Pain outcomes in patients with advanced breast cancer and bone metastases

Cleeland, Charles S, Body, Jean-Jacques, Stopeck, Alison, von Moos, Roger, Fallowfield, Lesley and et al, (2012) Pain outcomes in patients with advanced breast cancer and bone metastases. Cancer. n/a-n/a. ISSN 1097-0142

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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 2012. © 2012 American Cancer Society.

Item Type: Article
Additional Information: Online first edition
Keywords: RANK ligand;denosumab;clinical trial;zoledronic acid;breast neoplasms;pain;analgesics clinical trial zoledronic acid breast neoplasms pain analgesics
Schools and Departments: Brighton and Sussex Medical School > Sussex Health Outcomes Research & Education in Cancer (SHORE-C)
Subjects: R Medicine
R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology Including cancer and carcinogens
R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology Including cancer and carcinogens > RC0280 By region, system, or organ of the body, or type of tumor, A-Z > RC0280.B8 Breast. Mammary glands
Depositing User: Kathryn Monson
Date Deposited: 05 Oct 2012 13:36
Last Modified: 05 Oct 2012 13:40
URI: http://sro.sussex.ac.uk/id/eprint/40936
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