Why the study?
Does an intramuscular maintenance dose of HD-MPA improve objective response rates compared to an oral maintenance dose when combined with FAC in patients with metastatic breast cancer?
Does an intramuscular maintenance dose of HD-MPA improve objective response rates compared to an oral maintenance dose when combined with FAC in patients with metastatic breast cancer?
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Both intramuscular and oral maintenance regimens of high-dose medroxyprogesterone acetate combined with FAC are highly effective for metastatic breast cancer with similar response rates and survival.
Seventy-six patients with metastatic breast cancer were treated with fluorouracil, adriamycin (doxorubicin) and cyclophosphamide (FAC) plus high-dose medroxyprogesterone acetate (HD-MPA). MPA was given for 21 days at the dose of 500 mg/day i.m., then on a randomized basis, either 500 mg/week i.m. (FAC+HD-MPA i.m.) or 300 mg/day p.o. (FAC+HD-MPA p.o.). Objective response rates were 79% in 39 patients on FAC+HD-MPA i.m. and 73% in the 37 patients on FAC+HD-MPA p.o. There was no significant difference in the median duration of response and median survival for the 2 regimens (respectively, 17 months and 22 months, and 15 months and 21 months for FAC+HD-MPA i.m. and FAC+HD-MPA p.o.). Toxicity was mild and similar in both groups. Although FAC+HD-MPA was highly effective, at present it is difficult to select which regimen provides the best initial treatment for metastatic breast cancer.
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Lopez et al. (1983) studied this question.
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