Vinorelbine plus prednisone versus docetaxel plus prednisone as first-line treatment in metastatic hormone-refractory prostate cancer.

Abstract

e15129 Background: Metastatic hormone refractory prostate cancer (mHRPC) is not curable and all attempts at therapeutic intervention have been based on palliating the disease. Androgen dependent prostate carcinoma responds poorly to chemotherapy. Recent protocols using vinorelbine, mitoxantrone and docetaxel have significantly improved response rate, survival and pain control for those patients. The study aims to compare the therapeutic benefit of the use of vinorelbine versus docetaxel both plus prednisone in patients with mHRPC. Methods: Sixty pts (50% gpA, 50% gpB) were enrolled between Mar 2005 and Sep 2007. All patients had histologically confirmed prostatic adencarcinoma with evidence of metastatic disease and progression on hormonal therapy. WHO PS O-2, adequate marrow, liver and renal functions. Patients were randomized to gpA; Vinorellrine (V) IV 30mg/m2 d1 and 8, or gpB; Docetaxe (D) IV 75mg/m2 d1. All patients received 5mg of prednisone orally twice daily for 5 days starting on day 1 of the tudy. Cycles repeated every 3 weeks. Patients with PD went off the study while those with CR, PR or SD continued treatment for 8 cycles maximum. Results: All pts were evaluable for response, toxicity and survival. The median age (gpA, gpB): 59 and 58 years, median WHO PS 1 (range 0-2) in both groups , Median basal PSA were 110 (90-780) and 120 (80-850) in group A&B respectively. The overall response rates were 53.3% (gpA) and 56.7% (gpB) P=0.24, the rates of PSA decline were higher in gpA than gpB (80% vs 70%) (p=0.27). Reduction of pain was better in patients receiving (V) than those treated with (D) (60% vs 50%) (p= 0.23). The improvement in the quality of life was higher in gp A than in gpB (50% vs 40%) but the difference was statistically insignificant. No WHO G3 or 4 toxicities in gp A. G3 alopecia (60%), G3 neutropenia (20%) were noted in gpB. Conclusions: Our results suggest that vinorelbine and docetaxel demonstrate similar efficacy as first line treatment for mHRPC. Vinorelbine is however better tolerated besides being a less costly therapeutic option in Egypt. Comparative phase III trial is needed to confirm these results.