Bone-targeted镭- 223症状,hormone-refractory前列腺癌:一个随机、多中心、安慰剂对照II期研究。
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帕克尼尔森年代,弗兰岑L, C, Tyrrell C,布鲁姆R, Tennvall J, Lennernas B, Petersson U, Johannessen,索米,Pigott K, Yachnin J, Garkavij M, Strang P, Harmenberg J, Bolstad B, Bruland操作系统
Bone-targeted镭- 223症状,hormone-refractory前列腺癌:一个随机、多中心、安慰剂对照II期研究。
柳叶刀杂志。2007年7月,8 (7):587 - 94。
- PubMed ID
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17544845 (在PubMed]
- 文摘
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背景:发射体镭- 223 (223)(Ra)是一种bone-seeking放射性核素研究作为一个新的治疗从hormone-refractory前列腺癌骨转移患者。我们旨在研究成熟的结果从一个随机,多中心,第二阶段的研究(223)Ra。方法:hormone-refractory前列腺癌患者骨痛需要外线束放射治疗被分配到四(223)的静脉注射Ra患者(50 kBq /公斤,33)或安慰剂(31例),每4周。主要终点是改变骨碱性磷酸酶(ALP)浓度和时间skeletal-related事件(sr)。二次端点包括毒性、时间前列腺特异抗原(PSA)进展,和整体的生存。所有的测试都是在5%的显著性水平,基于意图来治疗。发现:相对变化中值bone-ALP治疗期间是-65.6% (95% CI -69.5 - -57.7)和9.3% (3.8 - -60.9)(223)Ra组和安慰剂组,(p < 0.0001,分别Wilcoxon ranked-sums测试)。风险比时间第一行为基准,调整为1.75 (0.96 - -3.19,p = 0.065, Cox回归)。血液学的毒性两组之间没有显著差异。没有病人停止(223)Ra因为治疗的毒性。 Median time to PSA progression was 26 weeks (16-39) versus 8 weeks (4-12; p=0.048) for (223)Ra versus placebo, respectively. Median overall survival was 65.3 weeks (48.7-infinity) for (223)Ra and 46.4 weeks (32.1-77.4) for placebo (p=0.066, log rank). The hazard ratio for overall survival, adjusted for baseline covariates was 2.12 (1.13-3.98, p=0.020, Cox regression). INTERPRETATION: (223)Ra was well tolerated with minimum myelotoxicity, and had a significant effect on bone-ALP concentrations. Larger clinical trials are warranted to study (223)Ra on the prevention of SREs and on overall survival in patients with hormone-refractory prostate cancer. Bone-targeting properties of (223)Ra could also potentially be used for treating skeletal metastasis from other primary cancers.
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