A RANDOMIZED ADJUVANT BREAST-CANCER TRIAL COMPARING CONVENTIONAL WITHPERIOPERATIVE INITIATION OF CHEMOTHERAPY

Background - The rationale of the present study was to validate the hy pothesis of a favorable influence of a perioperative initiation of adj uvant chemotherapy in patients viith operable breast cancer of various prognostic groups, as suggested by results of experimental data. Pati ents and Methods - Patients with operable breast cancer were entered i nto a prospective trial and randomized to receive epidoxorubicin and c yclophosphamide either on days 1, 8 and 15 ( = perioperative) or on da ys 22, 29 and 35 ( = postoperative), day one being the day of surgery, All patients with lymph node involvement and lymph node-negative prem enopausal patients negative for estrogen receptor [ER] received 3 addi tional cycles of adjuvant chemotherapy with cyclophosphamide, methotre xate, and fluorouracil. All ER-positive patients received 20 mg tamoxi fen per day for two years. Results - No increased toxicity or wound he aling problems were found in patients in the perioperative group, With a median follow-up of 70 months, 76 out of 221 (34%) eligible patient s have relapsed, Neither the overall (p=0.09), nor the risk-factor-adj usted (p=0.22) comparison showed a significant association of timing o f treatment initiation with the risk of recurrence. Conclusion - We do not see an advantage in disease-free survival as a result of a periop erative initiation of adjuvant: chemotherapy.