Progestins such as MA have been shown lo reduce vasomotor flashes (VF) in breast cancer survivors with ovarian failure. Previous studies were of very short duration and tested a single MA dose. Therefore, S9626 was designed to determine optimal MA dose and duration of benefit in patients with VF refractory to non-hormonal therapy. Methods: Women with T1-3N0-1M0 breast cancer were eligible after completion of surgery and chemotherapy if they had ≥ 10 VF of any severity or ≥5 severe VF/wk. Ongoing tamoxifen (tam) was allowed if started ≥4 months prior to registration. Double blind randomization was to P, MA 20 mg or MA 40 mg for 3 months (strata: tam use, number VF, duration VF). Success at 3 months was defined as ≥75% reduction in VF. If success, another 3 months of blinded drug was given; if not, open label MA 20 mg was added to blinded drug and continued for 3 months. The trial concluded at the 6 month VF assessment. Further treatment was at investigator discretion. Assessments of toxicity, weight, and patient-reported quality of life (QOL) including mood, vaginal dryness, and sexual function were obtained at baseline, 3, and 6 months. Results: 288 women were randomized, of whom 15% were on tam, 40% had over 63 VF/week, and 74% had VF for ≥6 months. Success at 3 months was 14% P, 67% MA 20 mg and 48% MA 40 mg (chi square, 2df p<.0001). Most successes at 3 months continued at 6 months (64% P, 74% MA 20 mg, 82% MA 40 mg). Weight gain was reported in 11% P, 4% MA 20 mg and 8% MA 40 mg; depression: 8%, 5%, 13%; fatigue: 8%, 6%, 13%. Data on benefit from adding open label MA 20 mg at 3 months will be available in 12/01, as will QOL endpoints. Conclusions: Randomized symptom management studies in breast cancer survivors are feasible in cooperative group settings. MA significantly reduced VF with durable benefit over 6 months. 20 mg/d may be the preferred dose.
|Original language||English (US)|
|Number of pages||1|
|Journal||Breast Cancer Research and Treatment|
|State||Published - 2001|
ASJC Scopus subject areas
- Cancer Research