Abiraterone in advanced disease

30 May 2011

An important new study was published in the prestigious New England Journal of Medicine that provides positive news for men with advanced prostate cancer.

About the study

This was a randomised controlled trial involving 1,195 patients with advanced prostate cancer that had stopped responding to hormone therapy and who had been previously treated with docetaxel.

The men were all given the steroid prednisone.  797 were randomly assigned to be given abiraterone acetate in addition, whilst 398 were given a placebo.

The men were followed for an average of 12.8 months, and the researchers compared overall survival and PSA progression between the groups.

What they found

The researchers reported a 35% reduced risk of death amongst the men treated with abiraterone compared with the placebo group. This finding was statistically significant.

The PSA outcomes were also found to favour abiraterone.  Significant adverse events were reported, however.

What the results mean

This looks like important research that could influence clinical practice.  RCTs are the best known type of study for testing the benefits of a treatment.  Although they can have biases, and we are unable to appraise the specific quality of this study, they are more likely to yield valid results than other study types.

As with all research findings, they will need to be interpreted in context.  Each patient's clinical characteristics vary, and one individual may benefit more than another.

The Prostate Cancer Charity commented:

"We call urgently on NICE and the Scottish Medicines Consortium (SMC) to ensure that they are able to appraise this new drug as soon as possible, to ensure that guidance on its use in the NHS is available across the UK, and - more importantly - that the men who could benefit from this treatment gain access to it as quickly as possible".

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Page last edited: 02 October 2011