Evidence map›Paper›PMID 39754979›Full record

ArticleESMO open2025

Comparative overall survival of CDK4/6 inhibitors plus an aromatase inhibitor in HR+/HER2- metastatic breast cancer in the US real-world setting.

H S Rugo, R M Layman, F Lynce, X Liu, B Li, L McRoy, A B Cohen, M Estevez, G Curigliano, A Brufsky

Abstract readComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in ESMO open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 3 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

44 citing papers in PubMed, 3 syntheses or guidelines 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

10 authors.

H S RugoUniversity of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, USA. Electronic address: hope.rugo@ucsf.edu.
R M LaymanThe University of Texas MD Anderson Cancer Center, Houston, USA.
F LynceDana-Farber Cancer Institute, Boston, USA.
X LiuPfizer Inc., New York, USA.
B LiPfizer Inc., New York, USA.
L McRoyPfizer Inc., New York, USA.
A B CohenFlatiron Health Inc., New York, USA; NYU Langone School of Medicine, New York, USA.
M EstevezFlatiron Health Inc., New York, USA.
G CuriglianoEuropean Institute of Oncology, IRCCS, Milan, Italy; Department of Oncology and Hemato-Oncology, University of Milano, Milan, Italy.
A BrufskyUPMC Hillman Cancer Center, University of Pittsburgh Medical Center, Pittsburgh, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRandomized controlled trials have shown inconsistent overall survival (OS) benefit among the three cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) as first-line (1L) treatment of patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC). Several real-world studies compared CDK4/6i effectiveness, with inconsistent findings. This study compared overall survival (OS) of patients with HR+/HER2- mBC receiving 1L palbociclib, ribociclib, or abemaciclib, in combination with an aromatase inhibitor (AI), in US clinical practice. PATIENTS AND

methodsThis retrospective study used real-world data from the Flatiron Health electronic health record-derived deidentified longitudinal database. Patients with HR+/HER2- mBC aged ≥18 years at mBC diagnosis started 1L CDK4/6i therapy (index treatment) between February 2015 and November 2023, with a potential ≥6-month follow-up. OS was defined as months from start of index treatment to death. Stabilized inverse probability of treatment weighting (sIPTW; primary analysis) was used to balance baseline patient characteristics. Multivariable Cox proportional hazards model was carried out as a sensitivity analysis.

resultsOf 9146 eligible patients, 6831, 1279, and 1036 received palbociclib plus AI, ribociclib plus AI, or abemaciclib plus AI, respectively. After sIPTW, baseline characteristics were balanced between treatment groups. After sIPTW, no significant OS differences were found between treatment groups [ribociclib versus palbociclib: adjusted hazard ratio (aHR) 0.98, 95% confidence interval (CI) 0.87-1.10, P = 0.7531; abemaciclib versus palbociclib: aHR 0.95, 95% CI 0.84-1.08, P = 0.4292; abemaciclib versus ribociclib: aHR 0.97, 95% CI 0.82-1.14, P = 0.6956]. Sensitivity analysis including a subanalysis of patients who started index treatment in 2017 or later also showed no significant OS differences between treatment groups.

conclusionsThis large real-world study suggested that there were no significant OS differences between 1L ribociclib, abemaciclib, and palbociclib in combination with an AI for patients with HR+/HER2- mBC. These findings together with other factors such as safety and quality of life are helpful in the selection of CDK4/6i combination therapy for patients with HR+/HER2- mBC.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsBreast NeoplasmsCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6Protein Kinase InhibitorsAcrylamidesAdultAgedAminopyridinesBenzimidazolesErb-b2 Receptor Tyrosine KinasesFemaleHumansMiddle AgedPiperazinesabemaciclibAcrylamidesAminopyridinesAromatase InhibitorsBenzimidazolesCDK4 protein, humanCDK6 protein, humanCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6ERBB2 protein, humanErb-b2 Receptor Tyrosine KinasespalbociclibPiperazinesProtein Kinase InhibitorsPurinesPyridinesReceptors, EstrogenReceptors, Progesteroneribociclibabemaciclibcomparative effectivenesscyclin-dependent kinase 4/6 inhibitorpalbociclibribociclib

Identifiers

PMID39754979
PMCPMC11758200

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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.