Men with castration-resistant prostate cancer (CRPC) and bone metastases (BM) will eventually develop debilitating pain that impacts daily functioning and diminishes their quality of life. Based on prior studies, including a phase III trial, the superiority of denosumab over zoledronic acid (ZA) in delaying or preventing skeletal-related events (pathological fracture, radiation or surgery to the bone, spinal cord compression) in men with CRPC and BM has been established.

In an ad-hoc analysis of cancer specific quality of life (CSQoL), denosumab therapy significantly delayed the time to worsening of pain interference and helped to maintain a better overall CSQoL compared to ZA in men with CRPC having BM.

Men with CRPC and BM (no prior IV bisphosphonate use) were randomized to receive either denosumab 120 mg+IV placebo or placebo+IV ZA 4mg (adjusted for creatinine clearance) every four weeks. Additionally, the men were instructed to take calcium and vitamin D supplements.

The Brief Pain Inventory–Short Form (BPI-SF) was used to assess pain interference in the quality of life.

Of the 1,901 men enrolled (n=950, denosumab; n=951, ZA), 1,045 (55%) had no/mild pain at baseline. Compared with ZA, denosumab therapy delayed the time to pain interference over time.

Clinical trial information: NCT00321620.

J Clin Oncol 32, 2014 (suppl 4; abstr 12); Donald Patrick, Charles S. Cleeland, Lesley Fallowfield, Matthew Raymond Smith, Laurence Klotz, Stephane Oudard, Gavin M. Marx, Rachel Wei, Katarina Ohrling, Yi Qian.

Joel T Nowak, M.A., M.S.W.




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