The role of denosumab in the prevention of hypercalcaemia of malignancy in cancer patients with metastatic bone disease
The role of denosumab in the prevention of hypercalcaemia of malignancy in cancer patients with metastatic bone disease
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DOI：
10.1016/j.ejca.2015.04.017
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发表时间：
2015-07-01
影响因子：
8.4
通讯作者：
Braun, Ada
中科院分区：
文献类型：
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作者：
Diel, Ingo J.;Body, Jean-Jacques;Braun, Ada
背景资料：我们比较了地舒单抗与唑来膦酸在晚期癌症和骨转移或多发性骨髓瘤患者中延迟或预防恶性高钙血症（HCM）的活性。患者水平数据来自两个相同设计、随机、双盲、活性对照，乳腺癌和其他实体瘤（不包括乳腺癌或前列腺癌）或多发性骨髓瘤晚期癌症患者的III期试验。终点包括首次研究期间HCM发生的时间、首次和后续研究期间HCM发生的时间、发生HCM的患者比例和复发HCM的患者比例。结果：Denosumab显著延迟首次研究期间HCM发生的时间，与唑来膦酸相比，风险比（HR）降低37（HR，0.63; 95%置信区间（CI）：0.41-0.98; P = 0.042），并将发生复发性HCM的风险（至首次和后续研究期间HCM的时间）降低52%（率比，0.48; 95% CI：0.29-0.81; P = 0.006）。中位研究时间为12.9个月。与唑来膦酸相比，接受地舒单抗治疗的患者较少发生HCM事件（1.7% vs 2.7%; P = 0.028）。在84例发生HCM事件的患者中，40%接受唑来膦酸治疗的患者发生>1例HCM事件，而接受Denosumab治疗的患者发生> 1例HCM事件的比例为31%。结论：在晚期乳腺癌、其他实体瘤或多发性骨髓瘤患者中，Denosumab治疗比唑来膦酸治疗更有效。(C)2015爱思唯尔有限公司版权所有。
Background: We compared the activity of denosumab with zoledronic acid for delaying or preventing hypercalcaemia of malignancy (HCM) in patients with advanced cancer and bone metastases or with multiple myeloma.Methods: Patient-level data were combined from two identically designed, randomised, double-blind, active-controlled, phase III trials of advanced cancer patients with breast cancer and other solid tumours (excluding breast or prostate cancer) or multiple myeloma. End-points included time to first on-study HCM, time to first and subsequent on-study HCM, proportion of patients experiencing HCM and proportion of patients experiencing recurrent HCM.Results: Denosumab significantly delayed the time to first on-study HCM, representing a 37% reduction in the hazard ratio (HR) compared with zoledronic acid (HR, 0.63; 95% confidence interval (CI): 0.41-0.98; P = 0.042) and reduced the risk of developing recurrent HCM (time to first and subsequent on-study HCM) by 52% (rate ratio, 0.48; 95% CI: 0.29-0.81; P = 0.006). The median time on study was 12.9 months. Fewer patients receiving denosumab compared with zoledronic acid experienced an HCM event (1.7% versus 2.7%; P = 0.028). Of the 84 patients experiencing an HCM event, 40% of those receiving zoledronic acid experienced >1 event of HCM compared with 31% of those receiving denosumab.Conclusion: Denosumab treatment was more efficacious than treatment with zoledronic acid in delaying or preventing HCM in advanced cancer patients with breast cancer, other solid tumours or multiple myeloma. (C) 2015 Elsevier Ltd. All rights reserved.