ABSTRACT
Tamoxifen (Nolvadex), an anti-oestrogen, was evaluated as an adjunct to the local treatment of early breast cancer in a prospective randomized trial in which 1285 women (with pathological stage II premenopausal and pathological stage I and II postmenopausal disease) were treated by total mastectomy with either axillary node clearance or axillary node sampling and then randomized to receive either tamoxifen 10 mg twice daily for 2 years or no further treatment. Treatment failure (recurrent disease or death) at 21 months was reduced in patients receiving tamoxifen (14.2%) compared with controls (20.5%) (p = 0.01). This was equivalent to prolongation of the disease-free interval from 21 months to 30 months at a mean follow-up time of 21 months. Subgroup analyses by menopausal, axillary node and oestrogen receptor status did not reveal a significantly different treatment effect in any of these subgroups. There was no significant effect on mortality at this point in the study. This endocrine adjuvant therapy was well tolerated and treatment was discontinued in only 14 (2.2%) patients as a direct result of side effects. Thus, it was shown that tamoxifen significantly delayed recurrence in early breast cancer. The magnitude of the effect was comparable with that associated with adjuvant cytotoxic chemotherapy at a similar follow-up time, but with minimal toxicity and excellent compliance.
