Estrogen Receptor Status

Figure 12.9 Incidence of osteoporotic fractures of the hip, wrist, and spine observed in the placebo- and ta-moxifen-treated arms of the National Surgical Adjuvant Breast and Bowel Project tamoxifen prevention trial P-1. (Adapted from Fisher et al.106)

Figure 12.9 Incidence of osteoporotic fractures of the hip, wrist, and spine observed in the placebo- and ta-moxifen-treated arms of the National Surgical Adjuvant Breast and Bowel Project tamoxifen prevention trial P-1. (Adapted from Fisher et al.106)

reaching statistical significance. This reduction was greatest in women who were 50 years and older at study entry. No differences in the risks of myocardial infarction, angina, coronary artery bypass grafting, or angioplasty were noted between groups.106

This study confirms the association between tamoxifen and endometrial carcinoma.114,158 The RR of endometrial cancer in the tamoxifen group was 2.5, with women over age 50 having a RR of 4.01. All endometrial cancers in the ta-moxifen group were grade 1, and none of the women receiving tamoxifen died of endometrial cancer. There was one endometrial cancer death in the placebo group. Although there is no doubt that tamoxifen increases the risk of endometrial cancer, it is important to recognize that this increase translates to a yearly incidence of 2.3 women per 1000.

More women in the tamoxifen group developed deep vein thrombosis106 with the excess risk confined to women over 50 years. The RR of deep vein thrombosis in the older age group was 1.71 (95% confidence interval 0.85-3.58). An increase in pulmonary emboli was also seen in the older women taking tamoxifen, with an RR of approximately 3. Three deaths from pulmonary emboli occurred in the tamoxifen arm, all in women with significant comorbidities. An increased incidence of stroke (RR = 1.75) was also seen in the tamoxifen group, but this did not reach statistical significance.

Assessment of quality of life showed similar depression scores between groups. Hot flashes were noted in 81% of the women on tamoxifen compared to 69% of the placebo group, and the tamoxifen-associated hot flashes appeared to be of comparable severity. In the tamoxifen group, 29% of the women and 13% in the placebo group reported moderate or severe vaginal discharge. No differences in the occurrence of irregular menses, nausea, fluid retention, skin changes, or weight gain or loss were reported.

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