WEEKLY DOXORUBICIN WITH OR WITHOUT HIGH-DOSE A MEDROXYPROGESTERONE ACETATE IN HORMONE-RESISTANT ADVANCED BREAST-CANCER - A RANDOMIZED STUDY

In a randomised study, 218 patients with advanced breast cancer, resis tant to hormone therapy, received either doxorubicin 20 mg every week (Awkly) alone or Awkly combined with high doses (1000 mg daily) of ora l medroxyprogesterone acetate (HD-MPA). Of the 210 evaluable patients, the response rates were 26% [95% confidence interval (CI) 18-34%] for Awkly and 38% (95% CI 29-47%) for Awkly + HD-MPA (P = 0.08). There wa s no significant difference with regard to duration of response. Media n survival was 11 months in both groups. Considerable toxicity was see n from HD-MPA, particularly weight gain and fluid retention. The prese nt study provides evidence that, in concordance with preclinical studi es and a previous randomised study, interaction between chemotherapy a nd HD-MPA may exist in breast cancer normally resistant to hormone the rapy. For further studies, other gestagens and/or a dose reduction cou ld be investigated.