Division of Medical Oncology, Departments of Medicine and Urology, University of Washington and Fred Hutchinson Cancer Research Center, Seattle, Washington.
Division of Medical Oncology, Duke University Medical Center, Duke Cancer Institute, Duke University, Durham, North Carolina.
Cancer. 2019 Dec 1;125(23):4172-4180. doi: 10.1002/cncr.32445. Epub 2019 Sep 4.
The large registry, PROVENGE Registry for the Observation, Collection, and Evaluation of Experience Data (PROCEED)(NCT01306890), evaluated sipuleucel-T immunotherapy for asymptomatic/minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC).
PROCEED enrolled patients with mCRPC receiving 3 biweekly sipuleucel-T infusions. Assessments included overall survival (OS), serious adverse events (SAEs), cerebrovascular events (CVEs), and anticancer interventions (ACIs). Follow-up was for ≥3 years or until death or study withdrawal.
In 2011-2017, 1976 patients were followed for 46.6 months (median). The median age was 72 years, and the baseline median prostate-specific antigen level was 15.0 ng/mL; 86.7% were white, and 11.6% were African American. Among the patients, 1902 had 1 or more sipuleucel-T infusions. The median OS was 30.7 months (95% confidence interval [CI], 28.6-32.2 months). Known prognostic factors were independently associated with OS in a multivariable analysis. Among the 1255 patients who died, 964 (76.8%) died of prostate cancer (PC) progression. The median time from the first infusion to PC death was 42.7 months (95% CI, 39.4-46.2 months). The incidence of sipuleucel-T-related SAEs was 3.9%. The incidence of CVEs was 2.8%, and the rate per 100 person-years was 1.2 (95% CI, 0.9-1.6). The CVE incidence among 11,972 patients with mCRPC from the Surveillance, Epidemiology, and End Results-Medicare database was 2.8%; the rate per 100 person-years was 1.5 (95% CI, 1.4-1.7). One or more ACIs (abiraterone, enzalutamide, docetaxel, cabazitaxel, or radium 223) were received by 77.1% of the patients after sipuleucel-T; 32.5% and 17.4% of the patients experienced 1- and 2-year treatment-free intervals, respectively.
PROCEED provides contemporary survival data for sipuleucel-T-treated men in a real-world setting of new life-prolonging agents, which will be useful in discussing treatment options with patients and in powering future trials with sipuleucel-T. The safety and tolerability of sipuleucel-T in PROCEED were consistent with previous findings.
大型注册研究，即用于观察、收集和评估经验数据的普罗文奇注册研究（PROCEED）（NCT01306890），评估了前列腺癌患者免疫治疗药物 sipuleucel-T 用于无症状/轻度症状转移性去势抵抗性前列腺癌（mCRPC）的疗效。
PROCEED 纳入了接受 3 次两周一次的 sipuleucel-T 输注的 mCRPC 患者。评估包括总生存期（OS）、严重不良事件（SAEs）、脑血管事件（CVE）和抗癌干预（ACI）。随访时间≥3 年或直至死亡或研究退出。
2011-2017 年，1976 例患者随访 46.6 个月（中位数）。中位年龄为 72 岁，基线中位前列腺特异性抗原水平为 15.0ng/mL；86.7%为白人，11.6%为非裔美国人。其中 1902 例患者接受了 1 次或多次 sipuleucel-T 输注。中位 OS 为 30.7 个月（95%置信区间[CI]，28.6-32.2 个月）。多变量分析显示，已知的预后因素与 OS 独立相关。在 1255 例死亡患者中，964 例（76.8%）死于前列腺癌（PC）进展。从第一次输注到 PC 死亡的中位时间为 42.7 个月（95%CI，39.4-46.2 个月）。sipuleucel-T 相关 SAE 的发生率为 3.9%。CVE 的发生率为 2.8%，每 100 人年的发生率为 1.2（95%CI，0.9-1.6）。来自监测、流行病学和最终结果-医疗保险数据库的 11972 例 mCRPC 患者的 CVE 发生率为 2.8%；每 100 人年的发生率为 1.5（95%CI，1.4-1.7）。在接受 sipuleucel-T 治疗后，77.1%的患者接受了一种或多种 ACI（阿比特龙、恩杂鲁胺、多西他赛、卡巴他赛或镭 223）；32.5%和 17.4%的患者分别经历了 1 年和 2 年的无治疗间隔。
PROCEED 在新的延长生命药物的真实世界环境中为接受 sipuleucel-T 治疗的男性提供了当代生存数据，这将有助于与患者讨论治疗选择，并为未来的 sipuleucel-T 试验提供动力。PROCEED 中 sipuleucel-T 的安全性和耐受性与先前的研究结果一致。
