IMPROVED LOCAL-CONTROL AND DISEASE-FREE SURVIVAL AFTER PERIOPERATIVE CHEMOTHERAPY FOR EARLY-STAGE BREAST-CANCER - A EUROPEAN ORGANIZATION FOR RESEARCH AND TREATMENT OF CANCER BREAST-CANCER COOPERATIVE GROUP-STUDY

Purpose: To investigate whether a short intensive course of perioperat ive polychemotherapy can change the course of early breast cancer. Pat ients and Methods: A total of 2,795 women with early breast cancer, st age I to IIIA, were randomized onto a trial (European Organization for Research and Treatment of Cancer [EORTC] 10854) to compare surgery fo llowed by one course of perioperative chemotherapy versus surgery alon e. Patients assigned to the chemotherapy arm received one course of fl uorouracil 600 mg/m(2), doxorubicin 50 mg/m(2), and cyclophosphamide 6 00 mg/m(2) (FAG) intravenously, within 24 hours after surgery. In both randomized treatment arms, a recommendation was made for premenopausa l women with positive axillary nodes to receive prolonged courses of c yclophosphamide, methotrexate, and fluorouracil (CMF), according to th e standard treatment for this subgroup. Results: At a median follow-up time of 41 months, local control was significantly better in the peri operative treatment arm as compared with the observation arm (hazards ratio, 0.60; 95% confidence interval, 0.44 to 0.83; P < .01). Disease- free survival was significantly prolonged in the chemotherapy arm (haz ards ratio, 0.84; 95% confidence interval, 0.70 to 0.99; P = .04). Pre menopausa node-negative patients especially showed an advantage for th e perioperative chemotherapy arm. No advantage for perioperative chemo therapy was observed in premenopausal node-positive women who also had received prolonged chemotherapy. Conclusion: We conclude that one cou rse of perioperative FAC is able to improve local control and can prol ong disease-free survival in women with early breast cancer. However, our results also suggest that a perioperative timing cannot improve th e results of standard prolonged chemotherapy in premenopausal women wi th positive axillary nodes.