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2015泌尿生殖系统肿瘤研讨会（ASCO GU）于2月26日至28日在美国奥兰多举行。在此次会议上展出的III 期试验GETUG-AFU 15的长期分析结果，比较了雄激素去势治疗加
雄激素去势治疗（ADT）是转移性前列腺癌的标准治疗方法。最近，E3805临床试验结果表明去势治疗+多西他赛化疗对肿瘤体积较大的患者具有生存获益，而GETUG-15 试验在不严格选择的未经激素治疗的转移性前列腺癌患者中并没有发现生存结果的改善。研究人员更新了对GETUG 15试验总生存时间（OS）的最新分析结果，对肿瘤体积较大亚组和较小亚组统一了定义并进行分析。
研究人员分析了意向治疗人群（n= 385）的长期OS。此外，我们按E3805试验的标准回顾性评估GETUG 15试验中所有患者的肿瘤体积大小。
结果见下表。试验中位随访82.9个月（95% CI[80.5-84.3]），在原来的分析报告中位随访50个月（95% CI[80.5-84.3 ]）。其中212例（55%）死亡。雄激素去势治疗组（ADT）与雄激素去势治疗+多西他赛组（ADT+D）的中位OS分别为46.5个月[ 39.1-60.6]和60.9个月 [46.1-71.4 ]，HR:0.9 [ 95% CI:：0.7-1.2）。在肿瘤体积较大组中（HVD）（n = 183，47.5%），单独ADT亚组的中位OS为35.1个月[ 29.9-44.2],而ADT+D亚组的中位OS为39个月[28-52.6 ]（HR：0.8 [ 0.6-1.2 ]）。
更长时间的随访结果显示，多西他赛加雄激素去势治疗并没有显著改善未经激素治疗的转移性前列腺癌患者OS。在回顾性分析中，转移体积大小的定义与E3805保持一致，肿瘤体积较大组单独雄激素去势治疗结果与E3805试验相似，且该组行雄激素去势+多西他赛化疗比单独去势可非显著增加4个月的OS。临床试验资料编号：00104715
摘要原文
Background: ADT is standard treatment for metastatic PCa. Recently, the E3805 trial reported a survival benefit for (ADT+D) in high volume disease (HVD) patients, whereas the GETUG-15 trial did not demonstrate a survival improvement among a less selected group of patients (pts) with hormone-naïve metastatic PCa. We report an updated analysis of overall survival (OS) of the GETUG 15 trial and aligned the definition of HVD and low volume disease (LVD) subgroups.
Methods: Long-termOS was analyzed in the intention-to-treat population (n=385 pts). Additionally, we retrospectively assessed the tumor volume as defined per E3805criteria in all patients enrolled in GETUG 15.
Results: See Table. With a median follow-up of 82.9 months (95%CI [80.5-84.3]) (vs 50 months (95%CI [80.5-84.3] in the original analysis), 212 patients (55%) have died. The median OS is 46.5 [39.1-60.6] and 60.9 months [46.1-71.4] in the ADT and in the ADT + D arms, respectively (HR: 0.9 [95%CI: 0.7-1.2]). In HVD patients (n=183, 47.5%), median OS rates were 35.1 months [29.9-44.2] in the ADT alone arm and 39 months [28-52.6] in the ADT+D arm (HR: 0.8 [0.6-1.2]).
Conclusions: With longer follow-up, the addition of docetaxel to ADT did not significantly improve OS in patients with hormone-naïve metastatic prostate cancer. In the retrospective analysis using aligned definition of volume of metastasis as E3805, the HVD outcomes were similar to E3805 for ADT alone and there was a non-significant 4 months increase in OS with ADT+D, in this underpowered subset. Clinical trial information: 00104715.
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