Pain outcomes in patients with advanced breast cancer and bone metastases

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 ¼ .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 ¼ .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 ¼ .09). The time to pain improvement (P ¼ .72) and the time to decreased pain interference (P ¼ .92) were similar between the groups. Fewer denosumab-treated patients reported increased analgesic use from no/low use at baseline to strong opioid use. CONCLU-SIONS: 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;119:832-8.

Prevention and Treatment of Bone Metastases in Breast Cancer

“…There is insufficient evidence to recommend BPs for an immediate effect, as a first line therapy. Bisphosphonates and denosumab should be considered for the prevention of SREs, also, where analgesics and/or RT are adequate for the management of painful BM [54,59]. …”

Comparison of the efficacy and safety of denosumab versus bisphosphonates in breast cancer and bone metastases treatment: A meta-analysis of randomized controlled trials

“…One trial (39) assessed pain outcomes, including variation in pain severity, delay in pain progression, an increase or decrease in pain interference and the time taken for an increase of ≥2 points to be observed in pain interference scores among patients who had no or mild pain at baseline. Results revealed that denosumab-treated patients exhibited a lower incidence of worsening pain severity (2-point increase from baseline) than ZA-treated patients.…”

Where Do Bone-Targeted Agents RANK in Breast Cancer Treatment?

“…Denosumab also significantly decreased levels of bone turnover in all three studies, as determined by suppression of two bone turnover markers: urine N -telopeptide corrected for creatinine (uNTx), and bone-specific alkaline phosphatase (BSAP) [19,20,21]. Pre-specified analysis of the results from the breast cancer trial found that denosumab significantly delayed progression to moderate or severe pain in patients with no or mild pain at baseline [23]. Individuals in the denosumab arm of the study were also more likely to have an improvement in their quality-of-life scores and less likely to have a decline in quality of life than those in the zoledronic acid arm [24].…”