The hormonal treatments cyproterone acetate and medroxyprogesterone acetate are the most effective at reducing hot flushes, a common side-effect in men being treated with hormone therapy for prostate cancer. But overall, medroxyprogesterone should become the standard treatment for preventing hot flushes in these patients, finds an Article published Online First in The Lancet Oncology.
Androgen suppression therapy or hormone therapy is the gold standard treatment for advanced prostate cancer. It uses surgery or gonadotrophin-releasing hormone (GnRH) analogues such as leuprorelin to block the production of male producing sex hormones (androgens) that stimulate prostate cancer cells to grow. Hot flushes are a common and unpleasant side effect experienced by up to 80% of patients undergoing treatment with GnRH analogues.
Previous research has shown that hormonal treatments (eg, cyproterone acetate) and progestagens (eg, medroxyprogesterone), as well as non-hormonal treatments such as selective serotonin-re-uptake inhibitor antidepressants (eg, venlafaxine) are all effective at preventing hot flushes. However, direct comparisons between these drugs have not been made in men being treated with androgen -suppression therapy for prostate cancer.
In this randomised trial, Jacques Irani and colleagues from France examine the efficacy of three drugs—cyproterone acetate, medroxyprogesterone acetate, and venlafaxine—at preventing hot flushes, to establish clear treatment recommendations for these patients.
919 men with prostate cancer were recruited from 106 urology centres in France between 2004 and 2007. All patients were initially treated with leuprorelin for 6 months. After 6 months, patients who had 14 or more hot flushes in the week before assessment or those who spontaneously requested treatment were randomly assigned to further treatment with either venlafaxine (n=102), medroxyprogesterone (n=108), or cyproterone acetate (n=101). Patients were assessed at weeks 4, 8, and 12 after randomisation, and asked to complete a self-evaluation questionnaire to calculate the frequency and severity of hot flushes for a week before each assessment.
Overall, findings showed that all three drugs produced reduced the occurrence of hot flushes with little difference in tolerance, but the hormonal treatments cyproterone acetate and medroxyprogesterone acetate were significantly more effective at reducing hot flushes than venlafaxine over all time periods.
After 4 weeks of treatment, 219 patients (70•9%) had an improvement of at least 50% in their hot flush scores, and 70 patients (22•7%) reported a complete absence of hot flushes.
The median daily hot-flush score relative change between randomisation and week 4 was -47•2% for venlafaxine, -94•5% for cyproterone, and -83•7% for medroxyprogesterone.
Serious side-effects occurred in 16 patients—four, seven, and five cases in the venlafaxine, cyproterone, and medroxyprogesterone groups, respectively. Only two cases were thought to be related to the drugs.
The authors conclude: "Cyproterone acetate and medroxprogesterone acetate are more effective at 12 weeks for treating hot flushes in men treated with GnRH analogues for prostate cancer…[however] as cyproterone is a recognised treatment in prostate cancer, and its use could interfere with hormone therapy, medroxprogesterone should be the standard treatment."
Professor Jacques Irani, University Hospital, Poitiers, France. T) +33 (0) 5 49 44 44 75 E) j.irani@chu-poitiers.fr
For full Article, see: http://press.thelancet.com/tloirani.pdf
Journal
The Lancet Oncology