TY - JOUR
T1 - Pain outcomes in patients with advanced breast cancer and bone metastases
T2 - Results from a randomized, double-blind study of denosumab and zoledronic acid
AU - Cleeland, Charles S.
AU - Body, Jean Jacques
AU - Stopeck, Alison
AU - Von Moos, Roger
AU - Fallowfield, Lesley
AU - Mathias, Susan D.
AU - Patrick, Donald L.
AU - Clemons, Mark
AU - Tonkin, Katia
AU - Masuda, Norikazu
AU - Lipton, Allan
AU - De Boer, Richard
AU - Salvagni, Stefania
AU - Oliveira, Celia Tosello
AU - Qian, Yi
AU - Jiang, Qi
AU - Dansey, Roger
AU - Braun, Ada
AU - Chung, Karen
N1 - Copyright:
Copyright 2013 Elsevier B.V., All rights reserved.
PY - 2013/2/15
Y1 - 2013/2/15
N2 - 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. Denosumab demonstrates improved pain prevention and comparable pain palliation compared with zoledronic acid. Fewer denosumab-treated patients shift to strong opioid analgesic use.
AB - 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. Denosumab demonstrates improved pain prevention and comparable pain palliation compared with zoledronic acid. Fewer denosumab-treated patients shift to strong opioid analgesic use.
UR - https://www.scopus.com/pages/publications/84873411872
UR - https://www.scopus.com/pages/publications/84873411872#tab=citedBy
U2 - 10.1002/cncr.27789
DO - 10.1002/cncr.27789
M3 - Article
C2 - 22951813
AN - SCOPUS:84873411872
SN - 0008-543X
VL - 119
SP - 832
EP - 838
JO - Cancer
JF - Cancer
IS - 4
ER -
