Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden; Department of Oncology, Karolinska University Hospital, Stockholm, Sweden.
Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.
Eur J Cancer. 2016 Sep;65:43-51. doi: 10.1016/j.ejca.2016.06.011. Epub 2016 Jul 25.
To prospectively study differences in health-related quality of life (HRQoL) in patients with localised/locally advanced prostate cancer (PC) treated with curative intended radiation therapy and randomised to androgen receptor inhibitor monotherapy treatment versus castration plus an androgen receptor inhibitor used continuously. Time to Prostate Specific Antigen (PSA) relapse, time to symptomatic metastasis and overall survival (OS) were also described for the two groups.
From 2005 to 2011, a total of 110 patients were randomised at a ratio of 1:1. HRQoL was assessed at six time points: before randomisation, before radiotherapy (RT) start and 9, 12, 15 and 18 months after randomisation, using the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) and EORTC QLQ-PR25.
At the 3-month follow-up, statistically significant differences between the two groups were found for overall quality of life (p = 0.006), fatigue (p = 0.023), sexual interest (p < 0.001) and urinary problems (p = 0.036). Small clinical differences were noted for overall quality of life, role functioning, fatigue, pain, sleeping problems and urinary problems. At that assessment point, clinical differences between the groups were substantial regarding sexual interest and moderate regarding sexual functioning (the latter indicated only by patients reporting having sexual interest at baseline). All statistical and clinical differences favoured the androgen receptor inhibitor monotherapy arm. At 18 months after randomisation, statistically significant differences were found for cognitive functioning (p = 0.040) and sexual interest (p = 0.011), both favouring the androgen receptor inhibitor monotherapy arm.
The results suggest that neo-adjuvant androgen receptor inhibitor monotherapy might be preferred compared to castration plus an androgen receptor inhibitor before curative intended RT in men with localised/locally advanced PC, with higher levels of HRQoL, especially concerning sexual interest. HRQoL differences over time were small. The observation time and study sample were too small for evaluating time to PSA progression and OS. Further studies are needed to confirm the results. The study was registered in, identification number NCT02382094.
前瞻性研究局部/局部晚期前列腺癌（PC）患者接受根治性放疗和随机分组接受雄激素受体抑制剂单药治疗与去势加雄激素受体抑制剂连续使用的健康相关生活质量（HRQoL）差异。还描述了两组患者的前列腺特异性抗原（PSA）复发时间、症状性转移时间和总生存（OS）。
2005 年至 2011 年，以 1:1 的比例随机分配了 110 名患者。在六个时间点评估 HRQoL：随机分组前、放疗（RT）开始前和随机分组后 9、12、15 和 18 个月，使用欧洲癌症研究与治疗组织生活质量核心问卷（EORTC QLQ-C30）和 EORTC QLQ-PR25。
在 3 个月随访时，两组在总体生活质量（p=0.006）、疲劳（p=0.023）、性兴趣（p<0.001）和尿问题（p=0.036）方面存在统计学差异。在总体生活质量、角色功能、疲劳、疼痛、睡眠问题和尿问题方面，注意到了较小的临床差异。在该评估点，两组在性兴趣方面存在显著的临床差异，在性功能方面存在中度差异（后者仅由基线时报告有性兴趣的患者表示）。所有的统计和临床差异都有利于雄激素受体抑制剂单药治疗组。在随机分组后 18 个月时，认知功能（p=0.040）和性兴趣（p=0.011）方面存在统计学差异，这两个方面都有利于雄激素受体抑制剂单药治疗组。
结果表明，与去势加雄激素受体抑制剂相比，新辅助雄激素受体抑制剂单药治疗可能更适合局部/局部晚期 PC 患者，可提高 HRQoL，尤其是性兴趣。随时间的 HRQoL 差异较小。评估 PSA 进展和 OS 的观察时间和研究样本太小。需要进一步的研究来证实结果。该研究已在注册，注册号为 NCT02382094。
