The role of denosumab in the prevention of hypercalcaemia of malignancy in cancer patients with metastatic bone disease. Issue 11 (July 2015)

• Record Type: Journal Article
• Authors: Diel, Ingo J.; Body, Jean-Jacques; Stopeck, Alison T.; Vadhan-Raj, Saroj; Spencer, Andrew; Steger, Günther; von Moos, Roger; Goldwasser, François; Feng, Amy; Braun, Ada
• Is Part Of: European journal of cancer. Volume 51:Issue 11(2015:Jul.)
• Page Start: 1467
• Page End: 1475
• Publication Date: 2015-07
• Subjects: Cancer -- Periodicals; Neoplasms -- Periodicals; Cancer -- Périodiques; Cancer; Tumors; Electronic journals; Periodicals; Electronic journals; 616.994
• DOI: 10.1016/j.ejca.2015.04.017
• Languages: English
• ISSNs: 0959-8049

Abstract

<abstract xml:lang="en" abstract-type="author" id="ab005"> <title id="st005">Abstract</title> <sec> <title id="st010">Background</title> <p id="sp0005">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.</p> </sec> <sec> <title id="st015">Methods</title> <p id="sp0010">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.</p> </sec> <sec> <title id="st020">Results</title> <p id="sp0015">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; <italic>P</italic> = 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; <italic>P</italic> = 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%; <italic>P</italic> = 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.</p> </sec> <sec> <title id="st025">Conclusion</title> <p id="sp0020">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.</p> </sec> </abstract>