, Volume 42, Issue 1 Supplement, pp S68-S70

Phase III randomized comparison of postoperative adjuvant chemotherapy with 2-year oral uracil/tegafur versus 6-cycle cyclophosphamide/methotrexate/5-fluorouracil in high-risk node-negative breast cancer patients

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The value of cyclophosphamide/methotrexate/ 5-fluorouracil (CMF)-type regimens in surgical adjuvant therapy in certain subsets of patients with axillary lymph node-negative breast cancer has been evaluated in Europe and the USA. However, Japan has a distinctive standpoint regarding the indications for surgical adjuvant chemotherapy for breast cancer patients. In addition, oral fluoropyr-imidines are widely used to treat breast cancer patients in both adjuvant and metastatic settings due to their low toxicity and convenience for long-term administration. Although the antitumor activity and the ability to prolong disease-free survival times of oral fluoropyrimidines have been evaluated in patients with breast cancer, available data are not sufficient to justify replacing CMF-type regimens with oral fluoropyrimidines in postoperative chemotherapy for breast cancer patients. To evaluate the utility of oral fluoropyrimidines in surgical adjuvant chemotherapy, the National Surgical Adjuvant Study Group (N-SAS) was founded in 1995 as a government-funded research group, and nationwide multiinstitutional trials were designed for breast cancer as well as colon and gastric cancers. For high-risk, node-negative breast cancer patients, a prospective randomized trial of surgical adjuvant chemotherapy comparing 6 cycles of CMF with 2 years of daily uracil/tegafur (UFT) started in October 1996. The endpoints of this study include disease-free and overall survival, adverse reactions, quality of life, and cost.

Work presented at the 13th Bristol-Myers Squibb Nagoya International Cancer Treatment Symposium, “Strategic Cross Talk between Major Oncology Groups/Clinical Pharmacology in Cancer Chemotherapy,” 17–18 October 1997, Nagoya, Japan