[Phase II trial evaluating the effect of megestrol acetate-prednisolone combination in the treatment of anorexia during the palliative-care phase of lung cancer].

Objectives: Anorexia is one of the most frequent complaints in patients who have reached the palliative-care phase of lung cancer. Megestrol acetate (or medroxyprogesterone acetate) and corticosteroids have been used with success, but the effect of their combination remains unknown. We conducted a phase II trial to assess the impact of combination therapy.

Patients And Methods: Patients with lung cancer given palliative care and who developed anorexia with or without weight loss were given 320 mg/d megestrol acetate in 2 doses and 40 mg/d prednisolone in one dose in the morning for 1 month. The principal outcome criterion was anorexia assessed on a visual analog scale prior to treatment and then at day 15 and day 30. Variation in daily calorie intake and weight were also recorded. We used an Armitage sequential plan to determine the number of inclusions necessary and the preference method (closed schema) to evaluate the principal outcome criterion.

Results: Inclusions were stopped after the eighth patient (giving p<0.05) as we observed a significant improvement in patient appetite. Daily calorie intake improved significantly (p<0.0001), by 39.18% the first 15 days and 16.57% more the next 15 days. Body weight improved significantly by 5.4% in one month (p=0.5). No treatment-related complication occurred during the study period or during the six consecutive months.

Conclusions: The megestrol acetate-prednisolone combination was found to improve anorexia in patients with lung cancer in the palliative-care phase and allowed a significant improvement in calorie intake and body weight.