Background: Bone metastases (BM) are common in patients with solid tumours and may result in SREs such as spinal cord compression (SCC), pathologic fracture (PF), surgery to bone (SB) or radiation to bone (RB). SREs result in significant morbidity, debilitating pain, decreased health-related quality of life and increased HRU. An integrated analysis of data from three phase 3 trials demonstrated superiority of denosumab over zoledronic acid in patients with solid tumours and BM was used to assess HRU associated by SRE type.
Methods: Data through 41 weeks for patients with solid tumours and ≥1 BM were included in this post-hoc analysis. HRU data were estimated and compared between patients with ≥1 on-study SRE (by SRE type) and those not experiencing an on-study SRE. The index date was defined as the date that the first SRE was reported. Median time from randomisation to incidence of first SRE for each SRE type was used to establish an index date for the control (no SRE) group. The HRU window encompassed a 3-month period (i.e. 1 month before and 2 months after the index date) and was assessed by mean number of types of medical visits (outpatient clinical visits, emergency room visits and hospitalisations) during this window.
Results: Data from 5,543 patients were included in the analysis. PF was the most common type of first SRE (n=1,017), followed by RB (n=940), SCC (n=156), and SB (n=74). 3,618 patients did not have an SRE. For all types of medical visits HRU was higher for patients with an on-study SRE than those without.
Conclusions: SREs are associated with increased HRU, reflecting an increased burden for patients with solid tumours and BMs.

Study and writing supported by Amgen.