Originally published as JCO Early Release 10.1200/JCO.2008.18.3939 on February 9 2009

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Oral Uracil and Tegafur Compared With Classic Cyclophosphamide, Methotrexate, Fluorouracil As Postoperative Chemotherapy in Patients With Node-Negative, High-Risk Breast Cancer: National Surgical Adjuvant Study for Breast Cancer 01 Trial

From the Department of Medicine, Hamamatsu Oncology Center; Atami Hospital, International University of Health and Welfare; Department of Surgery, Shizuoka General Hospital, Shizuoka; Department of Surgery, Niigata Cancer Center Hospital, Niigata; Department of Surgery, National Hospital Organization Shikoku Cancer Center Hospital, Ehime; Department of Surgery, Tokai University School of Medicine, Kanagawa; Breast Center, Mita Hospital, International University of Health and Welfare; Department of Breast Cancer, Tokyo Medical University Hospital; Department of Breast Pathology, The Cancer Institute of Japanese Foundation for Cancer Research; Department of Biostatistics, School of Public Health, University of Tokyo, Tokyo; Department of Breast Oncology, Aichi Cancer Center Hospital, Aichi; Department of Health Science, Ritsumeikan University School of Engineering, Kyoto; Department of Breast and Thyroid Surgery, Kawasaki Medical School, Okayama; and the Department of Basic Pathology, National of Defense Medical College, Saitama.

Corresponding author: Toru Watanabe, MD, PhD, Department of Medicine, Hamamatsu Oncology Center, 3-6-13 Chuo, Naka-ku, Hamamatsu, Shizuoka, 430-0929, Japan; e-mail: twatanab{at}oncoloplan.com.

Purpose The primary aim of this study was to compare the effectiveness of oral uracil-tegafur (UFT) with that of classical cyclophosphamide, methotrexate, and fluorouracil (CMF) given as postoperative adjuvant treatment to women with node-negative, high-risk breast cancer.

Patients and Methods Women with node-negative, high-risk breast cancer were randomly assigned to receive either 2 years of UFT or six cycles of CMF after surgery. The primary end point was relapse-free survival (RFS). Overall survival (OS), toxicity, and quality of life (QOL) were secondary end points. The hypothesis was that UFT was not inferior to CMF in terms of RFS.

Results Between October 1996 and April 2001, a total of 733 patients were randomly assigned to receive either treatment. The median follow-up time was 6.2 years. The RFS rates at 5 years were 88.0% in the CMF arm and 87.8% in the UFT arm. OS rates were 96.0% and 96.2%, respectively. The hazard ratios of the UFT arm relative to the CMF arm were 0.98 for RFS (95% CI, 0.66 to 1.45; P = .92) and 0.81 for OS (95% CI, 0.44 to 1.48; P = .49). The toxicity profiles differed between the two groups. The QOL scores were better for patients given UFT than those given CMF.

Conclusion RFS and OS with oral UFT were similar to those with classical CMF. Given the higher QOL scores, oral UFT is a promising alternative to CMF for postoperative adjuvant chemotherapy in women with node-negative, high-risk breast cancer.

Supported by the Japan Health Sciences Foundation and by Taiho Pharmaceutical Co, Ltd, Tokyo, Japan. The National Surgical Adjuvant Study Group received governmental research grants from the Ministry of Health and Welfare in 1995 and 1996; and the N-SAS-BC 01 trial was financially supported by Taiho Pharmaceutical Co, Ltd.

Presented in part at the 43rd Annual Meeting of the American Society of Clinical Oncology, June 12-16, 2007, Chicago, IL.

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

Clinical Trials repository link available on JCO.org

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