Duration of Androgen Deprivation Therapy in High-risk Prostate Cancer: A Randomized Phase III Trial
Duration of Androgen Deprivation Therapy in High-risk Prostate Cancer: A Randomized Phase III Trial
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DOI：
10.1016/j.eururo.2018.06.018
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发表时间：
2018-10-01
期刊：
影响因子：
23.4
通讯作者：
Souhami, Luis
中科院分区：
文献类型：
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作者：
Nabid, Abdenour;Carrier, Nathalie;Souhami, Luis
背景资料：长期雄激素剥夺治疗（ADT）联合放疗（RT）是局部高危前列腺癌（HRPC）患者的标准治疗方法。然而，ADT的最佳持续时间尚未定义。目的：本优效性随机试验的目的是比较RT联合ADT 36个月或18个月的结局。设计、设置和参与者：从2000年10月至2008年1月，630例HRPC患者被随机分组，310例接受盆腔和前列腺RT联合ADT治疗36个月（长臂），320例接受相同RT联合ADT治疗18个月（短臂）。结果和局限性：中位随访9.4年，290例患者死亡（长臂147例，短臂143例）。长臂的5年OS率（95%置信区间）为91%（88-95%），短臂为86%（83-90%），p = 0.07。生活质量分析显示，在6个尺度和13个项目的显着差异（p < 0.001），有利于18个月的ADT，其中两个提出了临床相关的差异，平均得分>= 10 point.Conclusions：在本地HRPC，我们的研究结果支持，36个月是不是上级到18个月的ADT。在选定的男性中，ADT联合RT可能减少至18个月，而不会影响生存率或QoL。因此，18个月的ADT似乎代表一个有效的选择在HRPC.Patient摘要：在这项研究中，我们报告的结果与放疗和36或18个月的雄激素剥夺治疗的高危前列腺癌患者。两组之间的生存率没有差异，18个月组的生活质量更好。(C)2018年欧洲泌尿外科协会。Elsevier B. V.出版，保留所有权利。
Background: Long-term androgen deprivation therapy (ADT) combined with radiotherapy (RT) is a standard treatment for patients with localized high-risk prostate cancer (HRPC). However, the optimal duration of ADT is not yet defined.Objective: The aim of this superiority randomized trial was to compare outcomes of RT combined with either 36 or 18 mo of ADT.Design, setting and participants: From October 2000 to January 2008, 630 patients with HRPC were randomized, 310 to pelvic and prostate RT combined with 36 mo (long arm) and 320 to the same RT with 18 mo (short arm) of ADT.Outcome measurements and statistical analysis: Overall survival (OS) and quality of life (QoL) were primary end points. OS rates were compared with Cox Regression model and QoL data were analyzed through mixed linear model.Results and limitations: With a median follow-up of 9.4 yr, 290 patients had died (147 long arm vs 143 short arm). The 5-yr OS rates (95% confidence interval) were 91% for long arm (88-95%) and 86% for short arm (83-90%), p = 0.07. QoL analysis showed a significant difference (p < 0.001) in six scales and 13 items favoring 18 mo ADT with two of them presenting a clinically relevant difference in mean scores of >= 10 points.Conclusions: In localized HRPC, our results support that 36 mo is not superior to 18 mo of ADT. ADT combined with RT can potentially be reduced to 18 mo in selected men without compromising survival or QoL. Thus, 18 mo of ADT appears to represent a valid option in HRPC.Patient summary: In this study, we report outcomes from high-risk prostate cancer patients treated with radiotherapy and either 36 or 18 mo of androgen deprivation therapy. There was no difference in survival between the two groups, with the 18-mo group experiencing a better quality of life. (C) 2018 European Association of Urology. Published by Elsevier B.V. All rights reserved.