[A double-blind randomized comparative study of oral 5-fluorouracil (5-FU), cyclophosphamide (CPA), and 5-FU + CPA in advanced breast cancer].
A randomized trial was performed comparing the effects of oral 5-fluorouracil (5-FU), 300 mg/day, cyclophosphamide (CPA), 150 mg/day and 5-FU + CPA in advanced breast cancer. Some 181 patients were entered in the trial, with 1 ineligible, and 14 incomplete cases. Then 166 were evaluated for their rates of response in the treatment groups: 14.0% (8/57) in 5-FU, 23.6% (13/55) in CPA, and 37.0% (20/54) in 5-FU + CPA, with a P value of 0.019. The difference in response rates between 5-FU and 5-FU + CPA was shown to be significant (p = 0.005). When long NC was included in the comparison, there was a significant difference (p = 0.006) between the groups. A higher incidence of adverse effects was noted in the combination group. A significant difference was noted in TTP (time to progression) among the 3 groups (p = 0.0144), and between 5-FU and 5-FU + CPA (p = 0.0061). There were no significant differences in the overall survival among the groups (p = 0.6808). In conclusion, the combination oral treatment of 5-FU and CPA appears effective as a first line therapy for advanced breast cancer, and also in the postoperative adjuvant setting.
Takayama
T
T
Dept. of Breast Surgery, National Kyushu Cancer Center.
Nomura
Y
Y
D000284:Administration, Oral; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008875:Middle Aged; D016016:Proportional Hazards Models
D003520:Cyclophosphamide; D005472:Fluorouracil