© 1997 by Oxford University Press
Journal Of The National Cancer Institute, Vol 89, 776-782, Copyright © 1997 by Oxford University Press
JP Costantino, LH Kuller, DG Ives, B Fisher and J Dignam
BACKGROUND AND PURPOSE: Data from randomized clinical trials in Scotland
and Sweden testing the efficacy of tamoxifen therapy in patients with
breast cancer have suggested that the drug may also reduce the risk of
coronary heart disease. In view of these findings, we examined mortality
from coronary heart disease among patients with early stage breast cancer
who were enrolled in the National Surgical Adjuvant Breast and Bowel
Project B-14 trial of tamoxifen therapy. METHODS: Deaths occurring among
women who were randomly assigned to 5 years of either tamoxifen or placebo
in the first phase of the B-14 trial were reviewed to determine the cause.
Three categories of heart disease-related death were defined: 1) death from
a definite fatal myocardial infarction, 2) death from definite fatal
coronary heart disease/possible myocardial infarction, and 3) death from
possible fatal coronary heart disease. Comparisons of the findings by
treatment group were made on the basis of average annual hazard (i.e.,
death) rates and the corresponding relative hazard of death. RESULTS: The
average annual death rate from coronary heart disease was lower for
patients who received tamoxifen than for patients who received placebo, but
the difference was not statistically significant. There were eight definite
heart-related deaths (i.e., definite fatal myocardial infarction or
definite fatal coronary heart disease/possible myocardial infarction) among
the patients who received tamoxifen, yielding an average annual rate of
0.62 per 1000 patients. There were 12 definite heart-related deaths among
the patients who received placebo, yielding an average annual rate of 0.94
per 1000. The corresponding relative hazard of death from definite fatal
heart disease (tamoxifen versus placebo) was 0.66 (95% confidence interval
= 0.27-1.61). Eleven deaths in the tamoxifen group and 10 deaths in the
placebo group were classified as possible cases of fatal coronary heart
disease. When these cases and the definite cases were considered together,
the average annual death rate for the patients who received tamoxifen was
1.48 per 1000, and the rate for the patients who received placebo was 1.73
per 1000. The corresponding relative hazard of death was 0.85 (95%
confidence interval = 0.46-1.58). CONCLUSIONS: The findings from the B- 14
trial are consistent with the findings from the Scottish and the Swedish
trials, suggesting that tamoxifen treatment reduces coronary heart disease
among patients with breast cancer. Continued follow-up of the patients in
these trials and in ongoing prevention trials is needed to accumulate
enough data so that reliable conclusions can be drawn about the benefits of
tamoxifen in preventing heart disease.
ARTICLES
Coronary heart disease mortality and adjuvant tamoxifen therapy
Department of Biostatistics, University of Pittsburgh, National Surgical Adjuvant Breast and Bowel Project, PA 15261, USA.
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