LACK OF EFFECTIVENESS OF ADJUVANT ALTERNATING CHEMOTHERAPY IN NODE-POSITIVE, ESTROGEN-RECEPTOR-NEGATIVE PREMENOPAUSAL BREAST-CANCER PATIENTS - RESULTS OF A MULTICENTRIC ITALIAN STUDY

A multicentric randomized trial was performed in premenopausal women w ith node-positive, estrogen-receptor-negative breast tumors to assess the potential superiority of alternating adjuvant chemotherapy over 's tandard' CMF chemotherapy. Between January 1989 and June 1992, 107 pat ients were entered into the study and randomly allocated to receive ei ther cyclophosphamide 100 mg/m(2) per os on days 1-14, methotrexate 40 mg/m(2) and 5-fluorouracil 600 mg/m(2) intravenously (IV) on days 1, 8 (CMF), every 4 weeks for a total of 6 cycles, or the following regim ens: CMF as previously, epidoxorubicin 75 mg/m(2) IV on day 1 and vinc ristine 0.75 mg/m(2) IV on days 1, 8 (EV); mitomycin-C 10 mg/m(2) IV o n day 1 and vindesine 2 mg/m(2) IV on days 1, 8 (MVs). The three regim ens were given every 4 weeks for a total of 6 cycles according to the following schedule: CMF, EV, MVs, CMF, EV, MVs. At a median follow up to 48 months (range 30-72), 40 patients have relapsed and 17 have died overall. More patients in the triple-combination arm have relapsed an d more have died, the latter difference tending toward statistical sig nificance (p = 0.06). There was no statistical difference in the site of elapse between the two groups. Total duration of adjuvant therapy w as similar in the two arms (312 chemotherapy cycles in the triple arm and 308 in the CMF arm). Treatment toxicity was also comparable, altho ugh more patients in the triple-combination arm were still regularly m enstruating 6 months after the completion of chemotherapy. This study failed to show any advantage ensuing from the use of alternating chemo therapy in patients with early breast cancer.