Relationship between neutropenia caused by nanoliposomal irinotecan/fluorouracil/leucovorin and treatment outcomes in the NAPOLEON-2 study (NN-2301)
Abstract 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 w...
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2025-01-01
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| author | Tomonori Araki Yuki Sonoda Mototsugu Shimokawa Taiga Otsuka Kohei Hayashi Takuya Honda Kazuhiko Nakao Taro Shibuki Junichi Nakazawa Shiho Arima Keisuke Miwa Yoshinobu Okabe Futa Koga Yujiro Ueda Yoshihito Kubotsu Hozumi Shimokawa Shigeyuki Takeshita Azusa Komori Kazuo Nishikawa Satoshi Otsu Ayumu Hosokawa Hisanobu Oda Tatsunori Sakai Shuji Arita Machiko Kawahira Hiroki Taguchi Kengo Tsuneyoshi Yasunori Kawaguchi Toshihiro Fujita Takahiro Sakae Tsuyoshi Shirakawa Toshihiko Mizuta Kenji Mitsugi |
| author_facet | Tomonori Araki Yuki Sonoda Mototsugu Shimokawa Taiga Otsuka Kohei Hayashi Takuya Honda Kazuhiko Nakao Taro Shibuki Junichi Nakazawa Shiho Arima Keisuke Miwa Yoshinobu Okabe Futa Koga Yujiro Ueda Yoshihito Kubotsu Hozumi Shimokawa Shigeyuki Takeshita Azusa Komori Kazuo Nishikawa Satoshi Otsu Ayumu Hosokawa Hisanobu Oda Tatsunori Sakai Shuji Arita Machiko Kawahira Hiroki Taguchi Kengo Tsuneyoshi Yasunori Kawaguchi Toshihiro Fujita Takahiro Sakae Tsuyoshi Shirakawa Toshihiko Mizuta Kenji Mitsugi |
| author_sort | Tomonori Araki |
| collection | DOAJ |
| description | Abstract 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. |
| format | Article |
| id | doaj-art-3ca6d95d4b1741ed89e03178047ba418 |
| institution | Kabale University |
| issn | 2045-2322 |
| language | English |
| publishDate | 2025-01-01 |
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| spelling | doaj-art-3ca6d95d4b1741ed89e03178047ba4182025-02-02T12:22:12ZengNature PortfolioScientific Reports2045-23222025-01-0115111210.1038/s41598-025-88005-4Relationship between neutropenia caused by nanoliposomal irinotecan/fluorouracil/leucovorin and treatment outcomes in the NAPOLEON-2 study (NN-2301)Tomonori Araki0Yuki Sonoda1Mototsugu Shimokawa2Taiga Otsuka3Kohei Hayashi4Takuya Honda5Kazuhiko Nakao6Taro Shibuki7Junichi Nakazawa8Shiho Arima9Keisuke Miwa10Yoshinobu Okabe11Futa Koga12Yujiro Ueda13Yoshihito Kubotsu14Hozumi Shimokawa15Shigeyuki Takeshita16Azusa Komori17Kazuo Nishikawa18Satoshi Otsu19Ayumu Hosokawa20Hisanobu Oda21Tatsunori Sakai22Shuji Arita23Machiko Kawahira24Hiroki Taguchi25Kengo Tsuneyoshi26Yasunori Kawaguchi27Toshihiro Fujita28Takahiro Sakae29Tsuyoshi Shirakawa30Toshihiko Mizuta31Kenji Mitsugi32Department of Gastroenterology and Hepatology, Graduate School of Biomedical Sciences, Nagasaki UniversityDepartment of Gastroenterology and Hepatology, Graduate School of Biomedical Sciences, Nagasaki UniversityClinical Research Institute, National Kyushu Cancer CenterDepartment of Internal Medicine, Minato Medical ClinicDepartment of Gastroenterology and Hepatology, Graduate School of Biomedical Sciences, Nagasaki UniversityDepartment of Gastroenterology and Hepatology, Graduate School of Biomedical Sciences, Nagasaki UniversityDepartment of Gastroenterology and Hepatology, Graduate School of Biomedical Sciences, Nagasaki UniversityDepartment for the Promotion of Drug and Diagnostic Development, Division of Drug and Diagnostic Development Promotion, Translational Research Support Office, National Cancer Center Hospital EastDepartment of Medical Oncology, Kagoshima City HospitalDigestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental SciencesMultidisciplinary Treatment Cancer Center, Kurume University HospitalDivision of Gastroenterology, Department of Medicine, Kurume University School of MedicineDepartment of Hepatobiliary and Pancreatology, Saga Medical Center KoseikanDepartment of Hematology and Oncology, Japanese Red Cross Kumamoto HospitalDepartment of Internal Medicine, Karatsu Red Cross HospitalDepartment of Hematology Oncology, Community Healthcare Organization Kyushu HospitalDepartment of Gastroenterology, Japanese Red Cross Nagasaki Genbaku HospitalDepartment of Medical Oncology and Hematology, Oita University Faculty of MedicineDepartment of Medical Oncology and Hematology, Oita University Faculty of MedicineDepartment of Medical Oncology and Hematology, Oita University Faculty of MedicineDepartment of Clinical Oncology, University of Miyazaki HospitalDivision of Integrative Medical Oncology, Saiseikai Kumamoto HospitalDepartment of Medical Oncology, NHO Kumamoto Medical CenterDepartment of Chemotherapy, Miyazaki Prefectural Miyazaki HospitalDepartment of Gastroenterology, Kagoshima Kouseiren HospitalDepartment of Gastroenterology, Izumi General Medical CenterDepartment of Gastroenterology, Izumi General Medical CenterDepartment of Gastroenterology, Asakura Medical Association HospitalDepartment of Gastroenterology, Saiseikai Sendai HospitalDepartment of Gastroenterology, Saiseikai Sendai HospitalResearcher of Clinical Hematology Oncology Treatment Study GroupDepartment of Internal Medicine, Fujikawa HospitalDepartment of Medical Oncology, Sasebo Kyosai HospitalAbstract 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.https://doi.org/10.1038/s41598-025-88005-4 |
| spellingShingle | Tomonori Araki Yuki Sonoda Mototsugu Shimokawa Taiga Otsuka Kohei Hayashi Takuya Honda Kazuhiko Nakao Taro Shibuki Junichi Nakazawa Shiho Arima Keisuke Miwa Yoshinobu Okabe Futa Koga Yujiro Ueda Yoshihito Kubotsu Hozumi Shimokawa Shigeyuki Takeshita Azusa Komori Kazuo Nishikawa Satoshi Otsu Ayumu Hosokawa Hisanobu Oda Tatsunori Sakai Shuji Arita Machiko Kawahira Hiroki Taguchi Kengo Tsuneyoshi Yasunori Kawaguchi Toshihiro Fujita Takahiro Sakae Tsuyoshi Shirakawa Toshihiko Mizuta Kenji Mitsugi Relationship between neutropenia caused by nanoliposomal irinotecan/fluorouracil/leucovorin and treatment outcomes in the NAPOLEON-2 study (NN-2301) Scientific Reports |
| title | Relationship between neutropenia caused by nanoliposomal irinotecan/fluorouracil/leucovorin and treatment outcomes in the NAPOLEON-2 study (NN-2301) |
| title_full | Relationship between neutropenia caused by nanoliposomal irinotecan/fluorouracil/leucovorin and treatment outcomes in the NAPOLEON-2 study (NN-2301) |
| title_fullStr | Relationship between neutropenia caused by nanoliposomal irinotecan/fluorouracil/leucovorin and treatment outcomes in the NAPOLEON-2 study (NN-2301) |
| title_full_unstemmed | Relationship between neutropenia caused by nanoliposomal irinotecan/fluorouracil/leucovorin and treatment outcomes in the NAPOLEON-2 study (NN-2301) |
| title_short | Relationship between neutropenia caused by nanoliposomal irinotecan/fluorouracil/leucovorin and treatment outcomes in the NAPOLEON-2 study (NN-2301) |
| title_sort | relationship between neutropenia caused by nanoliposomal irinotecan fluorouracil leucovorin and treatment outcomes in the napoleon 2 study nn 2301 |
| url | https://doi.org/10.1038/s41598-025-88005-4 |
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