Tamoxifen Can Reduce Breast Pain In Prostate Cancer Patients

(I-Newswire) April 16, 2005 - A drug called bicalutamide has been licensed in some European countries as an additional therapy to the main treatment (removal of the prostate or radiotherapy) for early prostate cancer. Breast enlargement and breast pain are common side effects of bicalutamide therapy, and can cause some patients to withdraw from treatment. Because early withdrawal from treatment may compromise outcome, effective management strategies for breast enlargement and breast pain are needed. Currently, the most commonly used treatment to prevent breast enlargement in prostate patients is low-dose radiotherapy. Trials have suggested that preventative treatment with anti-oestrogen drugs, such as tamoxifen, could also be effective.

Giuseppe Di Lorenzo (University Federico II, School of Medicine, Naples, Italy) and colleagues undertook a randomised trial to compare the effectiveness of tamoxifen with that of electron-beam radiotherapy for the prevention and treatment of breast enlargement and breast pain caused by bicalutamide therapy for prostate cancer. They recruited 151 men who had received primary treatment for prostate cancer from five Italian centres between January 2002 and February 2004. 51 patients were randomly assigned to 150 mg bicalutamide only per day, 50 patients to 150 mg bicalutamide per day and 10 mg tamoxifen per day for 24 weeks, and 50 patients to 150 mg bicalutamide per day and one dose of radiotherapy at the start of treatment.

Patients were followed-up for an average of 25 months. The investigators found that 35 of the 51 patients assigned to bicalutamide alone developed enlarged breasts, compared with four of the 50 assigned the bicalutamide and tamoxifen and with 17 of the 50 assigned bicaluatmide and radiotherapy.

29 of the 51 patients on the drug alone developed breast pain, compared with three of the 50 receiving additional tamoxifen, and 15 of the 50 receiving an additional dose of radiotherapy. 35 patients assigned to bicalutamide only subsequently developed breast enlargement or had moderate to severe breast pain and were randomly allocated to receive additional treatment of 10mg tamoxifen or one dose of radiotherapy. In this sub-group tamoxifen substantially reduced the frequency of breast enlargement and breast pain when compared with radiotherapy. The treatments were well tolerated and the groups did not differ in quality of life or relapse-free survival.

Dr Di Lorenzo concludes: "We have shown that tamoxifen and radiotherapy can prevent breast enlargement and breast pain in some patients receiving bicalutamide therapy for prostate cancer, and that tamoxifen is more effective than radiotherapy."

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