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

背景 将醋酸阿比特龙与泼尼松龙 (AAP) 或多西紫杉醇与泼尼松龙 (DocP) 添加到标准护理 (SOC) 中，均提高了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开始长期雄激素剥夺治疗 (ADT) 的高危局部晚期或转移性 PCa 患者。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 的招募时间从 2011 年 11 月到 2013 年 3 月重叠。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放疗。分层随机分配 pts 2 : 1 : 2 至 SOC；SOC + 多西紫杉醇 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放疗的意图。主要结局指标是全因死亡。分析使用的 Cox 比例风险和灵活的参数模型，针对分层因素进行调整。这不是一个正式的比较。风险比 (HR) <1 有利于 SOC + AAP，而 HR > 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 (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 4 年，报告有 149 例死亡。对于总生存期，HR = 1.16 (95% CI 0.82-1.65)；无失败生存 HR = 0.51（95% CI 0.39-0.67）；无进展生存期 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)；和有症状的骨骼事件 HR = 0.83 (95% CI 0.55-1.25)。在安全人群中，报告≥1 级 3、4 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；双臂在 1 年和 2 年时的患病率为 11%。复发治疗模式因手臂而异。结论 这项针对激素初治前列腺癌的两种新治疗标准的直接、随机比较分析表明，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，其他重要结果（如有症状的骨骼事件）也没有差异。整个试验期间的最差毒性等级相似，但根据药物的已知特性包含不同的毒性。试验注册 Clinicaltrials.gov：NCT00268476。