ANTICACHECTIC EFFICACY OF MEGESTROL-ACETATE AT DIFFERENT DOSES AND VERSUS PLACEBO IN PATIENTS WITH NEOPLASTIC CACHEXIA

Anorexia and cachexia are present in the majority of patients with adv anced-stage cancer. Several agents have been tested for their ability to reverse weight loss in these patients. Megestrol acetate has been d emonstrated to improve appetite and weight, independent of tumor respo nse, when used in the treatment of metastatic breast cancer. Several t rials have studied the ability of megestrol acetate to stimulate weigh t gain in patients with non-hormone-sensitive tumors. One hundred fift y patients with a weight lost of more than 5% in the 3 previous months were randomized between double-blind megestrol acetate 160 mg daily ( LMA), megestrol acetate 480 mg daily (HMA), or placebo (P). Weight, mi d-arm circumference, triceps skinfold thickness (TST), performance sta tus (Karnofsky index), and a quality-of-life status by seven linear an alogic self-assessment scales were assessed before the start of treatm ent and at 4, 8, and 12 weeks thereafter. One hundred seven patients w ere assessable at 4 weeks, 79 at 8 weeks, and 64 at 12 weeks. Sixty-ei ght percent of patients treated with HMA increased their weights durin g their permanence on study, versus 37% and 38% of patients treated wi th P or LMA (p < 0.03). The mean weight gain after 12 weeks of treatme nt with HMA was 5.41 kg. A significant increase on TST was observed in the HMA group versus the LMA and P groups. There was no gain in perfo rmance status or quality of life in any group of treatment. The toxici ty registered was mild. There were no thromboembolic events. This tria l supports the efficacy of megestrol acetate at 480 mg/day in the trea tment of cancer-related cachexia and anorexia, with mild toxicity. How ever, performance status and quality of life were not influenced by th is treatment.