Simultaneous antiandrogen withdrawal and treatment with ketoconazole and hydrocortisone in patients with advanced prostate carcinoma

✍ Scribed by Eric J. Small; Ari Baron; Robert Bok

• Publisher: John Wiley and Sons
• Year: 1997
• Tongue: English
• Weight: 66 KB
• Volume: 80
• Category: Article
• ISSN: 0008-543X
• DOI: 10.1002/(sici)1097-0142(19971101)80:9<1755::aid-cncr9>3.0.co;2-d

✦ Synopsis

drawal and simultaneous ketoconazole as a means of inhibiting adrenal steroid production. Prostate specific antigen (PSA) response was defined as a ú 50% fall in PSA from baseline that was maintained for at least 8 weeks.

RESULTS.

Ten patients had established metastatic disease, 2 had high PSAs and no imaging studies (PSA of 70 and 160 ng/mL, respectively), 3 had microscopically positive lymph nodes and serologic progression, and 5 had serologic progression alone. Overall, of 20 evaluable patients, 11 (55%) had a ú 50% fall in PSA (95% confidence interval [CI], 31.5-76.9%). The median PSA response duration was 8.5 months (95% CI, 7-17 months). The median survival was 19 months. Toxicity was mild, with Grade 1 and 2 nausea and emesis in 15% of patients, Grade 1 fatigue in 10% of patients, and reversible Grade 1 or 2 hepatotoxicity in 10% of patients.

Mild skin toxicity was observed in 20% of patients.

CONCLUSIONS.

The addition of ketoconazole and hydrocortisone to antiandrogen withdrawal appears to increase the PSA response proportion observed with antiandrogen withdrawal alone. Toxicity is mild.