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Clinical Trial
. 1978 Apr 30;64(2):143-9.
doi: 10.1177/030089167806400204.

High dose medroxyprogesterone acetate (MPA) treatment in metastatic carcinoma of the breast: a dose-response evaluation

Clinical Trial

High dose medroxyprogesterone acetate (MPA) treatment in metastatic carcinoma of the breast: a dose-response evaluation

G R Cuna et al. Tumori. .

Abstract

The results of controlled clinical trial that used high doses of medroxyprogesterone acetate (MPA) in the treatment of metastatic breast cancer are reported. Two treatment reigmens were used: regimen A, 500 mg daily with a total dose of 30 g; regimen B, 1,000 mg daily with a total dose of 60 g. The overall response rates were similar, with no statistically significant difference between the two treated groups. Regimen A (lower dosage group) reached a remission rate of 44%, whereas regimen B (higher dosage group) had a remission rate of 41%. The mean duration of response was 8 months with regimen A and 9 months with regimen B. The advantages of the lower dosage regimen as opposed to the higher dosage regimen of MPA in the treatment of advanced breast cancer are discussed.

PIP: A controlled clinical trial that used high doses of medroxyprogesterone acetate (MPA) in the treatment of metastatic breast cancer was conducted. Therapy consisted of 2 treatments: regimen A, 500 mg daily with a total dose of 30 g; regimen B, 1000 mg daily with a total dose of 60 g. From June 1975 to September 1976, 101 patients entered into the study and were randomly allocated into the 2 treatment groups. Both treatment groups were comparable in terms of age, menopausal status, free interval, and dominant site of lesions. Selection of patients was done according to the following criteria: histologically proved progressive metastatic carcinoma of the breast, without any treatment for at least 2 months; no prior hormonal manipulation; performance status 50 or more, and life expectancy longer than 3 months; measurable disease. Overall response rates were similar, with no statistically significant difference between the 2 treated groups. Regimen A reached a remission rate of 44%; regimen B had a remission rate of 41%. The mean duration of response was 8 months with regimen A and 9 months with regimen B. Both regimens were well tolerated. Clinical toxicity was mild with both dosages of MPA. The main side effect was gluteus abscess, with a higher incidence in group B. This was probably due to the greater amount of injected drug suspension in the 1000 mg/day regimen. The incidence of thrombophlebitis and vaginal bleeding was negligible.

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