Department of Radiation Oncology, National Institute of Radiological Sciences, Chiba, Japan.
Department of Urology, Toho University School of Medicine, Chiba, Japan.
Br J Cancer. 2014 May 13;110(10):2389-95. doi: 10.1038/bjc.2014.191. Epub 2014 Apr 10.
The purpose of this study was to evaluate the feasibility of a new shortened 3-week treatment schedule of carbon ion radiotherapy (CIRT) for prostate cancer.
Beginning in May 2010, patients with T1b-T3bN0M0, histologically proven prostate adenocarcinoma were enrolled in the phase II trial of CIRT. Patients received 51.6 GyE in 12 fractions over 3 weeks (protocol 1002). The primary end point was defined as the incidence of late adverse events that were evaluated based on the Common Terminology Criteria for Adverse Events version 4.0. Biochemical failure was determined using the Phoenix definition (nadir +2.0 ng ml(-1)).
Forty-six patients were enrolled, and all patients were included in the analysis. The number of low-, intermediate-, and high-risk patients was 12 (26%), 9 (20%), and 25 (54%), respectively. The median follow-up period of surviving patients was 32.3 months. Two patients had intercurrent death without recurrence, and the remaining 44 patients were alive at the time of this analysis. In the analysis of late toxicities, grade 1 (G1) rectal haemorrhage was observed in 3 (7%) patients. The incidence of G1 haematuria was observed in 6 (13%) patients, and G1 urinary frequency was observed in 17 (37%) patients. No ⩾G2 late toxicities were observed. In the analysis of acute toxicities, 2 (4%) patients showed G2 urinary frequency, and no other G2 acute toxicities were observed.
The new shortened CIRT schedule over 3 weeks was considered as feasible. The analysis of long-term outcome is warranted.
本研究旨在评估一种新的 3 周短程碳离子放射治疗（CIRT）前列腺癌治疗方案的可行性。
自 2010 年 5 月起，我们对 T1b-T3bN0M0 期、组织学证实的前列腺腺癌患者进行了 CIRT 的 II 期试验。患者接受 51.6GyE，12 次分割，3 周内完成（方案 1002）。主要终点是根据通用不良事件术语标准 4.0 评估的晚期不良事件发生率。生化失败采用凤凰定义（最低点+2.0ng/ml）确定。
共纳入 46 例患者，所有患者均纳入分析。低、中、高危患者分别为 12 例（26%）、9 例（20%）和 25 例（54%）。存活患者的中位随访时间为 32.3 个月。2 例患者因并发疾病死亡而无复发，其余 44 例患者在分析时仍存活。晚期毒性分析中，3 例（7%）患者出现 G1 直肠出血。6 例（13%）患者出现 G1 血尿，17 例（37%）患者出现 G1 尿频。无 ⩾G2 晚期毒性。急性毒性分析中，2 例（4%）患者出现 G2 尿频，无其他 G2 急性毒性。
新的 3 周短程 CIRT 方案是可行的。需要进一步分析长期疗效。
