1253 Efficacy of megestrol acetate on anorexia in patients with advanced non hormone-related tumors: A double-blind placebo controlled clinical trial

Abstract

Megestrol acetate (MA) was reported to induce weight gain and increase of appetite in cancer patients. <h3>Methods</h3> Out-patients of the "Divisione Terapia del Dolore" of the "Istituto Nazionale per la Cura dei Tumori" (Milano) with advanced non hormone-responsive tumors and loss or absence of appetite, who didn't assume any corticosteroid were randomized for a Phase III trial, that consisted of two consecutive phases: a double-blind placebo controlled phase of 14 days (phase A) and an open phase of 76 days (phase B). During phase A patients were treated with MA 2 tablets × 160mg/day (a low dose for this indication) or placebo. In phase B all patients received different dosages of MA according to the response to treatment. A patient was considered responsive if his appetite, evaluated by means of a categoric-numeric scale, increased by 2 or more points. Other parameters investigated were: food intake, body weight, Perfonnance Status (Karnofsky), mood state (POMS) and pain. <h3>Results</h3> Forty-two patients were enrolled in this trial. Thirty-three patients were evaluable for efficacy: 13/16 MA patients were responsive for appetite vs 5/17 placebo patients. This result is clinically and statistically significant (<i>P</i><0.003). No relevant toxicity occurred during the study. <h3>Conclusions</h3> MA showed a remarkable effect on appetite with a low dose (2 tablets × 160mg/die) already after 14 days, without side-effects of relief. This result is of great importance considering the relevance of the quality of life and the low life expectancy of these patients and the low daily therapy costs of this treatment.