Ten-year results of a randomized trial on adjuvant chemo-endocrine therapy with tamoxifen for stage II breast cancer

Abstract

Background

A prospective randomized multi-center study was undertaken for 2 years and 3 months from November 1982, with the aim of examining the significance of using a combination of futraful (FT) and tamoxifen (TAM) for postoperative adjuvant therapy for stage II breast cancer after curative surgery.

Methods

Patients were divided into two groups and received one of the following treatment protocols: treatment A, intravenous administration of doxorubicin (DOX) 20 mg/body on the day of surgery and 10 mg/body the next day, followed by oral FT 600 mg/day for 2 years from the 14th day after surgery; treatment B, the same pattern of DOX administration followed by combined therapy with FT and TAM 20 mg/day for 2 years. The number of patients was 428 (treatment A 210 and treatment B 218), of whom 418 (97.7%) were followed for 10 years for analysis.

Results

Significantly higher 5- and 10-year overall survival (OS) rates were observed with treatment B compared with treatment A (p = 0.0101 and 0.0219). Node-positive patients appeared to derive more benefit from TAM than node-negative patients. The difference in 10-year OS between treatment A and treatment B was more evident than that of the 5-year OS in patients with more than 4 positive nodes (p = 0.0313 vs. 0.0479). No increase in adverse reactions was seen as a result of combining TAM with FT.

Conclusion

The study results demonstrate that for stage II breast cancer concomitant administration of FT and TAM is superior to FT alone for postoperative adjuvant therapy, and administration of TAM for 2 years may contribute not only to 5-year survival rates but also to 10-year survival rates of node-positive patients.