Nabid Abdenour, Carrier Nathalie, Martin André-Guy, Bahary Jean-Paul, Vavassis Peter, Vass Sylvie, Bahoric Boris, Archambault Robert, Vincent François, Bettahar Redouane, Souhami Luis
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke, 3001, 12e Avenue Nord, Sherbrooke, CA, J1H 5N4, Canada.
CHU de Québec de l'Université Laval, Québec, CA, Canada.
Qual Life Res. 2025 Mar;34(3):725-737. doi: 10.1007/s11136-024-03843-5. Epub 2024 Nov 20.
The aim was to compare quality of life (QoL) of patients with testosterone recovery (TR) to patients without TR after the completion of either 18- or 36-month androgen deprivation therapy (ADT) for prostate cancer.
From a Phase III trial, we selected all 630 randomised patients with testosterone measured at baseline (during screening, before randomisation) and follow-up and who completed baseline, 6-month and, at least, one further QoL questionnaire in follow-up (EORTC 30 - PR25). We estimated means and standard deviation of items and scales for each group at each time point. We analyzed items and scales scores with general linear model with repeated measures to evaluate changes between patients with or without TR to a normal level. p-values were adjusted for multiple comparisons with Benjamini-Hochberg's false discovery rate procedure (p). A p < 0.05 was considered significant and mean differences of 10 points or more considered clinically relevant.
494 patients retained for analysis (median follow-up 16.2 years). A significantly higher number of patients (177/314 vs 79/180, p = 0.008) recovered a normal testosterone level in a significantly shorter time [median (IQR): 3.06 (2.55-3.65) vs 5.00 years (4.5-5.96), p < 0.001] in the 18- vs the 36-month cohort. Patients with TR had a significantly better QoL: 37/55 items and 14/21 scales (p<0.05) in the 18-month and 25/55 items and 13/21 scales in the 36-month cohort. Moreover, 9 items and one scale reached clinical relevance in the 18-month cohort and 7 items and one scale in the 36-month cohort.
TR is associated with significant regaining in QoL. A faster and significantly higher TR is seen in the shorter ADT schedule.
旨在比较前列腺癌患者在接受18个月或36个月雄激素剥夺治疗（ADT）结束后，睾酮恢复（TR）患者与未恢复患者的生活质量（QoL）。
从一项III期试验中，我们选取了所有630名随机分组的患者，这些患者在基线（筛查期间，随机分组前）和随访时测量了睾酮水平，并且在随访中完成了基线、6个月以及至少一份后续生活质量问卷（欧洲癌症研究与治疗组织30 - PR25）。我们估计了每个组在每个时间点的项目和量表的均值及标准差。我们使用重复测量的一般线性模型分析项目和量表得分，以评估有或无TR的患者恢复到正常水平之间的变化。p值通过Benjamini-Hochberg错误发现率程序（p）进行多重比较调整。p < 0.05被认为具有显著性，均值差异10分或更多被认为具有临床相关性。
494名患者被保留用于分析（中位随访时间16.2年）。在18个月队列中，恢复正常睾酮水平的患者数量显著更多（177/314 vs 79/180，p = 0.008），且恢复时间显著更短[中位（四分位间距）：3.06（2.55 - 3.65）年 vs 5.00年（4.5 - 5.96）年，p < 0.001]，与36个月队列相比。有TR的患者生活质量显著更好：在18个月队列中有37/55个项目和14/21个量表（p < 0.05），在36个月队列中有25/55个项目和13/21个量表。此外，在18个月队列中有9个项目和1个量表达到临床相关性，在36个月队列中有7个项目和1个量表达到临床相关性。
TR与生活质量的显著恢复相关。在较短的ADT疗程中观察到更快且显著更高的TR。
