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日本早期乳腺癌围手术期化疗患者发热性中性粒细胞减少相关住院的真实世界证据。

Real-world evidence of febrile neutropenia-related hospitalization on patients with perioperative chemotherapy for early breast cancer in Japan.

作者信息

Yoshinami Tetsuhiro, Shibata Nobuhiro, Tamaki Kentaro, Ishimaru Kentaro, Ito Satoru, Nukada Tomoyuki, Ohno Shinji

机构信息

Department of Breast and Endocrine Surgery, Graduate School of Medicine, Osaka University, 2-2-E10 Yamadaoka, Suita City, Osaka, 565-0871, Japan.

Department of Clinical Oncology, Kansai Medical University Hospital, 2-3-1 Shinmachi, Hirakata City, Osaka, 573-1191, Japan.

出版信息

Breast Cancer. 2025 May 19. doi: 10.1007/s12282-025-01714-6.

Abstract

PURPOSE

To clarify particularly how febrile neutropenia-related hospitalization (FNH) affects patients' daily lives, by analyzing real-world data on FNH among patients with early breast cancer (EBC) receiving perioperative chemotherapy in Japan.

METHODS

This retrospective nationwide large-scale database study was conducted using anonymized claims data from 2010 to 2020. The patients with EBC who had available surgical records were included. Men, those aged < 18 years, and those who had not available chemotherapy records were excluded. FNH was defined as hospitalization during perioperative chemotherapy for EBC, with administration of intravenous antibacterial drugs and a diagnosis of FN, sepsis, infection, or fever.

RESULTS

The analysis population included 33,310 EBC patients with a mean age of 56.9 years, who received a total of 267,535 perioperative chemotherapy cycles. FNH occurred in 1,910 patients (5.73%) and 2144 chemotherapy cycles (0.80%). Median duration of FNH was 6.0 days. Fourth-generation cephalosporins were the most used intravenous antibacterial drugs (50.42%). Median duration of intravenous antibacterial drugs administration was 4.0 days. Therapeutic granulocyte-colony stimulating factor (G-CSF) was used in 1285 patients (67.28%). Median cost for FNH was estimated to be 189 thousand yen in 1,474 chemotherapy cycles with FNH, in which patients received intravenous antibacterial drugs administration for 3-8 days.

CONCLUSION

This nationwide real-world data analysis revealed the incidence, duration, treatment patterns, and medical cost of FNH in patients with EBC receiving perioperative chemotherapy in Japan. These findings indicate that FNH imposes a considerable burden on patients' daily lives, including time and financial impacts, contributing to the implementation of appropriate shared decision-making for primary G-CSF prophylaxis.

摘要

目的

通过分析日本接受围手术期化疗的早期乳腺癌(EBC)患者中与发热性中性粒细胞减少相关住院(FNH)的真实世界数据,特别阐明FNH如何影响患者的日常生活。

方法

本回顾性全国大规模数据库研究使用了2010年至2020年的匿名索赔数据。纳入有可用手术记录的EBC患者。排除男性、年龄<18岁者以及无可用化疗记录者。FNH定义为EBC围手术期化疗期间的住院,伴有静脉使用抗菌药物以及中性粒细胞减少、脓毒症、感染或发热的诊断。

结果

分析人群包括33310例EBC患者,平均年龄56.9岁,共接受267535个围手术期化疗周期。1910例患者(5.73%)和2144个化疗周期(0.80%)发生了FNH。FNH的中位持续时间为6.0天。第四代头孢菌素是最常用的静脉抗菌药物(50.42%)。静脉抗菌药物给药的中位持续时间为4.0天。1285例患者(67.28%)使用了治疗性粒细胞集落刺激因子(G-CSF)。在1474个发生FNH且患者接受3-8天静脉抗菌药物给药的化疗周期中,FNH的中位费用估计为18.9万日元。

结论

这项全国性真实世界数据分析揭示了日本接受围手术期化疗的EBC患者中FNH的发生率、持续时间、治疗模式和医疗费用。这些发现表明,FNH给患者的日常生活带来了相当大的负担,包括时间和经济影响,有助于为一级G-CSF预防实施适当的共同决策。

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