Background Adding abiraterone acetate with prednisolone (AAP) or docetaxel with prednisolone (DocP) to standard-of-care (SOC) each improved survival in systemic therapy for advanced or metastatic prostate cancer: evaluation of drug efficacy: a multi-arm multi-stage platform randomised controlled protocol recruiting patients with high-risk locally advanced or metastatic PCa starting long-term androgen deprivation therapy (ADT). The protocol provides the only direct, randomised comparative data of SOC + AAP versus SOC + DocP. Method Recruitment to SOC + DocP and SOC + AAP overlapped November 2011 to March 2013. SOC was long-term ADT or, for most non-metastatic cases, ADT for ≥2 years and RT to the primary tumour. Stratified randomisation allocated pts 2 : 1 : 2 to SOC; SOC + docetaxel 75 mg/m2 3-weekly×6 + prednisolone 10 mg daily; or SOC + abiraterone acetate 1000 mg + prednisolone 5 mg daily. AAP duration depended on stage and intent to give radical RT. The primary outcome measure was death from any cause. Analyses used Cox proportional hazards and flexible parametric models, adjusted for stratification factors. This was not a formally powered comparison. A hazard ratio (HR) <1 favours SOC + AAP, and HR > 1 favours SOC + DocP. Results A total of 566 consenting patients were contemporaneously randomised: 189 SOC + DocP and 377 SOC + AAP. The patients, balanced by allocated treatment were: 342 (60%) M1; 429 (76%) Gleason 8-10; 449 (79%) WHO performance status 0; median age 66 years and median PSA 56 ng/ml. With median follow-up 4 years, 149 deaths were reported. For overall survival, HR = 1.16 (95% CI 0.82-1.65); failure-free survival HR = 0.51 (95% CI 0.39-0.67); progression-free survival HR = 0.65 (95% CI 0.48-0.88); metastasis-free survival HR = 0.77 (95% CI 0.57-1.03); prostate cancer-specific survival HR = 1.02 (0.70-1.49); and symptomatic skeletal events HR = 0.83 (95% CI 0.55-1.25). In the safety population, the proportion reporting ≥1 grade 3, 4 or 5 adverse events ever was 36%, 13% and 1% SOC + DocP, and 40%, 7% and 1% SOC + AAP; prevalence 11% at 1 and 2 years on both arms. Relapse treatment patterns varied by arm. Conclusions This direct, randomised comparative analysis of two new treatment standards for hormone-naïve prostate cancer showed no evidence of a difference in overall or prostate cancer-specific survival, nor in other important outcomes such as symptomatic skeletal events. Worst toxicity grade over entire time on trial was similar but comprised different toxicities in line with the known properties of the drugs. Trial registration Clinicaltrials.gov: NCT00268476.

中文翻译：

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在前列腺癌的长期激素治疗中添加阿​​比特龙或多西紫杉醇：来自 STAMPEDE 多臂、多阶段平台方案的直接随机数据。


背景 在标准护理 (SOC) 中添加醋酸阿比特龙联合泼尼松龙 (AAP) 或多西他赛联合泼尼松龙 (DocP) 均可改善晚期或转移性前列腺癌全身治疗的生存率：药物疗效评估：多臂多阶段平台随机对照方案招募患有高风险局部晚期或转移性前列腺癌的患者，开始长期雄激素剥夺治疗（ADT）。该协议提供了 SOC + AAP 与 SOC + DocP 的唯一直接、随机比较数据。方法 SOC + DocP 和 SOC + AAP 的招募重叠于 2011 年 11 月至 2013 年 3 月。SOC 是长期 ADT，或者对于大多数非转移性病例，ADT ≥2 年并对原发肿瘤进行 RT。分层随机化将 2 : 1 : 2 分分配给 SOC； SOC + 多西他赛 75 mg/m2 3 周×6 + 泼尼松龙 10 mg 每日；或 SOC + 醋酸阿比特龙 1000 mg + 泼尼松龙 5 mg 每日。 AAP 持续时间取决于阶段和给予根治性 RT 的意图。主要结局指标是全因死亡。分析使用 Cox 比例风险和灵活的参数模型，并根据分层因素进行调整。这不是正式的比较。风险比 (HR) <1 id=19> 1 有利于 SOC + DocP。结果 共有 566 名同意的患者同时被随机分组​​：189 名 SOC + DocP 和 377 名 SOC + AAP。按分配治疗平衡的患者为： 342 名 (60%) M1； 429 (76%) 格里森 8-10； 449 (79%) 世卫组织绩效状况 0；中位年龄 66 岁，中位 PSA 56 ng/ml。中位随访时间为 4 年，报告有 149 人死亡。对于总生存率，HR = 1.16 (95% CI 0.82-1.65)；无失败生存 HR = 0.51 (95% CI 0.39-0.67)；无进展生存 HR = 0.65 (95% CI 0.48-0.88)；无转移生存 HR = 0.77 (95% CI 0.57-1。03);前列腺癌特异性生存 HR = 1.02 (0.70-1.49)；症状性骨骼事件 HR = 0.83 (95% CI 0.55-1.25)。在安全人群中，报告≥1次3级、4级或5级不良事件的比例分别为36%、13%和1% SOC + DocP，以及40%、7%和1% SOC + AAP； 1 岁和 2 岁时，双臂的患病率为 11%。复发治疗模式因臂而异。结论 对未经激素治疗的前列腺癌的两种新治疗标准进行的直接、随机比较分析显示，没有证据表明总体生存率或前列腺癌特异性生存率存在差异，也没有证据表明在症状性骨骼事件等其他重要结局方面存在差异。整个试验期间的最差毒性等级相似，但包含与药物已知特性一致的不同毒性。试验注册 ClinicalTrials.gov：NCT00268476。