Department of Radiation Oncology, University of California, Los Angeles, CA, USA.
Department of Radiation Oncology, University of California San Francisco, San Francisco, CA, USA.
Prostate Cancer Prostatic Dis. 2023 Sep;26(3):625-627. doi: 10.1038/s41391-023-00663-5. Epub 2023 Mar 25.
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.
尚不清楚参加临床试验的癌症患者是否比非研究患者的结局更好。我们比较了真实环境下（SEER-医疗保险数据库）与临床试验（NRG/RTOG 0521）中前列腺癌特异性死亡率（PCSM）。试验组患者 7 年无 PCSM 生存率更高（92.4% vs. 88.1%，sHR=1.77[95%CI 1.05-2.97]，P=0.03）。与真实世界的黑人患者相比，黑人试验组患者无 PCSM 生存率显著更高（sHR 6.52，95%CI 1.43-29.72，P=0.02），而非黑人患者中则未观察到这种情况。试验组患者的结局可能更好，而在真实世界中，种族差异更加明显。
