© 2001 by Oxford University Press
Journal of the National Cancer Institute, Vol. 93, No. 9, 684-690,
May 2, 2001
© 2001 Oxford University Press
Five Versus More Than Five Years of Tamoxifen for Lymph Node-Negative Breast Cancer: Updated Findings From the National Surgical Adjuvant Breast and Bowel Project B-14 Randomized Trial
Affiliations of authors: B. Fisher, National Surgical Adjuvant Breast and Bowel Project (NSABP), and Department of Surgery, University of Pittsburgh, PA; J. Dignam, NSABP Biostatistical Center, University of Pittsburgh, and Department of Health Studies, University of Chicago, IL; J. Bryant, NSABP Biostatistical Center and Department of Biostatistics, University of Pittsburgh; N. Wolmark, NSABP and Allegheny General Hospital, Pittsburgh.
Correspondence to: Bernard Fisher, M.D., National Surgical Adjuvant Breast and Bowel Project, 4 Allegheny Center, Suite 602, Pittsburgh, PA 15212–5234 (e-mail: bernard.fisher{at}nsabp.org).
Background: Previously reported information from B-14, a National Surgical Adjuvant Breast and Bowel Project (NSABP) randomized, placebo-controlled clinical trial, demonstrated that patients with estrogen receptor (ER)-positive breast cancer and negative axillary lymph nodes experienced a prolonged benefit from 5 years of tamoxifen therapy. When these women were rerandomized to receive either placebo or more prolonged tamoxifen therapy, they obtained no additional advantage from tamoxifen through 4 years of follow-up. Because the optimal duration of tamoxifen administration continues to be controversial and because there have been 3 more years of follow-up and a substantial increase in the number of events since our last report, an update of the B-14 study is appropriate. Methods: Patients (n = 1172) who had completed 5 years of tamoxifen therapy and who were disease free were rerandomized to receive placebo (n = 579) or tamoxifen (n = 593). Survival, disease-free survival (DFS), and relapse-free survival (RFS) were estimated by the Kaplan–Meier method; the differences between the treatment groups were assessed by the log-rank test. Relative risks of failure (with 95% confidence intervals) were determined by the Cox proportional hazards model. P values were two-sided. Results: Through 7 years after reassignment of tamoxifen-treated patients to either placebo or continued tamoxifen therapy, a slight advantage was observed in patients who discontinued tamoxifen relative to those who continued to receive it: DFS = 82% versus 78% (P = .03), RFS = 94% versus 92% (P = .13), and survival = 94% versus 91% (P = .07), respectively. The lack of benefit from additional tamoxifen therapy was independent of age or other characteristics. Conclusion: Through 7 years of follow-up after rerandomization, there continues to be no additional benefit from tamoxifen administered beyond 5 years in women with ER-positive breast cancer and negative axillary lymph nodes.
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