756O - Chemohormonal Therapy Versus Hormonal Therapy for Hormone Naïve High Volume Newly Metastatic Prostate Cancer (Prca): Ecog Led Phase III Randomized Trial

Abstract

ABSTRACT Aim: Androgen deprivation therapy (ADT) is standard therapy for metastatic PrCa and although most respond, many develop castration resistant prostate cancer (CRPC). Patients with high volume disease have poorer outcomes compared with low volume patients. Docetaxel (D) prolongs the overall survival of men with CRPC and we aimed to see if D improves overall survival when given at time of starting ADT. Methods: 1:1 randomization to ADT alone or ADT + D at 75mg/m2 every 3 weeks for 6 cycles within 4 mos of ADT. Stratification factors: high volume (HV) vs. low volume (LV) disease (HV: visceral metastases and/or 4 or more bone metastases with at least one outside of the vertebral column and pelvis); Anti-androgen use beyond 30 days; Age ≥70 vs. 12 vs. ≤ 12 mos (mos); FDA approved drug for delaying skeletal related events. Key eligibility criteria: suitable organ and neurological function for D; adjuvant ADT ≤ 24 mos and no progression within 12 mos of adjuvant ADT. Overall survival was the primary endpoint with an improvement in median OS of 33.3% (80% power and 1-sided alpha = 2.5%). Projected median OS for ADT alone: HV-33 mos; LV - 67 mos. Results: 790 men were accrued from 7/28/06 to 11/21/2012: ADT n = 393; ADT + D: 397; balanced for demographic, stratification and disease factors. Median age: 63 years (range: 36 to 91); 99% ECOG PS 0 or 1; 89% Caucasian; 24% prior prostatectomy; HV 64% on ADT and 67% on ADT + D. ADT + D: Gde 3/4 Neutropenic fever: 4/2%; Gde 3 neuropathy: 1% sensory, 1% motor; 1 death due to treatment was in the LV subset (no death on ADT alone). Efficacy data for high volume subset of pts in table 1. Conclusions: ADT + D improves disease control and OS over ADT alone in men with HV disease. NCT00309985 Disclosure: C. Sweeney: Consultant with compensation: Sanofi; M. Carducci: Compensated consultant; M. Eisenberger: Compensated consultant. All other authors have declared no conflicts of interest. Intent to treat Analysis High Volume Pts ADT N = 253 ADT + D N = 265 p-value Hazard Ratio (95%CI * ) PSA 6.3% 15.5% 0.0011 N with PSA or clinical PD 137 113 Time to PSA or clinical PD 8.8 mos 15.0 mos 0.55(0.42-0.71) N with clinical PD 112 70 Time to clinical PD 14.1 mos 29.5 mos 0.43 (0.32-0.59) N with docetaxel for CRPC 98 38 Median OS 32.2 mos 49.2 mos 0.0013 0.62 (0.46, 0.83) * CI: confidence intervals; #PD: progressive disease in months; N = number of patients