Re: Temsirolimus, Interferon Alfa, or Both for Advanced Renal-Cell Carcinoma

摘要

Experts' summary:In this multicenter, international, open-label, phase 3 clinical trial, patients were eligible for inclusion if they had histologically confirmed advanced renal cell carcinoma (RCC); a Karnofsky performance score (PS) >60; no previous treatment with systemic therapy; a measurable tumor according to the Response Evaluation Criteria in Solid Tumors(RECIST); adequate renal, bone marrow, and hepatic functions; and at least three predictors of short survival. Six hundred twenty-six previously untreated patients with poor-prognosis metastatic renal cell carcinoma (mRCC) were randomized into three treatment groups: intravenous temsirolimus, subcutaneous interferon-alpha (INF-alpha), or combination therapy. The primary study end point was overall survival (OS). Secondary end points were progression-free survival (as determined by study investigators and independent reviewers), objective response rate, clinical benefit rate (defined by the authors as objective response or stable disease [SD] for >24 wk), and adverse events.