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The Effect of SERMs on the Endometrium
Author(s) -
GOLDSTEIN STEVEN R.
Publication year - 2001
Publication title -
annals of the new york academy of sciences
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.712
H-Index - 248
eISSN - 1749-6632
pISSN - 0077-8923
DOI - 10.1111/j.1749-6632.2001.tb04027.x
Subject(s) - tamoxifen , medicine , breast cancer , endometrial cancer , gynecology , oncology , population , relative risk , cancer , obstetrics , cohort , carcinoma , confidence interval , environmental health
A bstract : Tamoxifen, the first clinically available SERM, was developed in 1966 and approved by the FDA (United States Food and Drug Administration) in 1978. It is the most prescribed antineoplastic drug in the world, with approximately 10 million women‐use‐years of experience. Tamoxifen has proved efficacious in all settings of breast cancer. However, in the mid‐to‐late 1980s, a series of letters to the editor and case reports announced an association between tamoxifen therapy in women with breast cancer and the development of endometrial carcinoma. Subsequently, in 1998, the observation of a significant 49% reduction in invasive breast cancer relative to placebo in a cohort of women at increased risk for the disease resulted in the early stopping of the National Surgical Adjuvant Breast and Bowel Project's (NSABP) P‐1: Breast Cancer Prevention Trial (BCPT). Importantly, this was the first time that information became available about the effects of tamoxifen in healthy women, that is, women who did not already have breast cancer. In this healthy population, the relative risk of developing endometrial carcinoma in the tamoxifen arm was 2.54, although when stratified by age, in women over 50, the risk grew to 4.01. Thus, the risk appears to be confined to women over 50 because, in contrast, in women under 50 there was no statistically significant increase in the risk of endometrial carcinoma.