OR YEARS, THERE HAS BEEN CONcern about possible associations of gynecologic malignancies with postmenopausal hormone therapy. The development of endometrial hyperplasia and endometrial cancer with unopposed estrogen is well recognized. To reduce or avoid this complication, progestin has been added, 1-3 although results from randomized trials are extremely limited. These concerns have created a need for reasonable monitoring guidelines to follow-up women who experience vaginal bleeding while taking estrogen plus progestin. The Women's Health Initiative (WHI) trial of estrogen plus progestin provides the first opportunity to examine possible associations of gynecologic malignancies with continuous combined postmenopausal hormone therapy in a large, randomized, double-blind, placebo-controlled setting. The trial was stopped early at the recommendation of the independent data and safety monitoring board on the basis of an increased risk of breast cancer supported by a summary measure of effects indicating risks exceeded
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