© 2001 by Oxford University Press
Journal of the National Cancer Institute, Vol. 93, No. 9, 662-664,
May 2, 2001
© 2001 Oxford University Press
EDITORIAL |
Tamoxifen: Five Versus Ten YearsIs the End in Sight?
Affiliation of author: Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.
Correspondence to: Jeffrey S. Abrams, M.D., National Institutes of Health, 6130 Executive Blvd., EPN 7040, Bethesda, MD 20892 (e-mail: abramsj@ctep.nci.nih.gov).
This issue of the Journal updates a truly seminal study, the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-14 (1). For students of history, few clinical trials provide as many valuable lessons as B-14 does with regard to both hormone-responsive breast cancer treatment and clinical trials methodology. Initiated in 1981, it was the first placebo-controlled trial performed by the NSABP. A total of 2892 women with lymph node-negative, estrogen receptor (ER)-positive tumors were enrolled. By 1988, initial results indicated a disease-free survival (DFS) benefit for tamoxifen in this subset of women (2). More important, premenopausal and postmenopausal women benefited equally from tamoxifen in B-14, contrary to the predominant belief at the time that only postmenopausal women should receive adjuvant tamoxifen (3). The findings led to the issuance by the National Cancer Institute (NCI) (Bethesda, MD) of a clinical alert (4), with
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