• R Scott Braithwaite, Rowan T Chlebowski, Joseph Lau, Suzanne George, Rachel Hess, and Nananda F Col.
• Section of Clinical Systems Modeling, Division of General Internal Medicine, Department of Medicne, University of Pittsburgh, Pittsburgh, PA 15213, USA. braithwaiters@msx.upmc.edu
• J Gen Intern Med. 2003 Nov 1; 18 (11): 937947937-47.

ObjectiveTamoxifen reduces the risk of developing breast cancer but also affects the risks of certain vascular and neoplastic events. Our purpose was to estimate the effects of tamoxifen on potentially life-threatening vascular and neoplastic outcomes.DesignRandom effects meta-analysis of published randomized controlled trials.PatientsParticipants in all trials in which a treatment arm that included tamoxifen was compared to a similar control arm. Breast cancer risk reduction and treatment trials were included.InterventionsTamoxifen at variable dose and duration.Measurements And Main ResultsThirty-two trials (52,929 patients) reported one or more outcomes of interest. Tamoxifen was associated with significantly increased risks of endometrial cancer (relative risk [RR] 2.70; 95% CI, 1.94 to 3.75), gastrointestinal cancers (RR 1.31; 95% CI, 1.01 to 1.69), strokes (RR 1.49; 95% CI, 1.16 to 1.90), and pulmonary emboli (RR 1.88; 95% CI, 1.77 to 3.01). Tamoxifen had no effect on secondary malignancies other than endometrial and gastrointestinal cancers (RR 0.96; 95% CI, 0.81 to 1.13). In contrast, tamoxifen significantly decreased myocardial infarction deaths (RR 0.62; 95% CI, 0.41 to 0.93) and was associated with a statistically insignificant decrease in myocardial infarction incidence (RR 0.90; 95% CI, 0.66 to 1.23). Postmenopausal women had greater risk increases for neoplastic outcomes.ConclusionsThis meta-analysis of randomized trials found tamoxifen use to be significantly associated with several neoplastic and vascular outcomes. Consideration of tamoxifen use requires balance of potential benefits and risks.

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