Long-term follow-up of elderly patients randomized to primary tamoxifen or wedge mastectomy as initial therapy for operable breast cancer

One hundred and thirty-one fit elderly patients (> 70 years) presenting with operable breast cancer (< 5 cm) between 1982 and 1987 were randomized to receive primary tamoxifen 20 mg b.d. (n = 66) or wedge mastectomy (n = 65) as sole initial therapy, unselected by oestrogen receptor status. Outcome measures were comparison of loco-regional control, metastasis and overall survival. With median follow-up of 145 months there is no statistical difference in breast cancer specific survival or rate of metastasis. Local control, however, has been significantly better with surgery-38% of mastectomy patients having developed local recurrence by 10 years compared to 81% with local progression on primary tamoxifen (P < 0.0001 Wilcoxon-Gehan statistic). Of the latter 50% have since required mastectomy in order to achieve local control. In conclusion, primary tamoxifen or wedge mastectomy are comparable treatments in terms of metastasis and overall survival but a high local failure rate on tamoxifen suggests that optimal management of the fit elderly should include surgery.