Evidence map›Paper›PMID 33939324›Full record

ArticleCancer reports (Hoboken, N.J.)2022

Evaluation of potential complication of interstitial lung disease with abemaciclib and palbociclib treatments.

Hideki Nawa, Takahiro Niimura, Kenta Yagi, Mitsuhiro Goda, Yoshito Zamami, Keisuke Ishizawa

Open access · goldAbstract readEvaluation Study
In one paragraph

Article in Cancer reports (Hoboken, N.J.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.2field-weighted citation impact, top 12% of its field
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

10 citing papers in PubMed, 15 citations in OpenAlex.

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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

6 authors at 3 institutions in 1 country.

Hideki NawaDepartment of Pharmacy, Faculty of Pharmacy, Shujitsu University, Okayama, Japan.ORCID 0000-0002-1774-5821
Takahiro NiimuraDepartment of Clinical Pharmacology and Therapeutics, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.
Kenta YagiClinical Research Center for Developmental Therapeutics, Tokushima University Hospital, Tokushima, Japan.ORCID 0000-0003-0869-5786
Mitsuhiro GodaDepartment of Pharmacy, Tokushima University Hospital, Tokushima, Japan.
Yoshito ZamamiDepartment of Clinical Pharmacology and Therapeutics, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.
Keisuke IshizawaDepartment of Clinical Pharmacology and Therapeutics, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.
Tokushima University Hospital · JPShujitsu University · JPTokushima University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVarious cyclin-dependent kinase 4/6 (CDK4/6) inhibitors have demonstrated promising anti-tumor effects. The Japanese Ministry of Health, Labour and Welfare has issued a warning about interstitial lung diseases as an adverse effect of CDK4/6 inhibitors. However, a large-scale evaluation of potential complications has not been conducted to date, and the occurrence of these adverse effects is unclear.

aimThe aim of this study was to evaluate the clinical incidence of interstitial lung disease caused by two CDK4/6 inhibitors, abemaciclib and palbociclib, and assess the relationship between each drug and interstitial lung disease. METHODS AND

resultsWe evaluated the relationship between the CDK4/6 inhibitors (abemaciclib and palbociclib) and interstitial lung disease in clinical practice using data from the Japanese Adverse Drug Event Report (JADER) database and FDA Adverse Event Reporting System (FAERS) to detect adverse event signals with reported odds ratios (RORs). Furthermore, we performed an adverse event-time analysis for each drug using data from the JADER database to examine the time of onset of the adverse events. The analysis of the reports in the JADER database showed that the lower limit of the 95% confidence interval (CI) of ROR for abemaciclib was >1 regardless of age, and a signal was detected. Interstitial lung disease associated with abemaciclib and palbociclib use has been reported, with an average onset period from treatment initiation [median (25th-75th quartile)] of 65.1 [56.0 days (25.3-98.3 days)] and 53.1 days [38.0 days (10.8-76.0 days)], respectively. The analysis of the reports in the FAERS showed that the lower limit of the 95% CI of the ROR for the two drugs was >1, and a signal was detected.

conclusionTreatment with abemaciclib and palbociclib is associated with a potential complication of interstitial lung disease, regardless of age.

Indexed as

AdultAgedAminopyridinesBenzimidazolesDatabases, FactualFemaleHumansIncidenceJapanLung Diseases, InterstitialMaleMiddle AgedPiperazinesProtein Kinase InhibitorsPyridinesRetrospective StudiesabemaciclibAminopyridinesBenzimidazolespalbociclibPiperazinesProtein Kinase InhibitorsPyridinescyclin-dependent kinasedatabaseinterstitial lung disease

Identifiers

PMID33939324
PMCPMC8789605
OpenAlexW3157057610

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Registered trials

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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.