Huntsman Cancer Institute, University of Utah, Salt Lake City.
Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio.
JAMA Netw Open. 2023 Aug 1;6(8):e2326546. doi: 10.1001/jamanetworkopen.2023.26546.
Black patients present with more aggressive disease and experience higher mortality than White patients with prostate cancer. Race and social determinants of health influence prostate cancer-specific mortality and overall survival (OS); however, in a previous trial, Black patients did not have inferior outcomes compared with White patients, possibly because of equitable access to care available in a clinical trial setting.
To compare differences in survival outcomes of patients with metastatic castration-sensitive prostate cancer (mCSPC) by race in a phase 3 trial with a large proportion of Black patients.
DESIGN, SETTING, AND PARTICIPANTS: This secondary analysis of patient-level data of a prospective phase 3 randomized clinical trial included patients with newly diagnosed mCSPC enrolled between March 1, 2013, and July 15, 2017. Analysis was conducted between December 2022 and February 2023.
Patients receiving androgen deprivation therapy were randomized (1:1) to receive either orteronel 300 mg orally twice daily (experimental group) or bicalutamide 50 mg orally daily (control group).
OS, with progression-free survival (PFS) as a secondary end point.
Among 1313 participants, 135 (10%) identified as Black and 1077 (82%) as White, with an equal racial distribution between groups. Black patients were younger (median [IQR] age, 65.8 [60-70] vs 68.4 [62.5-74.1] years; P = .001) and had a higher median (IQR) baseline prostate-specific antigen response rate than White patients (54.7 [19.8-222.0] vs 26.7 [9.2-96.0] ng/mL; P < .001). At a median follow-up of 4.9 years, Black and White patients had similar median PFS (2.3 years; 95% CI, 1.8-1.4 years vs 2.9 years; 95% CI, 2.5-3.3 years; P = .71) and OS (5.5 years; 95% CI, 4.8-NR vs 6.3 years; 95% CI, 5.7-NR; P = .65). The multivariable analysis confirmed similar PFS and OS after adjusting for known prognostic factors. No interaction between race and treatment was observed.
In this secondary analysis of a randomized clinical trial studying androgen deprivation therapy with first- or second-generation androgen receptor pathway inhibitors, both Black and White patients demonstrated similar OS and PFS. Equitable access to care may reduce historical differences in outcomes between Black and White patients with advanced prostate cancer.
ClinicalTrials.gov Identifier: NCT01809691.
黑人患者的疾病表现比白人患者更具侵袭性，死亡率更高。种族和健康的社会决定因素会影响前列腺癌特异性死亡率和总生存率（OS）；然而，在之前的一项试验中，黑人患者的结局并不比白人患者差，这可能是因为在临床试验环境中，他们能够获得公平的医疗服务。
在一项纳入了大量黑人患者的 3 期试验中，比较转移性去势敏感型前列腺癌（mCSPC）患者的生存结局差异。
设计、地点和参与者：这是一项对前瞻性 3 期随机临床试验的患者水平数据进行的二次分析，纳入了 2013 年 3 月 1 日至 2017 年 7 月 15 日期间新诊断为 mCSPC 的患者。分析于 2022 年 12 月至 2023 年 2 月进行。
接受雄激素剥夺治疗的患者被随机（1:1）分为接受阿特龙 300 mg 每日两次口服（实验组）或比卡鲁胺 50 mg 每日一次口服（对照组）。
OS，以无进展生存期（PFS）作为次要终点。
在 1313 名参与者中，有 135 名（10%）为黑人，1077 名（82%）为白人，两组的种族分布均衡。黑人患者年龄更轻（中位数[IQR]年龄，65.8[60-70]岁比 68.4[62.5-74.1]岁；P = .001），且基线前列腺特异性抗原反应率高于白人患者（中位数[IQR]，54.7[19.8-222.0]比 26.7[9.2-96.0]ng/mL；P < .001）。中位随访 4.9 年后，黑人患者和白人患者的中位 PFS（2.3 年；95%CI，1.8-1.4 年比 2.9 年；95%CI，2.5-3.3 年；P = .71）和 OS（5.5 年；95%CI，4.8-NR 比 6.3 年；95%CI，5.7-NR；P = .65）相似。多变量分析在调整了已知预后因素后，证实了 PFS 和 OS 相似。未观察到种族和治疗之间存在交互作用。
在这项对使用第一代或第二代雄激素受体通路抑制剂的雄激素剥夺治疗进行的随机临床试验的二次分析中，黑人和白人患者的 OS 和 PFS 相似。公平获得医疗服务可能会减少黑人和白人晚期前列腺癌患者之间在结局方面的历史差异。
ClinicalTrials.gov 标识符：NCT01809691。
