Berthold DR et al. (2008) Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer: updated survival in the TAX 327 study. J Clin Oncol 26: 242–245

In 2004, the TAX 327 study investigators reported that high-dose docetaxel given every 2 weeks produced better survival outcomes than did mitoxantrone in men with metastatic hormone-refractory prostate cancer (HRPC). In their updated analysis of this trial, Berthold et al. confirm the survival benefit conferred by docetaxel-based regimens and evaluate survival in various subgroups of patients.

The TAX 327 trial enrolled 1,006 men with progressive metastatic HRPC. All patients received prednisone 5 mg twice daily and were randomly assigned to receive docetaxel 75 mg/m2 administered every 3 weeks for up to 10 cycles (D3P), docetaxel 30 mg/m2 administered weekly for 5 of 6 weeks for up to 5 cycles (D1P), or mitoxantrone 12 mg/m2 every 3 weeks; participants were followed up every 3 weeks.

This analysis found a significant difference in the median survival time of patients on the D3P regimen and those receiving mitoxantrone (19.2 months vs 16.3 months; P = 0.004), which was greater than that found in the 2004 analysis (18.9 months vs 16.5 months; P = 0.009). The difference in survival between patients on D1P and those receiving mitoxantrone was not significant. The survival benefit conferred by D3P was maintained in patients with a greater or lesser disease burden and in the following subgroups: patients with visceral disease; those with substantial pain; individuals with a Karnofsky performance status ≤80%; and those with PSA levels above or below 115 ng/ml. or <115 ng/ml.

The authors conclude that high-dose docetaxel administered every 3 weeks improves survival compared with mitoxantrone in men with HRPC treated with prednisone.