Institute of Cancer Research, London, UK.
The Departments of Surgery & Urology, The Christie & Salford Royal Hospitals, Manchester, UK.
Int J Cancer. 2022 Aug 1;151(3):422-434. doi: 10.1002/ijc.34018. Epub 2022 May 16.
Abiraterone acetate plus prednisolone (AAP) previously demonstrated improved survival in STAMPEDE, a multiarm, multistage platform trial in men starting long-term hormone therapy for prostate cancer. This long-term analysis in metastatic patients was planned for 3 years after the first results. Standard-of-care (SOC) was androgen deprivation therapy. The comparison randomised patients 1:1 to SOC-alone with or without daily abiraterone acetate 1000 mg + prednisolone 5 mg (SOC + AAP), continued until disease progression. The primary outcome measure was overall survival. Metastatic disease risk group was classified retrospectively using baseline CT and bone scans by central radiological review and pathology reports. Analyses used Cox proportional hazards and flexible parametric models, accounting for baseline stratification factors. One thousand and three patients were contemporaneously randomised (November 2011 to January 2014): median age 67 years; 94% newly-diagnosed; metastatic disease risk group: 48% high, 44% low, 8% unassessable; median PSA 97 ng/mL. At 6.1 years median follow-up, 329 SOC-alone deaths (118 low-risk, 178 high-risk) and 244 SOC + AAP deaths (75 low-risk, 145 high-risk) were reported. Adjusted HR = 0.60 (95% CI: 0.50-0.71; P = 0.31 × 10 ) favoured SOC + AAP, with 5-years survival improved from 41% SOC-alone to 60% SOC + AAP. This was similar in low-risk (HR = 0.55; 95% CI: 0.41-0.76) and high-risk (HR = 0.54; 95% CI: 0.43-0.69) patients. Median and current maximum time on SOC + AAP was 2.4 and 8.1 years. Toxicity at 4 years postrandomisation was similar, with 16% patients in each group reporting grade 3 or higher toxicity. A sustained and substantial improvement in overall survival of all metastatic prostate cancer patients was achieved with SOC + abiraterone acetate + prednisolone, irrespective of metastatic disease risk group.
醋酸阿比特龙联合泼尼松（AAP）在 STAMPEDE 中显示出改善生存，这是一项多臂、多阶段平台试验，纳入了开始长期激素治疗的前列腺癌男性。这是一项在转移性患者中的长期分析，计划在首次结果后 3 年进行。标准治疗（SOC）为去势治疗。比较随机将患者以 1:1 的比例分配至 SOC 单药治疗或 SOC 联合每日醋酸阿比特龙 1000mg+泼尼松 5mg（SOC+AAP）治疗，直至疾病进展。主要终点是总生存期。采用中心放射学评估和病理报告对基线 CT 和骨扫描进行回顾性分类，确定转移性疾病风险组。采用 Cox 比例风险和灵活参数模型进行分析，考虑了基线分层因素。1030 例患者同期随机分组（2011 年 11 月至 2014 年 1 月）：中位年龄 67 岁；94%为初诊；转移性疾病风险组：48%为高危，44%为低危，8%无法评估；中位 PSA 97ng/mL。中位随访 6.1 年时，SOC 单药治疗组有 329 例死亡（低危组 118 例，高危组 178 例），SOC+AAP 治疗组有 244 例死亡（低危组 75 例，高危组 145 例）。调整后的 HR=0.60（95%CI：0.50-0.71；P=0.31×10）有利于 SOC+AAP，SOC+AAP 组的 5 年生存率从 SOC 单药治疗组的 41%提高至 60%。低危组（HR=0.55；95%CI：0.41-0.76）和高危组（HR=0.54；95%CI：0.43-0.69）患者中均观察到相似的结果。SOC+AAP 的中位和当前最大用药时间分别为 2.4 年和 8.1 年。随机分组后 4 年时的毒性相似，每组各有 16%的患者报告有 3 级或更高毒性。所有转移性前列腺癌患者均实现了 SOC+阿比特龙+泼尼松治疗的总生存期的持续和显著改善，而与转移性疾病风险组无关。
