Evidence map›Paper›PMID 39556171›Full record

ArticleBreast cancer (Tokyo, Japan)2025

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).

Sayuka Nakayama, Ayuha Yoshizawa, Junji Tsurutani, Kenichi Yoshimura, Gaku Aoki, Takayuki Iwamoto, Hiroyuki Nagase, Naoya Sugimoto, Konomi Kobayashi, Shinyu Izumi and 7 more

Abstract read
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In one paragraph

Article in Breast cancer (Tokyo, Japan), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Sayuka NakayamaDepartment of Breast Surgical Oncology, Showa University Hospital, Tokyo, Japan.
Ayuha YoshizawaDepartment of Breast Surgical Oncology, Showa University Hospital, Tokyo, Japan.
Junji TsurutaniAdvanced Cancer Translational Research Institute, Showa University, Tokyo, Japan. tsurutaj@med.showa-u.ac.jp.ORCID http://orcid.org/0000-0002-6260-6943
Kenichi YoshimuraClinical Research Center in Hiroshima, Hiroshima University Hospital, Hiroshima, Japan.
Gaku AokiDepartment of Biostatistics, Clinical Research Center, Hiroshima University Hospital, Hiroshima, Japan.
Takayuki IwamotoBreast and Thyroid Surgery, Kawasaki Medical School Hospital, Kurashiki, Japan.
Hiroyuki NagaseDivision of Respiratory Medicine and Allergology, Department of Medicine, Teikyo University School of Medicine, Tokyo, Japan.
Naoya SugimotoDivision of Respiratory Medicine and Allergology, Department of Medicine, Teikyo University School of Medicine, Tokyo, Japan.
Konomi KobayashiDivision of Respiratory Medicine and Allergology, Department of Medicine, Teikyo University School of Medicine, Tokyo, Japan.
Shinyu IzumiDepartment of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan.
Terufumi KatoDepartment of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan.
Yasunari MiyazakiDepartment of Respiratory Medicine, Tokyo Medical and Dental University, Tokyo, Japan.
Yasuyuki KuriharaDepartment of Radiology, St. Luke's International Hospital, Tokyo, Japan.
Naruto TairaBreast and Thyroid Surgery, Kawasaki Medical School Hospital, Kurashiki, Japan.
Tomohiko AiharaBreast Center, Aihara Hospital, Osaka, Japan.
Yuichiro KikawaDepartment of Breast Surgery, Kansai Medical University Hospital, Osaka, Japan.
Hirofumi MukaiDepartment of Medical Oncology, National Cancer Center Hospital East, Chiba, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe 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

methodsRetrospective 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.

resultsAmong 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).

conclusionsIn 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).

Indexed as

AminopyridinesBenzimidazolesBreast NeoplasmsLung Diseases, InterstitialAdultAgedAged, 80 and overCase-Control StudiesFemaleHumansIncidenceJapanMiddle AgedRetrospective StudiesRisk FactorsabemaciclibAminopyridinesBenzimidazolesAbemaciclibCase–control studyInterstitial lung diseaseRisk factor

Identifiers

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.