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18-11-2024 | Breast Cancer | Original Article

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)

Authors: 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

Published in: Breast Cancer

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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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Literature
3.
go back to reference Cristofanilli M, Turner NC, Bondarenko I, et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol. 2016;17(4):425–39. https://doi.org/10.1016/s1470-2045(15)00613-0.CrossRefPubMed Cristofanilli M, Turner NC, Bondarenko I, et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol. 2016;17(4):425–39. https://​doi.​org/​10.​1016/​s1470-2045(15)00613-0.CrossRefPubMed
13.
go back to reference Inoue K, Masuda N, Iwata H, et al. Japanese subpopulation analysis of MONARCH 2: phase 3 study of abemaciclib plus fulvestrant for treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer that progressed on endocrine therapy. Breast Cancer. 2021;28(5):1038–50. https://doi.org/10.1007/s12282-021-01239-8.CrossRefPubMed Inoue K, Masuda N, Iwata H, et al. Japanese subpopulation analysis of MONARCH 2: phase 3 study of abemaciclib plus fulvestrant for treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer that progressed on endocrine therapy. Breast Cancer. 2021;28(5):1038–50. https://​doi.​org/​10.​1007/​s12282-021-01239-8.CrossRefPubMed
14.
22.
go back to reference Ushiki A, Hanaoka M. Clinical characteristics of DLI: what are the clinical features of DLI? In: Hanaoka M, Nakamura H, Aoshiba K, editors. Drug-induced lung injury. Springer: Singapore; 2018. p. 27–33.CrossRef Ushiki A, Hanaoka M. Clinical characteristics of DLI: what are the clinical features of DLI? In: Hanaoka M, Nakamura H, Aoshiba K, editors. Drug-induced lung injury. Springer: Singapore; 2018. p. 27–33.CrossRef
Metadata
Title
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)
Authors
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
Publication date
18-11-2024
Publisher
Springer Nature Singapore
Published in
Breast Cancer
Print ISSN: 1340-6868
Electronic ISSN: 1880-4233
DOI
https://doi.org/10.1007/s12282-024-01648-5
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