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

Purpose The 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 trial...

Full description

Saved in:
Bibliographic Details
Published in:Breast cancer research and treatment 2021-12, Vol.190 (3), p.531-540
Main Authors: Rocque, Gabrielle B., Caston, Nicole E., Franks, Jeffrey A., Williams, Courtney P., Aswani, Monica S., Azuero, Andres, Gidwani, Risha
Format: Article
Language:English
Subjects:
Aged
Breast cancer
Breast Neoplasms - drug therapy
Breast Neoplasms - pathology
Cancer
Cancer research
Cancer therapies
Carboplatin
Chemotherapy
Clinical trials
Clinical Trials as Topic - statistics & numerical data
Comorbidity
Epidemiology
Evidence-based medicine
Female
Humans
Medical research
Medicine
Medicine & Public Health
Medicine, Experimental
Middle Aged
Neoplasm Staging
Oncology
Patients
Pertuzumab
Product development
Retrospective Studies
Toxicity
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Purpose The 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. Methods This 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. Results Of 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 
ISSN:0167-6806
1573-7217
DOI:10.1007/s10549-021-06381-7