Cancer Control Research
1R03CA073964-01
Subak, Leslee L.
UTERINE SURVEILLANCE & MANAGEMENT DURING TAMOXIFEN THERA
AbstractDESCRIPTION: Tamoxifen is beneficial for treatment of breast cancer, but is
associated with a marked increased risk of uterine cancer. With over
1,000,000 women worldwide taking tamoxifen, uterine surveillance has become
a major clinical issue. There are currently few data on the value of
routine uterine screening to detect premalignant uterine pathology in
asymptomatic women or diagnostic testing in women with abnormal uterine
bleeding. Early detection and treatment of premalignant disease may prevent
uterine cancer, but screening and treatment protocols have not been
established. We propose a cross-sectional study to collect pilot data on
prevalence of endometrial pathology and a brief prospective cohort study to
determine response to treatment of premalignant uterine pathology in 100
women with a uterus who have breast cancer and are taking tamoxifen. We
will also obtain pilot data on the accuracy of screening and diagnostic
testing with endovaginal ultrasound (EVS) and magnetic resonance imaging
(MRI) to detect abnormal uterine pathology. Women will be recruited from
the UCSF/Mount Zion Breast Care Center and the UCSF Medical Oncology Clinic
which currently care for 175 women receiving tamoxifen. All women on
tamoxifen for at least one year will be asked to participate in this study
and undergo EMB, EVS, and MRI. If premalignant uterine pathology is found,
women may 1) continue tamoxifen, 2) discontinue tamoxifen, 3) continue
tamoxifen and add a progestin, 4) discontinue tamoxifen and add a progestin,
or 5) undergo hysterectomy. The choice of treatment will be left to the
woman and her physicians and will be depend on her estimated benefit of
tamoxifen and the risk associated with her specific endometrial abnormality.
The EMB, EVS, and MRI will be repeated in 3 months to evaluate treatment
response.
This pilot study data will allow us to assess the magnitude of the clinical
problem of premalignant uterine pathology and will provide preliminary data
on the accuracy of EVS and MRI for screening and diagnosis, using
endometrial biopsy (EMB) as the gold standard, in women with breast cancer
taking tamoxifen. It will also provide estimates of the effectiveness of
treatments for premalignant uterine pathology. These pilot data will not
provide adequate statistical power to evaluate our research questions, but
will allow planning of a longitudinal study of incidence of uterine
pathology, accuracy of screening tests, and response to treatment.
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