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

这项III期临床试验旨在评估两种不同的白细胞介素-2治疗方案对既往未经治疗的转移性肾细胞癌患者的无进展生存率的差异。 白细胞介素-2是FDA批准的转移性RCCa的疗法。 当通过高剂量推注法给药时，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，已经研究了通过皮下注射的IL-2的门诊给药，并且当与门诊干扰素-α一起给药时，与类似的应答率相关，尽管3年PFS略低。 本研究旨在通过一项确定性III期研究比较这两种方案，以确定高剂量推注治疗在该患者人群中的具体作用。

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.