Pain outcomes in patients with advanced breast cancer and bone metastases: results from a randomized, double-blind study of denosumab and zoledronic acid
Charles S Cleeland, Jean-Jacques Body, Alison Stopeck, Roger von Moos, Lesley Fallowfield, Susan D Mathias, Donald L Patrick, Mark Clemons, Katia Tonkin, Norikazu Masuda, Allan Lipton, Richard de Boer, Stefania Salvagni, Celia Tosello Oliveira, Yi Qian, Qi Jiang, Roger Dansey, Ada Braun, Karen Chung, Charles S Cleeland, Jean-Jacques Body, Alison Stopeck, Roger von Moos, Lesley Fallowfield, Susan D Mathias, Donald L Patrick, Mark Clemons, Katia Tonkin, Norikazu Masuda, Allan Lipton, Richard de Boer, Stefania Salvagni, Celia Tosello Oliveira, Yi Qian, Qi Jiang, Roger Dansey, Ada Braun, Karen Chung
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.
Copyright © 2012 American Cancer Society.
Source: PubMed