Evidence map›Paper›PMID 42413325›Full record

ArticleESMO open2026

Real-world postprogression outcomes after first-line treatment with ribociclib plus aromatase inhibitor versus aromatase inhibitor alone in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer in the United States of America.

L Hart, H S Rugo, P Sharma, S Sammons, V K Gadi, P Mavros, M Kaur, N Boualam, C Keane, G Sopher and 2 more

Abstract read
In one paragraph

Article in ESMO open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

L HartDepartment of Cancer Medicine, Wake Forest University School of Medicine, Winston-Salem, USA. Electronic address: llhart@flcancer.com.
H S RugoDepartment of Medical Oncology & Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, USA.
P SharmaDivision of Medical Oncology, Department of Internal Medicine, University of Kansas Medical Center, Westwood, USA.
S SammonsBreast Oncology Center, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA.
V K GadiDivision of Hematology and Oncology, Department of Medicine, University of Illinois College of Medicine and University of Illinois Cancer Center, Chicago, USA.
P MavrosKREDHERA, LLC, Hampton, USA.
M KaurFlatiron Health, New York, USA.
N BoualamFlatiron Health, New York, USA.
C KeaneFlatiron Health, New York, USA.
G SopherNovartis Pharmaceuticals Corporation, East Hanover, USA.
P PathakNovartis Pharmaceuticals Corporation, East Hanover, USA.
P TarantinoDepartment of Medicine, Harvard Medical School, Boston, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRibociclib remains the only cyclin-dependent kinase 4/6 inhibitor to consistently demonstrate overall survival (OS) benefits in the metastatic breast cancer (MBC) setting, with statistically significant and clinically meaningful OS results from all three MONALEESA studies in hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER)-negative MBC. However, real-world (RW) data concerning ribociclib are limited, with brief follow-up durations among RW patients restricting comprehensive OS assessments. Hence, real-world progression-free survival 2 (rwPFS2) and real-world chemotherapy-free survival (rwCFS) can serve as reliable postprogression endpoints. MATERIALS AND

methodsThis retrospective analysis utilized deidentified electronic health record data from the Flatiron Health Research Database, evaluating female patients with HR-positive/HER2-negative MBC who initiated first-line treatment with ribociclib plus an aromatase inhibitor (AI) (n = 2571) or AI monotherapy (n = 3078) between 1 January 2020 and 31 January 2025. Analyses were adjusted using inverse probability of treatment weighting.

resultsIn the overall cohort, risk of rwPFS2 event was 42% lower with ribociclib plus AI versus AI monotherapy [hazard ratio (HR) 0.58, 95% confidence interval (CI) 0.52-0.65]. A consistent 42% reduction in risk of rwPFS2 event was also observed among patients aged ≥65 years (HR 0.58, 95% CI 0.49-0.68). Risk of rwCFS event was 36% lower with ribociclib plus AI versus AI alone in the overall cohort (HR 0.64, 95% CI 0.57-0.72) and 40% lower among patients aged ≥65 years (HR 0.60, 95% CI 0.51-0.71).

conclusionsThese RW findings align with clinical trial results, reinforcing that ribociclib provides consistent and substantial postprogression survival benefit for patients with HR-positive/HER2-negative MBC, including those aged ≥65 years.

Indexed as

AminopyridinesAntineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsBreast NeoplasmsPurinesAgedErb-b2 Receptor Tyrosine KinasesFemaleHumansProgression-Free SurvivalReceptors, ProgesteroneRetrospective StudiesUnited StatesAminopyridinesAromatase InhibitorsERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesPurinesReceptors, ProgesteroneribociclibCDK4/6 inhibitorCFSHR-positive/HER2-negative metastatic breast cancerPFS2ribociclib

Identifiers

PMID42413325
PMCPMC13356718

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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.