COMPARISON OF THE EFFECT OF MEGE-STROL VERSUS MIRTAZAPINE IN THE TREATMENT OF ANOREXIA-CACHEX-IA SYNDROME IN PATIENTS WITH ADVANCED CANCER

Introduction: Cancer-associated anorexia-cachexia is an insidious syndrome that has an impact on the patient’s quality of life and survival. Mirtazapine has a special therapeutic potential due to its well-known orexigenic action in clinical practice. Objective: To evaluate the effect of mirtazapine compared to megestrol in the treatment of cancer-related anorexia-cachexia syndrome in cancer patients with advanced disease. Method: A randomized, double-blind, controlled clinical trial enrolled 52 patients with anorexia-cachexia syndrome and advanced cancer. Participants were randomized to receive mirtazapine 30 mg/day or megestrol 320 mg/day for eight weeks. The primary outcome measure was the effect of mirtazapine compared to megestrol on loss of appetite and weight gain. The linear regression model with mixed effects was used for the comparative analysis. A significance level of 5% was adopted. The project was registered on the Clinical Trials platform and approved by the local Research Ethics Committee. Results: 239 patients were eligible, of which 52 were randomized. The mean age was 65.8±8.4 years, with a predominance of men (51.9%). There was improvement in appetite in 92% of the participants in the megestrol group and in only 56% of the mirtazapine group at 60 days after the intervention (p=0.007). In the weight assessment, there was improvement in 52% of participants in the megestrol group and in only 38% of the participants in the mirtazapine group at 30 days after the intervention (p=0.040). However, this difference was not maintained after 60 days, with weight maintenance or improvement in 50% of the participants in both groups (p=0.166). In the sub-analysis performed by sex, there was a difference in the therapeutic response. Although the improvement in appetite was more evident with megestrol in both sexes, only women showed benefit with the use of mirtazapine at 30 days and 60 days (p<0.01). In addition, there was weight gain in the group of women who received mirtazapine at 30 (p=0.02) and 60 days (p<0.01), which was not observed in men. Therapeutic adherence was better in the megestrol group (p=0.02). Conclusion: Megestrol appears to be superior to mirtazapine in improving 30-day weight and 60-day appetite in patients with advanced cancer and anorexia-cachexia syndrome. However, there may be a difference between the sexes in the therapeutic response and women seem to benefit from the use of mirtazapine.