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metabolites, estramustine and estromustine, and has demonstrated cytotoxic activity in vitro. It showed activity in hormone-refractory prostate cancer (HRPC) when administered concurrently with agents with synergistic mechanisms of action (intravenous taxanes, vinca alkaloids, oral etoposide) in three comparative (n = 127–193) and numerous small noncomparative trials. The prostate-specific antigen (PSA) response rates for estramustine phosphate-based regimens with docetaxel (67% and 63%), paclitaxel (48%) or vinblastine (25%) were greater than those for comparators, mitoxantrone, paclitaxel or vinblastine, respectively. Median times to PSA progression were also longer with estramustine phosphate plus docetaxel or vinblastine, compared with mitoxantrone or vinblastine. Survival durations (beyond the 9–12 months observed with historical controls) in comparative and noncom- parative studies demonstrate a trend in favor of estramustine phosphate-based regimens; there was a significant survival advantage with cyclic administration of estramustine phosphate (840 mg/day for 5 days per 21-day cycle) plus docetaxel (70 mg/m given in one or two doses per cycle) over mitoxantrone (secondary endpoint, p = 0.002) and a trend for a survival advantage for estramustine phosphate with vinblastine over vinblastine alone (primary endpoint, p = 0.051). Adverse effects of estramustine phosphate are mainly estrogenic, and those of combination treatment largely reflect the profile of
American Journal of Cancer – Springer Journals
Published: Aug 10, 2012
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