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A multicenter retrospective observational NAPOLEON2 study of nanoliposomal irinotecan with fluorouracil and folinic acid in patients with unresectable pancreatic cancer.
- Source :
-
Scientific reports [Sci Rep] 2024 May 30; Vol. 14 (1), pp. 12422. Date of Electronic Publication: 2024 May 30. - Publication Year :
- 2024
-
Abstract
- Nanoliposomal irinotecan with fluorouracil and folinic acid (NFF) is a standard regimen after gemcitabine-based therapy for patients with unresectable or recurrent pancreatic cancer. However, there are limited clinical data on its efficacy and safety in the real-world. We therefore initiated a retrospective and prospective observational study (NAPOLEON-2). The results of the retrospective part were reported herein. In this retrospective study, we evaluated 161 consecutive patients who received NFF as second-or-later-line regimen. The main endpoint was overall survival (OS), and the other endpoints were response rate, disease control rate, progression-free survival (PFS), dose intensity, and adverse events (AEs). The median age was 67 years (range, 38-85 years). The median OS and PFS were 8.1 and 3.4 months, respectively. The objective response and disease control rates were 5% and 52%, respectively. The median relative dose intensity was 81.6% for nanoliposomal irinotecan and 82.9% for fluorouracil. Grade 3 or 4 hematological and nonhematological AEs occurred in 47 and 42 patients, respectively. Common grade 3 or 4 AEs included neutropenia (24%), anorexia (12%), and leukocytopenia (12%). Subanalysis of patients treated with second-line and third-or-later-line demonstrated no statistical significant difference in OS (7.6 months vs. 9.1 months, respectively; hazard ratio, 0.92; 95% confidence interval, 0.64-1.35; pā=ā0.68). In conclusion, NFF has acceptable efficacy and safety profile even in real-world clinical settings. The prospective study is in progress to validate these findings.<br /> (© 2024. The Author(s).)
- Subjects :
- Humans
Aged
Female
Middle Aged
Male
Aged, 80 and over
Retrospective Studies
Adult
Treatment Outcome
Prospective Studies
Fluorouracil administration & dosage
Fluorouracil adverse effects
Fluorouracil therapeutic use
Leucovorin administration & dosage
Leucovorin therapeutic use
Leucovorin adverse effects
Irinotecan administration & dosage
Irinotecan therapeutic use
Irinotecan adverse effects
Pancreatic Neoplasms drug therapy
Pancreatic Neoplasms pathology
Pancreatic Neoplasms mortality
Liposomes
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Antineoplastic Combined Chemotherapy Protocols adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 2045-2322
- Volume :
- 14
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Scientific reports
- Publication Type :
- Academic Journal
- Accession number :
- 38816500
- Full Text :
- https://doi.org/10.1038/s41598-024-63172-y