D'Agostino G, Franzese C, De Rose F, Franceschini D, Comito T, Villa E, Alongi F, Liardo R, Tomatis S, Navarria P, Mancosu P, Reggiori G, Cozzi L, Scorsetti M
Radiosurgery and Radiotherapy Department, Istituto Clinico Humanitas Cancer Center and Research Hospital, Rozzano, Milan, Italy.
Radiosurgery and Radiotherapy Department, Istituto Clinico Humanitas Cancer Center and Research Hospital, Rozzano, Milan, Italy.
Clin Oncol (R Coll Radiol). 2016 Dec;28(12):e173-e178. doi: 10.1016/j.clon.2016.06.013. Epub 2016 Jul 4.
The aim of this phase II study was to evaluate the efficacy and toxicity of stereotactic body radiotherapy in patients with low or intermediate risk prostate cancer.
Biopsy-confirmed prostate cancer patients were enrolled, provided that they had the following characteristics: initial prostate-specific antigen (PSA) ≤ 20 ng/ml, Gleason Score < 7, International Prostate Symptom Score < 7. The treatment schedule was 35 Gy in five fractions, delivered with volumetric modulated arcs with flattening filter free beams. Toxicity was recorded according to CTCAE criteria v4.0. Biochemical failure was calculated according to the Phoenix definition. The Expanded Prostate Cancer Index Composite questionnaire was used to record health-related quality of life.
Between December 2011 and March 2015, 90 patients were enrolled (53 low risk, 37 intermediate risk). The median age was 71 years (range 48-82). In total, 58 (64.5%) of the patients had Gleason Score=6, the remaining had Gleason Score=7.The median initial PSA was 6.9 ng/ml (range 2.7-17.0). Acute toxicity was mild, with 32.2 patients presenting grade 1 urinary toxicity and 32.2% of patients presenting grade 2 urinary toxicity, mainly represented by urgency, dysuria and stranguria. Rectal grade 1 toxicity was found in 15.5% of patients, whereas grade 2 toxicity was recorded in 6.6% of patients. Regarding late toxicity, grade 1 proctitis was recorded in 11.1% of patients and grade 1 urinary in 38.8%; only two events of grade 2 urinary toxicity were observed (transient urethral stenosis, resolved by a 24 h catheterisation). At a median follow-up of 27 months (6-62 months) only two intermediate risk patients experienced a biochemical failure. Health-related quality of life revealed a slight worsening in all the domains during treatment, with a return to baseline 3 months after treatment.
Stereotactic body radiotherapy delivered using linac-based flattening filter free volumetric modulated arc radiotherapy in low and intermediate risk prostate cancer patients is associated with mild toxicity profiles and good patient-reported quality of life.
本II期研究旨在评估立体定向体部放射治疗对低危或中危前列腺癌患者的疗效和毒性。
纳入经活检确诊的前列腺癌患者,其需具备以下特征:初始前列腺特异性抗原(PSA)≤20 ng/ml, Gleason评分<7,国际前列腺症状评分<7。治疗方案为分5次给予35 Gy,采用容积调强弧形放疗技术及无均整器射束。毒性反应根据CTCAE v4.0标准记录。生化复发按照Phoenix定义计算。采用扩展前列腺癌指数综合问卷记录健康相关生活质量。
2011年12月至2015年3月,共纳入90例患者(53例低危,37例中危)。中位年龄为71岁(范围48 - 82岁)。总体上,58例(64.5%)患者Gleason评分为6分,其余患者Gleason评分为7分。初始PSA中位数为6.9 ng/ml(范围2.7 - 17.0)。急性毒性反应较轻,32.2%的患者出现1级泌尿系统毒性,32.2%的患者出现2级泌尿系统毒性,主要表现为尿急、尿痛和排尿困难。15.5%的患者出现直肠1级毒性,6.6%的患者出现2级毒性。晚期毒性方面,11.1%的患者出现1级直肠炎,38.8%的患者出现1级泌尿系统毒性;仅观察到2例2级泌尿系统毒性事件(短暂性尿道狭窄,通过24小时导尿缓解)。中位随访27个月(6 - 62个月)时,仅2例中危患者出现生化复发。健康相关生活质量显示,治疗期间所有领域均略有恶化,治疗后3个月恢复至基线水平。
在低危和中危前列腺癌患者中,使用基于直线加速器的无均整器容积调强弧形放疗进行立体定向体部放射治疗,毒性反应较轻,患者报告的生活质量良好。