The Pharmaceutical Journal
Vol 274 No 7346 p483
23 April 2005

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Tamoxifen reduces prostate treatment pain

Tamoxifen is more effective than radiotherapy in preventing breast enlargement and breast pain in men being treated for prostate cancer, according to a study published last week.

Sisto Perdonà, of the National Tumour Institute, Naples, and colleagues compared the effectiveness of the two strategies for relieving side effects caused by bicalutamide — an adjunctive treatment used in advanced prostate cancer.

The researchers explain that gynaecomastia and breast pain are frequent adverse events associated with non-steroidal antiandrogens such as bicalutamide. The effects arise from an increase in the ratio of effective oestrogen to androgen in the breast as a result of bicalutamide’s hypergonadotropic effects.

The researchers assigned men with prostate cancer to one of three treatment strategies: 150mg bicalutamide daily; 150mg bicalutamide daily plus 10mg tamoxifen daily for 24 weeks; or 150mg bicalutamide daily plus 12Gy radiotherapy given as one dose at the start of therapy.

Of the 51 men assigned to bicalutamide alone, 35 went on to develop gynaecomastia. This compared with four of the 50 men assigned to bicalutamide plus tamoxifen (odds ratio 0.1, 95 per cent confidence interval 0.08–0.12, P=0.0009) and with 17 of the 50 men assigned to bicalutamide plus radiotherapy (0.51, 0.47–0.54, P=0.008). A similar pattern was observed for breast pain, which developed in 29 men allocated to bicalutamide alone, in three men assigned to tamoxifen and 15 men assigned to radiotherapy.

Although tamoxifen did not increase adverse events associated with bicalutamide and did not compromise quality of life, the researchers acknowledge that there are some concerns about its use in patients with prostate cancer. “Although blocking the effects of oestrogen might effectively prevent or treat gynaecomastia, the consequences of such treatment are unknown,” they warn.

Reassuringly, prostate specific antigen response rates (a marker of persistent or recurrent disease) were not affected by tamoxifen treatment. But the researchers suggest that clinical trials are needed to test whether antioestrogen treatment could increase androgen secretion by blocking the negative feedback of oestradiol on the hypothalamic-pituitary axis (Lancet Oncology published online on 14 April).