Context

Randomized clinical trials have recently examined the benefit of adding docetaxel or abiraterone to androgen deprivation therapy (ADT) in hormone-naïve advanced prostate cancer (PCa).

Objective

To perform a systematic review and network meta-analysis of randomized clinical trials, indirectly evaluating overall survival (OS) for men treated with abiraterone acetate plus prednisone/prednisolone with ADT (Abi-ADT) versus docetaxel with ADT (Doce-ADT) in hormone-naïve high-risk and metastatic PCa.

Evidence acquisition

Medline, Embase, Web of Science, Scopus, and Clinicaltrials.gov databases were searched in August 2017. We pooled results using the inverse variance technique and random-effects models. The Bucher technique for indirect treatment comparison was used to compare Abi-ADT with Doce-ADT. A priori subgroup and sensitivity analyses were performed.

Evidence synthesis

Overall, 6067 patients from five trials were included: 1181 (19.5%) patients who received Doce-ADT, 1557 (25.7%) patients who received Abi-ADT, and 3329 (54.9%) patients who received ADT-alone. There was a total of 1921 deaths: 391 in the Doce-ADT group, 353 in the Abi-ADT group, and 1177 in the ADT-only group. The pooled hazard ratio (HR) for OS was 0.75 (95% confidence interval [CI]: 0.63–0.91, I² = 51%, 3 trials, 2951 patients) for Doce-ADT versus ADT-alone and 0.63 (95% CI: 0.55–0.72, I² = 0%, 2 trials, 3116 patients) for Abi-ADT versus ADT-alone. The indirect comparison of Abi-ADT to Doce-ADT demonstrated no statistically significant difference in OS between these approaches (HR: 0.84, 95% CI: 0.67–1.06). Findings were similar in various a priori subset analyses, including patients with metastatic disease. Bayesian analyses demonstrated comparable results (HR: 0.83, 95% CI: 0.63–1.16). Despite the lack of statistical significance, Surface Under the Cumulative Ranking Analysis demonstrated an 89% probability that Abi-ADT was preferred.

Conclusions

We did not identify a significant difference in OS between Abi-ADT and Doce-ADT for men with hormone-naïve high-risk or metastatic PCa, although Bayesian analysis demonstrates a high likelihood that Abi-ADT was preferred.

Patient summary

We synthesized the evidence available from studies examining the administration of docetaxel or abiraterone in combination with hormonal therapy for patients with newly diagnosed, advanced prostate cancer. While these studies did not directly compare these agents, we used methodological techniques to indirectly compare them and found no significant difference in overall survival.

中文翻译：

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醋酸阿比特龙和多西他赛与雄激素剥夺疗法在高危和转移性激素初治前列腺癌中的比较：系统评价和网络荟萃分析

语境

最近，一项随机临床试验研究了在未经激素治疗的晚期前列腺癌（PCa）中，在雄激素剥夺治疗（ADT）中添加多西他赛或阿比特龙的益处。

客观的

为了对随机临床试验进行系统评价和网络荟萃分析，间接评估醋酸阿比特龙加泼尼松/泼尼松龙联合ADT（Abi-ADT）与多西他赛联合ADT（Doce-ADT）治疗的男性的总生存期（OS）幼稚的高风险和转移性PCa。

取证

2017年8月对Medline，Embase，Web of Science，Scopus和Clinicaltrials.gov数据库进行了搜索。我们使用逆方差技术和随机效应模型汇总了结果。间接治疗比较的Bucher技术用于比较Abi-ADT和Doce-ADT。进行了先验亚组和敏感性分析。

证据综合

总的来说，包括五项试验的6067名患者：接受Doce-ADT的1181名患者（19.5％），接受Abi-ADT的1557名患者（25.7％）和仅接受ADT的3329名患者（54.9％）。共有1921人死亡：Doce-ADT组中391人，Abi-ADT组中353人，仅ADT组中1177人。 Doce-ADT与单纯ADT的OS合并风险比（HR）为0.75（95％置信区间[CI]：0.63-0.91，I ² = 51％，3个试验，2951名患者）和0.63（95％CI ：0.55–0.72，我² = 0％，2个试验，3116例患者），Abi-ADT相对于单独的ADT。Abi-ADT与Doce-ADT的间接比较表明，这些方法之间的OS差异无统计学意义（HR：0.84、95％CI：0.67-1.06）。在各种先验子集分析中，包括转移性疾病患者，研究结果相似。贝叶斯分析显示出可比的结果（HR：0.83，95％CI：0.63-1.16）。尽管缺乏统计意义，但“累积排名分析下的表面”显示89％的可能性会首选Abi-ADT。

结论

尽管没有贝叶斯分析表明有较高的可能性选择Abi-ADT，但对于激素初免高危或转移性PCa的男性，我们没有发现Abi-ADT和Doce-ADT在OS上有显着差异。

病人总结

我们综合了研究对新诊断，晚期前列腺癌患者进行多西他赛或阿比特龙与激素治疗联合给药的研究得出的证据。尽管这些研究没有直接比较这些药物，但我们使用方法学技术间接比较了它们，但发现总生存期无显着差异。