Delayed adjuvant tamoxifen: Ten-year results of a collaborative randomizedcontrolled trial in early breast cancer (TAM-02 trial)

Aim: Immediate adjuvant tamoxifen reduces disease recurrence and improves s urvival in patients with early breast cancer. However, is it too late to ad minister tamoxifen to patients who have already undergone treatment, but we re unable to benefit from this adjuvant therapy? The French National Cancer Centers (FNCLCC) have investigated the efficacy of delayed tamoxifen admin istration in a randomized controlled trial. Patients and methods: From September 1986 to October 1989, women with prima ry breast cancer, who had undergone surgery, radiotherapy, and/or received adjuvant chemotherapy but not hormone therapy more than two years earlier, were randomized to receive either 30 mg/day tamoxifen or no treatment. The 10-year disease-free and overall survival rates of the two groups of patien ts and of various subgroups were determined according to the Kaplan-Meyer m ethod and compared by the log-rank test. Results: This intention-to-treat analysis comprised 250 women in the tamoxi fen group and 244 in the control group. Patient characteristics (age, T sta ge, number of positive nodes, receptor status, and interval since tumor tre atment) were comparable in both groups. Delayed adjuvant tamoxifen signific antly improved overall survival only in node-positive patients and in patie nts with estrogen receptor-positive (ER+) or progesterone receptor-positive (PR+) tumors. Disease-free survival, however, was significantly improved i n the global population and in several patient subgroups (node-positive, ER +, PR+). Patients in whom the interval between primary treatment and delaye d adjuvant tamoxifen was greater than five years also had significantly imp roved disease-free survival. Conclusions: Overall and disease-free survival results indicate that delaye d adjuvant tamoxifen administration (30 mg/day) is justified in women with early breast cancer, even if this treatment is initiated two or more years after primary treatment.