Relationship between neutropenia caused by nanoliposomal irinotecan/fluorouracil/leucovorin and treatment outcomes in the NAPOLEON-2 study (NN-2301)

被引：0

作者：

Araki, Tomonori ^{[1
]}

Sonoda, Yuki ^{[1
]}

Shimokawa, Mototsugu ^{[2
,3
]}

Otsuka, Taiga ^{[4
]}

Hayashi, Kohei ^{[1
]}

Honda, Takuya ^{[1
]}

Nakao, Kazuhiko ^{[1
]}

Shibuki, Taro ^{[5
,6
]}

Nakazawa, Junichi ^{[7
]}

Arima, Shiho ^{[8
]}

Miwa, Keisuke ^{[9
]}

Okabe, Yoshinobu ^{[10
]}

Koga, Futa ^{[11
]}

Ueda, Yujiro ^{[12
]}

Kubotsu, Yoshihito ^{[13
]}

Shimokawa, Hozumi ^{[14
]}

Takeshita, Shigeyuki ^{[15
]}

Komori, Azusa ^{[16
,17
]}

Nishikawa, Kazuo ^{[16
]}

Otsu, Satoshi ^{[16
]}

Hosokawa, Ayumu ^{[18
]}

Oda, Hisanobu ^{[19
]}

Sakai, Tatsunori ^{[20
]}

Arita, Shuji ^{[21
]}

Kawahira, Machiko ^{[22
]}

Taguchi, Hiroki ^{[23
,24
]}

Tsuneyoshi, Kengo ^{[23
]}

Kawaguchi, Yasunori ^{[25
]}

Fujita, Toshihiro ^{[26
]}

Sakae, Takahiro ^{[26
]}

Shirakawa, Tsuyoshi ^{[27
,28
]}

Mizuta, Toshihiko ^{[29
]}

Mitsugi, Kenji ^{[30
]}

机构：

[1] Nagasaki Univ, Grad Sch Biomed Sci, Dept Gastroenterol & Hepatol, Nagasaki, Japan

[2] Natl Kyushu Canc Ctr, Clin Res Inst, Fukuoka, Japan

[3] Yamaguchi Univ, Grad Sch Med, Dept Biostat, Yamaguchi, Japan

[4] Minato Med Clin, Dept Internal Med, Fukuoka, Japan

[5] Natl Canc Ctr Hosp East, Dept Promot Drug & Diagnost Dev, Div Drug & Diagnost Dev Promot, Translat Res Support Off, Chiba, Japan

[6] Natl Canc Ctr Hosp East, Dept Hepatobiliary & Pancreat Oncol, Chiba, Japan

[7] Kagoshima City Hosp, Dept Med Oncol, Kagoshima, Japan

[8] Kagoshima Univ, Grad Sch Med & Dent Sci, Digest & Lifestyle Dis, Kagoshima, Japan

[9] Kurume Univ Hosp, Multidisciplinary Treatment Canc Ctr, Kurume, Fukuoka, Japan

[10] Kurume Univ, Sch Med, Dept Med, Div Gastroenterol, Fukuoka, Japan

[11] Saga Med Ctr Koseikan, Dept Pathol, Saga, Japan

[12] Japanese Red Cross Kumamoto Hosp, Dept Paediat, Kumamoto, Japan

[13] Karatsu Red Cross Hosp, Dept Internal Med, Saga, Japan

[14] Kyushu Hosp, Japan Community Healthcare Org, Fukuoka, Japan

[15] Japanese Red Cross Nagasaki Genbaku Hosp, Dept Gastroenterol, Nagasaki, Japan

[16] Oita Univ, Fac Med, Dept Med Oncol & Hematol, Oita, Japan

[17] Natl Hosp Org Shikoku Canc Ctr, Dept Gastrointestinal Med Oncol, Matsuyama, Ehime, Japan

[18] Univ Miyazaki Hosp, Dept Clin Oncol, Miyazaki, Japan

[19] Saiseikai Kumamoto Hosp, Div Integrat Med Oncol, Kumamoto, Japan

[20] NHO Kumamoto Med Ctr, Dept Med Oncol, Kumamoto, Japan

[21] Miyazaki Prefectural Miyazaki Hosp, Dept Chemotherapy, Miyazaki, Japan

[22] Kagoshima Kouseiren Hosp, Dept Gastroenterol, Kagoshima, Japan

[23] Izumi Gen Med Ctr, Dept Gastroenterol, Kagoshima, Japan

[24] Kagoshima City Hosp, Dept Gastroenterol, Kagoshima, Japan

[25] Asakura Med Assoc Hosp, Dept Gastroenterol, Asakura City, Japan

[26] Saiseikai Sendai Hosp, Dept Gastroenterol, Kagoshima, Japan

[27] Oncol Treatment Study Grp, Clin Hematol, 1-14-6 Muromi Gaoka,Nishi Ku, Fukuoka, Fukuoka 8190030, Japan

[28] Eikoh Hosp, 3-8-15 Befu Nishi, Shime, 8112232, Japan

[29] Fujikawa Hosp, Dept Internal Med, Saga, Japan

[30] Sasebo Kyosai Hosp, Dept Med Oncol, Sasebo, Japan

来源：

SCIENTIFIC REPORTS | 2025年 / 15卷 / 01期

关键词：

CHEMOTHERAPY-INDUCED NEUTROPENIA; CELL LUNG-CANCER; PANCREATIC-CANCER; LIPOSOMAL IRINOTECAN; COLORECTAL-CANCER; SURVIVAL; FLUOROURACIL; GEMCITABINE; TRIAL;

D O I：

10.1038/s41598-025-88005-4

中图分类号：

O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

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.

引用

页数：12

共 15 条

[1] Neutropenia as a predictive and prognostic factor in nanoliposomal-irinotecan/fluorouracil/leucovorin therapy for pancreatic cancer: Findings from the NAPOLEON-2 study (NN-2301)
Sonoda, Y.
Araki, T.
Shimokawa, M.
Otsuka, T.
Shibuki, T.
Nakazawa, J.
Arima, S.
Miwa, K.
Koga, F.
Ueda, Y.
Kubotsu, Y.
Shimokawa, H.
Takeshita, S.
Nishikawa, K.
Hosokawa, A.
Oda, H.
Arita, S.
Shirakawa, T.
Mizuta, T.
Mitsugi, K.
ANNALS OF ONCOLOGY, 2023, 34 : S1546 - S1546
[2] A real-world prospective analysis of the relationship between nanoliposomal irinotecan and fluorouracil with folinic acid and neutropenia in patients with pancreatic cancer (NAPOLEON-2 study, NN-2401).
Shirakawa, Tsuyoshi
Araki, Tomonori
Shimokawa, Mototsugu
Otsuka, Taiga
Nakazawa, Junichi
Shimokawa, Hozumi
Koga, Futa
Oda, Hisanobu
Takeshita, Shigeyuki
Arima, Shiho
Arita, Shuji
Kawaguchi, Yasunori
Nishikawa, Kazuo
Taguchi, Hiroki
Jikuya, Kenichi
Sakai, Tatsunori
Ueda, Yujiro
Sakae, Takahiro
Mizuta, Toshihiko
Mitsugi, Kenji
JOURNAL OF CLINICAL ONCOLOGY, 2025, 43 (4_SUPPL) : 762 - 762
[3] Multicenter observational study of nanoliposomal irinotecan and fluorouracil/leucovorin in patients with unresectable or recurrent pancreatic cancer (NAPOLEON-2): Final retrospective results.
Imajima, Takashi
Shirakawa, Tsuyoshi
Shimokawa, Mototsugu
Otsuka, Taiga
Shibuki, Taro
Nakazawa, Junichi
Arima, Shiho
Miwa, Keisuke
Koga, Futa
Kubotsu, Yoshihito
Ueda, Yujiro
Hosokawa, Ayumu
Takeshita, Shigeyuki
Shimokawa, Hozumi
Komori, Azusa
Oda, Hisanobu
Sakai, Tatsunori
Arita, Shuji
Mizuta, Toshihiko
Mitsugi, Kenji
JOURNAL OF CLINICAL ONCOLOGY, 2023, 41 : 706 - 706
[4] A multicenter observational study of liposomal irinotecan and fluorouracil/leucovorin in patients with unresectable or recurrent pancreatic cancer (NAPOLEON-2): Retrospective
Imajima, T.
Shirakawa, T.
Shimokawa, M.
Otsuka, T.
Shibuki, T.
Nakazawa, J.
Arima, S.
Miwa, K.
Okabe, Y.
Koga, F.
Kubotsu, Y.
Ueda, Y.
Hosokawa, A.
Takeshita, S.
Shimokawa, H.
Komori, A.
Kawahira, M.
Oda, H.
Sakai, K.
Arita, S.
Mizuta, T.
Mitsugi, K.
ANNALS OF ONCOLOGY, 2022, 33 : S289 - S290
[5] Comparison of inflammatory markers before and after nanoliposomal irinotecan and fluorouracil with folic acid in patients with pancreatic cancer: results from the NAPOLEON-2 study (NN-2302)
Araki, Tomonori
Hayashi, Kohei
Shimokawa, Mototsugu
Otsuka, Taiga
Sonoda, Yuki
Honda, Takuya
Shibuki, Taro
Nakazawa, Junichi
Arima, Shiho
Miwa, Keisuke
Koga, Futa
Ueda, Yujiro
Kubotsu, Yoshihito
Shimokawa, Hozumi
Takeshita, Shigeyuki
Nishikawa, Kazuo
Komori, Azusa
Otsu, Satoshi
Hosokawa, Ayumu
Sakai, Tatsunori
Oda, Hisanobu
Kawahira, Machiko
Arita, Shuji
Taguchi, Hiroki
Tsuneyoshi, Kengo
Fujita, Toshihiro
Sakae, Takahiro
Kawaguchi, Yasunori
Shirakawa, Tsuyoshi
Mizuta, Toshihiko
Mitsugi, Kenji
THERAPEUTIC ADVANCES IN MEDICAL ONCOLOGY, 2025, 17
[6] Interim analysis of the NAPOLEON-2 study: Safety evaluation of nanoliposomal irinotecan with fluorouracil and folinic acid for unresectable pancreatic cancer patients with prior biliary drainage
Koga, F.
Shirakawa, T.
Shimokawa, M.
Otsuka, T.
Shimokawa, H.
Nakazawa, J.
Oda, H.
Takeshita, S.
Kawaguchi, Y.
Arita, S.
Taguchi, H.
Sakai, T.
Nishikawa, K.
Arima, S.
Ueda, Y.
Kawahira, M.
Sakae, T.
Ide, Y.
Mizuta, T.
Mitsugi, K.
ANNALS OF ONCOLOGY, 2023, 34 : S1534 - S1534
[7] Efficacy and safety of nanoliposomal irinotecan plus fluorouracil and folinic acid after irinotecan-based chemotherapy in patients with advanced pancreatic cancer: Results of the retrospective part of the NAPOLEON-2 study.
Kawaguchi, Yasunori
Aikawa, Tomomi
Shimokawa, Mototsugu
Otsuka, Taiga
Shibuki, Taro
Nakazawa, Junichi
Arima, Shiho
Miwa, Keisuke
Koga, Futa
Ueda, Yujiro
Kubotsu, Yoshihito
Shimokawa, Hozumi
Takeshita, Shigeyuki
Nishikawa, Kazuo
Hosokawa, Ayumu
Oda, Hisanobu
Sakai, Tatsunori
Shirakawa, Tsuyoshi
Mizuta, Toshihiko
Mitsugi, Kenji
JOURNAL OF CLINICAL ONCOLOGY, 2023, 41 : 705 - 705
[8] Interim analysis of the NAPOLEON-2 study: Safety evaluation of nano-liposomal irinotecan with fluorouracil and folinic acid for advanced pancreatic cancer
Kusano, W.
Arita, S.
Shimokawa, M.
Otsuka, T.
Shimokawa, H.
Nakazawa, J.
Koga, F.
Oda, H.
Takeshita, S.
Kawaguchi, Y.
Taguchi, H.
Sakai, T.
Nishikawa, K.
Arima, S.
Ueda, Y.
Kawahira, M.
Sakae, T.
Shirakawa, T.
Mizuta, T.
Mitsugi, K.
ANNALS OF ONCOLOGY, 2023, 34 : S1537 - S1537
[9] A multicenter retrospective observational NAPOLEON2 study of nanoliposomal irinotecan with fluorouracil and folinic acid in patients with unresectable pancreatic cancer
Kodama, Tomoko
Imajima, Takashi
Shimokawa, Mototsugu
Otsuka, Taiga
Kawahira, Masahiro
Nakazawa, Junichi
Hori, Takeshi
Shibuki, Taro
Arima, Shiho
Ido, Akio
Miwa, Keisuke
Okabe, Yoshinobu
Koga, Futa
Ueda, Yujiro
Kubotsu, Yoshihito
Shimokawa, Hozumi
Takeshita, Shigeyuki
Nishikawa, Kazuo
Komori, Azusa
Otsu, Satoshi
Hosokawa, Ayumu
Sakai, Tatsunori
Sakai, Kenji
Oda, Hisanobu
Kawahira, Machiko
Arita, Shuji
Honda, Takuya
Taguchi, Hiroki
Tsuneyoshi, Kengo
Kawaguchi, Yasunori
Fujita, Toshihiro
Sakae, Takahiro
Shirakawa, Tsuyoshi
Mizuta, Toshihiko
Mitsugi, Kenji
SCIENTIFIC REPORTS, 2024, 14 (01):
[10] Nanoliposomal irinotecan with fluorouracil and folinic acid, S-1 alone, or FOLFIRINOX as second-line chemotherapy for advanced pancreatic cancer after gemcitabine plus nabpaclitaxel: A pooled analysis of NAPOLEON-1 and NAPOLEON-2
Otsuka, T.
Shirakawa, T.
Shimokawa, M.
Shibuki, T.
Nakazawa, J.
Arima, S.
Miwa, K.
Koga, F.
Kubotsu, Y.
Ueda, Y.
Hosokawa, A.
Takeshita, S.
Shimokawa, H.
Komori, A.
Kawahira, M.
Oda, H.
Sakai, T.
Arita, S.
Mizuta, T.
Mitsugi, K.
ANNALS OF ONCOLOGY, 2022, 33 : S1473 - S1473

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