Prognostic factors in metastatic renal cell carcinoma after failure of immunotherapy: Lessons from a large phase III trial

4547 Background: Immunotherapy (IT) remains first-line treatment for metastatic renal cell carcinoma (RCC). For patients (pts) with progressive disease following IT, no treatment is available, and new approaches are needed. However, prognostic factors (PF) in this patient population are not yet well described. We reported the results of a prospective, randomized, double-blind, placebo-controlled trial of Neovastat in pts who failed IT (Escudier et al, ECCO 2003). Neovastat failed to improve survival in this group of pts. Data from that trial were analyzed to evaluate the effect of PF on survival for pts failing IT. Methods: using univariate (UVA) and multivariate (MVA) analyses, 300 pts were evaluated for recognized PF in RCC pts: ECOG PS, nephrectomy, time from diagnosis to metastasis (TDM), number and site of metastases, and biological variables previously defined by Motzer (same cut-off values): hemoglobin (Hb), corrected calcium (CAc), albumin, LDH, alkaline phosphatase (AP). Results: the overall surv...