© 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 = 0.58–0.74), 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 = 0.71–0.99) 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; 88:1529–42]
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