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首页> 外文期刊>European journal of cancer: official journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR) >A randomized, dose-response, multicenter phase II study of radium-223 chloride for the palliation of painful bone metastases in patients with castration-resistant prostate cancer
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A randomized, dose-response, multicenter phase II study of radium-223 chloride for the palliation of painful bone metastases in patients with castration-resistant prostate cancer

机译：一项随机，剂量反应，多中心II期研究，研究镭223氯化物对去势抵抗性前列腺癌患者疼痛性骨转移的缓解作用

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Purpose: To investigate the dose-response relationship and pain-relieving effect of radium-223, a highly bone-targeted alpha-pharmaceutical. Methods: One hundred patients with castration-resistant prostate cancer (CRPC) and painful bone metastases were randomized to a single intravenous dose of 5, 25, 50 or 100 kBq/kg radium-223. The primary end-point was pain index (visual analogue scale [VAS] and analgesic use), also used to classify patients as responders or non-responders. Results: A significant dose response for pain index was seen at week 2 (P =.035). At week 8 there were 40%, 63%, 56% and 71% pain responders (reduced pain and stable analgesic consumption) in the 5, 25, 50 and 100 kBq/kg groups, respectively. On the daily VAS, at week 8, pain decreased by a mean of -30, -31, -27 and -28 mm, respectively (P =.008, P =.0005, P =.002, and P <.0001) in these responders (post-hoc analysis). There was also a significant improvement in the brief pain inventory functional index for all dose-groups (P =.04,.01,.002 and.02, Wilcoxon signed rank test). Furthermore, a decrease in bone alkaline phosphatase in the highest dose-group was demonstrated (P =.0067). All doses were safe and well tolerated. Conclusion: Pain response was seen in up to 71% of the patients with a dose response observed 2 weeks after administration. The highly tolerable side-effect profile of radium-223 previously reported was confirmed.
机译：目的：研究镭-223（一种高度靶向骨的α-药物）的剂量反应关系和缓解疼痛的作用。方法：将100例去势抵抗性前列腺癌（CRPC）和疼痛性骨转移患者随机分配至5、25、50或100 kBq / kg镭223的单次静脉内剂量。主要终点是疼痛指数（视觉模拟量表[VAS]和止痛药的使用），也用于将患者分类为反应者或非反应者。结果：在第2周时，疼痛指数出现了明显的剂量反应（P = .035）。在第8周时，分别在5、25、50和100 kBq / kg组中有40％，63％，56％和71％的疼痛反应者（减轻疼痛和稳定的镇痛剂消耗）。在第8周的每日VAS上，疼痛分别平均减少了-30，-31，-27和-28 mm（P = .008，P = .0005，P = .002和P <.0001 ）（事后分析）。所有剂量组的短暂疼痛清单功能指数也有显着改善（P = .04，.01，.002和.02，Wilcoxon符号秩检验）。此外，在最高剂量组中，骨碱性磷酸酶降低了（P = .0067）。所有剂量均安全且耐受性良好。结论：服药2周后观察到高达71％的患者出现疼痛反应。先前报道的镭223的高度耐受的副作用得到了证实。

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