Abstract

4591 Background: Recent scoring systems for mRCC include laboratory markers, clinical course and performance status, without considering the response to systemic therapy. We therefore describe the validity of the PFS during first line VEGF-targeted therapy as an independent prognostic marker for the overall survival (OS) in mRCC. Methods: Medical records of 119 patients (pts.) treated with first line VEGF targeted therapy were retrieved and analyzed retrospectively. 91 pts. received sunitinib, 16 pts. sorafenib, 8 pts. axitinib and 4 pts. bevacizumab combined with either interferon-alfa or everolimus. The median OS and PFS were determined from start of first line VEGF-targeted therapy. Response to treatment was assessed according to response evaluation criteria in solid tumors (RECIST) 1.0. Log-rang test, Kaplan-Meier-, and Cox-regression analysis were employed to predict OS or PFS. Results: Best response to first line therapy consisted of stable disease in 46, partial remission in 18, complete remission in 6 and progressive disease in 25 pts. In 24 pts. best response was not evaluated. The median PFS of first line therapy was 8.1 months (range: 3.9-18.0) and was associated with a median OS of 22.7 months (range: 0.8-46.8). On univariate analysis, a PFS above 6 months (P <.0001), second line treatment (P=0.018), absence of osseous lesions (P=0.012), less than 3 metastatic organ sites (P=0.011), a good MSKCC score (P=0.011), clear cell histology (P=0.04), ECOG 0 (P=0.01), and achievement of complete response were associated with a prolonged OS. On multivariate analyses pts. with a PFS above 6 months (95% CI 0.145-0.438; HR 0.252), good MSKCC score (95% CI 0.072-0.530; HR 0.195), and pts. receiving second line treatment (95% CI 0.156-.674; HR 0.324) were identified as independent prognostic factors. The median OS in pts. with a PFS ≤6 or >6 months was 12 or 33 months, respectively. Conclusions: Our analyses describes first line PFS as an independent prognostic parameter in mRCC, suggesting that VEGF-responsiveness may play a key role for pts. prognosis and may serve as a selection criterion for subsequent therapy.

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