ORLANDO, FL USA (UroToday.com) -
...comparing androgen-deprivation therapy (ADT) plus docetaxel versus ADT alone in hormone-naive metastatic prostate cancer (GETUG-AFU 15/0403) - Session Highlights
This group's study addressed the use of ADT as the standard treatment of hormone naïve metastatic prostate cancer (HNMPC). They performed a phase III multicentre trial comparing ADT, with or without docetaxel (D), in HNMPC (GETUG 15). The study’s ultimate primary endpoint is overall survival. Dr. Gravis referred to Dr. Maha Hussain’s previous finding that PSA progression defined as an increase of 25% over baseline or nadir in the first 7 months is a strong predictor of death in HNMPC.
In this study, HNMPC patients were randomized to either arm A (ADT plus D: 75mg/m2 q3w, 9 cycles) or arm B (ADT). From 2004 to 2008, 385 patients were enrolled. The median baseline PSA values were 29.4 ng/ml in arm A and 25.3 ng/ml in arm B. Data on PSA response were available in 171/192 arm A patients and 181/193 arm B patients at 3 months and 156 arm A patients and 148 arm B patients at 6 months.
At 3 months, a PSA response > 30% was achieved in 93.6% arm A and 85.1% arm B patients (p=0.02). A PSA response > 50% was achieved at 3 months in 90.6% arm A patients versus 80.1% arm B patients (p=0.01). At 6 months, a PSA response > 30% was obtained in 94.9% arm A patients vs. 86.5% arm B patients (p=0.02). A PSA response > 50% was achieved in 94.9% arm A patients vs. 85.8% arm B patients (p=0.01). PSA progression (defined as a 25% increase) was observed in 1.3% of arm A and 10.1% of arm B patients (p=0.002). This data suggests that the addition of 3-weekly docetaxel to ADT improves PSA response and reduces PSA progression at 6 months in patients with HNMPC. Data on overall survival are not yet available.
Presented by Gwenaelle Gravis, MD at the 2011 Genitourinary Cancers Symposium, Oral Abstract Session A: Prostate Cancer - February 17-19, 2011 - Orlando World Center Marriott, Orlando, Florida USA