Evidence map›Paper›PMID 31560580›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2019

Outcomes of Older Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor-Negative Metastatic Breast Cancer Treated With a CDK4/6 Inhibitor and an Aromatase Inhibitor: An FDA Pooled Analysis.

Lynn J Howie, Harpreet Singh, Erik Bloomquist, Suparna Wedam, Laleh Amiri-Kordestani, Shenghui Tang, Rajeshwari Sridhara, Jacqueline Sanchez, Tatiana M Prowell, Paul G Kluetz and 7 more

Open access · bronzeAbstract read
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In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 5 pooled it
7.0field-weighted citation impact, top 2% 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.

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

43 citing papers in PubMed, 5 syntheses or guidelines pooled it, 86 citations in OpenAlex.

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  14. CDK4/6 inhibitors for metastatic breast cancer in routine clinical practice in Spain: survey of patterns of use and oncologists' perceptions.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 1 institution in 1 country.

Lynn J HowieUS Food and Drug Administration, White Oak, MD.
Harpreet SinghUS Food and Drug Administration, White Oak, MD.
Erik BloomquistUS Food and Drug Administration, White Oak, MD.
Suparna WedamUS Food and Drug Administration, White Oak, MD.
Laleh Amiri-KordestaniUS Food and Drug Administration, White Oak, MD.
Shenghui TangUS Food and Drug Administration, White Oak, MD.
Rajeshwari SridharaUS Food and Drug Administration, White Oak, MD.
Jacqueline SanchezUS Food and Drug Administration, White Oak, MD.
Tatiana M ProwellUS Food and Drug Administration, White Oak, MD.
Paul G KluetzUS Food and Drug Administration, White Oak, MD.
Belinda L King-KallimanisUS Food and Drug Administration, White Oak, MD.
Jennifer J GaoUS Food and Drug Administration, White Oak, MD.
Amna IbrahimUS Food and Drug Administration, White Oak, MD.
Kirsten B GoldbergUS Food and Drug Administration, White Oak, MD.
Marc TheoretUS Food and Drug Administration, White Oak, MD.
Richard PazdurUS Food and Drug Administration, White Oak, MD.
Julia A BeaverUS Food and Drug Administration, White Oak, MD.
United States Food and Drug Administration · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeMany older women will be treated with a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor and an aromatase inhibitor (AI), given US Food and Drug Administration approval of three agents in this class. The current pooled analysis examines the efficacy and safety of this combination in older women. PATIENTS AND

methodsWe pooled data from three randomized controlled studies (N = 1,827) of different CDK4/6 inhibitors in combination with an AI for initial treatment of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer. The effect of age on progression-free survival was evaluated using Kaplan-Meier estimates and a Cox proportional hazards regression model.

resultsFor patients age 75 years or older (n = 198) who were treated with a CDK4/6 inhibitor and an AI, hazard ratio was 0.49 (95% CI, 0.31 to 0.76) with an estimated median progression-free survival of 31.1 months (95% CI, 20.2 months to not reached) versus 13.7 months (95% CI, 10.9 months to 24.9 months) for those treated with an AI. Incidence of grade 3 to 4 adverse events was 88.8% in patients age 75 years and older and 73.4% in patients younger than age 75 years. Patients age 75 years or older reported a decline in quality-of-life measures using the EQ-5D regardless of treatment with AI alone or with the addition of a CDK4/6 inhibitor.

conclusionThere was similar efficacy with a CDK4/6 inhibitor in combination with an AI compared with AI alone for first-line treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer in older women compared with younger patients. Patients older than age 75 years experienced higher rates of toxicity, dose modifications, and a decrease from baseline in quality-of-life measures.

Indexed as

AgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsBreast NeoplasmsCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6FemaleHumansMiddle AgedProgression-Free SurvivalProtein Kinase InhibitorsRandomized Controlled Trials as TopicReceptors, EstrogenReceptors, ProgesteroneTreatment OutcomeAromatase InhibitorsCDK4 protein, humanCDK6 protein, humanCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6Protein Kinase InhibitorsReceptors, EstrogenReceptors, Progesterone

Identifiers

PMID31560580
OpenAlexW2975749949

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.