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JNCI Journal of the National Cancer Institute 2001 93(9):684-690; doi:10.1093/jnci/93.9.684
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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

Bernard Fisher, James Dignam, John Bryant, Norman Wolmark

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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J. R. Benson
Re: 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
J Natl Cancer Inst, October 3, 2001; 93(19): 1493 - 1494.
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 JCOHome page
D. L. Wickerham
Ductal Carcinoma-In-Situ
J. Clin. Oncol., September 15, 2001; 19(90001): 98s - 100.
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 JNCI J Natl Cancer InstHome page
National Institutes of Health Consensus Development Conference Statement: Adjuvant Therapy for Breast Cancer, November 1-3, 2000
J Natl Cancer Inst, July 4, 2001; 93(13): 979 - 989.
[Abstract] [Full Text] [PDF]

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 CMAJHome page
K. I. Pritchard, M. Levine, and B. Walley
Raloxifene: handle with care
Can. Med. Assoc. J., July 1, 2001; 165(2): 151 - 153.
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 JNCI J Natl Cancer InstHome page
J. S. Abrams
Tamoxifen: Five Versus Ten Years--Is the End in Sight?
J Natl Cancer Inst, May 2, 2001; 93(9): 662 - 664.
[Full Text] [PDF]


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