Aim and background: The aim of the study was to assess the activity and the safety of pazopanib as first-line therapy in patients with metastatic renal cell carcinoma.
Methods and study design: Between September 2011 and April 2014, 15 patients (8 females and 7 males) with metastatic renal cell carcinoma, referred to the Medical Oncology Unit of Policlinico-Bari, were treated with pazopanib, administered orally at the dose of 800 mg daily. Patients were assessed for activity every three months by computed tomography. The primary endpoint was response rate evaluated by RECIST criteria and progression-free survival.
Results: To date, 15 patients have been evaluated for response: 11 (73.4%) achieved a partial response after 3 months of therapy with a median duration of 11.6 months (range, 5-31); 3 (20%) had stable disease with a median of 6 months (range, 4-7). No complete response has been observed. One patient progressed, and the median time to disease progression was 11 months. At a median time of 21 months, 14 patients are continuing therapy with pazopanib, and the benefit achieved has remained unchanged in all of them. The median progression-free survival was 10.52 months. Grade 3-4 toxicity was hypertension in 2 patients.
Conclusions: The data confirm other experiences showing the efficacy of pazopanib as first-line therapy in metastatic renal cell carcinoma. The overall clinical benefit rate (partial response + stable disease) was particularly high (>90). There is strong evidence of a long-lasting disease control both for patients achieving partial response and for those with stable disease.