Uracil-tegafur and tamoxifen vs cyclophosphamide, methotrexate, fluorouracil, and tamoxifen in post-operative adjuvant therapy for stage I, II, or IIIA lymph node-positive breast cancer: a comparative study

Y Park, K Okamura, S Mitsuyama, T Saito, J Koh, S Kyono, K Higaki, M Ogita, T Asaga, H Inaji, H Komichi, N Kohno, K Yamazaki, F Tanaka, T Ito, H Nishikawa, A Osaki, H Koyama, T Suzuki, Y Park, K Okamura, S Mitsuyama, T Saito, J Koh, S Kyono, K Higaki, M Ogita, T Asaga, H Inaji, H Komichi, N Kohno, K Yamazaki, F Tanaka, T Ito, H Nishikawa, A Osaki, H Koyama, T Suzuki

Abstract

Background: It has been reported that treatment with uracil-tegafur (UFT) has shown significantly better survival and relapse-free survival (RFS) than surgery alone. Therefore, we compared UFT with a combination therapy of cyclophosphamide, methotrexate, and fluorouracil (CMF) in patients who had undergone curative surgery for axillary lymph node-positive breast cancer.

Methods: A total of 377 node-positive patients with stage I, II, or IIIA disease were registered from September 1996 through July 2000 and were randomly assigned to either 6 cycles of CMF or 2 years of UFT. In both arms, tamoxifen (TAM) was concurrently administered for 2 years. The primary end point in this study was the non-inferiority of UFT to CMF.

Results: No statistically significant difference between the two groups was observed with regard to the 5-year RFS rate (72.2% in the UFT and 76.3% in the CMF). Adverse event profiles differed between the two groups, with a significantly lower incidence of leukopenia and anaemia in the UFT group, as well as anorexia, nausea/vomiting, stomatitis, and alopecia, which have implications for quality of life.

Conclusion: UFT administered in combination with TAM holds promise in the treatment of lymph node-positive early breast cancer. On stratified analysis, the recurrence rate in the UFT group was found to be better in oestrogen receptor (ER)-positive patients. Tegafur-based treatment should be evaluated by a prospective randomised trial conducted in ER-positive patients.

Figures

Figure 1
Figure 1
Study design. ER, oestrogen receptor; CMF, cyclophosphamide–methotrexate–fluorouracil; TAM, tamoxifen; UFT, uracil-tegafur; W, week; Y, year; Surg, surgery; po, per os; CPA, cyclophosphamide; d, day; MTX, methotrexate; 5-FU, fluorouracil; i.v., intravenous.
Figure 2
Figure 2
Relapse-free and overall survival. (A) Relapse-free survival; (B) overall survival. CMF, cyclophosphamide–methotrexate–fluorouracil; UFT, uracil-tegafur; CI, confidence interval.
Figure 3
Figure 3
Relapse-free survival by age, number of involved nodes and ER, PgR, and ER/PgR status.

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Source: PubMed

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