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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
The Lancet Oncology - Online First, 08/13/09
Dearnaley DP et al. - In a trial to assess the use of sodium clodronate in men with prostate cancer (PCa), it was shown that sodium clodronate improves overall survival (OS) in men with metastatic PCa who are starting hormone therapy, but there is no evidence of an effect in men with non-metastatic PCa.
Methods- 311 men with metastatic disease were recruited to PR05 between 1994 and 1998, and 508 men with non-metastatic disease were recruited to PR04 from 1994 to 1997.
- All men were treated according to the recruiting site's standard practice at the time: for metastatic disease, all men were starting or responding to long-term hormone therapy; for non-metastatic disease, most men had radiotherapy, hormone therapy, or both.
- Men were randomly assigned to take 4 tablets per day of sodium clodronate (2080 mg) or matching placebo for up to 3 yrs (metastatic disease) or 5 yrs (non-metastatic).
- Long-term OS was assessed on an intention-to-treat basis in all men using data from the National Health Service Information Centre, which held data for 278 of 311 men in the PR05 trial and 471 of 508 men in the PR04 trial.
- Of the 278 men with metastatic disease, 258 (93%) were reported to have died.
- Evidence of a benefit for those with metastatic disease from use of sodium clodronate compared with placebo was seen in OS.
- Of the 471 men with non-metastatic disease, 281 (60%) were reported to have died, with no evidence of improvement in OS with clodronate compared with placebo.
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