Evidence map›Paper›PMID 40145289›Full record

Observational studyCancer medicine2025

Overall Survival With Palbociclib and Aromatase Inhibitor Versus Aromatase Inhibitor Alone in Older Patients With HR+/HER2- Metastatic Breast Cancer.

Adam M Brufsky, Rickard Sandin, Stella Stergiopoulos, Connie Chen, Siddharth Karanth, Benjamin Li, Elizabeth Esterberg, Doris Makari, Sean D Candrilli, Ravi K Goyal and 1 more

Registry-linked trialAbstract readComparative StudyObservational Study
In one paragraph

Observational study in Cancer medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06086340 (Comparative Assessment of Overall Survival in Medicare Patients With HR+/HER2- Metastatic Breast Cancer Treated With Palbociclib in Combination With Aromatase Inhibitor), which is not on this 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.

NCT06086340 completednot on this map

Comparative Assessment of Overall Survival in Medicare Patients With HR+/HER2- Metastatic Breast Cancer Treated With Palbociclib in Combination With Aromatase Inhibitor (AI vs. AI Alone)

TypeobservationalSponsorPfizerRan2023 to 2024Enrolled779ConditionsBreast CancerArmsPalbociclib, Aromatase Inhibitor
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

11 authors.

Adam M BrufskyUniversity of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Rickard SandinPfizer AB, Stockholm, Sweden.
Stella StergiopoulosPfizer Inc., New York, New York, USA.ORCID https://orcid.org/0000-0001-6868-0493
Connie ChenPfizer Inc., New York, New York, USA.
Siddharth KaranthRTI Health Solutions, Research Triangle Park, Raleigh, North Carolina, USA.
Benjamin LiPfizer Inc., New York, New York, USA.
Elizabeth EsterbergRTI Health Solutions, Research Triangle Park, Raleigh, North Carolina, USA.
Doris MakariPfizer Inc., New York, New York, USA.
Sean D CandrilliRTI Health Solutions, Research Triangle Park, Raleigh, North Carolina, USA.
Ravi K GoyalRTI Health Solutions, Research Triangle Park, Raleigh, North Carolina, USA.ORCID https://orcid.org/0000-0003-1632-036X
Hope S RugoUniversity of California San Francisco, San Francisco, California, USA.

Funding

NCI NIH HHS HHSN261201800009CNCI NIH HHS HHSN261201800009INCI NIH HHS HHSN261201800015CNCI NIH HHS HHSN261201800015INCI NIH HHS HHSN261201800032CNCI NIH HHS HHSN261201800032IPfizer
6 · The paper itself

Abstract

introductionCyclin-dependent kinase 4/6 inhibitors (CDK4/6is) in combination with endocrine therapy are the current standard of care for first-line (1L) treatment of hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC). To investigate the effectiveness of palbociclib, the first-in-class CDK4/6i, plus an aromatase inhibitor (AI) in older patients, we compared overall survival (OS) in a Medicare population treated with 1L palbociclib + AI versus an AI alone.

methodsPatients aged ≥ 65 years who were diagnosed with de novo HR+/HER2- mBC from 2015 to 2019 were identified from the Surveillance, Epidemiology, and End Results (SEER)-linked Medicare database and were eligible if they initiated 1L palbociclib + AI or an AI alone. The primary endpoint was OS. Stabilized inverse probability of treatment weighting (sIPTW) was used to balance baseline patient characteristics.

resultsOf 779 eligible patients, 296 received palbociclib + AI and 483 received AI alone as 1L treatment. After sIPTW, the median follow-up was 23.1 months with palbociclib + AI and 18.2 months with AI alone. Adjusted median OS was longer with palbociclib + AI versus AI alone (sIPTW: 37.6 vs. 25.5 months, HR = 0.73 [95% CI, 0.59-0.91]). In multivariable Cox proportional hazards regression, patients treated with palbociclib + AI versus AI alone had a 39% lower risk of death (HR = 0.61 [95% CI, 0.48-0.77]).

conclusionIn routine US clinical practice, palbociclib + AI was associated with significantly prolonged OS versus AI alone in 1L treatment of patients aged ≥ 65 years with de novo HR+/HER2- mBC, adding to the growing body of evidence on the survival benefit of palbociclib + AI in this patient population.

trial registrationClinicalTrials.gov identifier: NCT06086340.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsBreast NeoplasmsPiperazinesPyridinesAgedAged, 80 and overErb-b2 Receptor Tyrosine KinasesFemaleHumansProtein Kinase InhibitorsReceptors, EstrogenReceptors, ProgesteroneSEER ProgramUnited StatesAromatase InhibitorsERBB2 protein, humanErb-b2 Receptor Tyrosine KinasespalbociclibPiperazinesProtein Kinase InhibitorsPyridinesReceptors, EstrogenReceptors, ProgesteroneCDK4/6 inhibitorHR+/HER2– metastatic breast cancerolder adultsoverall survivalpalbociclibreal‐world evidenceSEER

Identifiers

PMID40145289
PMCPMC11947744

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Registered trials

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.