Korean J Urol.  2011 Nov;52(11):746-751.

Comparison of Ketoconazole and Estramustine for Treating Patients with Castration-Resistant Prostate Cancer

• Yun BH
• Hwang EC
• Yoo DH
• Hwang IS
• Kim SO
• Jung SI
• Kang TW
• Kwon DD
• Park K
• Ryu SB

Abstract

PURPOSE
We investigated the efficacy of ketoconazole and estramustine before chemotherapy for treating patients with progressive castration-resistant prostate cancer (CRPC) after anti-androgen withdrawal syndrome.
MATERIALS AND METHODS
Eighty-four patients who were diagnosed with CRPC and were treated between 2005 and 2009 were included. Thirty-nine patients were treated with 600 mg of ketoconazole and 10 mg of prednisolone per day (group I), and 45 patients were treated with 560 mg of estramustine per day (group II). The prostate-specific antigen (PSA) response, progression-free survival, and side effects were compared.
RESULTS
The median age of the patients, PSA level, and follow-up period were 72 years, 48.5 ng/ml, and 4 months (range, 1 to 29 months), respectively. The overall PSA response rate was 35.7%, and the PSA response rates were 33.3% for group I and 37.8% for group II (p=0.672). The median progression-free survival times were 8 months (95% confidence interval [CI] 5.9-10.1) overall, 5 months (95% CI 1.6-8.3) in group I, and 8 months (95% CI 5.9-10.0) in group II (p=0.282). The most common complications in groups I and II were nausea and vomiting (51.3%) and anemia (77.8%), respectively. Nausea and vomiting and hepatotoxicity were observed more often in group I, and gynecomastia, neutropenia, and anemia were observed more often in group II. The toxicities of each adverse effect were < or =grade 2.
CONCLUSIONS
With a resultant PSA decline and mild adverse effects, both ketoconazole and estramustine are worth consideration as treatment options for progressive CRPC patients after primary hormonal therapy.

Keyword

Estramustine; Ketoconazole; Prostatic neoplasms

MeSH Terms

Anemia
Disease-Free Survival
Estramustine
Follow-Up Studies
Gynecomastia
Humans
Ketoconazole
Male
Nausea
Neutropenia
Prednisolone
Prostate
Prostate-Specific Antigen
Prostatic Neoplasms
Vomiting
Estramustine
Ketoconazole
Prednisolone
Prostate-Specific Antigen

Figure

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  FIG. 1 Progression-free survival curves according to treatment groups were not statistically different by the log-rank test. The median progression-free survival times were 8 months (95% confidence interval [CI] 5.9-10.1) overall, 5 months (95% CI 1.6-8.3) in group I and 8 months (95% CI 5.9-10.0) in group II (p=0.282). Group I: ketoconazole+prednisolone, Group II: estramustine.

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