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 Journal Article
| Authors: | Melisi, D.; Macarulla, T.; de la Fouchardière, C.; Pazo-Cid, R. A.; Chandana, S. R.; Kiss, I.; Lee, W. J.; Göetze, T. O.; van Cutsem, E.; Paulson, A. S. |
| Article Title: | 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 |
| Abstract: | 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. © 2025 Elsevier B.V., All rights reserved. |
| Keywords: | adult; controlled study; unclassified drug; major clinical study; constipation; fatigue; diarrhea; gemcitabine; antineoplastic agent; quality of life; multiple cycle treatment; pain; randomized controlled trial; ca 19-9 antigen; dyspnea; insomnia; liver metastasis; health status; multicenter study; nausea and vomiting; open study; phase 3 clinical trial; health-related quality of life; functional status; performance status; global health; deterioration; nab-paclitaxel; pancreatic ductal adenocarcinoma; pancreas metastasis; exploratory research; pancreatic ductal carcinoma; patient-reported outcome; intention to treat analysis; human; male; female; article; loss of appetite; primary tumor site; ecog performance status; european organization for research and treatment of cancer quality of life questionnaire core 30; antigen blood level; gemcitabine plus paclitaxel; metastasis site; nalirifox; fluorouracil plus leucovorin plus oxaliplatin |
| Journal Title: | ESMO Open |
| Volume: | 10 |
| Issue: | 8 |
| ISSN: | 20597029 |
| Publisher: | Elsevier B.V. |
| Date Published: | 2025-01-01 |
| Start Page: | 105534 |
| Language: | English |
| DOI: | 10.1016/j.esmoop.2025.105534 |
| PROVIDER: | scopus |
| PMCID: | PMC12345255 |
| PUBMED: | 40763412 |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
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