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 |
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Authors: | Roger von Moos Jean-Jacques Body Blair Egerdie Alison Stopeck Janet E Brown Danail Damyanov Lesley J Fallowfield Gavin Marx Charles S Cleeland Donald L Patrick Felipe G Palazzo Yi Qian Ada Braun Karen Chung |
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Institution: | 1. Kantonsspital Graubünden, Lo?strasse 170, 7000, Chur, Switzerland 2. Chu Brugmann, Université Libre De Bruxelles, Brussels, Belgium 3. Urology Associates/Urologic Medical Research, Kitchener, ON, Canada 4. Arizona Cancer Center, University of Arizona, Tucson, AZ, USA 5. Cancer Research UK Experimental Cancer Medicine Centres, Leeds and Sheffield, UK 6. National Hospital for Treatment in Oncology, Sofia, Bulgaria 7. Sussex Health Outcomes Research & Education in Cancer (SHORE-C), University of Sussex, Brighton, UK 8. Sydney Adventist Hospital, University of Sydney, Sydney, NSW, Australia 9. University of Texas MD Anderson Cancer Center, Houston, TX, USA 10. University of Washington, Seattle, WA, USA 11. CAIPO, San Miguel de Tucuman, Argentina 12. Amgen Inc., Thousand Oaks, CA, USA
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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. |
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