Cancer Chemotherapy and Pharmacology

, Volume 42, Supplement 1, 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

  • Toru Watanabe
Original Article

DOI: 10.1007/s002800051082

Cite this article as:
Watanabe, T. Cancer Chemother Pharmacol (1998) 42(Suppl 1): S68. doi:10.1007/s002800051082


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.

Key words

Uracil Tegafur Cyclophosphamide Methotrexate 5-FU Phase III 

Copyright information

© Springer-Verlag 1998

Authors and Affiliations

  • Toru Watanabe
    • 1
  1. 1.Department of Medical OncologyNational Cancer Center HospitalChuo-ku, TokyoJapan