Tamoxifen or tamoxifen in combination with chemotherapy in adjuvant therapy of breast carcinoma. Results of a multicenter randomized study

Between April 1994 and May 1997 103 breast cancer patients (pts) pT1c-3a pN0-1 M0 were randomised after surgery to adjuvant tamoxifen (20 mg per day) or to tamoxifen plus CMF (C 500 mg/m2 M 40 mg/m2 and F 600 mg/m2 on days 1st and 8th q 28 day) in 6 cycles. The median age (49-72 years median 58) tumour size number of involved lymphnodes (0-3) estrogens receptor status grade (I-III) and type of operation were well balanced among the 50 pts on tamoxifen and the 53 pts on tamoxifen plus CMF pts preferably postmenopausal. Results. Grade of toxicity according to WHO criteria was not higher than two in both arms. Toxicity both haematological and non-haematological was higher in the group treated with chemotherapy (0 vs 32 resp. 20%) except weight gain +5% (52% in both group). After median follow-up of 42 mos five recurrences in tamoxifen and seven in tamoxifen plus CMF pts were observed (p=NS). The projected 3-y DFS is 92% for tamoxifen and 88% for tamoxifen plus CMF (p=NS). The 3-y OS is 88% for tamoxifen and 80% for tamoxifen plus CMF pts (p=NS). Conclusions. Both regimens are equally effective with higher toxicity in the group with combined chemo- and hormonal therapy. (authors)