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Eligibility criteria in clinical trials in breast cancer: a cohort study

BACKGROUND: Breast cancer (BC) is the most common cancer type in women. The purpose of this study was to assess the eligibility criteria in recent clinical trials in BC, especially those that can limit the enrollment of older patients as well as those with comorbidities and poor performance status....

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Autores principales: Szlezinger, Katarzyna, Pogoda, Katarzyna, Jagiełło-Gruszfeld, Agnieszka, Kłosowska, Danuta, Górski, Andrzej, Borysowski, Jan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10318672/
https://www.ncbi.nlm.nih.gov/pubmed/37400830
http://dx.doi.org/10.1186/s12916-023-02947-y
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author Szlezinger, Katarzyna
Pogoda, Katarzyna
Jagiełło-Gruszfeld, Agnieszka
Kłosowska, Danuta
Górski, Andrzej
Borysowski, Jan
author_facet Szlezinger, Katarzyna
Pogoda, Katarzyna
Jagiełło-Gruszfeld, Agnieszka
Kłosowska, Danuta
Górski, Andrzej
Borysowski, Jan
author_sort Szlezinger, Katarzyna
collection PubMed
description BACKGROUND: Breast cancer (BC) is the most common cancer type in women. The purpose of this study was to assess the eligibility criteria in recent clinical trials in BC, especially those that can limit the enrollment of older patients as well as those with comorbidities and poor performance status. METHODS: Data on clinical trials in BC were extracted from ClinicalTrials.gov. Co-primary outcomes were proportions of trials with different types of the eligibility criteria. Associations between trial characteristics and the presence of certain types of these criteria (binary variable) were determined with univariate and multivariate logistic regression. RESULTS: Our analysis included 522 trials of systemic anticancer treatments started between 2020 and 2022. Upper age limits, strict exclusion criteria pertaining to comorbidities, and those referring to inadequate performance status of the patient were used in 204 (39%), 404 (77%), and 360 (69%) trials, respectively. Overall, 493 trials (94%) had at least one of these criteria. The odds of the presence of each type of the exclusion criteria were significantly associated with investigational site location and trial phase. We also showed that the odds of the upper age limits and the exclusion criteria involving the performance status were significantly higher in the cohort of recent trials compared with cohort of 309 trials started between 2010 and 2012 (39% vs 19% and 69% vs 46%, respectively; p < 0.001 for univariate and multivariate analysis in both comparisons). The proportion of trials with strict exclusion criteria was comparable between the two cohorts (p > 0.05). Only three of recent trials (1%) enrolled solely patients aged 65 or 70 and older. CONCLUSIONS: Many recent clinical trials in BC exclude large groups of patients, especially older adults, individuals with different comorbidities, and those with poor performance status. Careful modification of some of the eligibility criteria in these trials should be considered to allow investigators to assess the benefits and harms of investigational treatments in participants with characteristics typically encountered in clinical practice. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12916-023-02947-y.
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spelling pubmed-103186722023-07-05 Eligibility criteria in clinical trials in breast cancer: a cohort study Szlezinger, Katarzyna Pogoda, Katarzyna Jagiełło-Gruszfeld, Agnieszka Kłosowska, Danuta Górski, Andrzej Borysowski, Jan BMC Med Research Article BACKGROUND: Breast cancer (BC) is the most common cancer type in women. The purpose of this study was to assess the eligibility criteria in recent clinical trials in BC, especially those that can limit the enrollment of older patients as well as those with comorbidities and poor performance status. METHODS: Data on clinical trials in BC were extracted from ClinicalTrials.gov. Co-primary outcomes were proportions of trials with different types of the eligibility criteria. Associations between trial characteristics and the presence of certain types of these criteria (binary variable) were determined with univariate and multivariate logistic regression. RESULTS: Our analysis included 522 trials of systemic anticancer treatments started between 2020 and 2022. Upper age limits, strict exclusion criteria pertaining to comorbidities, and those referring to inadequate performance status of the patient were used in 204 (39%), 404 (77%), and 360 (69%) trials, respectively. Overall, 493 trials (94%) had at least one of these criteria. The odds of the presence of each type of the exclusion criteria were significantly associated with investigational site location and trial phase. We also showed that the odds of the upper age limits and the exclusion criteria involving the performance status were significantly higher in the cohort of recent trials compared with cohort of 309 trials started between 2010 and 2012 (39% vs 19% and 69% vs 46%, respectively; p < 0.001 for univariate and multivariate analysis in both comparisons). The proportion of trials with strict exclusion criteria was comparable between the two cohorts (p > 0.05). Only three of recent trials (1%) enrolled solely patients aged 65 or 70 and older. CONCLUSIONS: Many recent clinical trials in BC exclude large groups of patients, especially older adults, individuals with different comorbidities, and those with poor performance status. Careful modification of some of the eligibility criteria in these trials should be considered to allow investigators to assess the benefits and harms of investigational treatments in participants with characteristics typically encountered in clinical practice. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12916-023-02947-y. BioMed Central 2023-07-03 /pmc/articles/PMC10318672/ /pubmed/37400830 http://dx.doi.org/10.1186/s12916-023-02947-y Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research Article
Szlezinger, Katarzyna
Pogoda, Katarzyna
Jagiełło-Gruszfeld, Agnieszka
Kłosowska, Danuta
Górski, Andrzej
Borysowski, Jan
Eligibility criteria in clinical trials in breast cancer: a cohort study
title Eligibility criteria in clinical trials in breast cancer: a cohort study
title_full Eligibility criteria in clinical trials in breast cancer: a cohort study
title_fullStr Eligibility criteria in clinical trials in breast cancer: a cohort study
title_full_unstemmed Eligibility criteria in clinical trials in breast cancer: a cohort study
title_short Eligibility criteria in clinical trials in breast cancer: a cohort study
title_sort eligibility criteria in clinical trials in breast cancer: a cohort study
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10318672/
https://www.ncbi.nlm.nih.gov/pubmed/37400830
http://dx.doi.org/10.1186/s12916-023-02947-y
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