PURPOSE African Americans experience greater prostate cancer risk and mortality than do Caucasians. An analysis of pooled phase III data suggested differences in overall survival (OS) between African American and Caucasian men receiving sipuleucel-T. We explored this in PROCEED (NCT01306890), an FDA-requested registry in over 1900 patients with metastatic castration-resistant prostate cancer (mCRPC) treated with sipuleucel-T. PATIENTS AND METHODS OS for patients who received ≥1 sipuleucel-T infusion was compared between African American and Caucasian men using an all patient set and a baseline prostate-specific antigen (PSA)-matched set (two Caucasians to every one African American with baseline PSAs within 10% of each other). Univariable and multivariable analyses were conducted. Survival data were examined using Kaplan-Meier and Cox proportional hazard methodologies. RESULTS Median follow-up was 46.6 months. Overall survival differed between African American and Caucasian men with hazard ratios (HR) of 0.81 (95% confidence interval [CI]: 0.68-0.97, P = 0.03) in the all patient set and 0.70 (95% CI: 0.57-0.86, P < 0.001) in the PSA-matched set. Median OS was longer in African Americans than in Caucasian men for both analysis sets, e.g., 35.3 and 25.8 months, respectively, in the PSA-matched set. Similar results were observed in the all patient set. Differences were larger when treatment began at lower baseline PSA; curves were more similar among patients with higher baseline PSA. In patients with baseline PSA below the median, the HR was 0.52 (95% CI: 0.37-0.72, P < 0.001), with median OS of 54.3 versus 33.4 months. Known prognostic factors and African American race (multivariable analyses; HR: 0.60, 95% CI: 0.48-0.74, P < 0.001) were independently associated with OS. Use of post-sipuleucel-T anticancer interventions was balanced between races. CONCLUSION In this exploratory analysis of a registry including nearly 12% African American men with mCRPC, OS was significantly different between African Americans and Caucasians, indicating further research is warranted.

中文翻译：

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sipuleucel-T 免疫疗法后非裔美国人和白种人男性的存活率：PROCEED 注册的结果。

目的 与白人相比，非裔美国人患前列腺癌的风险和死亡率更高。对汇总的 III 期数据的分析表明，接受 sipuleucel-T 的非裔美国人和白人男性之间的总生存率 (OS) 存在差异。我们在 PROCEED (NCT01306890) 中探索了这一点，这是 FDA 要求的注册中心，涉及 1900 多名接受 sipuleucel-T 治疗的转移性去势抵抗性前列腺癌 (mCRPC) 患者。患者和方法 使用所有患者组和基线前列腺特异性抗原 (PSA) 匹配组（两个高加索人对每一个有基线的非洲裔美国人）比较接受≥1 sipuleucel-T 输注的患者的 OS PSA 相差在 10% 以内）。进行了单变量和多变量分析。使用 Kaplan-Meier 和 Cox 比例风险方法检查生存数据。结果 中位随访时间为 46.6 个月。非裔美国人和白种人男性的总生存率不同，所有患者组的风险比 (HR) 为 0.81（95% 置信区间 [CI]：0.68-0.97，P = 0.03）和 0.70（95% CI：0.57-0.86， P < 0.001) 在 PSA 匹配组中。对于两个分析组，非裔美国人的中位 OS 都比白种人的男性更长，例如，在 PSA 匹配组中分别为 35.3 和 25.8 个月。在所有患者组中观察到类似的结果。当治疗开始于较低的基线 PSA 时，差异更大；基线 PSA 较高的患者的曲线更相似。在基线 PSA 低于中位数的患者中，HR 为 0.52（95% CI：0.37-0.72，P < 0.001），中位 OS 分别为 54.3 个月和 33.4 个月。已知的预后因素和非裔美国人种族（多变量分析；HR：0.60，95% CI：0.48-0.74，P < 0.001）与 OS 独立相关。sipuleucel-T 后抗癌干预的使用在种族之间是平衡的。结论 在这项对包括近 12% 患有 mCRPC 的非裔美国男性的登记处的探索性分析中，非裔美国人和高加索人的 OS 显着不同，表明需要进一步研究。