Journal of Clinical Oncology, Vol 19, Issue 9
(May), 2001: 2509-2516
© 2001 American Society for Clinical Oncology
Phase II Study of Docetaxel, Estramustine, and Low-Dose Hydrocortisone in Men With Hormone-Refractory Prostate Cancer: A Final Report of CALGB 9780
By D.M. Savarese,
S. Halabi,
V. Hars,
W.L. Akerley,
M-E Taplin,
P.A. Godley,
A. Hussain,
E.J. Small,
N.J. Vogelzang,
for the Cancer and Leukemia Group B
From the University of Massachusetts Memorial Health Care, Worcester, and Boston Medical Center, Boston, MA; Cancer and Leukemia Group B Statistical Center, Durham, and University of North Carolina, Chapel Hill, NC; University of Maryland, Baltimore, MD; University of California, San Francisco, San Francisco, CA; and University of Chicago, Chicago, IL.
Address reprint requests to Diane Savarese, MD, University of Massachusetts Memorial Medical Center, University Campus, 55 Lake Ave North, Worcester, MA 01655; email: dsavarese{at}uptodate.com
PURPOSE: To investigate the combination of docetaxel, estramustine (EM), and low-dose hydrocortisone in men with hormone-refractory prostate cancer (HRPC).
PATIENTS AND METHODS: Combinations of EM with other antimitotic agents such as docetaxel are synergistic in vitro and show significant clinical activity in patients with HRPC. We studied intravenous administration of docetaxel 70 mg/m2, oral estramustine, and low-dose daily hydrocortisone in men with HRPC who demonstrated progression after initial hormone therapy.
RESULTS: Of the 47 men enrolled onto this multicenter cooperative group study, 46 were assessable for response and/or toxicity. In the 24 patients with measurable disease, there were three complete and nine partial responses for a measurable disease response rate of 50% (12 of 24 patients; 95% confidence interval [CI], 27% to 73%). In the 44 patients in whom pretreatment prostate-specific antigen (PSA) was elevated, 30 (68%) had a 50% or greater decrease, and 25 (57%) had a 75% or greater decrease in PSA. The combined measurable disease and biochemical response rate in all 46 assessable patients was 54% (three complete responses, 22 partial responses, 95% CI, 37% to 71%). The predominant toxicity was neutropenia, with 26% of patients having grade 3 and 30% having grade 4 granulocytopenia; there were no episodes of febrile neutropenia. Other common but mild adverse effects included malaise/fatigue, peripheral edema, and hyperglycemia. The incidence of thromboembolic events during therapy was 9%. With a median follow-up of 17 months, the median survival was 20 months. The median time to disease progression was 8 months for all patients, and 10 months for those with measurable disease.
CONCLUSION: This therapy is efficacious and moderately well tolerated in HRPC and should be compared in a phase III trial with mitoxantrone and prednisone.
The contents of this publication are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.
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