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Pazopanib in Locally Advanced or Metastatic Renal Cell Carcinoma: Results of a Randomized Phase III Trial
Cora N Sternberg1, Ian D Davis1, Jozef Mardiak1
1From the Department of Medical Oncology, San Camillo and Forlanini Hospitals, Rome, Italy; Ludwig Oncology Unit, Austin Hospital, Melbourne, Australia; National Oncological Institute, Klenová, Bratislava, Slovakia; Department of Oncology, Military Institute of Medicine, Warsaw, Poland; Department of Urology, Seoul National University College of Medicine, Seoul, Korea; The South West Wales Cancer Institute, Singleton Hospital, Swansea; Cancer Research UK, Department of Medical Oncology, University of Manchester; Christie Hospital National Health Services Foundation Trust, Manchester, United Kingdom; Oncology Research Unit, Oncology Service, Hospital Sao Lucas, Pontifícia Universidade Católica do Rio Grande do Sol, Porto Alegre, Brazil; Division of Medical Oncology and Hematology, Fundación Arturo López Pérez, Santiago, Chile; Chelyabinsk Regional Oncology Center, Chelyabinsk, Russian Federation; Krankenhaus Heitzing, mit Neurologischem Zentrum Rosenhugel, Vienna, Austria; Centro Médico San Roque, Tucumán, Argentina; GlaxoSmithKline, Collegeville, PA; and GlaxoSmithKline, Research Triangle Park, NC.
Purpose:
Pazopanib is an oral angiogenesis inhibitor targeting vascular endothelial growth factor receptor, platelet-derived growth factor receptor, and c-Kit. This randomized, double-blind, placebo-controlled phase III study evaluated efficacy and safety of pazopanib monotherapy in treatment-naive and cytokine-pretreated patients with advanced renal cell carcinoma (RCC).
Patients And Methods:
Adult patients with measurable, locally advanced, and/or metastatic RCC were randomly assigned 2:1 to receive oral pazopanib or placebo. The primary end point was progression-free survival (PFS). Secondary end points included overall survival, tumor response rate (Response Evaluation Criteria in Solid Tumors), and safety. Radiographic assessments of tumors were independently reviewed.
Results:
Of 435 patients enrolled, 233 were treatment naive (54%) and 202 were cytokine pretreated (46%). PFS was significantly prolonged with pazopanib compared with placebo in the overall study population (median, PFS 9.2 v 4.2 months; hazard ratio [HR], 0.46; 95% CI, 0.34 to 0.62; P < .0001), the treatment-naive subpopulation (median PFS 11.1 v 2.8 months; HR, 0.40; 95% CI, 0.27 to 0.60; P < .0001), and the cytokine-pretreated subpopulation (median PFS, 7.4 v 4.2 months; HR, 0.54; 95% CI, 0.35 to 0.84; P < .001). The objective response rate was 30% with pazopanib compared with 3% with placebo (P < .001). The median duration of response was longer than 1 year. The most common adverse events were diarrhea, hypertension, hair color changes, nausea, anorexia, and vomiting. There was no evidence of clinically important differences in quality of life for pazopanib versus placebo.
Conclusion:
Pazopanib demonstrated significant improvement in PFS and tumor response compared with placebo in treatment-naive and cytokine-pretreated patients with advanced and/or metastatic RCC.
Insights
Pazopanib significantly improved progression-free survival in patients with advanced renal cell carcinoma (RCC). This oral angiogenesis inhibitor showed benefits in both treatment-naive and cytokine-pretreated populations.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Advanced renal cell carcinoma (RCC) is a significant clinical challenge.
- Angiogenesis inhibitors play a crucial role in RCC treatment.
- Pazopanib targets key receptors involved in tumor growth.
Purpose of the Study:
- To evaluate the efficacy and safety of pazopanib monotherapy in advanced RCC.
- To compare pazopanib against placebo in treatment-naive and cytokine-pretreated patients.
- To assess progression-free survival (PFS) as the primary endpoint.
Main Methods:
- A randomized, double-blind, placebo-controlled phase III study.
- 435 adult patients with measurable, advanced/metastatic RCC were enrolled.
- Patients received either oral pazopanib or placebo in a 2:1 ratio.
Main Results:
- Pazopanib significantly prolonged PFS in the overall population (9.2 vs 4.2 months) and both subpopulations.
- Objective response rate was 30% with pazopanib versus 3% with placebo (P < .001).
- Common adverse events included diarrhea, hypertension, and nausea; quality of life was not significantly different.
Conclusions:
- Pazopanib demonstrates significant efficacy in improving PFS and tumor response in advanced RCC.
- The drug is effective in both treatment-naive and previously treated patients.
- Pazopanib offers a valuable therapeutic option for advanced RCC.
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