Response to ketoconazole after failure of docetaxel in patients with advanced androgen-independent prostate cancer (AIPC).

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e15052 Background: In AIPC, the combination of docetaxel and prednisone has been shown to increase overall survival and progression free survival. Ketoconazole is considered in patients with AIPC to improve symptoms and progression free survival (PFS). Currently, literature evaluating PSA response rates (RR) in patients who receive ketoconazole after docetaxel failure is lacking. Methods: This study evaluated patients with AIPC treated with ketoconazole between January 1, 1999 and September 30, 2009. Patients included in the analysis had failed androgen deprivation therapy and were subsequently initiated on ketoconazole. Nominal data was evaluated with Fisher's Exact Test and continuous data was evaluated with Mann Whitney U or log rank tests. The primary objective of this study was to evaluate PSA response (PSA decline >50% maintained at least 4 weeks) in patients receiving ketoconazole therapy with or without prior docetaxel therapy. Results: A total of 30 patients were included in the analysis. Mean baseline age in the groups with (n=15) and without (n=15) prior docetaxel therapy was 68.8 and 72 years, respectively. More patients in the prior docetaxel group had a performance status of 0 or 1 (80% vs. 47%; p=0.13). Most patients had received prior therapy with an antiandrogen (93.3% and 100%), and the percentage of patients who received antiandrogen withdrawal therapy was 13.3% and 33.3% in prior docetaxel and no prior docetaxel groups, respectively. Median baseline PSA and duration of ketoconazole therapy were similar between groups (109.4 ng/ml vs. 80.4 ng/ml and 5.8 vs. 6.9 months, respectively). PSA response rates were 66.7% in patients with prior docetaxel and 46.7% in patients without prior docetaxel (p=0.46). Median PFS of 7.2 vs. 7.4 months (p=0.85) were similar between groups. Conclusions: Patients receiving ketoconazole who have received prior docetaxel have similar response rates compared to patients who have not received prior docetaxel. No significant financial relationships to disclose.