Krauss Daniel J, Ye Hong, Martinez Alvaro A, Mitchell Beth, Sebastian Evelyn, Limbacher Amy, Gustafson Gary S
Oakland University William Beaumont School of Medicine, Royal Oak, Michigan.
Oakland University William Beaumont School of Medicine, Royal Oak, Michigan.
Int J Radiat Oncol Biol Phys. 2017 Jan 1;97(1):98-106. doi: 10.1016/j.ijrobp.2016.08.011. Epub 2016 Nov 9.
To report the toxicity and preliminary clinical outcomes of a prospective trial evaluating 19-Gy, single-fraction high-dose-rate (HDR) brachytherapy for men with low- and intermediate-risk prostate cancer.
A total of 63 patients were treated according to an institutional review board-approved prospective study of single-fraction HDR brachytherapy. Eligible patients had tumor stage ≤T2a, prostate-specific antigen level ≤15 ng/mL, and Gleason score ≤7. Patients with a prostate gland volume >50 cm and baseline American Urologic Association symptom score >12 were ineligible. Patients underwent transrectal ultrasound-guided transperineal implantation of the prostate, followed by single-fraction HDR brachytherapy. Treatment was delivered using Ir to a dose of 19 Gy prescribed to the prostate, with no additional margin applied.
Of the 63 patients, 58 had data available for analysis. Five patients had withdrawn consent during the follow-up period. The median follow-up period was 2.9 years (range 0.3-5.2). The median age was 61.4 years. The median gland volume at treatment was 34.8 cm. Of the 58 patients, 91% had T1 disease, 71% had Gleason score ≤6 (29% with Gleason score 7), and the median pretreatment prostate-specific antigen level was 5.1 ng/mL. The acute and chronic grade 2 genitourinary toxicity incidence was 12.1% and 10.3%, respectively. No grade 3 urinary toxicity occurred. No patients experienced acute rectal toxicity grade ≥2, and 2 experienced grade ≥2 chronic gastrointestinal toxicity. Three patients experienced biochemical failure, yielding a 3-year cumulative incidence estimate of 6.8%.
Single-fraction HDR brachytherapy is well-tolerated, with favorable preliminary biochemical and clinical disease control rates.
报告一项前瞻性试验的毒性及初步临床结果，该试验评估了19 Gy单次分割高剂量率（HDR）近距离放射治疗低危和中危前列腺癌男性患者的疗效。
根据机构审查委员会批准的单次分割HDR近距离放射治疗前瞻性研究，共治疗了63例患者。符合条件的患者肿瘤分期≤T2a，前列腺特异性抗原水平≤15 ng/mL，Gleason评分≤7。前列腺体积>50 cm³且基线美国泌尿外科协会症状评分>12的患者不符合条件。患者接受经直肠超声引导下经会阴前列腺植入，随后进行单次分割HDR近距离放射治疗。使用铱进行治疗，前列腺处方剂量为19 Gy，不施加额外边界。
63例患者中，58例有可供分析的数据。5例患者在随访期间撤回了同意书。中位随访期为2.9年（范围0.3 - 5.2年）。中位年龄为61.4岁。治疗时的中位腺体体积为34.8 cm³。58例患者中，91%患有T1期疾病，71%的Gleason评分≤6（29%的Gleason评分为7），治疗前前列腺特异性抗原水平的中位数为5.1 ng/mL。急性和慢性2级泌尿生殖系统毒性发生率分别为12.1%和10.3%。未发生3级泌尿系统毒性。没有患者经历≥2级的急性直肠毒性，2例经历了≥2级的慢性胃肠道毒性。3例患者出现生化失败，3年累积发生率估计为6.8%。
单次分割HDR近距离放射治疗耐受性良好，初步生化和临床疾病控制率良好。
