Phase III, randomized, open-label study of triweekly versus biweekly docetaxel (T) as a treatment for advanced hormone-refractory prostate cancer (HRPC): Final analysis of the Finnish Uro-oncological Group Study 1-2003.

Abstract

4527 Background: T administered at 3-week intervals is standard treatment for advanced HRPC. We compared 2-weekly to 3-weekly T as first-line chemotherapy of advanced HRPC (prior estramustine phosphate allowed). Methods: 361 pts were entered in this prospective, randomized multicenter trial from March 2004 to May 2009. 346 pts were eligible and received at least one T cycle. The pts were centrally randomly assigned to receive T i.v. either 75 mg/m² d1 q3 wks (tT) or 50 mg/m² d1 and d 14, q4 wks (bT). Prednisolon 10 mg/d was administered orally in both groups. The groups were well balanced with the WHO performance status, mean age (69.3 yrs, range 45-87 yrs vs. 68 yrs, range, 46-85 yrs), and the median serum PSA content at study entry (108.5 µg/L, range 11-1230 vs. 116 µg/L, range 12-1870, respectively). The primary end point was time to treatment failure (TTTF). The planned sample size was 348 pts (α 0.05, 1-ß 0.80, 2-sided log-rank test). Study identifier: NCT00255606. Results: The 346 eligible pts who received at least one dose of docetaxel (tT, 176; bT, 170) are included in the analysis. 1249 and 1051 T cycles were administered in the tT and bT groups, respectively. Serious adverse events were reported more often with the 3-weekly schedule (5.9 vs. 9.4 % of cycles, p=0.002). The median TTTF was longer in the bT group compared to tT (5.6 vs. 4.9 mos, respectively; p=0.016). PSA response was equally frequent in both groups (CR+PR 23%; SD 46%). Overall survival did not differ significantly between the 2 groups (median, 11.2 vs. 11.8 mos, respectively, p=0.164). Conclusions: T administered every 2 weeks was better tolerated than 3-weekly administration and resulted in a longer TTTF, but did not improve survival.