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纳米脂质体伊立替康/氟尿嘧啶/亚叶酸钙所致中性粒细胞减少与NAPOLEON-2研究(NN-2301)治疗结局的关系

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

作者信息

Araki Tomonori, Sonoda Yuki, Shimokawa Mototsugu, Otsuka Taiga, Hayashi Kohei, Honda Takuya, Nakao Kazuhiko, Shibuki Taro, Nakazawa Junichi, Arima Shiho, Miwa Keisuke, Okabe Yoshinobu, Koga Futa, Ueda Yujiro, Kubotsu Yoshihito, Shimokawa Hozumi, Takeshita Shigeyuki, Komori Azusa, Nishikawa Kazuo, Otsu Satoshi, Hosokawa Ayumu, Oda Hisanobu, Sakai Tatsunori, Arita Shuji, Kawahira Machiko, Taguchi Hiroki, Tsuneyoshi Kengo, Kawaguchi Yasunori, Fujita Toshihiro, Sakae Takahiro, Shirakawa Tsuyoshi, Mizuta Toshihiko, Mitsugi Kenji

机构信息

Department of Gastroenterology and Hepatology, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan.

Clinical Research Institute, National Kyushu Cancer Center, Fukuoka, Japan.

出版信息

Sci Rep. 2025 Jan 27;15(1):3427. doi: 10.1038/s41598-025-88005-4.

DOI:10.1038/s41598-025-88005-4
PMID:39870769
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11772893/
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.

摘要

纳米脂质体伊立替康/氟尿嘧啶/亚叶酸钙(NFF)治疗胰腺癌患者的疗效与中性粒细胞减少之间的关系尚未得到充分研究。因此,我们对接受NFF治疗的胰腺癌患者的数据进行了回顾性分析,以研究这种关系。根据不良事件通用术语标准,在三个临界值下评估中性粒细胞减少情况:A(0级与1 - 4级)、B(0 - 1级与2 - 4级)和C(0 - 2级与3 - 4级)。主要终点是总生存期(OS),次要终点是总缓解率、无进展生存期(PFS)和相对剂量强度。在161例患者中,分别有93、8、22、30和8例患者的中性粒细胞减少为0级、1级、2级、3级和4级。在临界值C时,总缓解率有显著差异(p = 0.02),临界值C的优势比最高,其次是临界值B和A。在临界值A(风险比[HR],0.65;95%置信区间[CI],0.44 - 0.94;p = 0.02)和B(HR,0.63;95% CI,0.43 - 0.92,p = 0.02)时,观察到OS有显著差异。同样,PFS在临界值A和B时显示出显著差异(p < 0.01)。NFF诱导的中性粒细胞减少可能是胰腺癌患者有用的预后因素。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f7e/11772893/edb38a2d60fc/41598_2025_88005_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f7e/11772893/2a57d087bd93/41598_2025_88005_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f7e/11772893/74e2dea4ab25/41598_2025_88005_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f7e/11772893/edb38a2d60fc/41598_2025_88005_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f7e/11772893/2a57d087bd93/41598_2025_88005_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f7e/11772893/74e2dea4ab25/41598_2025_88005_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f7e/11772893/edb38a2d60fc/41598_2025_88005_Fig3_HTML.jpg

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本文引用的文献

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A multicenter retrospective observational NAPOLEON2 study of nanoliposomal irinotecan with fluorouracil and folinic acid in patients with unresectable pancreatic cancer.NAPOLEON2 研究:不可切除胰腺癌患者接受伊立替康纳米脂质体联合氟尿嘧啶和亚叶酸治疗的多中心回顾性观察研究。
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