BACKGROUND:Patients with metastatic bone disease are living longer in the metastatic stage due to improvements in cancer therapy, making strategies to prevent the aggravation of bone disease and its complications, such as skeletal-related events (SREs) and pain, increasingly important. PATIENTS AND RESULTS: In this phase 3 trial in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma, denosumab reduced the risk of radiation to bone by 22% relative to zoledronic acid (P = 0.026), prevented worsening of pain and pain interference (2-point increase in Brief Pain Inventory score; P < 0.05 versus zoledronic acid), and reduced the frequency of a shift from no/weak opioid analgesic use to strong opioids (P < 0.05 versus zoledronic acid at months 3-5). Denosumab delayed the time to moderate-to-severe pain compared with zoledronic acid in patients with mild or no pain at the baseline (P = 0.04), supporting early treatment. Health-related quality-of-life scores were similar in both groups. The number needed to treat to avoid one SRE for denosumab was 3 patient-years versus placebo and 10 patient-years versus zoledronic acid. CONCLUSION: The use of denosumab was associated with better prevention of the complications of metastatic bone disease secondary to solid tumors or multiple myeloma versus zoledronic acid.
RCT Entities:
BACKGROUND:Patients with metastatic bone disease are living longer in the metastatic stage due to improvements in cancer therapy, making strategies to prevent the aggravation of bone disease and its complications, such as skeletal-related events (SREs) and pain, increasingly important. PATIENTS AND RESULTS: In this phase 3 trial in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma, denosumab reduced the risk of radiation to bone by 22% relative to zoledronic acid (P = 0.026), prevented worsening of pain and pain interference (2-point increase in Brief Pain Inventory score; P < 0.05 versus zoledronic acid), and reduced the frequency of a shift from no/weak opioid analgesic use to strong opioids (P < 0.05 versus zoledronic acid at months 3-5). Denosumab delayed the time to moderate-to-severe pain compared with zoledronic acid in patients with mild or no pain at the baseline (P = 0.04), supporting early treatment. Health-related quality-of-life scores were similar in both groups. The number needed to treat to avoid one SRE for denosumab was 3 patient-years versus placebo and 10 patient-years versus zoledronic acid. CONCLUSION: The use of denosumab was associated with better prevention of the complications of metastatic bone disease secondary to solid tumors or multiple myeloma versus zoledronic acid.
Authors: Rohini K Hernandez; Jane Quigley; Melissa Pirolli; David Quach; Kristina S Chen; Jorge Arellano; Alexander Liede Journal: Support Care Cancer Date: 2014-05-02 Impact factor: 3.603
Authors: Donald L Patrick; Charles S Cleeland; Roger von Moos; Lesley Fallowfield; Rachel Wei; Katarina Öhrling; Yi Qian Journal: Support Care Cancer Date: 2014-12-23 Impact factor: 3.603
Authors: Staci Martin; Shawn Nelson Schmitt; Pamela L Wolters; Brittany Abel; Mary Anne Toledo-Tamula; Andrea Baldwin; Rikard K Wicksell; Melinda Merchant; Brigitte Widemann Journal: Pain Med Date: 2014-11-06 Impact factor: 3.750
Authors: Roger von Moos; Jean-Jacques Body; Blair Egerdie; Alison Stopeck; Janet Brown; Lesley Fallowfield; Donald L Patrick; Charles Cleeland; Danail Damyanov; Felipe Salvador Palazzo; Gavin Marx; Ying Zhou; Ada Braun; Arun Balakumaran; Yi Qian Journal: Support Care Cancer Date: 2015-09-02 Impact factor: 3.603