Department of Radiation Oncology, Nagoya Proton Therapy Center, Nagoya City West Medical Center, Nagoya, Japan.
Department of Radiology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
Cancer Med. 2018 Mar;7(3):677-689. doi: 10.1002/cam4.1350. Epub 2018 Feb 14.
This is the first multi-institutional retrospective survey of the long-term outcomes of proton therapy (PT) for prostate cancer in Japan. This retrospective analysis comprised prostate cancer patients treated with PT at seven centers between January 2008 and December 2011 and was approved by each Institutional Review Board. The NCCN classification was used. Biochemical relapse was based on the Phoenix definition (nadir + 2.0 ng/mL). Toxicities were evaluated with the Common Terminology Criteria for Adverse Events version 4.0. There were 215, 520, and 556 patients in the low-risk, intermediate-risk, and high-risk groups, respectively. The median follow-up period of surviving patients was 69 months (range: 7-107). Among all patients, 98.8% were treated using a conventional fractionation schedule and 1.2% with a hypofractionation schedule; 58.5% and 21.5% received neoadjuvant and adjuvant androgen deprivation therapy, respectively. The 5-year biochemical relapse-free survival (bRFS) and overall survival rates in the low-risk, intermediate-risk, and high-risk groups were 97.0%, 91.1%, and 83.1%, and 98.4%, 96.8%, and 95.2%, respectively. In the multivariate analysis, the NCCN classification was a significant prognostic factor for bRFS, but not overall survival. The incidence rates of grade 2 or more severe late gastrointestinal and genitourinary toxicities were 4.1% and 4.0%, retrospectively. This retrospective analysis of a multi-institutional survey suggested that PT is effective and well-tolerated for prostate cancer. Based on this result, a multi-institutional prospective clinical trial (UMIN000025453) on PT for prostate cancer has just been initiated in order to define its role in Japan.
这是日本首次对质子治疗（PT）前列腺癌的长期结果进行的多机构回顾性调查。这项回顾性分析包括 2008 年 1 月至 2011 年 12 月期间在 7 个中心接受 PT 治疗的前列腺癌患者，并获得了每个机构审查委员会的批准。采用 NCCN 分类。生化复发基于凤凰定义（最低点+2.0ng/mL）。毒性采用通用术语标准 4.0 版进行评估。低危、中危和高危组分别有 215、520 和 556 例患者。存活患者的中位随访期为 69 个月（范围：7-107）。所有患者中，98.8%采用常规分割方案治疗，1.2%采用低分割方案治疗；58.5%和 21.5%分别接受新辅助和辅助雄激素剥夺治疗。低危、中危和高危组的 5 年生化无复发生存率（bRFS）和总生存率分别为 97.0%、91.1%和 83.1%，98.4%、96.8%和 95.2%。多因素分析显示，NCCN 分类是 bRFS 的重要预后因素，但不是总生存率。回顾性分析显示，2 级或更严重晚期胃肠道和泌尿生殖系统毒性的发生率分别为 4.1%和 4.0%。这项多机构调查的回顾性分析表明，PT 治疗前列腺癌是有效且耐受良好的。基于这一结果，一项针对前列腺癌 PT 的多机构前瞻性临床试验（UMIN000025453）刚刚启动，以确定其在日本的作用。
