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| |  Pazopanib Improves Progression-Free Survival, Response Rate in Patients With Advanced Renal Cell Carcinoma: Presented at ASCO By Deborah Brauser ORLANDO, Fla -- June 3, 2009 -- Pazopanib increases progression-free survival (PFS) and overall response rate for both treatment-naïve and cytokine-pretreated patients with advanced renal cell carcinoma (RCC), according to results from a phase 3 trial presented at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO). Lead author Cora N. Sternberg, MD, San Camillo and Forlanini Hospitals, Rome, Italy, presented the results here on June 1. In the study, 435 patients (233 treatment-naïve and 202 cytokine-pretreated) were enrolled at 80 sites in 22 countries and randomised 2:1 to receive either pazopanib 800 mg/day (n = 290; median age 59.0 years; 68% male) or matching placebo (n = 145; median age 60.0; 75% male). All patients received continuous treatment until disease progression, death, or unacceptable toxicity. The primary endpoint was PFS. Secondary endpoints included overall survival (to be reported later), response rate, and safety. The results showed that progression-free survival was significantly prolonged with pazopanib in the overall study population compared with placebo (9.2 versus 4.2 months; P < .0000001). For treatment-naïve patients, PFS was also prolonged with pazopanib compared with placebo (11.1 vs 2.8 months; P < .0000001), as well as in cytokine-pretreated patients (7.4 vs 4.2 months; P < .001). In addition, all patients treated with pazopanib also had a significantly higher overall response rate (30%) compared with placebo (3%). The median duration of response was 58.7 weeks. The most common adverse events experienced by the pazopanib-treated patients included diarrhoea (52% vs 9% for placebo), hypertension (40% vs 10%), and hair colour change (38% vs 3%). The most common laboratory abnormality was alanine aminotransferase elevation (53% vs 22%). The median duration of exposure for the pazopanib group was 7.4 months vs 3.8 months for placebo. "Pazopanib results in a favourable risk-benefit profile in the treatment of patients with both treatment-naïve and cytokine-pretreated advanced renal cell carcinoma," concluded Dr. Sternberg. [Presentation title: A Randomized, Double-Blind Phase III Study of Pazopanib in Treatment-Naive and Cytokine-Pretreated Patients With Advanced Renal Cell Carcinoma (RCC). Abstract 5021]
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