Academic Department of Urology of la Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris, Faculté de Médecine Pierre et Marie Curie, University Paris VI, Paris, France.
BJU Int. 2013 May;111(5):761-6. doi: 10.1111/bju.12000. Epub 2013 Jan 31.
To describe the most recent data from phase I and II clinical trials of stereotactic body radiation therapy (SBRT) using image-guided robotic radiosurgery, specifically the Cyberknife(®) (Accuracy Incorporated, Sunnyvale, CA, USA). To better determine thecurrent role of this type of radiosurgery in prostate cancer (PCa) management.
Current clinical trials and relevant retrospective studies were identified from the literature, clinical trial databases, websites and conference abstracts. The indications, technical aspects, efficacy and toxicity of SBRT using the Cyberknife(®) system were summarized.
The Cyberknife(®) system is an experimental treatment mostly used for localized PCa in stage cT1/T2a-b N0 M0 with a Gleason score ≤ 7 and PSA level ≤ 20 ng/mL. Hypofractionated radiation therapy was delivered in five fractions of 7-7.25 Gy for a total dose of 35-36.25 Gy. After treatment, the median PSA levelfell from 4.9-8.3 ng/mL to 0.1-1.6 ng/mL at a median follow-up of 4-60 months. The biochemical progression-free survival rates ranged from 78.3 to 100%. Acute and late toxicities were mostly grade 1/2 rectal or urinary complications. Few grade 3 and no grade 4 toxicities occurred during follow-up; however, erectile dysfunction and testes toxicity were also reported.
The use of the Cyberknife(®) system is limited mainly by its pretreatment and maintenance costs. Despite encouraging preliminary results, longer-term follow-up and randomized controlled phase III clinical trials are necessary before the Cyberknife(®) system becomes a standard treatment method.
描述使用影像引导机器人放射外科（Cyberknife®）立体定向体放射治疗（SBRT）的 I 期和 II 期临床试验的最新数据，特别是 Cyberknife®（Accuracy Incorporated，加利福尼亚州桑尼维尔）。以更好地确定这种放射外科治疗在前列腺癌（PCa）管理中的当前作用。
从文献、临床试验数据库、网站和会议摘要中确定了当前的临床试验和相关的回顾性研究。总结了使用 Cyberknife®系统进行 SBRT 的适应证、技术方面、疗效和毒性。
Cyberknife®系统是一种实验性治疗方法，主要用于局灶性 PCa，分期为 cT1/T2a-b N0 M0，Gleason 评分≤7，PSA 水平≤20ng/mL。采用 7-7.25Gy 的五分割方案进行低分割放疗，总剂量为 35-36.25Gy。治疗后，中位 PSA 水平从 4.9-8.3ng/mL 降至 0.1-1.6ng/mL，中位随访时间为 4-60 个月。生化无进展生存率为 78.3%-100%。急性和迟发性毒性主要为 1/2 级直肠或泌尿系统并发症。随访期间仅发生少数 3 级毒性，无 4 级毒性；但也有报道称出现了勃起功能障碍和睾丸毒性。
Cyberknife®系统的使用主要受到其预处理和维持成本的限制。尽管初步结果令人鼓舞，但在 Cyberknife®系统成为标准治疗方法之前，还需要进行更长时间的随访和随机对照 III 期临床试验。
