Observational studyBreast cancer (Tokyo, Japan)2025
Real-world evidence from Japan regarding survival outcomes and treatment sequence in patients receiving CDK4/6 inhibitor plus endocrine therapy as first- or second-line treatment for hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.
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. An erratum has been issued. Cited by 3 papers.
What it found
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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.
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.
Who cites it
3 citing papers in PubMed.
- Machine learning and cox model-based prediction of CDK4/6 inhibitor outcomes in HR+/HER2 - metastatic breast cancer: a multicenter real-world study.Breast cancer research and treatment · 2026Article
- Review
- Real-world treatment patterns and outcomes in HER2-low, HR+ metastatic breast cancer patients previously treated with endocrine therapy in the United States.Breast (Edinburgh, Scotland) · 2026Article
Corrections and comments
- Erratum issued
Authors and funding
23 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundA cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) plus endocrine therapy (ET) is a current standard first-/second-line treatment for hormone receptor (HR)-positive, HER2-negative advanced/metastatic breast cancer (AMBC). We aimed to provide real-world evidence regarding CDK4/6i therapy in this population.
methodsIn this multicenter observational study, data from patients who had started CDK4/6i therapy between January 1, 2019, and December 31, 2021, as first-/second-line treatment for AMBC were used; real-world progression-free survival (rwPFS), chemotherapy-free survival, and overall survival were analyzed using the Kaplan-Meier method. Additionally, data were analyzed by separating patients with treatment-free interval (TFI) < 12 months (deemed resistant to ET) from the first-line treatment group (hereafter, the exclusive first-line treatment group).
resultsData from 745 patients were analyzed. Compared with palbociclib, abemaciclib was used in younger patients and those with expected poor prognosis. Median rwPFS was 36.8, 17.8, and 31.4 months in patients with de novo stage IV disease, TFI < 12 months, and TFI ≥ 12 months, respectively, in the first-line treatment group, and 17.4 months in the second-line treatment group. In the exclusive first-line treatment group, median rwPFS of the subsequent treatment after initial CDK4/6i plus ET was < 7 months, regardless of the type of subsequent treatment; prognosis was especially poor in those who were switched to chemotherapy.
conclusionsThe real-world survival outcomes found in this study for patients receiving first-/second-line CDK4/6i therapy were consistent with those of randomized phase 3 studies. As outcomes of subsequent treatment after initial CDK4/6i plus ET remain insufficient, further improvement in treatment is necessary.
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Registered trials
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