University of Florida Proton Therapy Institute, Jacksonville, Florida.
University of Florida Proton Therapy Institute, Jacksonville, Florida.
Int J Radiat Oncol Biol Phys. 2014 Mar 1;88(3):596-602. doi: 10.1016/j.ijrobp.2013.11.007.
To report 5-year clinical outcomes of 3 prospective trials of image-guided proton therapy for prostate cancer.
A total of 211 prostate cancer patients (89 low-risk, 82 intermediate-risk, and 40 high-risk) were treated in institutional review board-approved trials of 78 cobalt gray equivalent (CGE) in 39 fractions for low-risk disease, 78 to 82 CGE for intermediate-risk disease, and 78 CGE with concomitant docetaxel therapy followed by androgen deprivation therapy for high-risk disease. Toxicities were graded according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Median follow-up was 5.2 years.
Five-year rates of biochemical and clinical freedom from disease progression were 99%, 99%, and 76% in low-, intermediate-, and high-risk patients, respectively. Actuarial 5-year rates of late CTCAE, version 3.0 (or version 4.0) grade 3 gastrointestinal and urologic toxicity were 1.0% (0.5%) and 5.4% (1.0%), respectively. Median pretreatment scores and International Prostate Symptom Scores at >4 years posttreatment were 8 and 7, 6 and 6, and 9 and 8, respectively, among the low-, intermediate-, and high-risk patients. There were no significant changes between median pretreatment summary scores and Expanded Prostate Cancer Index Composite scores at >4 years for bowel, urinary irritative and/or obstructive, and urinary continence.
Five-year clinical outcomes with image-guided proton therapy included extremely high efficacy, minimal physician-assessed toxicity, and excellent patient-reported outcomes. Further follow-up and a larger patient experience are necessary to confirm these favorable outcomes.
报告 3 项前列腺癌图像引导质子治疗前瞻性研究的 5 年临床结果。
在机构审查委员会批准的试验中，共治疗了 211 例前列腺癌患者（89 例低危、82 例中危和 40 例高危），采用 78 钴格雷等效剂量（CGE）的 39 个分次治疗低危疾病，78 至 82 CGE 治疗中危疾病，78 CGE 联合多西他赛治疗高危疾病，然后进行雄激素剥夺治疗。毒性分级采用不良事件通用术语标准（CTCAE），版本 3.0。中位随访时间为 5.2 年。
低危、中危和高危患者的 5 年生化无进展生存率分别为 99%、99%和 76%。5 年累积晚期 CTCAE 版本 3.0（或 4.0）胃肠和泌尿系统毒性 3 级发生率分别为 1.0%（0.5%）和 5.4%（1.0%）。低危、中危和高危患者的中位预处理评分和国际前列腺症状评分（IPSS）分别为治疗后>4 年的 8 分和 7 分、6 分和 6 分、9 分和 8 分。>4 年时，肠道、尿路刺激和/或梗阻以及尿控的中位预处理总评分和扩展前列腺癌指数复合评分均无显著变化。
图像引导质子治疗的 5 年临床结果包括极高的疗效、最小的医生评估毒性和良好的患者报告结局。需要进一步随访和更大的患者经验来证实这些有利的结果。
