Nakayama Sayuka, Iwamoto Takayuki, Araki Kazuhiro, Narui Kazutaka, Nakayama Takahiro, Nagase Hiroyuki, Sugimoto Naoya, Taira Naruto, Aihara Tomohiko, Kikawa Yuichiro, Mukai Hirofumi
Department of Breast Surgical Oncology, Showa University Hospital, Tokyo, Japan.
Breast and Thyroid Surgery, Kawasaki Medical School Hospital, Kurashiki, Japan.
Breast Cancer. 2025 May;32(3):607-612. doi: 10.1007/s12282-025-01680-z. Epub 2025 Feb 10.
The safety of combination therapy with abemaciclib and hormone therapy in patients with hormone receptor-positive (HR +), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC) who were previously treated with chemotherapy for MBC remains unclear. Caution is required as the Pharmaceuticals and Medical Devices Agency (PMDA) and the U.S. Food and Drug Administration (FDA) have issued warnings about abemaciclib-induced interstitial lung disease (ILD).
This study was a secondary analysis of a prospective observational study involving patients who had previously undergone chemotherapy for HR + MBC. A certificated respiratory specialist reviewed the clinical information of patients who were suspected of having ILD to adjudicate abemaciclib-induced ILD and definitively diagnosed abemaciclib-induced ILD. In this study, the incidence, risk factors, and clinical course of interstitial lung disease (ILD) are reported.
All cases of patients who received abemaciclib had no radiological evidence of ILD prior to abemaciclib treatment. The incidence of abemaciclib-induced ILD was 7.4% (n = 9/122). CTCAE grade 1/2 occurred in 77.8% (n = 7), with no grade 4/5 cases. The timing of ILD onset varied and our study did not identify any significant risk factors for abemaciclib-induced ILD. All cases of ILD ultimately were confirmed to be in remission or cured.
In this multicenter prospective cohort study with a follow-up period of 3.3 years and a definition of ILD by a certified pulmonologist, we accurately evaluated abemaciclib-associated ILD after chemotherapy. The favorable clinical course of ILD indicate that abemaciclib treatment is an acceptable option for these MBC patients. However, because abemaciclib-induced ILD is difficult to predict, careful monitoring is required during abemaciclib treatment.
对于先前接受过转移性乳腺癌（MBC）化疗的激素受体阳性（HR +）、人表皮生长因子受体2阴性（HER2 -）转移性乳腺癌患者，阿贝西利与激素疗法联合治疗的安全性尚不清楚。由于日本药品和医疗器械管理局（PMDA）及美国食品药品监督管理局（FDA）已发布关于阿贝西利诱发间质性肺病（ILD）的警告，故需谨慎使用。
本研究是一项对先前接受过HR + MBC化疗患者的前瞻性观察性研究的二次分析。由一名获得认证的呼吸专科医生审查疑似患有ILD患者的临床信息，以判定阿贝西利诱发的ILD并明确诊断阿贝西利诱发的ILD。本研究报告了间质性肺病（ILD）的发病率、危险因素及临床病程。
所有接受阿贝西利治疗的患者在阿贝西利治疗前均无ILD的影像学证据。阿贝西利诱发ILD的发生率为7.4%（n = 9/122）。CTCAE 1/2级发生在77.8%（n = 7）的患者中，无4/5级病例。ILD发病时间各异，且我们的研究未发现阿贝西利诱发ILD的任何显著危险因素。所有ILD病例最终均被确认为缓解或治愈。
在这项随访期为3.3年且由认证肺科医生定义ILD的多中心前瞻性队列研究中，我们准确评估了化疗后与阿贝西利相关的ILD。ILD良好的临床病程表明，阿贝西利治疗对于这些MBC患者是一个可接受的选择。然而，由于阿贝西利诱发的ILD难以预测，在阿贝西利治疗期间需要仔细监测。
