© 1996 by Oxford University Press
Journal of the National Cancer Institute, Vol. 88, No. 21, 1529-1542,
November 6, 1996
© 1996 Oxford University Press
Five Versus More Than Five Years of Tamoxifen Therapy for Breast Cancer Patients With Negative Lymph Nodes and Estrogen Receptor-Positive Tumors
National Surgical Adjuvant Breast and Bowel Project (NSABP) and Department of Surgery, University of Pittsburgh, PA
NSABP and Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh
NSABP Medical Oversight, University of Pittsburgh
NSABP and Allegheny General Hospital, Pittsburgh
Department of Biometry and Epidemiology, College of Medicine, Medical University of South Carolina Charleston
Institute of Pathology, Shadyside Hospital Pittsburgh
Manitoba Cancer Foundation, Winnipeg, Canada
St. Sacrement Hospital Quebec City, PQ, Canada
Department of Medicine, Michigan State University East Lansing
Jewish General Hospital Montreal PQ, Canada
Hotel-Dieu, Montreal
Royal Victoria Hospital Montreal
City of Hope Medical Center Duarte, CA
Cross Cancer Institute Edmonton, AB, Canada
Boston University MA
Ohio State University Columbus
Geisinger Medical Center Danville, PA
Women's College Hospital Toronto, ON, Canada
*Bernard Fisher, M.D., University of Pittsburgh School of Medicine, 3550 Terrace St., Rm. 914, Pittsburgh, PA 15261.
Background: In 1982, the National Surgical Adjuvant Breast and Bowel Project initiated a randomized, double-blinded, placebo-controlled trial (B-14) to determine the effectiveness of adjuvant tamoxifen therapy in patients with primary operable breast cancer who had estrogen receptor-positive tumors and no axillary lymph node involvement. The findings indicated that tamoxifen therapy provided substantial benefit to patients with early stage disease. However, questions arose about how long the observed benefit would persist, about the duration of therapy necessary to maintain maximum benefit, and about the nature and severity of adverse effects from prolonged treatment Purpose: We evaluated the outcome of patients in the B-14 trial through 10 years of follow-up. In addition, the effects of 5 years versus more than 5 years of tamoxifen therapy were compared. Methods: In the trial, patients were initially assigned to receive either tamoxifen at 20 mg/day (n = 1404) or placebo (n = 1414). Tamoxifen-treated patients who remained disease free after 5 years of therapy were then reassigned to receive either another 5 years of tamoxifen (n = 322) or 5 years of placebo (n = 321). After the study began, another group of patients who met the same protocol eligibility requirements as the randomly assigned patients were registered to receive tamoxifen (n = 1211). Registered patients who were disease free after 5 years of treatment were also randomly assigned to another 5 years of tamoxifen (n = 261) or to 5 years of placebo (n = 249). To compare 5 years with more than 5 years of tamoxifen therapy, data relating to all patients reassigned to an additional 5 years of the drug were combined. Patients who were not reassigned to either tamoxifen or placebo continued to be followed in the study. Survival, disease-free survival, and distant disease-free survival (relating to failure at distant sites) were estimated by use of the Kaplan-Meier method; differences between the treatment groups were assessed by use of the logrank test. The relative risks of failure (with 95% confidence intervals [CIs]) were determined by use of the Cox proportional hazards model. Reported P values are two-sided. Results: Through 10 years of follow-up, a significant advantage in disease-free survival (69% versus 57%, P<.0001; relative risk = 0.66; 95% CI = 0.580.74), distant diseasefree survival (76% versus 67%, P<.0001; relative risk = 0.70; 95% CI = 0.61-0.81), and survival (80% versus 76%, P = .02; relative risk = 0.84; 95% CI = 0.710.99) was found for patients in the group first assigned to receive tamoxifen. The survival benefit extended to those 49 years of age or younger and to those 50 years of age or older. Tamoxifen therapy was associated with a 37% reduction in the incidence of contralateral (opposite) breast cancer (P =.007). Through 4 years after the reassignment of tamoxifentreated patients to either continued-therapy or placebo groups, advantages in disease-free survival (92% versus 86%, P =.003) and distant disease-free survival (96% versus 90%, P = .01) were found for those who discontinued tamoxifen treatment. Survival was 96% for those who discontinued tamoxifen compared with 94% for those who continued tamoxifen treatment (P = .08). A higher incidence of thromboembolic events was seen in tamoxifen-treated patients (through 5 years, 1.7% versus 0.4%). Except for endometrial cancer, the incidence of second cancers was not increased with tamoxifen therapy. Conclusions and Implications: The benefit from 5 years of tamoxifen therapy persists through 10 years of follow-up. No additional advantage is obtained from continuing tamoxifen therapy for more than 5 years. [J Natl Cancer Inst 1996; 88:152942]
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L. M. Greenberger, T. Annable, K. I. Collins, B. S. Komm, C. R. Lyttle, C. P. Miller, P. G. Satyaswaroop, Y. Zhang, and P. Frost A New Antiestrogen, 2-(4-Hydroxy-phenyl)-3-methyl-1-[4-(2-piperidin-1-yl-ethoxy)-benzyl]-1H-indol-5-ol hydrochloride (ERA-923), Inhibits the Growth of Tamoxifen-sensitive and -resistant Tumors and Is Devoid of Uterotropic Effects in Mice and Rats Clin. Cancer Res., October 1, 2001; 7(10): 3166 - 3177. [Abstract] [Full Text] [PDF] |
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M. S. Aapro Adjuvant Therapy of Primary Breast Cancer: A Review of Key Findings from the 7th International Conference, St. Gallen, February 2001 Oncologist, August 1, 2001; 6(4): 376 - 385. [Abstract] [Full Text] [PDF] |
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A. S. Knoop, S. M. Bentzen, M. M. Nielsen, B. B. Rasmussen, and C. Rose Value of Epidermal Growth Factor Receptor, HER2, p53, and Steroid Receptors in Predicting the Efficacy of Tamoxifen in High-Risk Postmenopausal Breast Cancer Patients J. Clin. Oncol., July 15, 2001; 19(14): 3376 - 3384. [Abstract] [Full Text] [PDF] |
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S. M. Swain Tamoxifen and Contralateral Breast Cancer: the Other Side J Natl Cancer Inst, July 4, 2001; 93(13): 963 - 965. [Full Text] [PDF] |
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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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J. Chang, S. G. Hilsenbeck, J. H. Sng, J. Wong, and G. C. Ragu Pathological Features and BRCA1 Mutation Screening in Premenopausal Breast Cancer Patients Clin. Cancer Res., June 1, 2001; 7(6): 1739 - 1742. [Abstract] [Full Text] [PDF] |
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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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B. Fisher, J. Dignam, J. Bryant, and N. Wolmark 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, May 2, 2001; 93(9): 684 - 690. [Abstract] [Full Text] [PDF] |
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T. A. Buchholz, S. L. Tucker, J. Erwin, D. Mathur, E. A. Strom, M. D. McNeese, G. N. Hortobagyi, M. Cristofanilli, F. J. Esteva, L. Newman, et al. Impact of Systemic Treatment on Local Control for Patients With Lymph Node-Negative Breast Cancer Treated With Breast-Conservation Therapy J. Clin. Oncol., April 15, 2001; 19(8): 2240 - 2246. [Abstract] [Full Text] [PDF] |
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I. N.H. White, P. Carthew, R. Davies, J. Styles, K. Brown, J. E. Brown, L. L. Smith, and E. A. Martin Short-term dosing of {{alpha}}-hydroxytamoxifen results in DNA damage but does not lead to liver tumours in female Wistar/Han rats Carcinogenesis, April 1, 2001; 22(4): 553 - 557. [Abstract] [Full Text] [PDF] |
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H. J. Stewart, R. J. Prescott, and A. P. M. Forrest Scottish Adjuvant Tamoxifen Trial: a Randomized Study Updated to 15 Years J Natl Cancer Inst, March 21, 2001; 93(6): 456 - 462. [Abstract] [Full Text] [PDF] |
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B. Fisher, J. Dignam, E. Tan-Chiu, S. Anderson, E. R. Fisher, J. L. Wittliff, and N. Wolmark Prognosis and Treatment of Patients With Breast Tumors of One Centimeter or Less and Negative Axillary Lymph Nodes J Natl Cancer Inst, January 17, 2001; 93(2): 112 - 120. [Abstract] [Full Text] [PDF] |
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S. Demissie, R. A. Silliman, and T. L. Lash Adjuvant Tamoxifen: Predictors of Use, Side Effects, and Discontinuation in Older Women J. Clin. Oncol., January 15, 2001; 19(2): 322 - 328. [Abstract] [Full Text] [PDF] |
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B. G. Macik, J. H. Rand, and B. A. Konkle Thrombophilia: What's a Practitioner to Do? Hematology, January 1, 2001; 2001(1): 322 - 338. [Abstract] [Full Text] [PDF] |
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E. S. Lee, J. M. Schafer, K. Yao, G. England, R. M. ORegan, A. D. L. Reyes, and V. C. Jordan Cross-Resistance of Triphenylethylene-type Antiestrogens but not ICI 182,780 in Tamoxifen-stimulated Breast Tumors Grown in Athymic Mice Clin. Cancer Res., December 1, 2000; 6(12): 4893 - 4899. [Abstract] [Full Text] |
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J. M. Nabholtz, A. Buzdar, M. Pollak, W. Harwin, G. Burton, A. Mangalik, M. Steinberg, A. Webster, and M. von Euler Anastrozole Is Superior to Tamoxifen as First-Line Therapy for Advanced Breast Cancer in Postmenopausal Women: Results of a North American Multicenter Randomized Trial J. Clin. Oncol., November 15, 2000; 18(22): 3758 - 3767. [Abstract] [Full Text] [PDF] |
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V. R. Agarwal, E. D. Bischoff, T. Hermann, and W. W. Lamph Induction of Adipocyte-specific Gene Expression Is Correlated with Mammary Tumor Regression by the Retinoid X Receptor-Ligand LGD1069 (Targretin) Cancer Res., November 1, 2000; 60(21): 6033 - 6038. [Abstract] [Full Text] |
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B. Gerber, A. Krause, H. Muller, T. Reimer, T. Kulz, J. Makovitzky, G. Kundt, and K. Friese Effects of Adjuvant Tamoxifen on the Endometrium in Postmenopausal Women With Breast Cancer: A Prospective Long-Term Study Using Transvaginal Ultrasound J. Clin. Oncol., October 20, 2000; 18(20): 3464 - 3470. [Abstract] [Full Text] [PDF] |
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K. Holli, R. Valavaara, G. Blanco, V. Kataja, P. Hietanen, M. Flander, E. Pukkala, and H. Joensuu Safety and Efficacy Results of a Randomized Trial Comparing Adjuvant Toremifene and Tamoxifen in Postmenopausal Patients With Node-Positive Breast Cancer J. Clin. Oncol., October 20, 2000; 18(20): 3487 - 3494. [Abstract] [Full Text] [PDF] |
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T. Delozier, M. Spielmann, J. Mace-Lesec'h, M. Janvier, C. Hill, B. Asselain, J.-P. Julien, B. Weber, L. Mauriac, J.-C. Petit, et al. Tamoxifen Adjuvant Treatment Duration in Early Breast Cancer: Initial Results of a Randomized Study Comparing Short-Term Treatment With Long-Term Treatment J. Clin. Oncol., October 20, 2000; 18(20): 3507 - 3512. [Abstract] [Full Text] [PDF] |
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D. B. Muchmore Raloxifene: A Selective Estrogen Receptor Modulator (SERM) with Multiple Target System Effects Oncologist, October 1, 2000; 5(5): 388 - 392. [Abstract] [Full Text] |
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C. K. Osborne and S. A. W. Fuqua Selective Estrogen Receptor Modulators: Structure, Function, and Clinical Use J. Clin. Oncol., September 17, 2000; 18(17): 3172 - 3186. [Abstract] [Full Text] [PDF] |
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A. U. Buzdar Tamoxifen's Clinical Applications: Old and New Arch Fam Med, September 1, 2000; 9(9): 906 - 912. [Abstract] [Full Text] [PDF] |
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K. Yao, E.-S. Lee, D. J. Bentrem, G. England, J. I. M. Schafer, R. M. O'Regan, and V. C. Jordan Antitumor Action of Physiological Estradiol on Tamoxifen-stimulated Breast Tumors Grown in Athymic Mice Clin. Cancer Res., May 1, 2000; 6(5): 2028 - 2036. [Abstract] [Full Text] [PDF] |
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S. M. Lippman and P. H. Brown Tamoxifen Prevention of Breast Cancer: an Instance of the Fingerpost J Natl Cancer Inst, November 3, 1999; 91(21): 1809 - 1819. [Full Text] [PDF] |
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W. McCaskill-Stevens, E. T. Hawk, P. J. Flynn, and S. M. Lippman National Cancer Institute-Supported Cancer Chemoprevention Research: Coming of Age J. Clin. Oncol., November 1, 1999; 17(90001): 53 - 62. [Full Text] [PDF] |
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L. Bernstein, D. Deapen, J. R. Cerhan, S. M. Schwartz, J. Liff, E. McGann-Maloney, J. A. Perlman, and L. Ford Tamoxifen Therapy for Breast Cancer and Endometrial Cancer Risk J Natl Cancer Inst, October 6, 1999; 91(19): 1654 - 1662. [Abstract] [Full Text] [PDF] |
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J. M. Hrung, C. P. Langlotz, S. G. Orel, K. R. Fox, M. D. Schnall, and J. S. Schwartz Cost-effectiveness of MR Imaging and Core-Needle Biopsy in the Preoperative Work-up of Suspicious Breast Lesions Radiology, October 1, 1999; 213(1): 39 - 49. [Abstract] [Full Text] |
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