Adjuvant chemotherapy with cyclophosphamide or CMF in premenopausal women with stage II breast cancer.

After total mastectomy and partial axillary dissection, 805 premenopausal women with stage II breast cancer were randomized to receive postoperative radiotherapy (RT) alone, RT + cyclophosphamide (C) for 12 monthly cycles, or RT + cyclophosphamide/methotrexate/5-fluorouracil (CMF) for 12 monthly cycles. At 3 years actuarial relapse-free survival for RT + C and RT + CMF was significantly better than for RT alone (p = 0.0009 and 0.0001, respectively). There was no significant difference in relapse-free survival between RT + C and RT + CMF. C resulted in more pronounced haematologic toxicity and a higher frequency of amenorrhoea and of alopecia than CMF, while CMF resulted in more pronounced nausea and stomatitis than C. In the preliminary results, C alone may be as effective as CMF in prolonging relapse-free survival in premenopausal women with stage II breast cancer.

RCT Entities:   Population Interventions Outcomes