Henderson Randal H, Bryant Curtis, Hoppe Bradford S, Nichols R Charles, Mendenhall William M, Flampouri Stella, Su Zhong, Li Zuofeng, Morris Christopher G, Mendenhall Nancy P
a University of Florida Health Proton Therapy Institute , Jacksonville , FL , USA.
Acta Oncol. 2017 Jul;56(7):963-970. doi: 10.1080/0284186X.2017.1287946. Epub 2017 Feb 22.
To report 5-year outcomes of a prospective trial of image-guided accelerated hypofractionated proton therapy (AHPT) for prostate cancer.
215 prostate cancer patients accrued to a prospective institutional review board-approved trial of 70Gy(RBE) in 28 fractions for low-risk disease (n = 120) and 72.5Gy(RBE) in 29 fractions for intermediate-risk disease (n = 95). This trial excluded patients with prostate volumes of ≥60 cm or International Prostate Symptom Scores (IPSS) of ≥15, patients on anticoagulants or alpha-blockers, and patients in whom dose-constraint goals for organs at risk (OAR) could not be met. Toxicities were graded prospectively according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. This trial can be found on ClinicalTrials.gov (NCT00693238).
Median follow-up was 5.2 years. Five-year rates of freedom from biochemical and clinical disease progression were 95.9%, 98.3%, and 92.7% in the overall group and the low- and intermediate-risk subsets, respectively. Actuarial 5-year rates of late radiation-related CTCAE v3.0 grade 3 or higher gastrointestinal and urologic toxicities were 0.5% and 1.7%, respectively. Median IPSS before treatment and at 4+ years after treatment were 6 and 5 for low-risk patients and 4 and 6 for intermediate-risk patients.
Image-guided AHPT 5-year outcomes show high efficacy and minimal physician-assessed toxicity in selected patients. These results are comparable to the 5-year results of our prospective trials of standard fractionated proton therapy for patients with low-risk and intermediate-risk prostate cancer. Longer follow-up and a larger cohort are necessary to confirm these findings.
报告一项关于影像引导下加速分割质子治疗（AHPT）前列腺癌的前瞻性试验的5年结果。
215例前列腺癌患者参加了一项前瞻性机构审查委员会批准的试验，低危疾病（n = 120）患者接受28次分割、70Gy（相对生物效应）的治疗，中危疾病（n = 95）患者接受29次分割、72.5Gy（相对生物效应）的治疗。该试验排除了前列腺体积≥60 cm³或国际前列腺症状评分（IPSS）≥15的患者、正在使用抗凝剂或α受体阻滞剂的患者，以及无法实现危及器官（OAR）剂量限制目标的患者。毒性反应根据不良事件通用术语标准（CTCAE）第3.0版进行前瞻性分级。该试验可在ClinicalTrials.gov（NCT00693238）上查询。
中位随访时间为5.2年。总体组以及低危和中危亚组的5年无生化和临床疾病进展率分别为95.9%、98.3%和92.7%。放射治疗相关CTCAE v3.0 3级或更高等级的5年胃肠道和泌尿系统晚期毒性反应精算发生率分别为0.5%和1.7%。低危患者治疗前和治疗后4年以上的IPSS中位数分别为6和5，中危患者分别为4和6。
影像引导下的AHPT 5年结果显示，在选定患者中疗效高且医生评估的毒性最小。这些结果与我们对低危和中危前列腺癌患者进行的标准分割质子治疗前瞻性试验的5年结果相当。需要更长时间的随访和更大的队列来证实这些发现。
