Evaluating pain and analgesic use in patients with solid tumours and bone metastases receiving denosumab or zoledronic acid (ZA) from 3 identically-designed, randomised, double-blind, trials — ASN Events
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Evaluating pain and analgesic use in patients with solid tumours and bone metastases receiving denosumab or zoledronic acid (ZA) from 3 identically-designed, randomised, double-blind, trials (#875)

Sally Woodhead RN 1 , Gisela Mayer RN 2 , Gail Fitzpatrick RN 3 , Georgette Frey RN 4 , Hannah Wigginton RN 5 , Charles Cleeland PhD 6 , Ada Braun MD, PhD 7 , Yi Qian PhD 7 , Karen Chung PharmD, MS 7
  1. Sydney Adventist Hospital, Wahroonga, Sydney, Australia
  2. Kantonsspital Graubunden Medizin, Chur, Switzerland
  3. Urology Associates/Urologic Medical Research, Kitchener, ON, Canada
  4. Pitt Pavillion, The University of Arizona Cancer Center, Tucson, AZ, USA
  5. Cancer Research UK Clinical Centre, St James's University Hospital, Leeds, UK
  6. MD Anderson Cancer Center, University of Texas, Houston, TX, USA
  7. Amgen Inc., Thousand Oaks, CA, USA

Introduction: Clinical research nursing focuses on the care and education of research participants, and this is particularly important for patients with solid tumours and bone metastases (BMs), who may experience complications such as skeletal-related events (SREs), pain, impaired mobility, or increased analgesic use. In three phase 3 trials, denosumab was superior to ZA in preventing SREs in patients with solid tumours and BMs. In this analysis, pain and analgesic use were evaluated in an integrated analysis of these trials.

Methods: Patients randomly received double blind subcutaneous denosumab 120mg or IV ZA 4mg (adjusted for renal function) Q4W. Pain severity and analgesic use were assessed at baseline and before each monthly dose. Worst-pain severity ratings were classified as no/mild (0–4) and moderate/severe (5–10). Analyses included all randomised patients (N=5544). To assess pain progression, patients with no/mild pain at baseline were evaluated for time to moderate/severe pain.

Results: Denosumab reduced risk of progression from no/mild pain at baseline to moderate/severe pain by 17% (HR 0•83; p<0•001). Furthermore, the proportion of patients who progressed was less with denosumab versus ZA (average 13.5% less), statistically significant at the majority of visits (p<0•05). Patients (%) shifting from baseline no/low analgesic use (AQA score 0–2) to strong opioid use (AQA score >2) was less (average 13.4% less) with denosumab versus ZA.

Conclusion: These findings indicate bone-targeted agents play an important role in pain control in these patients, with denosumab preventing pain worsening more effectively than ZA in patients with solid tumours and BMs, and with fewer patients on denosumab shifting from no/low analgesia to strong opioid analgesia compared with ZA.

Study and writing supported by Amgen.