Evidence map›Paper›PMID 36414795›Full record

Observational studyBreast cancer research and treatment2023

Patient characteristics, treatment patterns, and outcomes of hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer patients prescribed cyclin-dependent kinase 4 and 6 inhibitors: large-scale data analysis using a Japanese claims database.

Masaaki Kawai, Masahiro Takada, Takahiro Nakayama, Norikazu Masuda, Hirokazu Shiheido, Zhihong Cai, Yu-Jing Huang, Tsutomu Kawaguchi, Yoshinori Tanizawa

Open access · hybridAbstract readObservational Study
In one paragraph

Observational study in Breast cancer research and treatment, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 10% 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

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
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  4. Review
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  7. Observational
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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 at 6 institutions in 2 countries.

Masaaki KawaiDepartment of Surgery I, Yamagata University Graduate School of Medical Science, Yamagata, Japan.
Masahiro TakadaDepartment of Breast Surgery, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Takahiro NakayamaDepartment of Breast and Endocrine Surgery, Osaka International Cancer Institute, Osaka, Japan.
Norikazu MasudaDepartment of Breast and Endocrine Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Hirokazu ShiheidoJapan Drug Development and Medical Affairs, Eli Lilly Japan K.K., Kobe, Japan.
Zhihong CaiJapan Drug Development and Medical Affairs, Eli Lilly Japan K.K., Kobe, Japan.
Yu-Jing HuangGlobal Patient Safety, Eli Lilly and Company, Indianapolis, IN, USA.
Tsutomu KawaguchiJapan Drug Development and Medical Affairs, Eli Lilly Japan K.K., Kobe, Japan.
Yoshinori TanizawaJapan Drug Development and Medical Affairs, Eli Lilly Japan K.K., Kobe, Japan. tanizawa_yoshinori@lilly.com.ORCID http://orcid.org/0000-0002-5014-2483
Eli Lilly (Japan) · JPEli Lilly (United States) · USKyoto University · JPNagoya University · JPOsaka International Cancer Institute · JPYamagata University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe aim was to understand real-world cyclin-dependent kinase (CDK) 4 and 6 inhibitor use in Japan.

methodsThis retrospective observational study used a Japanese administrative claims database and included patients with presumptive hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer (ABC) prescribed CDK4 and 6 inhibitor therapy between December 2017 and March 2021. Patient characteristics, treatment patterns, and selected clinical and safety outcomes were descriptively summarized. Time to discontinuation (TTD) and chemotherapy-free survival (CFS) were examined using Kaplan-Meier estimates.

resultsThe study cohort (N = 6442) was predominantly female (99.4%; median [range] age 64 [26-99] years) with records of metastases (79.6%) within 1 year prior to initiating CDK4 and 6 inhibitor therapy. In total, 4463 (69.3%) and 1979 (30.7%) were prescribed palbociclib and abemaciclib, respectively, as their first CDK4 and 6 inhibitor, most commonly in combination with fulvestrant (n = 3801; 59.0%). Overall, 3756 patients initiated a subsequent anticancer treatment, of whom 748 (19.9%) initiated a different CDK4 and 6 inhibitor in combination with the same or different endocrine therapy. Median TTD (95% confidence interval) was 9.7 (9.3, 10.1) months for the first CDK4 and 6 inhibitor therapy. Median CFS was 26.1 (24.6, 27.8) months. Incidence of clinically relevant diarrhea was higher after abemaciclib initiation (9.8%) than after palbociclib initiation (1.5%). More patients experienced dose reduction with palbociclib (69.3%) than with abemaciclib (53.0%).

conclusionThe data provide insights into current clinical practices for CDK4 and 6 inhibitor use in Japan that could help establish future treatment strategies for ABC.

Indexed as

Breast NeoplasmsAminopyridinesAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesCyclin-Dependent Kinase 4East Asian PeopleErb-b2 Receptor Tyrosine KinasesFemaleHumansMiddle AgedProtein Kinase InhibitorsabemaciclibAminopyridinesBenzimidazolesCyclin-Dependent Kinase 4ERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesProtein Kinase InhibitorsAdministrative claims databaseCDK4 and 6 inhibitorEffectivenessMetastatic breast cancerReal-world evidenceSafety

Identifiers

PMID36414795
PMCPMC9823084
OpenAlexW4309646809

What OpenQuestion holds

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LicenceCC BY
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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.