Journal of Clinical Oncology, Vol 10, 1754-1761, Copyright © 1992 by American Society of Clinical Oncology
Phase II study of estramustine and vinblastine, two microtubule inhibitors, in hormone-refractory prostate cancer
GR Hudes, R Greenberg, RL Krigel, S Fox, R Scher, S Litwin, P Watts, L Speicher, K Tew and R Comis
Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, PA 19111.
PURPOSE: Estramustine phosphate (EMP) and vinblastine are two microtubule
inhibitors with distinct molecular targets and at least additive
antimicrotubule effects in vitro. Their modest single-agent activities in
hormone-refractory prostate cancer, nonoverlapping toxicities, and lack of
cross-resistance prompted a phase II trial in hormone-refractory prostate
cancer. PATIENTS AND METHODS: Thirty-six assessable patients at the Fox
Chase Cancer Center and seven Fox Chase Cancer Center Network institutions
were treated with oral EMP 600 mg/m2 on days 1 to 42 and vinblastine 4
mg/m2 intravenously (IV) once a week for 6 weeks. Courses were repeated
every 8 weeks. Response assessment was based on a change in serum
prostate-specific antigen (PSA) levels and was correlated with change in
pain scores. RESULTS: PSA decreased from baseline by at least 50% in 22
patients (61.1%) and by > or = 75% in eight patients (22.2%). A 50% or
more decrease in PSA on three successive 2-week measurements together with
an improved or stable pain score, performance status, and measurable soft
tissue disease (if present) was required for a partial response (PR), which
occurred in 11 patients for an overall response rate of 30.5% (95%
confidence interval, 15.6% to 45.6%). In seven patients with measurable
nonosseous disease, there was one PR (14%) and one minor response (MR). In
28 patients with assessable pain, major pain responses occurred in 12
(42.9%). PSA response (> or = 50% decrease times three measurements) was
predictive of major pain response with a 93.7% specificity, a 50%
sensitivity, and a positive predictive value of 85.7%. CONCLUSION: We
conclude that EMP and vinblastine is an active combination in hormone-
refractory prostate cancer.
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