Spry N A, Kristjanson L, Hooton B, Hayden L, Neerhut G, Gurney H, Corica T, Korbel E, Weinstein S, McCaul K
Department of Medicine, University of Western Australia, Perth, WA, Australia.
Eur J Cancer. 2006 May;42(8):1083-92. doi: 10.1016/j.ejca.2006.01.029. Epub 2006 May 2.
Health-related quality of life (HQOL) research is a means of broadening the assessment of treatment effects. This longitudinal study investigated the dynamic change to quality of life (QOL) and testosterone dependant physiology in men commencing an intermittent maximal androgen blockade program (IMAB). Two hundred and fifty men were accrued to the multi-centre study of IMAB (Flutamide 250 mg TDS, Leuprolide 22.5 mg depot) ceasing treatment after 9 months if PSA <4 ng/ml, and restarting when PSA >20 ng/ml. QOL was assessed every 3 months for 30 months using the EORTC QLQ-C30 and EORTC QLQ-PR25 module. Data completion for the whole study was 90%. At baseline, our cohort was less symptomatic and had better function than the EORTC reference cohort, which may be related to a shift in clinical practice with time. Testosterone suppression (AS) lead to a significant reduction in global HQOL and deterioration in most function and symptom scales. During the off period, there was a trend of progressive improvement in HQOL that paralleled testosterone recovery but was slower than the rate of deterioration during the treatment phase. Maximum recovery of HQOL occurred most frequently by months 9-12. Testosterone recovery was slower and less complete in older men, and lead to concomitant poorer HOQL recovery. Whilst the magnitude of mean change to scale scores was small, there was a consistent and simultaneous deterioration during maximal androgen blockade (MAB) and improvement during androgen recovery. Older men are more likely to show an impaired testosterone recovery, and this was paralleled by a slower HQOL recovery. Newer methods of analysis to describe results in a way that has meaning to the individual patient are warranted.
健康相关生活质量（HQOL）研究是拓宽治疗效果评估的一种手段。这项纵向研究调查了开始间歇性最大雄激素阻断方案（IMAB）的男性生活质量（QOL）和睾酮依赖性生理机能的动态变化。250名男性参与了IMAB的多中心研究（氟他胺250毫克，每日三次，亮丙瑞林22.5毫克长效制剂），如果前列腺特异性抗原（PSA）<4纳克/毫升，则在9个月后停止治疗，当PSA>20纳克/毫升时重新开始治疗。使用欧洲癌症研究与治疗组织（EORTC）QLQ-C30和EORTC QLQ-PR25模块，每3个月评估一次QOL，为期30个月。整个研究的数据完成率为90%。在基线时，我们的队列症状较轻，功能比EORTC参考队列更好，这可能与临床实践随时间的变化有关。睾酮抑制（AS）导致全球HQOL显著降低，大多数功能和症状量表恶化。在停药期，HQOL有逐渐改善的趋势，与睾酮恢复平行，但比治疗阶段的恶化速度慢。HQOL的最大恢复最常发生在9至12个月。老年男性的睾酮恢复较慢且不完全，导致HQOL恢复也较差。虽然量表分数的平均变化幅度较小，但在最大雄激素阻断（MAB）期间有持续且同时的恶化，而在雄激素恢复期间有改善。老年男性更有可能出现睾酮恢复受损，这与HQOL恢复较慢平行。需要新的分析方法，以便以对个体患者有意义的方式描述结果。
