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


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 >or= 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 >or= 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).


CONCLUSIONS
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.
Goodwin
J Wendall
JW
Cancer Research for the Ozarks, 1730 E Republic Rd, Suite V, Springfield, MO 65804, USA. jgoodwin@sprg.mercy.net
Green
Stephanie J
SJ
Moinpour
Carol M
CM
Bearden
James D
JD
Giguere
Jeffrey K
JK
Jiang
Caroline S
CS
Lippman
Scott M
SM
Martino
Silvana
S
Albain
Kathy S
KS
D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage*; D001943:Breast Neoplasms / Q000188:drug therapy*; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D019290:Megestrol Acetate / Q000008:administration & dosage*; D008593:Menopause / Q000187:drug effects*; D008875:Middle Aged; D010919:Placebos; D013629:Tamoxifen / Q000627:therapeutic use
D018931:Antineoplastic Agents, Hormonal; D010919:Placebos; D013629:Tamoxifen; D019290:Megestrol Acetate