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

这项III期试验旨在评估两种不同的白介素-2方案对先前未经治疗的转移性肾细胞癌患者的无进展生存的差异。白介素-2是FDA批准的治疗转移性RCCa的药物。当采用大剂量丸法给药时，由于严重低血压和其他治疗相关并发症，需要在ICU环境中给予。总体而言，缓解率为15-20%，3年PFS为10%。相比之下，已经研究了门诊皮下注射IL-2，当与门诊干扰素- α一起使用时，与类似的缓解率相关，尽管3年的PFS略低。本研究的目的是比较这两种方案，在一项明确的III期研究中确定高剂量丸治疗在该患者群体中的具体作用。

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.