Cardiff University/Velindre Cancer Centre, Cardiff, UK.
The Institute of Cancer Research, London, UK.
Eur Urol Oncol. 2021 Dec;4(6):980-992. doi: 10.1016/j.euo.2021.07.005. Epub 2021 Sep 3.
Moderate hypofractionation is the recommended standard of care for localised prostate cancer following the results of trials including Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy in Prostate Cancer (CHHiP). Evaluation of long-term patient-reported outcomes (PROs) is important to confirm safety and enhance patient information.
To determine whether 5-yr PROs from the CHHiP quality of life (QoL) substudy confirm 2-yr findings and assess patterns over follow-up.
DESIGN, SETTING, AND PARTICIPANTS: A phase III randomised controlled trial recruited from 2002 to 2011. The QoL substudy completed accrual in 2009; participants were followed up to 5 yr after radiotherapy. Analyses used data snapshot taken on August 26, 2016. A total of 71 radiotherapy centres were included in the study (UK, Republic of Ireland, Switzerland, and New Zealand); all 57 UK centres participated in the QoL substudy. CHHiP recruited 3216 men with localised prostate cancer (cT1b-T3aN0M0).
Conventional (74 Gy/37 fractions/7.4 wk) or hypofractionated radiotherapy (60 Gy/20 fractions/4 wk or 57 Gy/19 fractions/3.8 wk) was delivered with intensity-modulated techniques.
University of California Los Angeles Prostate Cancer Index, Short Form 36 and Functional Assessment of Cancer Therapy-Prostate, or Expanded Prostate Cancer Index Composite and Short Form 12 questionnaires were administered at baseline, before radiotherapy, at 10 wk, and at 6, 12, 18, 24, 36, 48, and 60 mo after radiotherapy. The QoL primary endpoint was overall bowel bother.
The QoL substudy recruited 2100 patients; 1141 5-yr forms were available from 1957 patients still alive (58%). There were no statistically significant differences in 5-yr prevalence of overall "moderate or big" bowel bother: 19/349 (5.4%), 29/381 (7.6%), and 21/393 (5.3%) for 74, 60, and 57 Gy, respectively; overall urinary or sexual bother at 5 yr was similar between schedules. Bowel and urinary symptoms remained stable from 2 to 5 yr for all schedules. Some evidence of worsening overall sexual bother from baseline to 5 yr was less likely in the hypofractionated schedules compared with 74 Gy (odds ratios for increase in bother score vs 74 Gy: 0.55 [0.30-0.99], p = 0.009 for 60 Gy, and 0.52 [0.29-0.94], p = 0.004 for 57 Gy). General QoL scores were similar between schedules at 5 yr.
Longer follow-up confirms earlier findings, with similar patient-reported bowel, urinary, and sexual problems between schedules overall. The continued low incidence of moderate or high bother confirms that moderate hypofractionation should be the standard of care for intermediate-risk localised prostate cancer.
We looked at patient-reported outcomes up to 5 yr after treatment in a trial of different radiotherapy schedules for prostate cancer. The findings confirmed that shorter radiotherapy schedules were as safe as standard radiotherapy in terms of bowel, urinary, and sexual problems. TAKE HOME MESSAGE: Bowel, urinary, and sexual symptoms were similar between schedules up to 5 yr. The continued low incidence of moderate/high bother confirms that moderate hypofractionated radiotherapy should be considered the standard of care for men with intermediate-risk prostate cancer.
在常规或局部前列腺癌高强度调强放疗（CHHiP）等试验结果的基础上，中度适形分割已成为局限性前列腺癌的推荐标准治疗方法。评估长期患者报告结局（PROs）对于确认安全性和增强患者信息非常重要。
确定 CHHiP 生活质量（QoL）子研究的 5 年 PROs 是否证实了 2 年的发现，并评估随访期间的模式。
设计、地点和参与者：这是一项从 2002 年至 2011 年招募的 III 期随机对照试验。QoL 子研究在 2009 年完成了入组；参与者在放疗后随访 5 年。分析使用 2016 年 8 月 26 日的数据集快照。共有 71 个放疗中心参与了这项研究（英国、爱尔兰共和国、瑞士和新西兰）；所有 57 个英国中心都参与了 QoL 子研究。CHHiP 招募了 3216 名局部前列腺癌（cT1b-T3aN0M0）患者。
常规（74Gy/37 次/7.4 周）或适形分割放疗（60Gy/20 次/4 周或 57Gy/19 次/3.8 周）采用强度调制技术进行。
在基线、放疗前、10 周以及放疗后 6、12、18、24、36、48 和 60 个月时，使用加利福尼亚大学洛杉矶前列腺癌指数、短表单 36 和癌症治疗功能评估-前列腺或扩展前列腺癌指数综合和短表单 12 问卷进行评估。QoL 主要终点是整体肠道困扰。
QoL 子研究招募了 2100 名患者；在仍然存活的 1957 名患者中，有 1141 名患者提供了 5 年的表格，可用（58%）。在 74、60 和 57Gy 治疗方案中，5 年时整体“中度或严重”肠道困扰的患病率没有统计学显著差异：分别为 19/349（5.4%）、29/381（7.6%）和 21/393（5.3%）；所有治疗方案的 5 年整体尿便困扰相似。所有治疗方案的肠道和尿便症状在 2 至 5 年内均保持稳定。与 74Gy 相比，在中度适形分割方案中，5 年内整体性功能困扰恶化的证据较少，可能性更低（与 74Gy 相比，困扰评分增加的比值比：0.55[0.30-0.99]，p=0.009 用于 60Gy，0.52[0.29-0.94]，p=0.004 用于 57Gy）。5 年内，各治疗方案的一般 QoL 评分相似。
更长时间的随访证实了早期的发现，各治疗方案的患者报告的肠道、尿便和性功能问题总体相似。中度或高度困扰的持续低发生率证实了中度适形分割应该成为中危局限性前列腺癌的标准治疗方法。
我们研究了不同放疗方案治疗前列腺癌患者的治疗后 5 年的患者报告结局。研究结果证实，在肠道、尿便和性功能问题方面，较短的放疗方案与标准放疗一样安全。
在 5 年内，各治疗方案的患者报告的肠道、尿便和性功能问题总体相似。中度或高度困扰的持续低发生率证实了中度适形分割应该成为中危局限性前列腺癌的标准治疗方法。
