Evidence map›Paper›PMID 39928253›Full record

Observational studyBreast cancer (Tokyo, Japan)2025

A prospective cohort study of abemaciclib-induced interstitial lung disease in metastatic breast cancer after chemotherapy.

Sayuka Nakayama, Takayuki Iwamoto, Kazuhiro Araki, Kazutaka Narui, Takahiro Nakayama, Hiroyuki Nagase, Naoya Sugimoto, Naruto Taira, Tomohiko Aihara, Yuichiro Kikawa and 1 more

Abstract readObservational Study
PubMed Publisher
In one paragraph

Observational study 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 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Observational
  2. Article
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

11 authors.

Sayuka NakayamaDepartment of Breast Surgical Oncology, Showa University Hospital, Tokyo, Japan.
Takayuki IwamotoBreast and Thyroid Surgery, Kawasaki Medical School Hospital, Kurashiki, Japan. tiwamoto@med.kawasaki-m.ac.jp.ORCID http://orcid.org/0000-0001-5835-5160
Kazuhiro ArakiDepartment of Medical Oncology, Gunma Prefectural Cancer Center, Gunma, Japan.
Kazutaka NaruiDepartment of Breast and Thyroid Surgery, Yokohama City University Medical Center, Yokohama, Japan.
Takahiro NakayamaDepartment of Breast and Endocrine Surgery, Osaka International Cancer Institute, Osaka, 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.
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

backgroundThe 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).

methodsThis 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.

resultsAll 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.

conclusionIn 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.

Indexed as

AminopyridinesAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesBreast NeoplasmsLung Diseases, InterstitialAdultAgedFemaleHumansIncidenceMiddle AgedProspective StudiesRisk FactorsabemaciclibAminopyridinesBenzimidazolesAbemaciclibChemotherapy-treatedInterstitial lung disease

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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 OpenQuestion graph.