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Phase III Randomized Placebo-Controlled Trial of Two Doses of Megestrol Acetate as Treatment for Menopausal Symptoms in Women With Breast Cancer: Southwest Oncology Group Study 9626

J. Wendall Goodwin, Stephanie J. Green, Carol M. Moinpour, James D. Bearden, III, Jeffrey K. Giguere, Caroline S. Jiang, Scott M. Lippman, Silvana Martino, Kathy S. Albain

From the Ozarks Regional Community Clinical Oncology Program, Springfield, MO; Pfizer Inc, New London, CT; Southwest Oncology Group Statistical Center, Seattle, WA; Upstate Carolina Community Clinical Oncology Program, Spartanburg; Greenville Community Clinical Oncology Program, Greenville, SC; Department of Medicine, University of Hawai’i, John A. Burns School of Medicine and The Queen's Medical Center, Honolulu, HI; The University of Texas M.D. Anderson Cancer Center, Houston, TX; The Angeles Clinic and Research Institute, Santa Monica, CA; and the Loyola University Chicago Stritch School of Medicine, Maywood, IL

Corresponding author: J. Wendall Goodwin, MD, Cancer Research for the Ozarks, 1730 E Republic Rd, Suite V, Springfield, MO 65804; e-mail: jgoodwin{at}sprg.mercy.net

Purpose Prior progestin studies treating hot flashes in women have been short duration and single dose. This study tests the progestin megesterol acetate (MA) at two doses versus placebo over 6 months.

Patients and Methods Patients with T1-3, N0-1, M0 breast cancer were eligible after completion of surgery and chemotherapy and at least 4 months of tamoxifen (if prescribed). Women were required to have at least 10 hot flashes of any severity or at least five severe episodes per week. Patients were randomly assigned to placebo, MA 20 mg, or MA 40 mg for 3 months. Success at 3 months was defined as completion of treatment with a 75% reduction in hot flashes from baseline. If success was achieved, drug treatment for another 3 months was given on the same blinded arm; if not, open-label MA 20 mg was added to blinded study drug and continued for 3 months. Other menopausal symptoms were also assessed.

Results Two hundred eighty eight eligible women were randomly assigned (286 eligible), of whom 85% were on tamoxifen, 40% had over 63 hot flashes/week, and 75% had vasomotor symptoms for 6 months. Success at 3 months was 14% on placebo, 65% on 20 mg, and 48% on 40 mg (both MA doses superior to placebo; P < .0001). Most successes at 3 months were maintained at 6 months (77% on 20 mg and 81% on 40 mg).

Conclusion MA significantly reduced vasomotor symptoms with durable benefit over 6 months. MA 20 mg/d is the preferred dose. There was no significant impact on other menopausal symptoms.

Supported in part by the following Public Health Service Cooperative Agreement grant numbers awarded by the National Cancer Institute, Department of Health and Human Services: CA38926, CA32102, CA35119, CA67663, CA45807, CA46441, CA76447, CA20319, CA35431, CA45377, CA58348, CA35281, CA67575, CA14028, CA58416, CA12213, CA35192, CA76132, CA46282, CA45808, CA35178, CA37981, CA04919, CA45450, CA03096, CA13612, CA42777, CA63844, CA12644, CA58882, CA76448, CA58658, CA22433, CA74647, CA76429, CA46136, CA63848, CA35262; and also by Bristol-Myers Squibb for active and placebo agents, as well as funding for distribution of study drug to participating institutions.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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