All patients were homoge nously treated and followed selleck chemical FTY720 up according to a protocol, which was based on the approved SPC and the published clinical studies. Sunitinib was administered Inhibitors,Modulators,Libraries at the approved dose of 50 mg daily on a 4 weeks on 2 weeks off schedule. Treatment was interrupted in case of Grade 3 or 4 toxicity and was reintroduced when toxicity was Grade 1. In case of Grade 3 non haematological toxicity or Grade 4 haematological toxicity, there was a successive reduction at a daily dose of 37. 5 mg and 25 mg. Thyroid dysfunction and arterial hypertension were managed with appropriate medication without dose reductions. Tumor evaluation was performed every 2 3 cycles of treatment unless clinically indicated. This is a retrospective analysis of patients treated with sunitinib in six Greek Oncology Units of HECOG.

Inclusion criteria were advanced RCC not amenable to surgery and treatment with sunitinib. Adjuvant or first line treatment with interferon was allowed but no pre vious targeted therapy with sorafenib, Inhibitors,Modulators,Libraries bevacizumab or temsirolimus. Measurable or evaluable disease was not required for inclusion in the analysis. Data was frozen at April 2009. Statistical analysis The SPSS software was used for statistical analysis. OS was measured from the date of randomization until death from any cause. PFS was measured from the date of randomiza tion until objective tumor progression or death. Time to event distributions were estimated using Kaplan Meier curves. The Cox proportional hazards model was used to assess the relationship of OS with various clinical and laboratory variables.

The backward selection procedure with removal criterion p 0. 10 based on Likelihood ratio test was performed to identify significant variables among the following number of metastatic sites, time between diagnosis sur gery and sunitinib initiation, ECOG PS, Haemoglobin, Calcium, Lactate dehydrogen Inhibitors,Modulators,Libraries ase, Alkaline phosphatase, prior nephrectomy. A model was developed to stratify patients according to risk. Significant risk factors were identified and model selection was performed through Likelihood ratio tests, Inhibitors,Modulators,Libraries comparing models to the established MSKCC models in the literature. The prognostic performance of the models was assessed through ROC curves, and AUC comparison was performed by a non parametric test proposed by DeLong. STATA was used for the analysis.

Results Patient characteristics One hundred and nine patients were included in this analysis. Their Inhibitors,Modulators,Libraries characteris tics are shown in Table 1. Seventeen patients had been treated with IFNa 2a, while 86 had under gone nephrectomy. One hundred patients had clear cell carcinoma, while in another 3 a clear cell component http://www.selleckchem.com/products/Sorafenib-Tosylate.html with other elements was also detected. The remaining cases were pure non clear cell carcinomas. At the time of analysis a total of 724 cycles of Sunitinib had been administered. Tumor response and PFS Thirty five patients were still on treatment.