Researchers from the UK have reported that Bonefos® (sodium clodronate) reduces the risk of death by 23% in men with metastatic prostate cancer. The details of this study appeared in an early online publication in The Lancet Oncology on August 11, 2009.[1]
Bonefos is an oral bisphosphonate that is primarily used to treat women with breast cancer. Bisphosphonates such as Bonefos have been beneficial for the treatment of patients with bone lesions due to multiple myeloma. Bisphosphonates have also significantly reduced the osteolytic complications of hypercalcemia, fractures, and pain associated with established bone metastases in patients with breast cancer. Biphosphonates may also decrease metastasis to bone in women with metastatic disease to other sites and may prevent metastatic spread to bone marrow.
Researchers in the UK conducted two randomized controlled studies to evaluate the effects of Bonefos in men with prostate cancer. The Medical Research Council (MRC) PR05 Study included 278 men with metastatic prostate cancer recruited between 1994 and 1998. The MRC PR04 Study also included 471 men with non-metastatic prostate cancer recruited between 1994 and 1997. Men were randomly assigned to oral Bonefos or placebo for up to three years if they had metastatic cancer and up to five years if they had non-metastatic disease.
Long-term overall survival was assessed using data from the National Health Service Information Centre. The results indicated that men with metastatic prostate cancer lived significantly longer when treated with Bonefos (HR=0.77). However, the same effect was not seen in men with non-metastatic disease (HR=1.12).
Comments: These researchers concluded that Bonefos improves survival in men with metastatic prostate cancer who are undergoing hormone therapy; however, Bonefos shows no benefit in men with non-metastatic disease. The main purpose of bisphosphonate use remains the prevention of osteoporosis and fractures, especially in men receiving hormonal therapy.
Reference:
[1] Dearnaley DP, Mason MD, Parmar MKB, et al. Adjuvant therapy with oral sodium clodronate in locally advanced and metastatic prostate cancer: Long-term overall survival results from the MRC PR04 and PR05 randomised controlled trials. Lancet Oncology. Published online August 11, 2009.
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