Pain Outcomes in Patients with Advanced Breast Cancer and Bone Metastases: Results from a Randomized, Double-Blind Study of Denosumab and Zoledronic Acid

Details

• Personal Author:
  Body J-J ; Braun A ; Chung K ; Cleeland CS ; Clemons M ; Dansey R ; de Boer R ; Fallowfield L ; Jiang Q ; Lipton A ; Masuda N ; Mathias SD ; Oliveira CT ; Patrick DL ; Qian Y ; Salvagni S ; Stopeck A ; Tonkin K ; von Moos R
• Description:
  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. [Description provided by NIOSH]
• Subjects:
  Delivery Of Health Care Occupational Health Safety
• Keywords:
  Analgesics Author Keywords: RANK Ligand Breast Cancer Breast Neoplasms Clinical Trial Denosumab Medical Care Medicinal Chemicals Pain Pain Tolerance Zoledronic Acid

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• ISSN:
  0008-543X
• Document Type:
  Text
• Funding:
  Grant
• Genre:
  Journal Article
• Place as Subject:
  Arizona ; Florida ; OSHA Region 10 ; OSHA Region 3 ; OSHA Region 4 ; OSHA Region 6 ; OSHA Region 9 ; Pennsylvania ; Texas ; Washington
• CIO:
  National Institute for Occupational Safety and Health (NIOSH)
• Topic:
  Workplace Safety & Health
• Location:
  North America
• Volume:
  119
• Issue:
  4
• NIOSHTIC Number:
  nn:20056182
• Citation:
  Cancer 2013 Feb; 119(4):832-838
• Contact Point Address:
  Charles S. Cleeland, PhD, University of Texas MD Anderson Cancer Center, 1100 Holcombe Boulevard, Unit 221, Houston, TX 77030
• Email:
  ccleeland@mdanderson.org
• Federal Fiscal Year:
  2013
• Performing Organization:
  University of Washington
• Peer Reviewed:
  True
• Start Date:
  20050701
• Source Full Name:
  Cancer
• End Date:
  20250630
• Collection(s):
  National Institute for Occupational Safety and Health
• Main Document Checksum:
  urn:sha-512:1960016148643b2b6095e3c2f3a878b4af71f29426b949196d2c4e5506b0004ff77b7dd442a8139a14b76b3f005b6d8b870d303ca4a7dde223d54e149acb3542
• Download URL:
  https://stacks.cdc.gov/view/cdc/213838/cdc_213838_DS1.pdf
• File Type:
  [PDF - 343.66 KB ]