Abstract
e16091 Background: HRPC criteria include stage T2b-T2c according to the AJCC classification, PSA ≥ 10 ng/ml, Gleason score (GS) 7–10 with 12, 6% 7-year cancer specific mortality rate (D'Amico AV, Cancer. 2006). Several small nonrandomized NA chemotherapy studies were performed in this setting (Kim N. Chi J Urol. 2008; Prayer-Galletti T. Br J Urol. 2007; Konety BR. J Urol. 2004) with DFS of 42%-70%. Aim of this study: to evaluate the feasibility, efficacy, and toxicity of NA-CHT followed by RP and postoperative RT. Methods: Histological diagnosis of LA HRPC (T2b-T4), GS > 8, PSA > 10 ng/ml, age < 65 years, PS 0–1. Treatment: group A) paclitaxel 80 mg/sqm/weekly and estramustine phosphate (EP) 10 mg/Kg/day for 5 days/week for 4 months. Group B) carboplatin (AUC 5) i.v day 1 q 21 plus docetaxel 30 mg/sqm i.v day 1,8 and EP day -1-+4 and 7–11 q 21 for 4 cycles. Thereafter, the responsive and stable patients (pts) were submitted to RP and adjuvant RT (60–70Gy/30–35 fr) or to radical (R) RT (78 Gy/39 fr) respectively. Primary endpoint: disease-free survival (DFS); secondary endpoint: PSA relapse-free survival (RFS), overall survival (OS). Results: Between 2002 and 2008, 29 pts entered onto the studies. The toxicity was mild. The down-staging was obtained on 2 group A pts and on 1 group B pt respectively. Conclusions: NA-CHT with both regimens was been shown feasible and nontoxic in LAHRPC. Although a clinical response was documented, the pathological response was anecdotal.The DFS and OS are encouraging considering the historical data but warrant a randomized study. [Table: see text] No significant financial relationships to disclose.
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