ESMO Gastrointestinal Oncology (Jun 2025)
Nanoliposomal irinotecan with fluorouracil and folinic acid in patients with unresectable or recurrent pancreatic cancer: a multicenter observational study (NAPOLEON-2)
- T. Shirakawa,
- M. Shimokawa,
- T. Otsuka,
- Y. Shinohara,
- K. Toyodome,
- W. Kusano,
- J. Nakazawa,
- T. Kodama,
- M. Kawahira,
- H. Shimokawa,
- T. Koike,
- F. Koga,
- S. Yunotani,
- S. Nakashita,
- N. Oza,
- S. Noge,
- K. Murayama,
- H. Oda,
- N. Mitsui,
- R. Kawasaki,
- T. Morikita,
- S. Takeshita,
- S. Arima,
- R. Shibata,
- A. Kakihara,
- T. Yoshihiro,
- T. Imajima,
- S. Yamaga,
- S. Arita,
- Y. Kawaguchi,
- K. Nishikawa,
- T. Inagaki,
- S. Otsu,
- H. Taguchi,
- K. Jikuya,
- T. Terada,
- T. Sakai,
- Y. Ueda,
- T. Sakae,
- H. Sawase,
- M. Kawahira,
- K. Nio,
- N. Araki,
- K. Sakai,
- Y. Ide,
- T. Shibuki,
- K. Miwa,
- Y. Kubotsu,
- A. Hosokawa,
- A. Komori,
- T. Honda,
- K. Tsuneyoshi,
- T. Fujita,
- T. Mizuta,
- K. Mitsugi
Affiliations
- T. Shirakawa
- Clinical Hematology Oncology Treatment Study Group, Fukuoka, Japan; Eikoh Hospital, Fukuoka, Japan; Correspondence to: Dr Tsuyoshi Shirakawa, Researcher of Clinical Hematology Oncology Treatment Study Group, 1-14-6 Muromi-gaoka, Nishi-ku, Fukuoka-shi, Fukuoka 819-0030, Japan. Tel: +81-92-406-4166; Fax: +81-92-406-8356 Director of Medical Checkup Center, Eikoh Hospital, 3-8-15 Befu-nishi, Shime-machi, Kasuya-gun, Fukuoka 811-2232, Japan. Tel: +81-92-935-0147; Fax: +81-92-936-3370
- M. Shimokawa
- Clinical Research Institute, National Kyushu Cancer Center, Fukuoka, Japan; Department of Biostatistics, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan
- T. Otsuka
- Department of Internal Medicine, Minato Medical Clinic, Fukuoka, Japan
- Y. Shinohara
- Department of Hematology and Oncology, Japan Community Healthcare Organization Kyushu Hospital, Fukuoka, Japan
- K. Toyodome
- Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan
- W. Kusano
- Department of Chemotherapy, Miyazaki Prefectural Miyazaki Hospital, Miyazaki, Japan
- J. Nakazawa
- Department of Medical Oncology, Kagoshima City Hospital, Kagoshima, Japan
- T. Kodama
- Department of Medical Oncology, Kagoshima City Hospital, Kagoshima, Japan
- M. Kawahira
- Department of Medical Oncology, Kagoshima City Hospital, Kagoshima, Japan
- H. Shimokawa
- Department of Hematology and Oncology, Japan Community Healthcare Organization Kyushu Hospital, Fukuoka, Japan
- T. Koike
- Department of Hematology and Oncology, Japan Community Healthcare Organization Kyushu Hospital, Fukuoka, Japan
- F. Koga
- Department of Hepatobiliary and Pancreatology, Saga Medical Center Koseikan, Saga, Japan
- S. Yunotani
- Department of Hepatobiliary and Pancreatology, Saga Medical Center Koseikan, Saga, Japan
- S. Nakashita
- Department of Hepatobiliary and Pancreatology, Saga Medical Center Koseikan, Saga, Japan
- N. Oza
- Department of Hepatobiliary and Pancreatology, Saga Medical Center Koseikan, Saga, Japan
- S. Noge
- Department of Hepatobiliary and Pancreatology, Saga Medical Center Koseikan, Saga, Japan
- K. Murayama
- Department of Hepatobiliary and Pancreatology, Saga Medical Center Koseikan, Saga, Japan
- H. Oda
- Division of Integrative Medical Oncology, Saiseikai Kumamoto Hospital, Kumamoto, Japan
- N. Mitsui
- Division of Integrative Medical Oncology, Saiseikai Kumamoto Hospital, Kumamoto, Japan
- R. Kawasaki
- Division of Integrative Medical Oncology, Saiseikai Kumamoto Hospital, Kumamoto, Japan
- T. Morikita
- Division of Integrative Medical Oncology, Saiseikai Kumamoto Hospital, Kumamoto, Japan
- S. Takeshita
- Department of Gastroenterology, Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki, Japan
- S. Arima
- Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan
- R. Shibata
- Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan
- A. Kakihara
- Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan
- T. Yoshihiro
- Department of Medical Oncology, Sasebo Kyosai Hospital, Nagasaki, Japan
- T. Imajima
- Department of Medical Oncology, Sasebo Kyosai Hospital, Nagasaki, Japan
- S. Yamaga
- Department of Medical Oncology, Sasebo Kyosai Hospital, Nagasaki, Japan
- S. Arita
- Department of Chemotherapy, Miyazaki Prefectural Miyazaki Hospital, Miyazaki, Japan
- Y. Kawaguchi
- Department of Gastroenterology, Asakura Medical Association Hospital, Fukuoka, Japan
- K. Nishikawa
- Department of Medical Oncology and Hematology, Oita University Faculty of Medicine, Oita, Japan
- T. Inagaki
- Department of Medical Oncology and Hematology, Oita University Faculty of Medicine, Oita, Japan
- S. Otsu
- Department of Medical Oncology and Hematology, Oita University Faculty of Medicine, Oita, Japan
- H. Taguchi
- Department of Gastroenterology, Imamura General Hospital, Kagoshima, Japan
- K. Jikuya
- Department of Gastroenterology, Imamura General Hospital, Kagoshima, Japan
- T. Terada
- Department of Gastroenterology, Imamura General Hospital, Kagoshima, Japan
- T. Sakai
- Department of Medical Oncology, NHO Kumamoto Medical Center, Kumamoto, Japan
- Y. Ueda
- Department of Hematology and Oncology, Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan
- T. Sakae
- Department of Gastroenterology, Saiseikai Sendai Hospital, Kagoshima, Japan
- H. Sawase
- Department of Internal Medicine, National Hospital Organization Saga Hospital, Saga, Japan
- M. Kawahira
- Department of Gastroenterology, Kagoshima Kouseiren Hospital, Kagoshima, Japan
- K. Nio
- Department of Medical Oncology, Hamanomachi Hospital, Fukuoka, Japan
- N. Araki
- Department of Gastroenterology, Saiseikai Sendai Hospital, Kagoshima, Japan
- K. Sakai
- Department of Medical Oncology, NHO Kumamoto Medical Center, Kumamoto, Japan
- Y. Ide
- Department of Internal Medicine, National Hospital Organization Saga Hospital, Saga, Japan
- T. Shibuki
- Department for the Promotion of Drug and Diagnostic Development, Division of Drug and Diagnostic Development Promotion, Translational Research Support Office, National Cancer Center Hospital East, Chiba, Japan; Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Chiba, Japan
- K. Miwa
- Multidisciplinary Treatment Cancer Center, Kurume University Hospital, Fukuoka, Japan
- Y. Kubotsu
- Department of Internal Medicine, Karatsu Red Cross Hospital, Saga, Japan
- A. Hosokawa
- Department of Clinical Oncology, University of Miyazaki Hospital, Miyazaki, Japan
- A. Komori
- Department of Medical Oncology and Hematology, Oita University Faculty of Medicine, Oita, Japan
- T. Honda
- Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan
- K. Tsuneyoshi
- Department of Gastroenterology, Izumi General Medical Center, Kagoshima, Japan
- T. Fujita
- Department of Gastroenterology, Saiseikai Sendai Hospital, Kagoshima, Japan
- T. Mizuta
- Department of Internal Medicine, Fujikawa Hospital, Saga, Japan
- K. Mitsugi
- Department of Medical Oncology, Sasebo Kyosai Hospital, Nagasaki, Japan; Dr Kenji Mitsugi, Department of Medical Oncology, Sasebo Kyosai Hospital, 10-17 Shimanji-cho, Sasebo-shi, Nagasaki 857-8575, Japan. Tel: +81-956-22-5136; Fax: +81-956-25-0662
- DOI
- https://doi.org/10.1016/j.esmogo.2025.100150
- Journal volume & issue
-
Vol. 8
p. 100150
Abstract
Background: Nanoliposomal irinotecan with fluorouracil and folinic acid (NFF) is a standard second- or later-line regimen after gemcitabine-based therapy for patients with unresectable or recurrent pancreatic cancer (urPC). However, limited prospective clinical data on the efficacy and safety of NFF in a real-world setting have been presented. Therefore, we conducted this observational, real-world study to investigate the efficacy and safety of NFF. Patients and methods: We collected prospective data of urPC patients treated with NFF in 17 hospitals in Japan from 2021 to 2023. The primary endpoint was overall survival (OS). Secondary endpoints were overall response rate, disease control rate, progression-free survival, dose intensity, and adverse events (AEs). Results: NFF was administered to 150 patients with a mean age of 72 years. The median follow-up period was 7.2 months. All patients had previously received gemcitabine-based therapy. The median OS was 7.8 months; median progression-free survival was 3.7 months; median overall response rate was 11%; and median disease control rate was 56%. Median relative dose intensity was 72.7% with nanoliposomal irinotecan and 79.4% with fluorouracil. Grade 3/4 hematological and nonhematological AEs occurred in 52 and 70 patients, respectively. Neutropenia (28%) and anorexia (19%) were common grade 3/4 AEs. Subanalysis of patients with second-line and third- or later-line therapy demonstrated no significant difference in OS (7.4 versus 7.8 months, respectively; P = 0.88). Integrated analysis of the prospective and retrospective phases of the study showed that median OS was 8.0 months. Conclusions: NFF has an appropriate efficacy and safety profile and is a candidate for second- or later-line therapy for urPC.
Keywords
