HIGH DOSE IL2 VS SUBCUTANEOUS IL2/IFN IN METASTATIC RENAL CELL CARCINOMA

点击翻译按钮获取中文摘要

This phase III trial is designed to assess the difference in progression free survival of two different interleukin-2 regimens for patients with previously untreated metastatic renal cell carcinoma. Interleukin-2 is the FDA approved therapy for metastatic RCCa. When administered by the high-dose bolus method, as it was approved, it needs to be given in an ICU setting due to severe hypotension and other therapy-related complications. Overall, a response rate of 15-20% with a 3-year PFS of 10% is seen. In contrast, out-patient administration of IL-2 by subcutaneous injection has been studied and when administered with out-patient interferon-alpha, is associated with a similar response rate though the 3-yr PFS is somewhat lower. This study is designed to compare these two regimens in a definitive phase III study to determine the specific role of high-dose bolus therapy in this patient population.