High-dose progestins for the treatment of cancer anorexia-cachexia syndrome: A systematic review of randomised clinical trials

Background: The aim of the present study was to summarise evidence from sci entific studies on cancer anorexia-cachexia syndrome in order to assess and highlight the efficacy of high-dose progestins (megestrol acetate and medr oxyprogesterone acetate) compared with placebo in patients with hormone-ind ependent tumors. Materials and methods: A systematic review of published randomised clinical trials was carried out by an extensive electronic and hand search through databases, relevant journals and books, congress proceedings, reference lis ts, without any language or year of publication restriction. The research w as conducted by two independent operators who collected the data in a form specifically designed for this review. Among the several possible outcomes, appetite and body weight were chosen. Results: Fifteen randomised clinical trials (more than 2000 patients) were retrieved for the review. There was a statistically significant advantage f or high-dose progestins as regards improved appetite: pooled odds ratio (OR ) = 4.23, 95% confidence interval (CI): 2.53-7.04. Although the effect of h igh-dose progestins on body weight was less impressive, statistical signifi cance was also reached for this outcome: pooled OR = 2.66, 95% CI: 1.80-3.9 2. Treatment morbidity was very low, due to the brief period of the treatment in most of the studies. Conclusions: The effects of high-dose progestins on appetite and body weigh t were clearly demonstrated. However, further studies are undoubtedly warra nted to investigate other aspects of progestin activity, especially as rega rds dosage, duration and timing with best therapeutic index.