10 Background: Androgen deprivation therapy (ADT) is the standard treatment of hormone naïve metastatic prostate cancer (HNMPC). We initiated a phase III multicentre trial comparing ADT with or without docetaxel (D) in HNMPC (GETUG 15) and the primary endpoint is overall survival. PSA progression defined as an increase of 25% over baseline or nadirin the first 7 months was recently shown to be a strong predictor of death in HNMPC (Hussain M et al J Clin Oncol 27: 2009). Methods: Patients (pts) with HNMPC were randomly assigned to either arm A (ADT plus D: 75mg/m2 q3w, 9 cycles) or arm B (ADT). From 10/2004 to 12/2008, 385 pts were accrued. The median baseline PSA values were 29.4 ng/mL (0.05-2,170) in arm A and 25.3 ng/mL (0.1-11,900) in arm B. Data on PSA response are available in 171/192 pts (arm A) pts and 181/193 pts (arm B) at 3 months and 156 pts (arm A) and 148 pts (arm B) at 6 months. Results: A PSA response (> 30%) was achieved at 3 months in 93.6% (arm A) and 85.1% (arm B; p=0.02). A PSA response (> 50%) was achieved at 3 months in 90.6% (arm A) versus 80.1% (arm B; p=0.01). When assessed at 6 months, a PSA response (> 30%) was obtained in 94.9% (arm A) versus 86.5% (arm B; p=0.02). A PSA response (> 50%) was achieved in 94.9% (arm A) versus 85.8% (arm B; p=0.01) A PSA progression (25% increase) was observed in 1.3% in arm A and 10.1% in arm B (p=0.002). Conclusions: The addition of 3-weekly docetaxel to ADT significantly improves PSA response and significantly reduces PSA progression at 6 months in patients with HNMPC. No significant financial relationships to disclose.
Survival Analysis of a Randomized Phase III Trial Comparing Androgen Deprivation Therapy (ADT) Plus Docetaxel Versus ADT Alone in Hormone-Sensitive Metastatic Prostate Cancer (GETUG-AFU 15/0403)
