Winship Cancer Institute, Emory University, Atlanta, Georgia.
NRG Oncology Statistics and Data Management Center, University of Pittsburgh, Pittsburgh, Pennsylvania.
JAMA Oncol. 2019 May 1;5(5):664-670. doi: 10.1001/jamaoncol.2018.6752.
Hypofractionated radiotherapy (HRT) would be more convenient for men with low-risk prostate cancer and cost less than conventional radiotherapy (CRT) as long as HRT is noninferior to CRT in terms of survival and quality of life (QOL) is not found to be worse.
To assess differences in QOL between men with low-risk prostate cancer who are treated with HRT vs CRT.
DESIGN, SETTING, AND PARTICIPANTS: In this phase 3 randomized clinical trial, men with low-risk prostate cancer were enrolled from sites within the National Cancer Institute's National Clinical Trials Network in the United States, Canada, and Switzerland.
Random assignment to CRT (73.8 Gy in 41 fractions over 8.2 weeks) or to HRT (70 Gy in 28 fractions over 5.6 weeks).
Quality of life was assessed using the Expanded Prostate Index Composite questionnaire measuring bowel, urinary, sexual, and hormonal domains; the 25-item Hopkins Symptom Checklist measuring anxiety and depression; and the EuroQol-5 Dimension questionnaire measuring global QOL. All data were collected at baseline and 6, 12, 24, and 60 months. Change scores were compared between treatment arms using the Wilcoxon signed rank test. A significance level of .0125 to adjust for multiple comparisons was used for an overall 2-sided type 1 error of .05. Clinical significance was determined for the Expanded Prostate Index Composite change scores by an effect size of 0.5.
Of 1092 patients analyzable for the primary end point, 962 (mean [SD] age, 66.6 [7.4] years) consented to the QOL component. No statistically significant differences with regard to baseline characteristics nor any of the QOL baseline domains were measured between arms. There were no differences in change score between arms with respect to any of the Expanded Prostate Index Composite questionnaire domain scores except at 12 months when the HRT arm had a larger decline than the CRT arm in the bowel domain (mean score, -7.5 vs -3.7, respectively; P<.001), but it did not reach clinical significance (effect size = 0.29). There were no differences between arms at any time point for the Hopkins Symptom Checklist nor EuroQol-5 Dimension questionnaire.
Treatment with HRT is noninferior to CRT in men with low-risk prostate cancer in terms of disease-free survival and, as shown in the present study, in prostate cancer-specific (eg, bowel, bladder, sexual) and general QOL, as well as in anxiety and depression. This study provides evidence to affirm that HRT is a practice standard for men with low-risk prostate cancer.
ClinicalTrials.gov identifier: NCT00331773.
对于低危前列腺癌患者来说， 与常规放疗（CRT）相比， 缩短分割放疗（HRT）更方便， 且只要 HRT 在生存方面不劣于 CRT， 同时未发现生活质量（QOL）更差， 那么 HRT 的费用将低于 CRT。
评估接受 HRT 与 CRT 治疗的低危前列腺癌患者之间 QOL 的差异。
设计、地点和参与者：这是一项在美国、加拿大和瑞士国家癌症研究所国家临床试验网络内的多个地点进行的 3 期随机临床试验， 纳入了低危前列腺癌患者。
随机分配接受 CRT（73.8 Gy， 41 次分割， 8.2 周）或 HRT（70 Gy， 28 次分割， 5.6 周）。
使用扩展前列腺指数复合问卷（测量肠道、泌尿、性和激素域）、25 项霍普金斯症状清单（测量焦虑和抑郁）和欧洲五维健康量表（测量全球 QOL）来评估生活质量。所有数据均在基线以及 6、12、24 和 60 个月时采集。使用 Wilcoxon 符号秩检验比较治疗臂之间的变化分数。使用.0125 来调整多重比较， 总体双侧 1 型错误率为.05。通过效应大小 0.5 来确定扩展前列腺指数复合变化分数的临床意义。
在可分析主要终点的 1092 例患者中， 962 例（平均[SD]年龄为 66.6[7.4]岁）同意进行 QOL 部分评估。在基线特征或任何 QOL 基线域方面， 各臂之间均无统计学意义上的差异。除了 12 个月时 HRT 臂的肠道域下降幅度大于 CRT 臂（平均评分分别为-7.5 与-3.7， P<.001）， 各臂之间在任何扩展前列腺指数复合问卷域评分的变化分数方面均无差异，但未达到临床意义（效应大小为 0.29）。在任何时间点， 霍普金斯症状清单或欧洲五维健康量表的得分在各臂之间均无差异。
在低危前列腺癌男性中， HRT 治疗在无病生存率方面不劣于 CRT， 正如本研究所示， HRT 在前列腺癌特异性（如肠道、膀胱、性）和一般 QOL 方面以及在焦虑和抑郁方面与 CRT 相当。本研究为 HRT 是低危前列腺癌男性的标准治疗方法提供了证据。
ClinicalTrials.gov 标识符：NCT00331773。
