Evidence map›Paper›PMID 37428347›Full record

Observational studyTargeted oncology2023

Real-World Tumor Response of Palbociclib in Combination With an Aromatase Inhibitor as First-Line Therapy in Pre/Perimenopausal Women With Metastatic Breast Cancer.

Angela DeMichele, Nicholas Robert, Connie Chen, Sindy Kim, Zhe Zhang, Dongrui Ray Lu, Kathleen M Aguilar, Yunfei Wang, Benjamin Li, Sebastian Schneeweiss and 3 more

Registry-linked trialOpen access · hybridAbstract readObservational Study
In one paragraph

Observational study in Targeted oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05012644 (REAL-WORLD TUMOR RESPONSE OF PALBOCICLIB IN COMBINATION WITH AN AROMATASE INHIBITOR AS FIRST-LINE THERAPY IN PRE/PERIMENOPAUSAL WOMEN WITH METASTATIC BREAST CANCER), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 14% of its field
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.

NCT05012644 completednot on this map

Real-world tumor response of palbociclib in combination with an aromatase inhibitor as first-line therapy in pre/perimenopausal women with metastatic breast cancer

TypeobservationalSponsorPfizerRan2021 to 2021Enrolled197ConditionsMetastatic Breast CancerArmsPalbociclib + aromatase inhibitor, Aromatase inhibitor
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Observational
  4. Article
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

13 authors at 5 institutions in 1 country.

Angela DeMicheleDivision of Hematology and Oncology, Department of Medicine, University of Pennsylvania, Philadelphia, PA, 19104, USA.
Nicholas RobertOntada, 6555 State Highway 161, Irving, TX, 75039, USA. nicholas.robertmd@mckesson.com.
Connie ChenPfizer Inc, New York, NY, 10017, USA.
Sindy KimPfizer Inc, San Diego, CA, 92121, USA.
Zhe ZhangPfizer Inc, San Diego, CA, 92121, USA.
Dongrui Ray LuPfizer Inc, San Diego, CA, 92121, USA.
Kathleen M AguilarOntada, 6555 State Highway 161, Irving, TX, 75039, USA.
Yunfei WangOntada, 6555 State Highway 161, Irving, TX, 75039, USA.
Benjamin LiPfizer Inc, New York, NY, 10017, USA.
Sebastian SchneeweissBrigham and Women's Hospital and Harvard Medical School, Boston, MA, 02115, USA.
Jeremy A RassenAetion, New York, NY, 10001, USA.
Michael GaffneyPfizer Inc, New York, NY, 10017, USA.
Lynn McRoyPfizer Inc, New York, NY, 10017, USA.
Pfizer (United States) · USAetion (United States) · USHarvard University · USMcKesson (United States) · USUniversity of Pennsylvania · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLimited real-world data exist regarding the efficacy of palbociclib in combination with endocrine therapy in pre/perimenopausal women with metastatic breast cancer.

objectiveWe aimed to compare real-world tumor responses among pre/perimenopausal women who initiated palbociclib plus an aromatase inhibitor (AI) or AI monotherapy as first-line treatment for hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer.

methodsThis retrospective observational cohort study (NCT05012644) used electronic health record data from The US Oncology Network. Tumor responses were determined based on treating clinicians' assessments of radiologic evidence for changes in disease burden. Normalized inverse probability treatment weighting was used to balance baseline characteristics between treatment cohorts.

resultsOf 196 pre/perimenopausal women, 116 and 80 were in the palbociclib plus AI cohort and AI cohort, respectively. Real-world response rates (complete or partial response) were 52.1% and 46.2%, respectively (odds ratio, 1.27 [95% confidence interval 0.72‒2.24]). Among patients with one or more tumor assessments on treatment, real-world response rates were 60.0% in the palbociclib plus AI cohort (n = 103) and 49.9% in the AI cohort (n = 71; odds ratio, 1.51 [95% confidence interval 0.82‒2.77]).

conclusionsThis real-world analysis suggests that pre/perimenopausal patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer appear more likely to respond to palbociclib plus AI versus AI alone as first-line therapy, which may support the combination as a standard-of-care treatment for this patient population.

Indexed as

Breast NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsErb-b2 Receptor Tyrosine KinasesFemaleHumansPerimenopausePiperazinesPyridinesRetrospective StudiesAromatase InhibitorsErb-b2 Receptor Tyrosine KinasespalbociclibPiperazinesPyridines

Identifiers

PMID37428347
PMCPMC10345062
OpenAlexW4383710396

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.