Megestrol acetate in advanced, progressive, hormone-insensitive cancer. Effects on the quality of life: a placebo-controlled, randomised, multicentretrial

A randomised double-blind placebo-controlled multicentre trial was performe d to investigate the effects of megestrol acetate (MA) on the quality of li fe (QoL), appetite, weight and survival of patients with advanced, incurabl e, hormone-insensitive cancer. QoL was assessed at the start of treatment a nd at 4, 8 and 12 weeks, using the EORTC-QLQ-C30 instrument. 255 patients w ere randomised to 320 mg of MA daily or placebo for 12 weeks. 244 patients were assessable at baseline, 190 at 4 weeks (placebo 94; MA 96), 150 at 8 w eeks (placebo 69; MA 81) and 112 at 12 weeks (placebo 55; IMA 57). A benefi cial effect of IMA on appetite loss was observed at week 4 (P < 0.0001) and possibly at week 8 (P = 0.058). Further weight loss during treatment was s ignificant only in the placebo group. In the first 8 weeks, changes in mean global QoL were small and similar in both groups. By 12 weeks the decrease in mean global QoL was more pronounced in the IMA group (P = 0.028), which was related to a deterioration in physical function, while psychosocial fu nction was not affected. Survival was not affected by MA, and side-effects were mild. The results show that MA has a beneficial effect on appetite and that it may retard weight loss with no adverse impact on survival and with mild toxicity. However, MA does not appear to improve global QoL as measur ed by the EORTC QLQ-C30. (C) 1999 Published by Elsevier Science Ltd. All ri ghts reserved.