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- Title
Pain outcomes in patients with advanced breast cancer and bone metastases.
- Authors
Cleeland, Charles S.; Body, Jean ‐ Jacques; Stopeck, Alison; von Moos, Roger; Fallowfield, Lesley; Mathias, Susan D.; Patrick, Donald L.; Clemons, Mark; Tonkin, Katia; Masuda, Norikazu; Lipton, Allan; de Boer, Richard; Salvagni, Stefania; Oliveira, Celia Tosello; Qian, Yi; Jiang, Qi; Dansey, Roger; Braun, Ada; Chung, Karen
- Abstract
BACKGROUND: In this study, the authors evaluated the effect of denosumab versus zoledronic acid (ZA) on pain in patients with advanced breast cancer and bone metastases. METHODS: The prevention of pain, reduction in pain interference with daily life activities, and the proportion of patients requiring strong opioid analgesics were assessed in a randomized, double-blind, double-dummy phase 3 study comparing denosumab with ZA for preventing skeletal-related events in 2046 patients who had breast cancer and bone metastases. Patients completed the Brief Pain Inventory-Short Form at baseline and monthly thereafter. RESULTS: Fewer patients who received denosumab reported a clinically meaningful worsening of pain severity (≥2-point increase) from baseline compared with patients who received ZA, and a trend was observed toward delayed time to pain worsening with denosumab versus ZA (denosumab, 8.5 months; ZA, 7.4 months; P = .08). In patients who had no/mild pain at baseline, a 4-month delay in progression to moderate/severe pain was observed with denosumab compared with ZA (9.7 months vs 5.8 months; P = .002). Denosumab delayed the time to increased pain interference by approximately 1 month compared with ZA (denosumab, 16.0 months; ZA, 14.9 months; P = .09). The time to pain improvement ( P = .72) and the time to decreased pain interference ( P = .92) were similar between the groups. Fewer denosumab-treated patients reported increased analgesic use from no/low use at baseline to strong opioid use. CONCLUSIONS: Denosumab demonstrated improved pain prevention and comparable pain palliation compared with ZA. In addition, fewer denosumab-treated patients shifted to strong opioid analgesic use. Cancer 2013. © 2012 American Cancer Society.
- Subjects
BREAST cancer treatment; BONE metastasis; PAIN perception; MONOCLONAL antibodies; ZOLEDRONIC acid; HEALTH outcome assessment; THERAPEUTICS
- Publication
Cancer (0008543X), 2013, Vol 119, Issue 4, p832
- ISSN
0008-543X
- Publication type
Article
- DOI
10.1002/cncr.27789