PSA response rate as a surrogate marker for median overall survival in docetaxel-based first-line treatments for patients with metastatic castration-resistant prostate cancer: an analysis of 22 trials.

The aim of this study was to determine the correlation between PSA response rate (PSA RR) and overall survival (OS) and identify PSA RR as a potential surrogate for OS, in docetaxel-based first-line treatments for castration-resistant prostate cancer (CRPC). Trials of first-line regimens with docetaxel for patients with metastatic CRCP published between 2004 and 2013 were identified, and data were evaluated statistically in order to investigate the correlation between PSA RR and OS. A total of 22 trials were identified and included in our analysis, for a total of 7,677 patients. In addition, we divided all the trails and arms of the randomized trials in two subgroups, the first one composed only of docetaxel (D) plus prednisone (P) regimens (standard therapy) and the second one composed of all D + other drug combinations (D combinations). Analysing all the trials and arms as a single unit, we found a statistically significant correlation between PSA RR and OS, with Spearman's rank correlation coefficient ρ = 0.50 (95% confidence interval (CI), 0.47 to 0.88) (P = 0.003). Also evaluating the standard therapy group, we found a statistically significant correlation between PSA RR and OS, with Spearman's ρ = 0.65 (95% CI, 0.38 to 0.70) (P = 0.02). However, when we assessed the D combination group, we found Spearman's rank correlation coefficient decreased (ρ = 0.42) (95% CI, 0.28 to 0.80) and resulted nonstatistically significant (P = 0.06). In conclusion, we found a statistically significant correlation between PSA RR and OS. The usage of PSA RR as a surrogate marker for OS in metastatic CRPC patients treated with D-based first-line regimens may be appropriate only in the D + P combination.