NAPOLI-1 试验中方案人群和非方案人群中纳武利尤单抗联合伊立替康脂质体与氟尿嘧啶+亚叶酸治疗的生存获益：一项全球性 3 期试验的扩展分析。
Survival with nal-IRI (liposomal irinotecan) plus 5-fluorouracil and leucovorin versus 5-fluorouracil and leucovorin in per-protocol and non-per-protocol populations of NAPOLI-1: Expanded analysis of a global phase 3 trial.
机构信息
National Institute of Cancer Research, National Health Research Institutes (NHRI), 367 Sheng-Li Road, Tainan 704, Taiwan; Department of Internal Medicine, National Cheng Kung University Hospital, National Cheng Kung University, No. 138, Sheng-Li Road, Tainan 704, Taiwan.
Division of Solid Tumor Translational Oncology, West German Cancer Center, University Hospital Essen, Hufelandstrasse 55, 45147 Essen, Germany; German Cancer Consortium (DKTK, Partner Site Essen) and German Cancer Research Center, DKFZ, Im Neuenheimer Feld 280, 69120 Heidelberg, Germany.
出版信息
Eur J Cancer. 2018 Dec;105:71-78. doi: 10.1016/j.ejca.2018.09.010. Epub 2018 Nov 8.
BACKGROUND
In the phase 3 randomised NAPOLI-1 clinical study, a 45% increase in median overall survival (OS) was shown with liposomal irinotecan, 5-fluorouracil and leucovorin (nal-IRI+5-FU/LV) versus 5-FU/LV in patients with metastatic pancreatic cancer progressing after gemcitabine-based therapy. Here, we report data from a pre-specified, expanded analysis of outcomes in the per-protocol (PP) population.
MATERIALS AND METHODS
The PP population comprised patients receiving ≥80% of planned treatment during the first 6 weeks, with no major protocol violations. A post-hoc analysis of the non-PP population was also performed.
RESULTS
For PP patients, median OS was 8.9 (95% confidence interval: 6.4-10.5) months with nal-IRI+5-FU/LV (n = 66) vs 5.1 (4.0-7.2) months with 5-FU/LV (n = 71; unstratified hazard ratio [HR] 0.57, p = 0.011). For non-PP patients, it was 4.4 (3.3-5.3) months with nal-IRI+5-FU/LV (n = 51) vs 2.8 (1.7-3.2) months with 5-FU/LV (n = 48; unstratified HR 0.64, p = 0.0648).
CONCLUSION
A statistically significant survival advantage was observed with nal-IRI+5-FU/LV vs 5-FU/LV in the PP patient population.
背景
在 3 期随机 NAPOLI-1 临床研究中，与 5-氟尿嘧啶/亚叶酸（5-FU/LV）相比，转移性胰腺癌患者在吉西他滨治疗后进展时，脂质体伊立替康、5-氟尿嘧啶和亚叶酸（nal-IRI+5-FU/LV）使中位总生存期（OS）延长了 45%。在此，我们报告了预先指定的方案人群（PP）扩展分析的结果数据。
材料和方法
PP 人群包括在第 1 至 6 周期间接受计划治疗≥80%的患者，且无主要方案违规。还对非 PP 人群进行了事后分析。
结果
对于 PP 患者，nal-IRI+5-FU/LV（n=66）的中位 OS 为 8.9 个月（95%置信区间：6.4-10.5），5-FU/LV（n=71）为 5.1 个月（4.0-7.2）；未分层风险比（HR）为 0.57，p=0.011。对于非 PP 患者，nal-IRI+5-FU/LV（n=51）的中位 OS 为 4.4 个月，5-FU/LV（n=48）为 2.8 个月；未分层 HR 为 0.64，p=0.0648。
结论
在 PP 患者人群中，nal-IRI+5-FU/LV 与 5-FU/LV 相比，观察到生存有统计学意义上的优势。
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