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：Davide Melisi, T. Macarulla, Christelle de la Fouchardière, Roberto Pazo-Cid, Sreenivasa R Chandana, I. Kiss, Woo Jin Lee, Thorsten Oliver Goetze, E. Van Cutsem, Andrew Scott Paulson, Tanios Bekaii‐Saab, Shubham Pant, Richard Hubner, Fiona Maxwell, L. Zhang, Fawzi Benzaghou, Eileen M. O’Reilly, Zev A. Wainberg · 发表于：ESMO Open · 年份：2025 · DOI：10.1016/j.esmoop.2025.105534 · 被引用次数：5 · 研究领域：Pancreatic and Hepatic Oncology Research、Lung Cancer Research Studies、Renal cell carcinoma treatment

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 a...