RANDOMIZED TRIAL COMPARING PROTRACTED INFUSION OF 5-FLUOROURACIL WITHWEEKLY DOXORUBICIN AND CYCLOPHOSPHAMIDE WITH A MONTHLY BOLUS FAC REGIMEN IN METASTATIC BREAST-CARCINOMA (SPM90)

Infusional 5-fluorouracil in advanced breast cancer has been associate d with improved clinical response rates when compared with conventiona l bolus therapy. As a first line of chemotherapy in proven metastatic breast carcinoma, 258 women were randomly assigned to receive FAC cons isting of 5-fluorouracil (F) 600 mg m(-2) intravenously (i.v.) over 1 h on days 1, 2 and 3, doxorubicin (A) 50 mg m(-2) i.v. bolus on day 1 and cyclophosphamide (C), 400 mg m(-2) i.v. bolus on days 1, 2 and 3 o r 'FULON' consisting of 5-fluorouracil 250 mg m(-2) day(-1) continuous ly infused from day 1 to day 22, doxorubicin 15 mg m(-2) i.v, bolus on days 1, 8, 15 and 22 and cyclophosphamide 300 mg m(-2) i.v. bolus on days 1, 8, 15 and 22. Chemotherapy courses were administered 4-weekly for the bolus regimen and 6-weekly for FULON. Pretreatment characteris tics were identical between the two groups. Response rates were 54% in the FAC arm and 53% in the FULON arm. Time to progression was 14 mont hs in the FAC an and 12 months in the FULON arm. Differences were not statistically significant. Median overall survival duration for all pa tients was 22 months. Haematological toxicity was more severe in the b olus-treated group (P = 0.05), as were nausea and vomiting (P less tha n or equal to 0.01). We conclude that the two regimens appeared equall y effective but have different toxicities.