Abstract
It is unclear whether cancer patients enrolled in clinical trials have improved outcomes compared with non-study patients. We compared prostate cancer-specific mortality (PCSM) in patients in a real-world setting (SEER-Medicare database) versus on a trial (NRG/RTOG 0521). The 7-year freedom from PCSM was superior in trial patients (92.4% vs. 88.1%, sHR = 1.77 [95% CI 1.05–2.97], P = 0.03). Black trial patients had significantly superior freedom from PCSM than Black real-world patients (sHR 6.52, 95% CI 1.43–29.72, P = 0.02), which was not seen among non-Black patients. Trial patients may have improved outcomes, and racial disparities are accentuated in the real world.
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Data availability
Data for these analyses were made available to the authors through agreement with the NRG/Radiation Therapy Oncology Group (RTOG) and the Surveillance, Epidemiology, and End Results (SEER)-Medicare database. As such, the authors cannot make these data publicly available due to data use agreement.
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Acknowledgements
We acknowledge that this study used the linked SEER-Medicare database and the efforts of the Applied Research Program, NCI; the Office of Research, Development and Information, CMS; Information Management Services (IMS), Inc.; and the SEER Program tumor registries in the creation of the SEER-Medicare database. The interpretation and reporting of these data are the sole responsibility of the authors.
Funding
Funding support for this study comes from the Prostate Cancer Foundation and ASTRO to AUK. AUK also thanks generous donations from the DeSilva, McCarrick, and Bershad families.
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Conception: TMM, MX, AUK Data curation: TMM, MX, AUK. Formal Analysis: TMM, MX, AUK. Funding acquisition: AUK Investigation: TMM, FYF, SAR, MBR, ACR, DES, MX, AUK. Project administration: MX, AUK. Supervision: MX, AUK. Writing—original draft: TMM, MX, AUK. Writing—review & editing: TMM, FYF, SAR, MBR, ACR, DES, MX, AUK.
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AUK reports funding support from grant P50CA09213 from the Prostate Cancer National Institutes of Health Specialized Programs of Research Excellence and grant W81XWH-22-1-0044 from the Department of Defense, as well as grant RSD1836 from the Radiological Society of North America, the STOP Cancer organization, the Jonsson Comprehensive Cancer Center, and the Prostate Cancer Foundation. ACR reports research grant from Intelligent Automation Inc. and Viewray Inc., consulting work for Viewray Inc and Clarity PSO/RO-ILS RO-HAC, honoraria from Clarity PSO/RO-ILS RO-HAC and as a rectal cancer panel member of the Veteran’s Health Administration Radiation Oncology Quality Surveillance Program Services, outside the submitted work. All other authors have no conflict of interest to declare.
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Ma, T.M., Feng, F.Y., Rosenthal, S.A. et al. Race-dependent association of clinical trial participation with improved outcomes for high-risk prostate cancer patients treated in the modern era. Prostate Cancer Prostatic Dis 26, 625–627 (2023). https://doi.org/10.1038/s41391-023-00663-5
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DOI: https://doi.org/10.1038/s41391-023-00663-5