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. Design : Randomised controlled clinical trial. Setting : 127 Institutions in Japan. Subjects : 785 Pati...

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Bibliographic Details
Published in:The European journal of surgery 2001-08, Vol.167 (8), p.598-604
Main Author: Tominaga, Muneaki Sano, Tsunehiro Nishi, Michio Sasaki, Kouichi Yoshida, Morihiko Kimura, Shigemistu Takashima, Testu Asano, Minoru Yoshida, Jun Fujiwara, Makoto Danno, Takeshi
Format: Article
Language:English
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Summary: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. Design : Randomised controlled clinical trial. Setting : 127 Institutions in Japan. Subjects : 785 Patients with stage II carcinoma (palpable axillary nodes) who had total mastectomy and axillary clearance. Interventions : 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. Conclusion : 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.
ISSN:1102-4151
1741-9271
DOI:10.3109/110241501753171209