Outcome of patients (pts) with metastatic renal cell carcinoma (mRCC) treated with systemic therapy without cytoreductive nephrectomy (CN).

e16035 Background: Targeted therapies (TT) have replaced cytokines in the management of pts with mRCC. CN has been incorporated in the management of pts with mRCC but many pts are not suitable candidates for CN. The median overall survival (OS) time of pts treated with interferon alfa (IFN-α) without CN was 7.8 months (mos) [Flanigan et al. Journal of Urology 2004]. The median OS time for pts with mRCC treated with TT sequentially without CN is unknown. METHODS We retrospectively reviewed the medical records of pts with mRCC who did not undergo CN and who received one or more TT (bevacizumab, sorafenib, sunitinib, or temsirolimus) sequentially for at least one month with or without chemotherapy (gemcitabine + capecitabine or 5-FU). We calculated OS time from date of diagnosis until date of death or last follow up. We excluded pts who had embolization, radiofrequency ablation or cryotherapy of the primary tumor. RESULTS We identified 88 pts between Jan 2002 and Dec 2007. Median follow-up time is 9.7 mos (range: 1.2-49.2). Median OS time for all pts is 10.7 mos (95% CI: 7.6-15.4). 55 pts (62.5%) had clear-cell and 33 (37.5%) had non-clear cell histology, with median OS times of 15.1 mos (95% CI: 9.6-17.7) and 7.4 mos (95% CI: 4.4-13.0), respectively. ECOG performance status (PS) at time of diagnosis was correlated with OS (HR 1.54; 95% CI: 1.16-2.05; p<0.01). Pts with PS 0, 1, 2, and 3 had median OS times of 22.8 mos (95% CI: 5.7,*), 16.5 mos (95% CI: 8.1-24.7), 7.6 mos (95% CI: 5.7-11.9), and 7.1 mos (95% CI: 3.3-9.6), respectively. Pts with clinical evidence of lymph node (LN) involvement had worse outcome,with median OS time of 7.6 mos (95% CI: 5.6-9.8) versus 17.2 mos (95% CI: 9.8-35.5) for pts without clinical evidence of LN involvement. CONCLUSIONS In this analysis, median OS time for pts with mRCC treated in the modern era with TT without CN is superior to historical experience with IFN- α.Compromised PS, LN involvement, and non-clear cell histology were associated with worse outcome. This data is useful in the design of randomized trials investigating the role of CN in mRCC. [Table: see text].