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| |  No Benefit in Adding Vandetanib to Docetaxel Plus Prednisolone for Patients With Advanced Prostate Cancer: Presented at EAU By Jill Stein MILAN, Italy -- March 30, 2008 -- The addition of vandetanib does not enhance the efficacy of combination treatment with docetaxel plus prednisolone in men with hormone-refractory prostate cancer (HRPC), according to results released here March 27 at the 23rd Annual European Association of Urology (EAU) Congress. Jozsef Horti, MD, Director, Department of Medical Oncology, National Institute of Oncology, Budapest, Hungary, and colleagues measured prostate-specific antigen (PSA) response in 86 patients with HRFC at 10 centres across 5 countries. All participants were treated with either vandetanib 100 mg/day plus docetaxel/prednisolone (docetaxel 75 mg/m2 intravenously every 3 weeks plus prednisolone in two 5-mg doses per day) or with placebo plus the docetaxel-prednisolone combination. PSA response was defined as a reduction of 50% or greater from baseline, confirmed within 2 to 4 weeks. The study, however, found a larger number of confirmed PSA responses with placebo plus docetaxel/prednisolone compared with vandetanib plus docetaxel/prednisolone (67% vs 40%, respectively; hazard ratio [HR] = 2.23; P = .01). The number of progression events (defined as disease progression or death from any cause), a secondary endpoint of this study, was greater in the vandetanib-plus-docetaxel/prednisolone arm than in the placebo-plus-docetaxel/prednisolone arm (65% vs 60% for the 2 groups, respectively; HR = 1.13; P = .66). The combination of vandetanib plus docetaxel/prednisolone was generally well tolerated, and the safety and tolerability profile was similar to that observed in previous vandetanib trials. The reduced tolerability of the vandetanib combination compared with placebo was no worse than would be expected from the known safety profile of these agents. The authors concluded that the study documents an absence of efficacy benefit for the vandetanib-plus-docetaxel/prednisolone combination compared with placebo plus docetaxel/prednisolone in patients with HRPC. Still, there is a "critical need to develop new therapies" for the clinical challenge of HRPC, commented Dr. Horti. "Docetaxel is the standard first-line agent for the treatment of HRPC," he stated, "and the combination of docetaxel with molecularly targeted therapies may offer the potential to increase the efficacy of chemotherapy in prostate cancer." Funding for this study was provided by AstraZeneca PLC. [Presentation title: A Randomized, Double-Blind, Placebo-Controlled Phase II Study of Vandetanib Plus Docetaxel/Prednisolone in Patients With Hormone-Refractory Prostate Cancer. Abstract 641]
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