Cardiac and vascular morbidity in women receiving adjuvant tamoxifen for breast cancer in a randomised trial. The Scottish Cancer Trials Breast Group.
OBJECTIVE
To determine any cardiac or vascular morbidity associated with long term treatment with tamoxifen given after mastectomy for primary breast cancer.


METHODS
Cohort study using linkage between database of a randomised trial and statistics of Scottish hospital inpatients to identify episodes of cardiac and vascular morbidity.


METHODS
NHS hospitals in Scotland.


METHODS
1312 women who had undergone mastectomy for breast cancer and who were randomised either to a treatment group to receive adjuvant tamoxifen or to a control group to be given tamoxifen only on first relapse of disease. Maximum duration of tamoxifen treatment was 14 years. Total woman years of follow up were 9943.


METHODS
Randomised and observational comparisons of risk (expressed as hazard ratios) of myocardial infarction, other cardiac event, cerebrovascular disease, or thromboembolic event according to treatment allocated and between nonusers, former users, and current users of tamoxifen.


RESULTS
Use of tamoxifen was associated with lower rates of myocardial infarction. Hazard ratio for women in control group was 1.92 (95% confidence interval 0.99 to 3.73) compared with women allocated to adjuvant treatment. The association was stronger for current use: hazard ratio for non-users was 3.49 (1.52 to 8.03) compared with current users. Current users of tamoxifen, however, had higher rates of thromboembolic events:hazard ratio for non-users was 0.40 (0.18 to 0.90) compared with current users.


CONCLUSIONS
Our results provide further evidence that tamoxifen reduces the risk of myocardial infarction. Thromboembolic events should be carefully monitored in trials of tamoxifen, particularly those of prophylactic treatment, in which tamoxifen is given to healthy women.
McDonald
C C
CC
Scottish Cancer Trials Office, Medical School, University of Edinburgh.
Alexander
F E
FE
Whyte
B W
BW
Forrest
A P
AP
Stewart
H J
HJ
D000328:Adult; D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D015331:Cohort Studies; D005260:Female; D006760:Hospitalization; D006801:Humans; D008134:Long-Term Care; D008408:Mastectomy; D008875:Middle Aged; D009203:Myocardial Infarction / Q000139:chemically induced*; D012307:Risk Factors; D016019:Survival Analysis; D013629:Tamoxifen / Q000009:adverse effects*; D013923:Thromboembolism / Q000139:chemically induced*; D016896:Treatment Outcome
D018931:Antineoplastic Agents, Hormonal; D013629:Tamoxifen