Evidence map›Paper›PMID 33453015›Full record

ArticleBreast cancer (Tokyo, Japan)2021

Characteristics of interstitial lung disease in patients from post-marketing data on metastatic breast cancer patients who received abemaciclib in Japan.

Yucherng Chen, Satoshi Noma, Yoshio Taguchi, Masashi Takahashi, Junji Tsurutani, Shiho Mori, Sachi Sakaguchi, Hiroya Asou, Keisuke Tomii

Abstract read
In one paragraph

Article in Breast cancer (Tokyo, Japan), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
–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

18 citing papers in PubMed, 1 synthesis or guideline pooled it.

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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

9 authors.

Yucherng ChenEli Lilly Japan K.K, Lilly Plaza One Building, 5-1-28 Isogamidori, Chuo-Ku, Kobe, Hyogo, 651-0086, Japan. chen_yucherng@lilly.com.ORCID http://orcid.org/0000-0002-2755-0147
Satoshi NomaDepartment of Radiology, Tenri Hospital, Tenri, Japan.
Yoshio TaguchiDepartment of Respiratory Medicine, Tenri Hospital, Tenri, Japan.
Masashi TakahashiYujin Yamazaki Hospital, Hikone, Japan.
Junji TsurutaniAdvanced Cancer Translational Research Institute, Showa University, Tokyo, Japan.
Shiho MoriEli Lilly Japan K.K, Lilly Plaza One Building, 5-1-28 Isogamidori, Chuo-Ku, Kobe, Hyogo, 651-0086, Japan.
Sachi SakaguchiEli Lilly Japan K.K, Tokyo, Japan.
Hiroya AsouEli Lilly Japan K.K, Lilly Plaza One Building, 5-1-28 Isogamidori, Chuo-Ku, Kobe, Hyogo, 651-0086, Japan.
Keisuke TomiiKobe City Medical Center General Hospital, Kobe, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study evaluated characteristics of patients treated with abemaciclib and diagnosed with interstitial lung disease (ILD), using 12-month post-marketing data from the real-world setting in Japan.

methodsSpontaneous reports of adverse events in patients receiving abemaciclib were collected regularly from healthcare providers (HCPs) from November 30, 2018, to November 29, 2019. Detailed follow-up was requested on suspected ILD cases via questionnaires and/or interviews. Radiological images (when available) were reviewed by an ILD adjudication committee of specialists. The age distribution of patients prescribed abemaciclib in Japan was estimated based on insurance claims data.

resultsOf 4700 patients estimated to be exposed to abemaciclib, 82 cases of ILD were reported (46 serious, 13 fatal). Most (91%) had ≥ 1 symptom at diagnosis, commonly dyspnea/shortness of breath (59%), cough (44%), and/or fever (37%). The majority (68%) received steroid therapy (24 [56%] recovered/recovering; 5 [12%] not recovered; 13 [30%] deaths, 1 [2.3%] unknown). No specific imaging patterns or sites of predilection were identified, but a diffuse alveolar damage (DAD) pattern was observed at outcome in 3 of 4 evaluated fatal cases (16 in total evaluated). Features of fatal cases included advanced age, pre-existing interstitial change, and advanced Eastern Cooperative Oncology Group Performance Status.

conclusionAdvanced age and a DAD pattern were identified as potential risk factors for cases with poorer outcomes, as previously reported for drug-induced ILD. HCPs should consider the benefit-risk profile when prescribing abemaciclib, informing patients of risks and regularly monitoring treated patients to ensure early detection and treatment of ILD.

Indexed as

AdultAgedAged, 80 and overAge FactorsAminopyridinesAntineoplastic AgentsBenzimidazolesBreast NeoplasmsFemaleHumansJapanLung Diseases, InterstitialMiddle AgedProduct Surveillance, PostmarketingTomography, X-Ray ComputedabemaciclibAminopyridinesAntineoplastic AgentsBenzimidazolesAbemaciclibBreast cancerCyclin-dependent kinase 4/6Interstitial lung disease

Identifiers

PMID33453015
PMCPMC8064939

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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.