Why the study?
Does a combination of doxorubicin, mitomycin C, and 5-fluorouracil improve response rates in patients with hormone refractory prostate cancer?
Does a combination of doxorubicin, mitomycin C, and 5-fluorouracil improve response rates in patients with hormone refractory prostate cancer?
The combination of doxorubicin, mitomycin C, and 5-fluorouracil is not recommended for metastatic hormone-refractory prostate cancer due to low response rates and significant toxicity.
Low activity in this early-phase trial cautions against use; leaves open pursuit of more effective regimens for hormone-refractory prostate cancer.
In a Southwest Oncology Group phase II clinical trial, 68 patients with hormone refractory carcinoma of the prostate were treated with a combination of doxorubicin, mitomycin C and 5-fluorouracil. Of the patients 11 were classified as good risk and 57 as poor risk. There were 1 complete and 10 partial remissions for a response rate of 16.2% (exact 95% confidence interval 8.4 to 27.1%). Median survival was 9 months (maximum 14) for good risk patients and 10 months (maximum 42) for poor risk patients. Toxicity was significant with leukopenia identified as dose limiting. Because of the low rate of response and significant toxicity, this regimen cannot be recommended as standard therapy for metastatic hormone refractory prostate cancer.
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Blumenstein et al. (1993) studied this question.
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