A multi-centre randomised phase III trial of Dexamethasone vs Dexamethasone and diethylstilbestrol in castration-resistant prostate cancer: immediate vs deferred Diethylstilbestrol
2011

Immediate vs Deferred Diethylstilbestrol in Prostate Cancer Treatment

Sample size: 270 publication 10 minutes Evidence: moderate

Author Information

Author(s): Jonathan Shamash, Tim Oliver, Shahid J. Sarker, Andrew Protheroe, Nitin Mithal, Richard Mills, Rachael Beard, Paul Wilson, Nick Tranter, Nigel O'Brien, Simon McFaul, Tom Oliver

Primary Institution: St Bartholomew's Hospital

Hypothesis

Does the immediate addition of Diethylstilbestrol improve outcomes compared to deferring its use in castration-resistant prostate cancer?

Conclusion

Deferring Diethylstilbestrol until failure of Dexamethasone is preferred due to similar efficacy and reduced toxicity.

Supporting Evidence

  • 68% of patients in the immediate group achieved a PSA response compared to 64% in the deferred group.
  • The median time to progression was significantly longer in the immediate group (8.6 months) compared to the deferred group (4.5 months).
  • Patients with previous haemoglobin levels ≥11 g/dl had a significantly decreased risk of death.
  • 22% of patients in the immediate group experienced veno-thromboembolic events compared to 11% in the deferred group.
  • Painful gynaecomastia occurred in 40% of the immediate group compared to only 1% in the deferred group.

Takeaway

This study looked at two ways to treat prostate cancer: giving a drug right away or waiting until the disease gets worse. It found that waiting is better because it causes fewer side effects.

Methodology

A multi-centre, randomised, open-label phase III trial comparing DAiS and DAdS in 270 men with chemotherapy-naive CRPC.

Potential Biases

Potential selection bias due to the exclusion of patients not meeting specific criteria.

Limitations

Some patients were not biochemically castrate in the DAdS arm, which could affect outcomes.

Participant Demographics

Median age was 76 years, with 76% having metastatic disease.

Statistical Information

P-Value

0.002

Confidence Interval

95% CI: 0.25–0.77

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/bjc.2011.7

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