Representativeness of patients enrolled in the Lung Cancer Master Protocol (Lung-MAP).
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Le résumé fourni par la source
6543 Background: A major goal of Lung-MAP, a biomarker-driven master protocol conducted within the National Clinical Trials Network of the NCI using a public-private partnership, was to improve access to novel therapeutics. Representative enrollment of patient sub-groups in clinical trials is essential for improving confidence that trial findings are valid and applicable to all patients. We examined the representativeness of patients enrolled in Lung-MAP by demographic and area-level measures compared to patients in other advanced non-small cell lung cancer (NSCLC) trials and with the US NSCLC population. Methods: We analyzed data on patients enrolled to Lung-MAP between 2014-2020 according to sex, age ( < 65 years v. ≥ 65 years), race (White v. Black v. Asian), ethnicity (Hispanic v. not Hispanic), residence (rural v. urban), insurance type (Medicaid or no insurance v. private), and neighborhood socioeconomic deprivation (quintiles of Area Deprivation Index score). Rates were compared to SWOG-led NSCLC trials conducted between 2001-2020 (date range to provide sufficient power) and, where possible, to US NSCLC population rates using Surveillance, Epidemiology, and End Results (SEER) registry data (2014-2018). Two-sided tests of proportions at the 5% level were used for all comparisons. Results: 3,556 patients enrolled to Lung-MAP were compared to 2,267 patients enrolled to SWOG-led NSCLC studies. Lung-MAP patients were more likely to be ≥ 65 years old (57.2% v. 46.7%; p <.001) and from rural areas (17.3% v. 14.3%; p =.002) but less likely to be female (38.6% v. 47.2%; p <.001), Asian (2.7% v. 5.1%; p < 0.0001), or Hispanic (2.4% v. 3.7%; p =.003). Compared to the US NSCLC population, Lung-MAP patients were less likely to be ≥ 65 years (57.2% v. 73.5%; p <.001), female (38.6% v. 47.8%; p <.001), or a racial or ethnic minority (15.5% v. 19.3%; p <.001). Lung-MAP patients were more likely to be from socioeconomically deprived neighborhoods (42.2% vs. 36.5%, p <.001). Among patients aged < 65 years, Lung-MAP enrolled more patients reporting Medicaid/no insurance as their primary insurance (27.6% v. 17.9%; p <.001). Conclusions: Lung-MAP improved access to novel therapeutics for older patients, rural patients, those with Medicaid/no insurance, and patients from socioeconomically deprived areas compared to other NSCLC trials. Lung-MAP enrolled exclusively squamous cell lung cancers from 2014-2018, which explains decreased representation of females. Consistent with prior research, Lung-MAP patients were younger and less diverse compared to the US NSCLC population. Further examination of the underrepresentation of Asian and Hispanic patients in Lung-MAP is required to identify barriers to access and potential solutions. The conduct of a master protocol across multiple locations may improve trial participation for patients with limited access due to area-level (rural, socioeconomic deprivation) or insurance barriers.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Representativeness of patients enrolled in the Lung Cancer Master Protocol (Lung-MAP).
- Date Crossref
- 01/06/2022
- Éditeur
- American Society of Clinical Oncology (ASCO)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Fred Hutch Cancer Center pays non établi dans la noticeOrganisation à but non lucratif
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Yale University pays non établi dans la noticeUniversité ou école supérieure
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UC Davis Comprehensive Cancer Center pays non établi dans la noticeÉtablissement de santé
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University of California pays non établi dans la noticeUniversité ou école supérieure
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Stanford Cancer Institute pays non établi dans la noticeÉtablissement de santé
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Stanford University pays non établi dans la noticeUniversité ou école supérieure
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University of Wisconsin–Madison pays non établi dans la noticeUniversité ou école supérieure
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Northwestern University pays non établi dans la noticeUniversité ou école supérieure
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Dartmouth–Hitchcock Medical Center pays non établi dans la noticeÉtablissement de santé
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Washington University in St. Louis pays non établi dans la noticeUniversité ou école supérieure
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Fox Chase Cancer Center pays non établi dans la noticeÉtablissement de santé
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Temple University Health System Fox Chase Cancer Center pays non établi dans la noticeUniversité ou école supérieure
Fred Hutch Cancer Center, Yale University et UC Davis Comprehensive Cancer Center, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.