Adjuvant cyclophosphamide, methotrexate and 5-fluorouracil versus cyclophosphamide plus futraful for premenopausal patients with stage I-II and one- to three-node-positive breast cancer: Results of a prospective randomized study

Abstract

A prospective randomized study was conducted to compare the adjuvant efficacy of 12 cycles of low-dose CMF (cyclophosphamide: CPA, methotrexate; MTX, 5-fluorouracil; 5-FU) with that of orally administered CPA plus FT (futraful) in premenopausal patients with stage I-II and one- to three-nodepositive breast cancer. The 12-cycle CMF group (91 patients) received, 100 mg CPA orally on days 1 to 14 plus 20 mg MTX and 500 mg 5-FU intravenously (iv) on days 1 and 8 of each cycle. The CPA plus FT group (85 patients) received 100 mg CPA and 600 mg FT orally each day for one year. The background characteristics of the two groups were comparable. At 5 and 10 years, there were non-significant trends towards better disease-free and overall survival rates in the CMF group. Both treatments were well tolerated, but more patients in the CPA plus FT group refused to continue chemotherapy because of continuous gastrointestinal disturbances. No clear benefit of adding low-dose MTX to CPA and fluoropyrimidines was observed in this subgroup of Japanese patients. Further studies will be required to clarify the superiority of conventional-dose of CMF treatment to orally administered CPA plust FT treatment.