在初治转移性胰腺导管腺癌患者中，NALIRIFOX与白蛋白结合型紫杉醇+吉西他滨相比的健康相关生活质量和体能状态：NAPOLI 3试验结果
Health-related quality of life and performance status with NALIRIFOX versus nab-paclitaxel + gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma: results from the NAPOLI 3 trial.
作者信息
Melisi D, Macarulla T, De La Fouchardière C, Pazo Cid R A, Chandana S R, Kiss I, Lee W J, Goetze T O, Van Cutsem E, Paulson A S, Bekaii-Saab T, Pant S, Hubner R A, Maxwell F, Zhang L, Benzaghou F, O'Reilly E M, Wainberg Z A
机构信息
Investigational Cancer Therapeutics Clinical Unit, Azienda Ospedaliera Universitaria Integrata, Verona, Italy; Digestive Molecular Clinical Oncology Research Unit, Università degli studi di Verona, Verona, Italy.
Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.
出版信息
ESMO Open. 2025 Aug;10(8):105534. doi: 10.1016/j.esmoop.2025.105534. Epub 2025 Aug 5.
BACKGROUND
In NAPOLI 3 (NCT04083235), first-line (1L) liposomal irinotecan plus 5-fluorouracil/leucovorin plus oxaliplatin (NALIRIFOX) demonstrated statistically significant improvements in overall survival and progression-free survival compared with gemcitabine plus nab-paclitaxel (Gem + NabP) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). In this exploratory analysis, health-related quality of life (HRQoL) and performance status (PS) outcomes from NAPOLI 3 were evaluated.
MATERIALS AND METHODS
HRQoL was assessed at baseline, day 1 of each treatment cycle, and at end of treatment (EoT) using the European Organisation for Research and Treatment of Cancer Quality of Life core questionnaire (EORTC QLQ-C30). Analyses included patients who provided baseline and at least one subsequent assessment. A mixed model for repeated measures was used to describe score evolution over time between treatment arms. Eastern Cooperative Oncology Group (ECOG) PS was recorded in the intention-to-treat (ITT) population at baseline, days 1, 8, and 15 of each treatment cycle, and EoT. Time to deterioration (TTD) in EORTC QLQ-C30 and ECOG PS scores was estimated using the Kaplan-Meier methodology.
RESULTS
Overall, 245 patients in the NALIRIFOX arm (ITT population, n = 383) and 232 patients in the Gem + NabP arm (n = 387) provided baseline and at least one subsequent EORTC QLQ-C30 assessment. There was an initial decline in global health status (GHS) from baseline to week 12 across both treatment arms [least-squares mean -2.4, 95% confidence interval (CI) -5.9 to 1.1; Gem + NabP: -0.7 (-4.2 to 2.9)], with no further deterioration from week 16 onwards. TTD in GHS (hazard ratio 0.74, 95% CI 0.53-1.04, nominal P = 0.08) and ECOG PS score (hazard ratio 0.72, 95% CI 0.55-0.92, nominal P = 0.009) was longer with NALIRIFOX than with Gem + NabP.
CONCLUSIONS
These data suggest that 1L NALIRIFOX provides efficacy benefits for patients with mPDAC without compromising HRQoL or PS compared with Gem + NabP.
背景
在NAPOLI 3（NCT04083235）研究中，与吉西他滨联合白蛋白结合型紫杉醇（Gem + NabP）相比，一线（1L）脂质体伊立替康联合5-氟尿嘧啶/亚叶酸钙联合奥沙利铂（NALIRIFOX）在转移性胰腺导管腺癌（mPDAC）患者的总生存期和无进展生存期方面显示出统计学上的显著改善。在这项探索性分析中，对NAPOLI 3研究中的健康相关生活质量（HRQoL）和体能状态（PS）结果进行了评估。
材料与方法
使用欧洲癌症研究与治疗组织生活质量核心问卷（EORTC QLQ-C30）在基线、每个治疗周期的第1天和治疗结束时（EoT）评估HRQoL。分析纳入了提供基线及至少一次后续评估的患者。采用重复测量混合模型来描述各治疗组间随时间的评分变化。在意向性治疗（ITT）人群中，于基线、每个治疗周期的第1、8和15天以及EoT记录东部肿瘤协作组（ECOG）体能状态。使用Kaplan-Meier方法估计EORTC QLQ-C30和ECOG体能状态评分的恶化时间（TTD）。
结果
总体而言，NALIRIFOX组的245例患者（ITT人群，n = 383）和Gem + NabP组的232例患者（n = 387）提供了基线及至少一次后续的EORTC QLQ-C30评估。在两个治疗组中，从基线到第12周，整体健康状况（GHS）均出现了初始下降[最小二乘均值 -2.4，95%置信区间（CI）-5.9至1.1；Gem + NabP组：-0.7（-4.2至2.9）]，从第16周起未进一步恶化。与Gem + NabP相比，NALIRIFOX组的GHS恶化时间（风险比0.74，95%CI 0.53 - 1.04，名义P = 0.08）和ECOG体能状态评分恶化时间（风险比0.72，95%CI 0.55 - 0.92，名义P = 0.009）更长。
结论
这些数据表明，与Gem + NabP相比，一线NALIRIFOX为mPDAC患者提供了疗效益处，且不影响HRQoL或PS。
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