Real-world incidence of and risk factors for abemaciclib-induced interstitial lung disease in Japan: a nested case-control study of abemaciclib-induced interstitial lung disease (NOSIDE).

IF 4 3区医学 Q1 OBSTETRICS & GYNECOLOGY Breast Cancer Pub Date : 2025-01-01 Epub Date: 2024-11-18 DOI:10.1007/s12282-024-01648-5

Sayuka Nakayama, Ayuha Yoshizawa, Junji Tsurutani, Kenichi Yoshimura, Gaku Aoki, Takayuki Iwamoto, Hiroyuki Nagase, Naoya Sugimoto, Konomi Kobayashi, Shinyu Izumi, Terufumi Kato, Yasunari Miyazaki, Yasuyuki Kurihara, Naruto Taira, Tomohiko Aihara, Yuichiro Kikawa, Hirofumi Mukai

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Abstract

Purpose: The exact incidence of and risk factors for interstitial lung disease (ILD), a serious side effect of abemaciclib, remain unknown in real-world settings. We examined the incidence of and risk factors for abemaciclib-induced ILD in patients with advanced breast cancer (ABC) in Japan.

Patients and methods: Retrospective clinical information was collected from charts of patients with ABC who had started abemaciclib treatment at 77 participating institutions between November 30, 2018 and December 31, 2019. The clinical information of patients who developed ILD (including suspected cases) were reviewed by an independent committee of extramural experts to adjudicate abemaciclib-induced ILD. We performed a nested case-control study for efficient identification of ILD risk factors and conducted multivariate Cox regression analysis to identify independent predictors of ILD.

Results: Among patients taking abemaciclib, the incidence of abemaciclib-induced ILD was 5.0% (n = 59/1189), and the mortality rate was 0.7% (n = 8). The timing of ILD onset varied but occurred most frequently within 180 days of beginning abemaciclib treatment (64.4%). The incidence of abemaciclib-induced ILD was significantly associated with Eastern Cooperative Oncology Group performance status (ECOG PS) ≥ 2 [hazard ratio (HR) 5.03; 95% confidence interval (CI) 2.26-11.11] or a past medical history of interstitial pneumonia (IP) (HR 6.49; 95% CI 3.09-13.70).

Conclusions: In this study, we have for the first time determined the real-world incidence of and risk factors for abemaciclib-induced ILD in Japan. Although abemaciclib-induced ILD is serious in real-world settings, careful patient selection and close monitoring of those with poor ECOG PS and/or a history of IP may minimize ILD risk. This study was registered on the UMIN registry (Date: May 11, 2020/ ID: UMIN000040357).

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日本阿贝昔单抗诱发间质性肺病的实际发病率和风险因素：阿贝昔单抗诱发间质性肺病的巢式病例对照研究（NOSIDE）。

目的：间质性肺病（ILD）是阿巴西利（abemaciclib）的一种严重副作用，在现实世界中的确切发病率和风险因素仍然未知。我们研究了日本晚期乳腺癌（ABC）患者中阿巴西利（abemaciclib）诱发ILD的发病率和风险因素：我们从 77 家参与机构 2018 年 11 月 30 日至 2019 年 12 月 31 日期间开始接受阿巴西克利治疗的 ABC 患者的病历中收集了回顾性临床信息。由校外专家组成的独立委员会对发生 ILD 的患者（包括疑似病例）的临床信息进行了审查，以判定阿贝昔单抗诱发的 ILD。我们进行了一项巢式病例对照研究，以有效识别ILD风险因素，并进行了多变量Cox回归分析，以确定ILD的独立预测因素：结果：在服用阿昔单抗的患者中，阿昔单抗诱发的ILD发病率为5.0%（n = 59/1189），死亡率为0.7%（n = 8）。ILD的发病时间不尽相同，但最常发生在开始阿巴西利治疗后的180天内（64.4%）。阿昔单抗诱发的ILD发病率与东部合作肿瘤学组表现状态（ECOG PS）≥2[危险比（HR）5.03；95%置信区间（CI）2.26-11.11]或既往有间质性肺炎（IP）病史（HR 6.49；95% CI 3.09-13.70）显著相关：在这项研究中，我们首次确定了阿巴西利诱导的 ILD 在日本的实际发病率和风险因素。尽管阿昔单抗诱发的 ILD 在现实世界中很严重，但谨慎选择患者并密切监测 ECOG PS 较差和/或有 IP 病史的患者可将 ILD 风险降至最低。本研究已在 UMIN 注册（日期：2020 年 5 月 11 日/编号：UMIN000040357）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Breast Cancer ONCOLOGY-OBSTETRICS & GYNECOLOGY

CiteScore

6.70

自引率

2.50%

发文量

105

审稿时长

6-12 weeks

期刊介绍： Breast Cancer, the official journal of the Japanese Breast Cancer Society, publishes articles that contribute to progress in the field, in basic or translational research and also in clinical research, seeking to develop a new focus and new perspectives for all who are concerned with breast cancer. The journal welcomes all original articles describing clinical and epidemiological studies and laboratory investigations regarding breast cancer and related diseases. The journal will consider five types of articles: editorials, review articles, original articles, case reports, and rapid communications. Although editorials and review articles will principally be solicited by the editors, they can also be submitted for peer review, as in the case of original articles. The journal provides the best of up-to-date information on breast cancer, presenting readers with high-impact, original work focusing on pivotal issues.