Prevention of Endometrial Tumors (POET)
- To determine if treatment with intrauterine levonorgestrel (using the Mirena®
intrauterine system [IUS]) reduces the incidence of atypical endometrial hyperplasia
(AEH) and endometrial cancer in women with hereditary non-polyposis colorectal cancer
or Lynch syndrome.
- Determine the age-related incidence of AEH and endometrial cancer in these patients.
- Determine the sensitivity and specificity of transvaginal sonography and endometrial
biopsy in detecting AEH and endometrial cancer.
- Determine the premalignant pathway to carcinoma.
- Determine if the Mirena® IUS reduces the rate of therapeutic hysterectomy for AEH or
- Determine the psychological benefits or adverse effects from the use of the Mirena®
- Determine the satisfaction and compliance with screening.
- Determine the extent of adverse effects of the Mirena® IUS and observation.
- Determine the molecular changes associated with pre-malignant changes in the
endometrium of these patients, and possibly the utility of tests on cervical mucus
samples in diagnosing endometrial cancer.
OUTLINE: This is a multicenter study. Patients are stratified by center and menopausal
status. Patients are randomized to 1 of 2 arms.
- Arm I: Patients undergo insertion of the Mirena® intrauterine device containing
levonorgestrel. The device is scheduled to remain in place for 4 years. Patients also
undergo observation comprising an assessment of menstrual history, transvaginal
scanning (TVS), and endometrial biopsy (or hysteroscopy) at baseline and then annually
for 4 years.
- Arm II: Patients undergo observation comprising an assessment of menstrual history,
TVS, and endometrial biopsy (or hysteroscopy) at baseline and then annually for 4
Patients complete a personal health and lifestyle questionnaire, the Life Events Scale, and
the Profile of Mood States (POMS) questionnaires at baseline and periodically during study.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Allocation: Randomized, Masking: Open Label, Primary Purpose: Prevention
Rate of atypical endometrial hyperplasia or endometrial cancer during the active follow-up period of the study
Shirley Hodgson, MD
St George's, University of London