BoneKEy Reports | BoneKEy Watch
Denosumab prevents bone metastasis in men with castration-resistant prostate cancer
DOI:10.1038/bonekey.2013.236
Smith et al. studied 1,432 men diagnosed with nonmetastatic prostate cancer that was castration resistant and therefore refractory to hormone-blocking therapies. The group was randomized 1: 1 to receive either a placebo or 120 mg of denosumab. After 4.5 years of follow-up, the impact of denosumab therapy on bone metastasis-free survival and overall survival was assessed.
Compared with the treatment group as a whole, the patients given placebo developed bone metastases sooner; this effect was particularly marked in those patients who had a prostate-specific antigen (PSA) doubling time of 8 months or less. A subgroup analysis of men with PSA doubling times of 10, 6 or 4 months or less showed that denosumab lengthened the median time to bone metastasis by 7, 7.2 or 7.5 months, respectively. Although overall survival was not changed, the patients in the denosumab group were spared the painful, life-changing impact of secondary bone involvement.
Editor’s comment: One of the major strengths of this large phase III clinical study is its clarification of the type of patient with nonmetastatic prostate cancer who could benefit from denosumab treatment. The study also underlines the crucial role that the bone microenvironment and levels of bone-derived RANKL play in the development of prostate cancer bone metastases.
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