Background Ketoconazole has been extensively used in chemo-naive patients with metastatic castration-resistant prostate cancer (mCRPC) due to the absence of therapeutic alternatives.
Purpose To determine the effectiveness of ketoconazole in chemo-naive patients with mCRPC.
Material and methods Retrospective observational study of chemo-naive patients treated with ketoconazole for ≥3 months for mCPRPC between 06/2010–06/2014 in a tertiary hospital. Patients with insufficient information in their medical records were excluded.
The following variables were collected: age, baseline PSA, % PSA decrease from baseline to nadir, PSA response rate (PSA-RR) at 12 weeks defined as the percentage of patients with a ≥50% PSA decline from baseline maintained for ≥3 weeks. Biochemical progression-free survival (bPFS) was defined as the time between ketoconazole initiation and PSA (or radiological) progression according to PCWG2 criteria.
Means ± standard deviation or the median and the 25th–75th percentiles summarise results. Kaplan-Meier analysis was performed to determine the bPFS. Data analysis was performed using SPSS Version 20.0.
Results Twenty-eight patients (age 76 ± 11 years) were included. The median baseline PSA was 29 [14–89] ng/ml. The % PSA decrease from baseline to nadir was 54% ± 29. PSA-RR to ketoconazole was 31% (9 patients). Eleven patients (39%) experienced a ≥50% reduction from baseline PSA. The mean time to achieve this reduction was 13 ± 15 weeks. Baseline PSA increased after starting ketoconazole in five patients (15%).
The bPFS for the 23 patients in whom baseline PSA declined after starting ketoconazole was 87 [IC95%: 35–139] weeks. The bPFS in patients with a ≥50% PSA decline at 12 weeks was not estimated because it have not been reached at the time of data analysis.
Conclusion Approximately one third of patients treated with ketoconazole experienced rapid PSA declines close to those observed with abiraterone (37–42%). The PSA-RR, the significant bPFS, its low cost and the possibility of starting abiraterone after ketoconazole explain why ketoconazole is an alternative in chemo-naïve patients with mCRPC.
References and/or Acknowledgements
Eur J Cancer 2014;50:2399–407
References and/or AcknowledgementsNo conflict of interest.
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