Royal Marsden NHS Foundation Trust, London, United Kingdom; Institute of Cancer Research, London, United Kingdom.
Institute of Cancer Research, London, United Kingdom.
Int J Radiat Oncol Biol Phys. 2022 Jun 1;113(2):305-315. doi: 10.1016/j.ijrobp.2021.12.160. Epub 2022 Jan 10.
CHHiP is a randomized trial evaluating moderately hypofractionated radiation therapy for treatment of localized prostate cancer. Of all participants, 97% of them had concurrent short-course hormone therapy (HT), either luteinizing hormone-releasing hormone analog (LHRHa) or 150 mg of bicalutamide daily. This exploratory analysis compares efficacy and side effects in a nonrandomized comparison.
In our study, 2700 patients received LHRHa and 403 received bicalutamide. The primary endpoint was biochemical/clinical failure. Groups were compared with Cox regression adjusted for various prognostic factors and stratified by radiation therapy dose. A key secondary endpoint was erectile dysfunction (ED) assessed by clinicians (using scores from Late Effects on Normal Tissues: Subjective/Objective/Management [LENT-SOM] subjective erectile function for vaginal penetration) and patients (single items within the University of California-Los Angeles Prostate Cancer Index [UCLA PCI] and Expanded Prostate Cancer Index Composite [EPIC]-50 questionnaires) at 2 years and compared between HT regimens by χ trend test.
Bicalutamide patients were significantly younger (median 67 vs 69 years LHRHa). Median follow-up was 9.3 years. There was no difference in biochemical or clinical failure with an adjusted hazard ratio or 0.97 (95% confidence interval, 0.77-1.23; P = .8). At 2 years, grade ≥2 LENT-SOM ED was reported in significantly more LHRHa patients (313 out of 590; 53%) versus bicalutamide (17 out of 68; 25%) (P < .0001). There were no differences in ED seen with UCLA-PCI and EPIC-50 questionnaires.
In this nonrandomized comparison, there was no evidence of a difference in efficacy according to type of HT received. Bicalutamide preserved clinician assessed (LENT-SOM) erectile function at 2 years but patient-reported outcomes were similar between groups.
CHHiP 是一项评估局部前列腺癌中度低分割放射治疗的随机试验。所有参与者中，97%的人同时接受短期激素治疗（HT），包括促黄体激素释放激素类似物（LHRHa）或每天 150mg 的比卡鲁胺。本探索性分析在非随机比较中比较了疗效和副作用。
在我们的研究中，2700 名患者接受了 LHRHa，403 名患者接受了比卡鲁胺。主要终点是生化/临床失败。通过 Cox 回归调整各种预后因素进行比较，并按放射治疗剂量分层。次要终点是勃起功能障碍（ED），由临床医生（使用阴道插入的晚期正常组织主观/客观/管理评分[LENT-SOM]主观勃起功能）和患者（加利福尼亚大学洛杉矶分校前列腺癌指数[UCLA PCI]和扩展前列腺癌指数综合评分[EPIC]-50 问卷中的单项）在 2 年时评估，并通过 χ 趋势检验比较 HT 方案之间的差异。
比卡鲁胺组患者明显更年轻（中位年龄 67 岁比 LHRHa 组 69 岁）。中位随访时间为 9.3 年。调整后的危险比为 0.97（95%置信区间，0.77-1.23；P=0.8），生化或临床失败无差异。在 2 年时，LHRHa 组中报告的 LENT-SOM 勃起功能障碍≥2 级的患者明显多于比卡鲁胺组（590 例中有 313 例，53%）比卡鲁胺组（68 例中有 17 例，25%）（P<0.0001）。UCLA-PCI 和 EPIC-50 问卷中勃起功能障碍无差异。
在这项非随机比较中，根据所接受的 HT 类型，没有证据表明疗效存在差异。比卡鲁胺在 2 年内保留了临床医生评估的勃起功能（LENT-SOM），但两组患者报告的结果相似。
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