Randomized comparison of megestrol acetate versus dexamethasone versus fluoxymesterone for the treatment of cancer anorexia/cachexia

Purpose: Previous double-blind, placebo-controlled, randomized clinical tri als have demonstrated that both corticosteroids and progestational agents d o partially alleviate cancer anorexia/cachexia. Pilot information suggested that an anabolic corticosteroid might also improve appetites in patients w ith cancer anorexia/cachexia. The current trial was developed to compare an d contrast a progestational agent, a corticosteroid, and an anabolic cortic osteroid 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 interva ls to evaluate appetites and drug toxicities. Results: Fluoxymesterone resulted in significantly less appetite enhancemen t and did not have a favor able toxicity profile. Megestrol acetate and dex amethasone caused a similar degree of appetite enhancement and similar chan ges in nonfluid weight status, with nonsignificant trends favoring megestro l 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 2 5%; 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. (C) 1999 by American Society of Clinical Oncology.