26
    關聯: Annals of Oncology. 2017 Jun 26;28(Suppl. 3):Abstract number PD-017.
    Link to: http://dx.doi.org/10.1093/annonc/mdx263.016
    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:000405528100408
    Cited Times(Scopus): https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85079680827
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