Saad Marniza, Umbas Rainy, Chiong Edmund, Kanesvaran Ravindran
Department of Clinical Oncology, University of Malaya Medical Centre, Kuala Lumpur, Malaysia Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.
Department of Urology, Faculty of Medicine, University of Indonesia, Jakarta, Indonesia.
Ther Adv Med Oncol. 2022 Nov 14;14:17588359221131525. doi: 10.1177/17588359221131525. eCollection 2022.
Several therapies are available for the treatment of advanced/metastatic prostate cancer (PC). However, the systematic assessment of evidence pertaining to the use of these therapies in Asian patients is lacking.
A systematic literature review (SLR) was conducted using PubMed/Medline search in May 2021 to identify the randomized/nonrandomized controlled trials (RCTs/non-RCTs) and real-world observational studies (prospective/retrospective). Only studies published as full manuscripts in English were included if reporting the efficacy, effectiveness, and/or safety of treatments in Asian patients with advanced/metastatic PC.
Of the 1,898 retrieved publications, 24 studies were included. These studies had patients with nonmetastatic castration-resistant PC (n = 2), metastatic castration-sensitive PC ( = 4), and metastatic castration-resistant PC ( = 18). Study designs included RCTs ( = 7), non-RCTs ( = 2), and real-world studies ( = 15). Treatments used in included studies were abiraterone acetate plus prednisone (AAP; = 6), enzalutamide, lutetium-177 prostate-specific membrane antigen (Lu-PSMA; = 4 each), docetaxel ( = 3), apalutamide, radium-223 ( = 2 each), darolutamide, cabazitaxel, and pembrolizumab ( = 1 each). The evidence from RCTs (i.e., ARAMIS, SPARTAN, ARCHES, TITAN, LATITUDE, PREVAIL) demonstrated the clinical benefits of apalutamide, darolutamide, enzalutamide, and AAP in terms of overall, disease-free, and metastasis-free survival in Asian patients. These treatments were reported to be well tolerated, with no new safety signals identified in Asian population. The efficacy and safety profiles in Asian patients were consistent with the overall trial population. Data from real-world studies supported the effectiveness and tolerability of AAP, enzalutamide, radium-223, docetaxel, cabazitaxel, Lu-PSMA, and pembrolizumab in patients with advanced/metastatic PC.
This SLR of the Asian data on therapies for advanced PC from the pivotal and real-world studies confirms similar efficacy and safety outcomes, consistent with the results from the pivotal clinical trials. These findings will help clinicians make better treatment decisions in clinical practice for patients with advanced/metastatic PC.
有多种疗法可用于治疗晚期/转移性前列腺癌（PC）。然而，缺乏对这些疗法在亚洲患者中应用证据的系统评估。
2021年5月利用PubMed/Medline进行系统文献综述（SLR），以识别随机/非随机对照试验（RCTs/非RCTs）和真实世界观察性研究（前瞻性/回顾性）。仅纳入以英文全文发表的研究，前提是报告这些疗法在亚洲晚期/转移性PC患者中的疗效、有效性和/或安全性。
在检索到的1898篇出版物中，纳入了24项研究。这些研究的患者包括非转移性去势抵抗性PC（n = 2）、转移性去势敏感性PC（ = 4）和转移性去势抵抗性PC（ = 18）。研究设计包括RCTs（ = 7）、非RCTs（ = 2）和真实世界研究（ = 15）。纳入研究中使用的治疗方法包括醋酸阿比特龙加泼尼松（AAP； = 6）、恩杂鲁胺、镥-177前列腺特异性膜抗原（Lu-PSMA；各 = 4）、多西他赛（ = 3）、阿帕鲁胺、镭-223（各 = 2）、达罗他胺、卡巴他赛和帕博利珠单抗（各 = 1）。来自RCTs（即ARAMIS、SPARTAN、ARCHES、TITAN、LATITUDE、PREVAIL）的证据表明，阿帕鲁胺、达罗他胺、恩杂鲁胺和AAP在亚洲患者的总生存期、无病生存期和无转移生存期方面具有临床益处。据报道，这些治疗耐受性良好，在亚洲人群中未发现新的安全信号。亚洲患者的疗效和安全性特征与总体试验人群一致。来自真实世界研究的数据支持AAP、恩杂鲁胺、镭-223、多西他赛、卡巴他赛、Lu-PSMA和帕博利珠单抗在晚期/转移性PC患者中的有效性和耐受性。
这项对来自关键和真实世界研究的亚洲晚期PC治疗数据的SLR证实了相似的疗效和安全性结果，与关键临床试验的结果一致。这些发现将有助于临床医生在临床实践中为晚期/转移性PC患者做出更好的治疗决策。
