Evidence map›Paper›PMID 36876172›Full record

ArticleBreast care (Basel, Switzerland)2023

CDK4/6 Inhibitors in Advanced HR+/HER2 - Breast Cancer: A Multicenter Real-World Data Analysis.

Carolin Müller, Verena Kiver, Erich-Franz Solomayer, Gudrun Wagenpfeil, Caroline Neeb, Jens-Uwe Blohmer, Alina Valik Abramian, Nicolai Maass, Florian Schütz, Cornelia Kolberg-Liedtke and 2 more

Abstract read
In one paragraph

Article in Breast care (Basel, Switzerland), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing 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

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

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  15. Retrospective registry of patients with locally advanced/metastatic HRClinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
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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

12 authors.

Carolin MüllerDepartment of Gynecology, Obstetrics and Reproductive Medicine, Saarland University Medical Center, Homburg, Germany.
Verena KiverDepartment of Gynecology with Breast Center, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Erich-Franz SolomayerDepartment of Gynecology, Obstetrics and Reproductive Medicine, Saarland University Medical Center, Homburg, Germany.
Gudrun WagenpfeilInstitute for Medical Biometry, Epidemiology and Medical Informatics (IMBEI), Saarland University Medical Center, Homburg, Germany.
Caroline NeebDepartment of Gynecology with Breast Center, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Jens-Uwe BlohmerDepartment of Gynecology with Breast Center, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Alina Valik AbramianDepartment of Gynecology and Obstetrics, University Medical Center Bonn, Bonn, Germany.
Nicolai MaassDepartment of Gynecology and Obstetrics, University Medical Center Schleswig-Holstein (UKSH), Kiel, Germany.
Florian SchützDepartment of Gynecology and Obstetrics, Diakonissen-Stiftungs-Krankenhaus Speyer, Speyer, Germany.
Cornelia Kolberg-LiedtkeDepartment of Gynecology and Obstetrics, University Medical Center Essen, Essen, Germany.
Damian Johannes RalserDepartment of Gynecology and Obstetrics, University Medical Center Bonn, Bonn, Germany.
Anna-Christina RambowDepartment of Gynecology and Obstetrics, University Medical Center Schleswig-Holstein (UKSH), Kiel, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: CDK4/6 inhibitors (CDK4/6i) combined with endocrine therapy are considered standard-of-care for first-line therapy of patients with hormone receptor positive, HER2 negative, advanced breast cancer (HR+/HER2- ABC). Superiority of combination therapy over endocrine monotherapy has been demonstrated in a multitude of randomized controlled trials (RCTs) in phase III and IV. However, RCTs reflect clinical reality only to a limited extent, as narrow inclusion criteria lead to a selected patient collective. Here, we present real-world data (RWD) on CDK4/6i treatment in patients with HR+/HER2- ABC at four certified German university breast cancer centers. Methods: Patients diagnosed with HR+/HER2- ABC who were treated in clinical routine with CDK4/6i between November 2016 and December 2020 at four certified German university breast cancer centers (Saarland University Medical Center, University Medical Center Charité Berlin, University Medical Center Bonn, and University Medical Center Hospital Schleswig-Holstein, Campus Kiel) were identified and enrolled in this retrospective study. Clinicopathological characteristics and clinical outcomes were recorded with particular emphasis on CDK4/6i therapy course [progression-free survival (PFS) following treatment initiation, toxicity, dose reduction, therapy discontinuation, prior and subsequent therapy line]. Results: Data from Conclusion: Our RWD analysis on CDK4/6i treatment in Germany supports data from RCTs regarding both treatment efficacy and safety of CDK4/6i for treatment of patients with HR+/HER2- ABC. In comparison to data from the pivotal RCTs, median PFS was lower but within the expected range for RWD, which could result from inclusion of patients with more advanced diseases (i.e., higher therapy lines) to our dataset.

Indexed as

CDK4/6 inhibitorsMetastatic breast cancerProgression-free survivalReal-world data

Identifiers

PMID36876172
PMCPMC9982335

What OpenQuestion holds

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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.