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The Pharmaceutical Journal
Vol 271 No 7271 p536
18 October 2003

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Survival improved by letrozole after tamoxifen

Treatment with the aromatase inhibitor letrozole (Femara), after completion of standard tamoxifen therapy, significantly improves disease-free survival early results of a study have shown.

The international trial studied 5,187 postmenopausal women with primary breast cancer who had completed around five years of adjuvant tamoxifen therapy. The women were randomly assigned to receive letrozole 2.5mg, or placebo, daily for five years.

Interim results at 2.4 years showed a 43 per cent reduction in the risk of breast cancer recurrence and a 46 per cent relative reduction in disease spreading from one breast to the other. There was a substantial reduction in the rate of distant metastases in the letrozole group compared with the placebo group, and the rate of death due to breast cancer was almost halved. Since these results were so promising, the independent data and safety monitoring committee recommended termination of the trial and consideration of letrozole therapy for women in the placebo group.

No significant difference in toxic effects was found between the two groups. However, the authors note that aromatase inhibitors decrease oestrogen levels and may also reduce bone mineral density and cause hypercholesterolaemia. There were new diagnoses of osteoporosis in 5.8 per cent of the letrozole group and 4.5 per cent the placebo group (New England Journal of Medicine 2003;349:19).

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