Raloxifene & Pre-menopausal Women

#A193 Effect of Raloxifene on Menstrual Cycle Length and Quality of Life in Premenopausal Women at High Risk for Invasive Breast Cancer.

Jennifer Eng-Wong,1 Pamela Stratton,2 Michelle Forman,1 David Venzon,1 Alan Remaley,1 Jo Anne Zujewski.1

National Cancer Inst.,1 Bethesda, MD, National Institute of Child Health and Human Development, 2 Bethesda, MD.

Background: Raloxifene is currently being studied for breast cancer risk reduction in postmenopausal women at high risk of breast cancer in the STAR trial against tamoxifen.

Raloxifene is currently indicated for the prevention and treatment of osteoporosis in postmenopausal women. However there is insufficient data about the safety of long term raloxifene use in premenopausal women.

To determine the effect of raloxifene on menstrual cycle length and menopause related quality of life issues, we evaluated premenopausal women at increased risk for breast cancer who took raloxifene for up to 12 months in an open-label uncontrolled pilot study.

Methods: Twenty nine subjects with regular menstrual cycles (26-35 days) tracked their cycle length for one to three months before starting raloxifene and then after starting drug for up to one year. Subjects agreed to use non-hormonal contraception while taking raloxifene.

The baseline cycle length was determined to be the median of documented baseline cycles. An irregular cycle on drug was defined as more than a 5 day difference from a subjects baseline cycle.

We determined intra-subject change in average cycle length, percent of irregular cycles, and percent of cycles >40 days and <21 days while on raloxifene. Subjects also completed the Menopause Specific Quality of Life Questionnaire (MENQOL) at baseline and after 6 and 12 months on drug to assess changes in four domains:

vasomotor, psychosocial, physical and sexual. Significance was determined by the Wilcoxon signed rank test. Results: The average median baseline cycle length was 26.3 days (range 20-31 days). On raloxifene, the average cycle length was 28.4 days (range 23.4 to 43.8 days).

The mean difference on drug was 2.2 days and is marginally different from zero (p=0.042). 18% of 392 cycles were irregular on raloxifene. Nine subjects reported at least one cycle >40 days in length (range 1-3 cycles per subject). 11 subjects reported at least one cycle <21 days long (range 1-3 cycles per subject). 24 subjects completed MENQOL assessment at baseline, 6 and 12 months.

In the vasomotor domain, subjects reported a non-significant increase in symptoms, from an average score of 1.35 (on a 1-8 scale) to 1.69 at 6 months and 1.70 at 12 months. For the psychosocial domain, the baseline average score is 2.26, 2.20 at 6 months and 2.36 at 12 months.

For the physical domain, the baseline score is 1.95, and 2.16 at 6 months and 2.17 at 12 months. For the sexual domain, the baseline score is 1.53, and 1.46 at 6 months and 1.53 at 12 months.

Conclusions: Raloxifene exposure for up to one year is associated with a small increase in menstrual cycle length in premenopausal women and has minimal effects on quality of life. Additional studies are needed to determine whether raloxifene use by premenopausal women is safe.

Frontiers in Cancer Prevention Research, 2003 AACR

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