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Postoperative Adjuvant Therapy With Tamoxifen, Tegafur Plus Uracil, or Both in Women With Node-Negative Breast Cancer: A Pooled Analysis of Six Randomized Controlled Trials

From the Collaborative Study Group of Adjuvant Chemo-Endocrine Therapy for Breast Cancer; St Luke’s Hospital, Tokyo; Department of Surgical Oncology, Osaka University Medical School; Osaka Medical Center for Cancer and Cardiovascular Disease, Osaka; Kushiro Rosai Hospital, Kushiro; Fukushima Medical College, Fukushima; Aichi Cancer Center, Nagoya; Kyushu Central Hospital, Fukuoka; and Niigata University, Niigata, Japan

Address reprint requests to Shinzaburo Noguchi, MD, Department of Surgical Oncology, Osaka University Medical School, 2-2 Yamadaoka Suita, Osaka 565-0871, Japan; e-mail: noguchi{at}onsurg.med.osaka-u.ac.jp

PURPOSE: This article reports the results of a pooled analysis of six randomized trials conducted to study the efficacy of uracil and tegafur (UFT) in the adjuvant treatment of node-negative breast cancer patients.

PATIENTS AND METHODS: Six randomized controlled trials on node-negative breast cancer patients were conducted from 1992 through 1995 in Japan that included the three, three-arm trials (control [no adjuvant], UFT, and tamoxifen [TAM] groups) and the three, four-arm trials (control, UFT, TAM, and UFT plus TAM groups). Pooled analysis was performed on the data obtained from these six trials (involving 2,934 patients).

RESULTS: Overall survival was compared between the UFT group (including both the UFT group and the TAM plus UFT group) and the non-UFT group (control group and TAM group). A significant difference (P = .04) was observed in 5-year survival rates between the UFT (95.9%) and the non-UFT (94.0%) groups. Overall survival was also compared between the TAM group (TAM group and TAM plus UFT group) and the non-TAM group (control group plus UFT group). The 5-year survival rate (95.2%) in the TAM group was not significantly different from that (93.9%) in the non-TAM group, but the subset analysis showed a significant (P = .01) improvement in the estrogen receptor-positive subset.

CONCLUSION: Adjuvant UFT improves the overall survival of node-negative breast cancer patients. Given that UFT has milder adverse effects, it is suggested that UFT can be a useful alternative to doxorubicin and cyclophosphamide, or cyclophosphamide, methotrexate, and fluorouracil in the adjuvant treatment for node-negative breast cancer.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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