High toxicity in patients receiving adjuvant docetaxel plus hormone treatment after radical radiotherapy for high-risk prostate cancer: A preplanned safety report of SPCG 13 trial.

63 Background: In two randomized trials a survival benefit has been shown for docetaxel (T) in metastatic, hormone refractory prostate cancer PrCa). In order to increase the recurrence-free survival and overall survival with adjuvant treatment we conducted a randomized trial using T in patients (pts) with high risk PrCa after radical radiotherapy (RT). Methods: Between May 2007 and April 2009 100 pts with PrCa Gleason score (GS) 7 (4+3) and cT2 tumors with PSA >10 to <70 ng/mL or cT2 tumors with GS 8-10 or any cT3 tumors without metastases were randomized between surveillance (S) or six courses of T 75 mg/m2 q21d at the end of RT. Neoadjuvant + adjuvant LHRH-treatment for 9 mo was mandatory. The defined end-point is PSA relapse (ASTRO-RTOG guidelines). The groups were well balanced; mean age 65 vs 66 years, ECOG (0/1, %) 90/10 vs 90/10; time from diagnosis 262 vs 270 days, GS (6-7/8-10, %) 60/40 vs 44/56; tumor stage (T2/T3, %) 26/74 vs 28/72 in groups T vs S, respectively. The mean PSA of the 100 pts at ...