Evidence map›Paper›PMID 34585334›Full record

ArticleBreast cancer research and treatment2021

Clinical trial representativeness and treatment intensity in a real-world sample of women with early stage breast cancer.

Gabrielle B Rocque, Nicole E Caston, Jeffrey A Franks, Courtney P Williams, Monica S Aswani, Andres Azuero, Risha Gidwani

Abstract read
In one paragraph

Article in Breast cancer research and treatment, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

8 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Patient Characteristics Associated with Intended Nonguideline Chemotherapy in Women with Stage I to IIIA Breast Cancer.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2024
    Article
  6. Article
  7. Article
  8. 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

7 authors.

Gabrielle B RocqueDivision of Hematology and Oncology, University of Alabama at Birmingham (UAB), WTI 240E, Birmingham, AL, 35294, USA. grocque@uabmc.edu.ORCID http://orcid.org/0000-0003-4188-9785
Nicole E CastonDivision of Hematology and Oncology, University of Alabama at Birmingham (UAB), WTI 240E, Birmingham, AL, 35294, USA.
Jeffrey A FranksDivision of Hematology and Oncology, University of Alabama at Birmingham (UAB), WTI 240E, Birmingham, AL, 35294, USA.
Courtney P WilliamsDivision of Hematology and Oncology, University of Alabama at Birmingham (UAB), WTI 240E, Birmingham, AL, 35294, USA.
Monica S AswaniUAB School of Health Professions, Birmingham, AL, USA.
Andres AzueroUAB School of Nursing, Birmingham, AL, USA.
Risha GidwaniDepartment of Health Management & Policy, UCLA Fielding School of Public Health, Los Angeles, CA, USA.

Funding

Evaluating the implementation and impact of navigator-delivered ePRO home symptom monitoring and managementR01NR019058 · NINR · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI ROCQUE, GABRIELLE · 2021 to 2025
$3.1M
NINR NIH HHS R01 NR019058Robert Wood Johnson Foundation 76306
6 · The paper itself

Abstract

purposeThe extent to which evidence-based treatments are applied to populations not well represented in early stage breast cancer (EBC) trials remains unknown. This study evaluated treatment intensity for patients traditionally well represented, underrepresented, and unrepresented in clinical trials.

methodsThis retrospective cohort study used real-world data to evaluate the intensity (high or low) of EBC chemotherapy by patient characteristics (age, race and ethnicity, presence of comorbidity) denoting clinical trial representation status (well represented, underrepresented, unrepresented) for patients diagnosed from 2011 to 2020. Odds ratios (OR) from a logistic regression model was used to evaluate the association between receipt of high-intensity chemotherapy and clinical trial representation status characteristics adjusting for cancer stage and subtype.

resultsOf 970 patients with EBC, 41% were characterized as well represented, 45% as underrepresented, and 13% as unrepresented in clinical trials. In adjusted models, patients aged ≥ 70 versus 45-69 had lower odds of receiving a high-intensity treatment (OR 0.40, 95% CI 0.26-0.60), while those aged < 45 versus 45-69 had higher odds of receiving high-intensity treatment (OR 1.82, 95% CI 1.10-3.01). In predicted estimates, the proportion of patients receiving a high-intensity treatment was 87% for patients aged < 45, 79% for patients aged 45-69, and 60% for patients aged ≥ 70.

conclusion59% of the EBC population is not well represented in clinical trials. Age was associated with differential treatment intensity. Widening clinical trial eligibility criteria should be considered to better understand survival outcomes, toxicity effects, and ultimately make evidence-based treatment decisions using a more diverse sample.

Indexed as

Breast NeoplasmsClinical Trials as TopicAgedFemaleHumansMiddle AgedNeoplasm StagingRetrospective StudiesClinical trialsEarly stage breast cancerRepresentationTreatment intensity

Identifiers

PMID34585334
PMCPMC8594932

What Socratic holds

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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 Socratic graph.