Summers Nicholas, Vanderpuye-Orgle Jacqueline, Reinhart Marcia, Gallagher Meghan, Sartor Oliver
a Precision Health Economics , Los Angeles , CA , USA.
b Tantalus Medical Communications , Victoria , BC , Canada.
Curr Med Res Opin. 2017 Nov;33(11):1995-2008. doi: 10.1080/03007995.2017.1341869. Epub 2017 Jul 10.
Prostate cancer is a highly prevalent form of cancer in older men and is one of the leading causes of death from cancer in men across the globe. Many therapeutic agents have been approved for patients with metastatic castration-resistant prostate cancer (mCRPC), particularly as a post-docetaxel treatment strategy. The objective of this systematic literature review was to assess published efficacy and safety data for select mCRPC therapies - such as abiraterone, cabazitaxel, and enzalutamide - in the post-docetaxel setting.
Database searches of MEDLINE, Embase, and Cochrane CENTRAL, in conjunction with hand searches of multiple congress abstracts, yielded 13 randomized studies and 107 non-randomized studies that met the inclusion criteria.
Randomized studies demonstrated significant improvements in median overall survival (OS) outcomes over placebo for abiraterone (15.8 vs. 11.2 months) and enzalutamide (18.4 vs. 13.6 months), and similar significant improvements were noted for cabazitaxel over mitoxantrone (15.1 vs. 12.7 months). Differences in progression-free survival (PFS) were similarly significant, although variance in the criteria for measuring PFS may limit the extent to which these outcomes can be compared between studies. Non-randomized evidence included multiple publications from several early access and compassionate use programs with a primary objective to report safety outcomes. Results from these studies largely reflected the findings in randomized trials.
Overall, there is a growing body of evidence for post-docetaxel treatment options available in patients with mCRPC. Further head-to-head trials or indirect treatment comparisons may be a valuable method to assess the comparative efficacy of these therapies.
前列腺癌是老年男性中一种高度常见的癌症形式,也是全球男性癌症死亡的主要原因之一。许多治疗药物已被批准用于转移性去势抵抗性前列腺癌(mCRPC)患者,尤其是作为多西他赛后的治疗策略。本系统文献综述的目的是评估在多西他赛后使用的特定mCRPC疗法(如阿比特龙、卡巴他赛和恩杂鲁胺)已发表的疗效和安全性数据。
对MEDLINE、Embase和Cochrane CENTRAL数据库进行检索,并手动检索多个会议摘要,共获得13项随机研究和107项非随机研究,这些研究均符合纳入标准。
随机研究表明,阿比特龙(15.8个月对11.2个月)和恩杂鲁胺(18.4个月对13.6个月)的中位总生存期(OS)结果相对于安慰剂有显著改善,卡巴他赛相对于米托蒽醌(15.1个月对12.7个月)也有类似的显著改善。无进展生存期(PFS)的差异同样显著,尽管测量PFS的标准存在差异可能会限制这些结果在不同研究之间的可比程度。非随机证据包括来自多个早期获取和同情用药项目的多篇出版物,其主要目的是报告安全性结果。这些研究的结果在很大程度上反映了随机试验的结果。
总体而言,越来越多的证据表明mCRPC患者有多西他赛后的治疗选择。进一步的头对头试验或间接治疗比较可能是评估这些疗法比较疗效的有价值方法。