PLACEBO-CONTROLLED TRIAL OF MEDROXYPROGESTERONE ACETATE IN GASTROINTESTINAL MALIGNANCIES AND CACHEXIA

Background: Cancer cachexia is a common and serve medical problem in t he management of patients with cancer, and its treatment remains a the rapeutic challenge. Medroxyprogesterone acetate (MPA), which has been used for many years for hormonal therapy of breast cancer, has been no ted to produce weight gain and increase appetite unrelated to any anti tumour effect. To assess its symptomatic therapeutic value in patients suffering from advanced gastrointestinal malignancies and cachexia, t he present double-blind placebo-controlled trial was initiated. Method s: Thirty-one patients with advanced gastrointestinal malignancies suf fering from anorexia and weight loss were entered into this study and randomised to receive the anabolic steroid medroxyprogesterone acetate (MPA) 500 mg/day or placebo for 3 months. The primary end-points for comparison were body weight, appetite, Karnofsky performance status an d quality of life, all of which were serially evaluated in monthly int ervals until death. Results: A beneficial effect of MPA was noted in t erms of weight as well as quality of life (measured by the functional living index for cancer). In the treatment arm, median body weight inc reased from 58 kg at study entry to 61 kg after 3 months, as compared to a decrease in median weight from 57.5 kg to 55 kg in the placebo ar m. Partial palliative responses in quality of life were documented in 4/10 (40%) evaluable patients treated with MPA versus 2/14 (14%) in th ose who received placebo. There was no difference between the two trea tment groups with regard to appetite (an improvement was indicated by 6 patients in each arm), Karnofsky performance score or overall surviv al. Conclusion: In summary, our preliminary data seem to support the p otential therapeutic value of MPA for symptomatic treatment of cancer cachexia in patients with advanced gastrointestinal malignancies.