The use of Ketoconazole (Keto) in men with advanced prostate cancer is not considered mainstream, however there is clear evidence that it does reduce PSA in men with castrate resistant prostate cancer. Currently, most men with advanced prostate cancer who do use Keto utilize it prior to chemotherapy. There has been little literature evaluating the possible role of Keto in men who have failed chemotherapy with taxotere (chemo failure).
Shah etal. Performed a study designed to evaluate the efficacy of Keto in men with castrate resistant prostate cancer, both pre and post chemotherapy. They looked at men who received Keto therapy between January 1, 1999 and September 30, 2009. Men included in the analysis had failed androgen deprivation therapy (ADT) 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 men receiving Keto Therapy with or without prior docetaxel therapy.
They included a total of 30 men in their analysis. Mean baseline age in the groups with (n=15) and (n=15) without prior docetaxel therapy was 68.8 and 72 years, respectively. More of the men in the prior to docetaxel group had a performance status of 0 or 1 (80% vs. 47%; p=0.13) and most of the men had received prior therapy with an antiandrogen (93.3% and 100%) while the percentage of men who received antiandrogen withdrawal therapy (stopping of the antiandrogen drug when there was evidence of androgen receptor mutation
The 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 men with prior docetaxel and 46.7% in men without prior docetaxel (p=0.46). Median PFS of 7.2 vs. 7.4 months (p=0.85) were similar between groups.
Men receiving ketoconazole who have received prior docetaxel have similar response rates compared to men who have not received prior docetaxel. So, if you have not used Keto Therapy and have failed chemotherapy consider trying Keto.
J Clin Oncol 28, 2010 (suppl; abstr e15052); G. W. Jean, S. Shah, S. V. Keisner, S. M. GressettUssery, J. Dowell; Texas Tech University Health Sciences Center School of Pharmacy/VA North Texas Health Care System, Dallas, TX; School of Pharmacy, Texas Tech University Health Science Center, Dallas, TX; VA North Texas Health Care System, Dallas, TX; University of Texas Southwestern Medical Center, Dallas, TX
2010 ASCO Annual Meeting
Abstract No: e15052
Joel T Nowak, M.A., M.S.W.