Introduction: Corticosteroids are a mainstay treatment for castration-resistant prostate cancer (CRPC). Although corticosteroids have been associated with adverse events, long-term outcomes related to their sustained use have not been assessed in men with CRPC.
Objective: This study evaluated the impact of cumulative corticosteroid exposure on the risk of developing specific adverse events in men with CRPC.
Methods: Data were obtained from administrative claims databases. Adult chemotherapy-naïve men who initiated CRPC treatment following surgical or medical castration were selected. Patients were grouped into four cohorts based on cumulative corticosteroid dose: no exposure, low exposure (< 0.5 g), medium exposure (0.5-2.0 g), and high exposure (> 2.0 g). Time to each adverse event was assessed using Kaplan-Meier analyses and time-dependent Cox proportional hazard models, adjusting for baseline characteristics.
Results: Overall, 9425 patients were included (no exposure, N = 6765; low exposure, N = 1660; medium exposure, N = 655; high exposure, N = 345). The mean age was 71-76 years across cohorts. During the study period, cumulative corticosteroid exposure was associated with a significantly higher risk of developing an infection [high vs. no exposure, adjusted hazard ratio (HR) 2.55; 95% confidence interval (CI) 2.27-2.85; p < 0.001 for trend], peptic ulcer (HR 1.91; 95% CI 1.39-2.64; p < 0.001), acute cardiovascular events (HR 1.62; 95% CI 1.43-1.83; p < 0.001), endocrine disorder (HR 1.61; 95% CI 1.34-1.94; p < 0.001), fracture (HR 1.59; 95% CI 1.37-1.86; p < 0.001), or mental health condition (HR 1.28; 95% CI 1.06-1.55; p = 0.014). Exposure to corticosteroids was associated with a more rapid onset of adverse events.
Conclusion: Patients with CRPC receiving corticosteroids had a higher risk of developing a wide range of adverse events than those not receiving them. The increased adverse event risk was observed after accounting, to the extent possible, for patients' overall disease severity.