Pain and health-related quality of life in patients with advanced solid tumours and bone metastases: integrated results from three randomized, double-blind studies of denosumab and zoledronic acid

von Moos, Roger, Body, Jean-Jacques, Egerdie, Blair, Stopeck, Alison, Brown, Janet E, Damyanov, Danail, Fallowfield, Lesley J, Marx, Gavin, Cleeland, Charles S, Patrick, Donald L, Palazzo, Felipe G, Qian, Yi, Braun, Ada and Chung, Karen (2013) Pain and health-related quality of life in patients with advanced solid tumours and bone metastases: integrated results from three randomized, double-blind studies of denosumab and zoledronic acid. Supportive Care in Cancer, 21 (12). pp. 3497-3507. ISSN 0941-4355

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Abstract

PURPOSE: This analysis evaluated patient-reported outcomes and analgesic use in patients with bone metastases from solid tumours across three comparative studies of denosumab and zoledronic acid. METHODS: Pooled data were analysed from three identically designed double-blind phase III studies comparing subcutaneous denosumab 120 mg with intravenous zoledronic acid 4 mg monthly in patients with bone metastases from breast cancer (n = 2,046), castration-resistant prostate cancer (n = 1,901) or other solid tumours (n = 1,597). Pain severity, pain interference, health-related quality of life and analgesic use were quantified. RESULTS: At baseline, approximately half of patients had no/mild pain (53 % [1,386/2,620] denosumab; 50 % [1,297/2,578] zoledronic acid). Denosumab delayed onset of moderate/severe pain by 1.8 months (median, 6.5 vs 4.7 months; hazard ratio, 0.83; 95 % CI, 0.76-0.92; p < 0.001; 17 % risk reduction) and clinically meaningful increases in overall pain interference by 2.6 months (median, 10.3 vs 7.7 months; hazard ratio, 0.83; 95 % CI, 0.75-0.92; p < 0.001; 17 % risk reduction) compared with zoledronic acid. Strong opioid use and worsening of health-related quality of life were less common with denosumab. CONCLUSIONS: Across three large studies of patients with advanced solid tumours and bone metastases, denosumab prevented progression of pain severity and pain interference more effectively than zoledronic acid.

Item Type: Article
Keywords: Denosumab, Bone metastases, Pain, Solid tumours, Zolendronic acid
Schools and Departments: Brighton and Sussex Medical School > Sussex Health Outcomes Research & Education in Cancer (SHORE-C)
Subjects: H Social Sciences > HA Statistics > HA154 Statistical data
R Medicine
R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology Including cancer and carcinogens
R Medicine > RM Therapeutics. Pharmacology > RM0260 Chemotherapy
Depositing User: Kathryn Monson
Date Deposited: 18 Oct 2013 15:12
Last Modified: 16 Jul 2014 15:36
URI: http://sro.sussex.ac.uk/id/eprint/46746
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