A phase II study of pazopanib as front-line therapy in patients with non-resectable or metastatic soft-tissue sarcomas who are not candidates for chemotherapy

Among patients with advanced soft-tissue sarcoma (STS) who were deemed not to be candidates for chemotherapy, pazopanib was tested as a first-line agent in this phase II study. Eligibility criteria included: at least 18 years of age, patients should not be candidates for chemotherapy, and should be treatment naive. Pazopanib was titrated from 200 mg twice daily to a goal of 800 mg daily. Clinical benefit rate (CBR) at 16 weeks was assessed as primary endpoint. Median progression-free survival was estimated to be 3.67 (2.62–7.25) months. A median overall survival of 14.16 months was reported, CBR = 39.29% (22/56) (CI = 0.265–0.533). There were no new or unexpected adverse events. Findings demonstrated that front-line pazopanib was beneficial in patients with STS who were not candidates for cytotoxic chemotherapy.