Relationship between neutropenia caused by nanoliposomal irinotecan/fluorouracil/leucovorin and treatment outcomes in the NAPOLEON-2 study (NN-2301)
The relationship between nanoliposomal irinotecan/fluorouracil/leucovorin (NFF) treatment outcomes and neutropenia in patients with pancreatic cancer has not been thoroughly examined. Thus, we conducted a retrospective analysis of data from patients with pancreatic cancer who were treated with NFF to investigate this relationship. Neutropenia was assessed according to the Common Terminology Criteria for Adverse Events across three cutoffs: A (grade 0 versus grade 1-4), B (grades 0-1 versus 2-4), and C (grades 0-2 versus 3-4). The primary endpoint was overall survival (OS), and the secondary endpoints were overall response rate, progression-free survival (PFS), and relative dose intensity. Of the 161 patients, 93, 8, 22, 30, and 8 patients had neutropenia of grades 0, 1, 2, 3, and 4, respectively. The overall response rates differed significantly at cutoff C (p = 0.02), with the odds ratio for cutoff C being the highest, followed by cutoffs B and A. Significant differences in OS were observed at cutoffs A (hazard ratio [HR], 0.65; 95% confidence interval [CI], 0.44-0.94; p = 0.02) and B (HR, 0.63; 95% CI, 0.43-0.92, p = 0.02). Similarly, PFS showed significant differences at cutoffs A and B (p < 0.01). NFF-induced neutropenia can be a useful prognostic factor for patients with pancreatic cancer.
Authors
- Takuya Honda
- Shigeyuki Takeshita
- Kengo Tsuneyoshi
- Hiroki Taguchi
- Mototsugu Shimokawa (ORCID: https://orcid.org/0000-0001-8140-4565)
- Taro Shibuki (ORCID: https://orcid.org/0000-0001-7302-7691)
- Junichi Nakazawa
- Keisuke Miwa (ORCID: https://orcid.org/0000-0002-2456-0358)
- Toshihiko Mizuta
- Hisanobu Oda (ORCID: https://orcid.org/0009-0006-8099-0543)
- Takahiro Sakae
- Kazuhiko Nakao (ORCID: https://orcid.org/0000-0002-7860-7123)
- Hozumi Shimokawa
- Kazuo Nishikawa (ORCID: https://orcid.org/0000-0003-1397-953X)
- Yoshihito Kubotsu
- Yujiro Ueda (ORCID: https://orcid.org/0000-0001-8340-0023)
- Tomonori Araki (ORCID: https://orcid.org/0000-0002-6811-1415)
- Kohei Hayashi (ORCID: https://orcid.org/0000-0003-1780-4825)
- Shuji Arita
- Tsuyoshi Shirakawa (ORCID: https://orcid.org/0000-0002-9317-8216)
- Yoshinobu Okabe
- Toshihiro Fujita
- Yuki Sonoda
- Kenji Mitsugi
- Ayumu Hosokawa (ORCID: https://orcid.org/0009-0003-6913-6950)
- Yasunori Kawaguchi
- Taiga Otsuka (ORCID: https://orcid.org/0000-0002-8552-8095)
- Azusa Komori (ORCID: https://orcid.org/0000-0003-0591-1025)
- Tatsunori Sakai
- Satoshi Otsu
- Futa Koga
- Shiho Arima
- Machiko Kawahira
Institutions
- Kurume University (JP)
- Kagoshima University (JP)
- Yamaguchi University (JP)
- Oita University (JP)
- Japanese Red Cross Society, Japan (JP)
- Fukuoka University (JP)
- Japan Hospital Association (JP)
- Sasebo City General Hospital (JP)
- National Hospital Organization Kyushu Cancer Center (JP)
- Takamatsu Red Cross Hospital (JP)
- Kurume University Hospital (JP)
- Saiseikai Kumamoto Hospital (JP)
- Saga-Ken Medical Centre Koseikan (JP)
- Japanese Red Cross Kumamoto Hospital (JP)
- Miyazaki Prefectural Hospital (JP)
- Kyushu Hospital (JP)
- Kagoshima City Hospital (JP)
- Nishikawa Hospital (JP)
- Ono Clinic (JP)
- Izumi City General Hospital (JP)
- Japan Community Healthcare Organization (JP)
- University of Miyazaki Hospital (JP)
- Shikoku Cancer Center (JP)
- National Cancer Center Hospital East (JP)
- Advanced Medical Research Institute (US)
- Sendai Shakai Hoken Hospital (JP)
- Kumamoto Medical Center (JP)
- Nagasaki University (JP)
Publication Details
- Journal
- Scientific Reports
- Published
- 2025-01-27
- DOI
- https://doi.org/10.1038/s41598-025-88005-4
- Citations
- 1
- Primary Topic
- Pancreatic and Hepatic Oncology Research
- Type
- article
- Field-Weighted Citation Impact
- 1.05
Funders
- Taiho Pharmaceutical
- Chugai Pharmaceutical