Duke University School of Medicine, 10 Duke Medicine Circle, Durham, NC, 27710, USA.
Department of Radiation Oncology, University of Washington School of Medicine, 1959 NE Pacific Street, Campus, Box 356043, Seattle, WA, 98195, USA.
Radiat Oncol. 2018 Sep 17;13(1):179. doi: 10.1186/s13014-018-1127-6.
We report prospectively captured clinical toxicity and patient reported outcomes in a single institutional cohort of patients treated for prostate cancer with proton beam therapy (PBT). This is the largest reported series of patients treated mostly with pencil beam scanning PBT.
We reviewed 231 patients treated on an IRB approved institutional registry from 2013 to 2016; final analysis included 192 patients with > 1-year of follow-up. Toxicity incidence was prospectively captured and scored using CTCAE v4.0. International Prostate Symptoms Score (IPSS), Sexual Health Inventory for Men (SHIM) score, and Expanded Prostate Cancer Index Composite (EPIC) bowel domain questionnaires were collected at each visit. Univariate Cox regression was used to explore associations of grade 2+ toxicity with clinical, treatment, and dosimetric variables.
Median follow-up was 1.7 years. Grade 3 toxicity was seen in 5/192 patients. No grade 4 or 5 toxicity was seen. Patient reported quality-of-life showed no change in urinary function post-radiation by IPSS scores. Median SHIM scores declined by 3.7 points at 1-year post-treatment without further decrease beyond year 1. On univariate analysis, only younger age (HR = 0.61, p = 0.022) was associated with decreased sexual toxicity. EPIC bowel domain scores declined from 96 at baseline (median) by an average of 5.4 points at 1-year post-treatment (95% CI: 2.5-8.2 points, p < 0.001), with no further decrease over time. Bowel toxicity was mostly in the form of transient rectal bleeding and was associated with anticoagulation use (HR = 3.45, p = 0.002).
Grade 3 or higher toxicity was rare at 2-years after treatment with PBT for localized prostate cancer. Longer follow-up is needed to further characterize late toxicity and biochemical control.
NCT, NCT01255748 . Registered 1 January 2013.
我们前瞻性地采集了质子束治疗（PBT）治疗前列腺癌的单机构队列患者的临床毒性和患者报告结局数据。这是报告的最大系列接受铅笔束扫描 PBT 治疗的患者。
我们回顾了 2013 年至 2016 年期间在 IRB 批准的机构注册中心接受治疗的 231 例患者；最终分析包括 192 例随访时间超过 1 年的患者。使用 CTCAE v4.0 前瞻性地采集毒性发生率并进行评分。每次就诊时采集国际前列腺症状评分（IPSS）、男性性功能健康问卷（SHIM）评分和前列腺癌综合指数问卷（EPIC）的肠道域问卷。使用单变量 Cox 回归探索 2+ 级毒性与临床、治疗和剂量学变量的相关性。
中位随访时间为 1.7 年。192 例患者中有 5 例出现 3 级毒性。未见 4 级或 5 级毒性。根据 IPSS 评分，患者报告的放射治疗后尿功能无变化。中位 SHIM 评分在治疗后 1 年下降 3.7 分，1 年后无进一步下降。单变量分析显示，只有年龄较小（HR=0.61，p=0.022）与性功能毒性降低相关。EPIC 肠道域评分从基线（中位数）的 96 分下降了 5.4 分，治疗后 1 年（95%CI：2.5-8.2 分，p<0.001），随时间无进一步下降。肠道毒性主要表现为短暂性直肠出血，与抗凝药物使用相关（HR=3.45，p=0.002）。
在接受局部前列腺癌 PBT 治疗后 2 年，3 级或更高级别的毒性罕见。需要更长时间的随访来进一步描述晚期毒性和生化控制。
NCT，NCT01255748。2013 年 1 月 1 日注册。
