Megestrol Acetate for the Prevention of Hot Flashes
Charles L. Loprinzi, John C. Michalak, Susan K. Quella, Judith R. O'Fallon, Alan K. Hatfield, Robert A. Nelimark, Ann Marie Dose, Tammy Fischer, Claudia Johnson, Nancy E. Klatt, Walter W. Bate, Raylene M. Rospond, and Joseph E. Oesterling
Background Vasomotor hot flashes are a common symptom in womenduring menopause and in men who have undergone androgen-deprivationtherapy for prostate cancer. Although treatment with estrogensin women and androgens in men can attenuate these symptoms,these hormones may be contraindicated in women with breast cancerand in men with prostate cancer. Pilot trials have suggestedthat the progestational agent megestrol acetate can amelioratehot flashes in both groups of patients.
Methods The patients included 97 women with a history of breastcancer and 66 men with prostate cancer who had undergone androgen-deprivationtherapy. All patients had experienced bothersome hot flashes(median number per day at base line, 6.1 for the women and 8.4for the men). After a one-week pretreatment observation period,the patients received megestrol acetate (20 mg twice daily)for four weeks, followed by placebo for four weeks, or viceversa in a double-blind manner as determined by pretreatmentrandomization. The patients documented the frequency and severityof hot flashes in daily symptom diaries.
Results After four weeks, hot flashes were reduced by 21 percentin the group receiving placebo first and by 85 percent in thegroup receiving megestrol acetate first (P<0.001). An intention-to-treatanalysis of data for all eligible treated patients showed that74 percent of the megestrol acetate group, as compared with20 percent of the placebo group, had a decrease of 50 percentor more in the frequency of hot flashes during the first fourweeks (P<0.001). The degree of efficacy was similar in menand women. The only side effect was withdrawal menstrual bleedingin women, generally occurring one to two weeks after the megestrolacetate had been discontinued.
Conclusions Low-dose megestrol acetate is well tolerated andcan substantially decrease the frequency of hot flashes in womenand men. .
Source Information
From the Departments of Oncology and Urology, Mayo Clinic and Mayo Foundation, Rochester, Minn. (C.L.L., S.K.Q., J.R.O., A.M.D., J.E.O.); Siouxland Hematology-Oncology Associates, Sioux City, Iowa (J.C.M.); the Carle Cancer Center Community Clinical Oncology Program, Urbana, Ill. (A.K.H.); the Sioux Community Cancer Consortium, Sioux Falls, S.D. (R.A.N.); the Quain and Ramstad Clinic, Bismarck, N.D. (T.F.); the St. Luke's Hospitals Community Clinical Oncology Program, Fargo, N.D. (C.J.); the Grand Forks Clinic, Grand Forks, N.D. (N.E.K.); the Iowa Oncology Research Association Community Clinical Oncology Program, Des Moines (W.W.B.); and the Nebraska Oncology Group, Creighton University and University of Nebraska Medical Center, Omaha (R.M.R.). Additional participating investigators and institutions are listed in the Appendix.
Address reprint requests to Dr. Loprinzi at the Mayo Clinic, 200 First St., SW, Rochester, MN 55905.
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