NAPOLI-1 phase 3 study of liposomal irinotecan in metastatic pancreatic cancer: Final overall survival analysis and characteristics of long-term survivors
NAPOLI-1 phase 3 study of liposomal irinotecan in metastatic pancreatic cancer: Final overall survival analysis and characteristics of long-term survivors
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DOI：
10.1016/j.ejca.2018.12.007
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发表时间：
2019-02-01
影响因子：
8.4
通讯作者：
Chen, Li-Tzong
中科院分区：
文献类型：
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作者：
Wang-Gillam, Andrea;Hubner, Richard A.;Chen, Li-Tzong
背景：脂质体伊立替康(Nal-IRI)联合5-氟尿嘧啶和亚叶酸钙(5-FU/LV)被批准用于既往接受吉西他滨治疗的转移性胰腺导管腺癌(MPDAC)患者。这一批准是基于在全球第三阶段那不勒斯-1试验中，与单独使用5-FU/LV相比，中位总存活率显著提高(6.1个月比4.2个月；风险比[HR]，0.67)。在这里，我们报告了那不勒斯-1试验中与长期生存者相关的最终生存分析和基线特征。患者和方法：在6周周期的前4周，mPDAC患者随机接受Nal-IRI刺针5-FU/LV(n=117)、Nal-IRI(n=151)或5-FU/LV(n=149)。将总体人群的基线特征和疗效与存活1年的患者进行比较。结果：在先前的基于吉西他滨的治疗(Napoli-1)分析后，Nal-IRI+5-FU/LV和5-FU/LV纳米脂质体联合氟尿嘧啶和亚叶酸治疗转移性胰腺癌保持了总体生存优势(分别为6.2个月和4.2个月；HR，0.75；95%可信区间：0.57-0.99)。中位无进展生存率、客观缓解率和疾病控制率也有利于NAL-IRI+5-FU/LV治疗。Nal-IRI+5-FU/LV组和5-FU/LV组的1年总生存率分别为26%和16%。与NAL-IRI+5-FU/LV组长期存活相关的基线特征是Karnofsky功能状态=90，年龄
Background: Liposomal irinotecan (nal-IRI) plus 5-fluorouracil and leucovorin (5-FU/LV) is approved for patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) previously treated with gemcitabine-based therapy. This approval was based on significantly improved median overall survival compared with 5-FU/LV alone (6.1 vs 4.2 months; hazard ratio [HR], 0.67) in the global phase 3 NAPOLI-1 trial. Here, we report the final survival analysis and baseline characteristics associated with long-term survivors (survival of >= 1 year) in the NAPOLI-1 trial.Patients and methods: Patients with mPDAC were randomised to receive nal-IRI thorn 5-FU/LV (n = 117), nal-IRI (n = 151), or 5-FU/LV (n = 149) for the first 4 weeks of 6-week cycles. Baseline characteristics and efficacy in the overall population were compared with those in patients who survived >= 1 year. Through 16th November 2015, 382 overall survival events had occurred.Results: The overall survival advantage for nal-IRI+5-FU/LVvs 5-FU/LV was maintained from the original nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy(NAPOLI-1) analysis (6.2 vs 4.2 months, respectively; HR, 0.75; 95% confidence interval: 0.57-0.99). Median progression-free survival, objective response rate and disease control rate also favoured nal-IRI+5-FU/LV therapy. Estimated one-year overall survival rates were 26% with nal-IRI+5-FU/LV and 16% with 5-FU/LV. Baseline characteristics associated with long-term survival in the nal-IRI+5-FU/LV arm were Karnofsky performance status >= 90, age