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Randomized Comparison of Megestrol Acetate Versus Dexamethasone Versus Fluoxymesterone for the Treatment of Cancer Anorexia/Cachexia

From the Mayo Clinic and Mayo Foundation, Rochester, and Duluth Community Clinical Oncology Program (CCOP), Duluth, MN; Illinois Oncology Research Association CCOP, Peoria, and Carle Cancer Center CCOP, Urbana; Missouri Valley Cancer Consortium, Omaha, NE; and Scottsdale CCOP, Scottsdale, AZ.

Address reprint requests to Charles L. Loprinzi, MD, Mayo Clinic, 200 First St, SW, Rochester, MN 55905; email loprinzi.charles@ mayo.edu.

PURPOSE: Previous double-blind, placebo-controlled, randomized clinical trials have demonstrated that both corticosteroids and progestational agents do partially alleviate cancer anorexia/cachexia. Pilot information suggested that an anabolic corticosteroid might also improve appetites in patients with cancer anorexia/cachexia. The current trial was developed to compare and contrast a progestational agent, a corticosteroid, and an anabolic corticosteroid for the treatment of cancer anorexia/cachexia.

PATIENTS AND METHODS: Patients suffering from cancer anorexia/cachexia were randomized to receive either dexamethasone 0.75 mg qid, megestrol acetate 800 mg orally every day, or fluoxymesterone 10 mg orally bid. Patients were observed at monthly intervals to evaluate weight changes and drug toxicity. Patients also completed questionnaires at baseline and at monthly intervals to evaluate appetites and drug toxicities.

RESULTS: Fluoxymesterone resulted in significantly less appetite enhancement and did not have a favorable toxicity profile. Megestrol acetate and dexamethasone caused a similar degree of appetite enhancement and similar changes in nonfluid weight status, with nonsignificant trends favoring megestrol acetate for both of these parameters. Dexamethasone was observed to have more corticosteroid-type toxicity and a higher rate of drug discontinuation because of toxicity and/or patient refusal than megestrol acetate (36% v 25%; P = .03). Megestrol acetate had a higher rate of deep venous thrombosis than dexamethasone (5% v 1%; P = .06).

CONCLUSION: Whereas fluoxymesterone clearly seems to be an inferior choice for treating cancer anorexia/cachexia, megestrol acetate and dexamethasone have similar appetite stimulating efficacy but differing toxicity profiles.

Conducted as a trial of the North Central Cancer Treatment Group Clinic and supported in part by Public Health Service grants no. CA-25224, CA-37404, CA-15083, CA-63849, CA-35269, CA-35113, CA-35195, CA-60276, CA-52352, CA-37417, CA-35415, CA-35272, CA-35448, CA-35103, and CA-35101 from the National Cancer Institute, Department of Health and Human Services.

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