Postoperative chemoendocrine therapy for women with node-positive stage II breast cancer with combined cyclophosphamide, tamoxifen, and 1-hexylcarbamoyl-5-fluorouracil.
OBJECTIVE
To find out whether the addition of 1-hexylcarbamoyl-5-fluorouracil to a postoperative regimen of oral cyclophosphamide and tamoxifen improved the prognosis of carcinoma of the breast.


METHODS
Randomised controlled clinical trial.


METHODS
127 Institutions in Japan.


METHODS
785 Patients with stage II carcinoma (palpable axillary nodes) who had total mastectomy and axillary clearance.


METHODS
The control group were given oral cyclophosphamide 50 mg/day and tamoxifen 20 mg/day for 2 years; the experimental group were given these drugs plus 1-hexylcarbamoyl-5-fluorouracil 300 mg/day for 2 years.


RESULTS
There was no survival advantage (and more toxicity) in the experimental group, except in a subgroup with 1-3 axillary nodes involved.


CONCLUSIONS
The advantage of triple chemotherapy in the subgroup must be substantiated by a new randomised trial confined to patients with 1-3 axillary nodes involved.
Tominaga
T
T
Department of Surgery, Tokyo Metropolitan Komagome Hospital, Japan.
Sano
M
M
Nishi
T
T
Sasaki
M
M
Yoshida
K
K
Kimura
M
M
Takashima
S
S
Asano
T
T
Yoshida
M
M
Fujiwara
J
J
Danno
M
M
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001365:Axilla; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006801:Humans; D008207:Lymphatic Metastasis; D008408:Mastectomy; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011446:Prospective Studies; D015996:Survival Rate; D013629:Tamoxifen / Q000008:administration & dosage
D013629:Tamoxifen; D003520:Cyclophosphamide; C017367:carmofur; D005472:Fluorouracil