A prospective randomized study of megestrol acetate and ibuprofen in gastrointestinal cancer patients with weight loss

The use of megestrol acetate in the treatment of weight loss in gastrointes tinal cancer patients has been disappointing. The aim of the present study was to compare the combination of megestrol acetate and placebo with megest rol acetate and ibuprofen in the treatment of weight loss in such patients. At baseline, 4-6 weeks and 12 weeks, patients underwent measurements of an thropometry, concentrations of albumin and C-reactive protein and assessmen t of appetite, performance status and quality of life using EuroQol-EQ-5D a nd EORTC QLQ-C30. Thirty-eight and 35 patients (median weight loss 18%) wer e randomized to megestrol acetate/placebo or megestrol acetate/ibuprofen, r espectively, for 12 weeks. Forty-six (63%) of patients failed to complete t he 12-week assessment. Of those evaluable at 12 weeks, there was a decrease in weight (median 2.8 kg) in the megestrol acetate/placebo group compared with an increase (median 2.3 kg) in the megestrol acetate/ibuprofen group ( P < 0.001). There was also an improvement in the EuroQol-EQ-5D quality of l ife scores of the latter group (P < 0.05). The combination of megestrol ace tate/ibuprofen appeared to reverse weight loss and appeared to improve qual ity of life in patients with advanced gastrointestinal cancer. Further tria ls of this novel regimen in weight-losing patients with hormone-insensitive cancers are warranted.