Four patients experienced early death prior to tumor assessment, while in the remaining 16 cases no tumor assessment had been per formed at the time of analysis. One patient selleckbio had complete tumor response and 19 Inhibitors,Modulators,Libraries patients had a partial response for a total of 22. 4% objective response rate. Stable disease was observed in 49 cases, while 20 patients had pro gressive disease at first tumor evaluation. Median follow up was 15. 8 months. Median PFS for the whole cohort was 8. 9 months, while 1 year PFS rate was 40%. Overall survival analyses Median OS was 17. 1 months and 1 year survival rate 61%. During follow up 48 patients died from RCC. Univariate analysis showed that the following factors were associated with worse OS 1 metastatic sites, 12 months between diag nosis and treatment with sunitinib, PS 1, abnormal ALP, low Hb levels and no prior nephrectomy.
The effect of LDH levels was not statistically Inhibitors,Modulators,Libraries significant, while previous therapy with IFN or histological type did not affect OS. The independent association with survival was examined in the backward selection procedure. With a removal criterion of p 0. 10, the final model for predicting survival included three inde pendent risk factors number of metastatic sites, interval from diagnosis surgery to treatment initiation, and PS. The combination of these three factors resulted in the stratification into 4 groups with distinct separation of OS curves. Prognostic stratification and comparison with the MSKCC Inhibitors,Modulators,Libraries model The application of the MSKCC model, using stratifica tion by LDH, Hb, Ca, PS, time from diagnosis to initia tion of Sunitinib into 3 risk groups, resulted in populations with distinctly separated OS curves.
The breakdown of patients and events into the four risk categories based on the identified risk factors and how this corresponds to the breakdown to the three MSKCC categories is presented in Table 5. Among the 15 patients in the favorable risk category by MSKCC, no deaths were observed for the six who were also identified Inhibitors,Modulators,Libraries as belonging to the most favorable risk category Inhibitors,Modulators,Libraries by the proposed model, while for the 9 who were categorized in the second risk category by the proposed model one of them died. Among the 25 patients with poor risk according to Motzer, for the patients in the least favorable risk category by both models, all 6 patients died in a short period, while for the remaining 19 patients categorized in the two intermedi ate risk categories according to the proposed model, 12 died during the observation period.
Among the 55 patients of the intermediate risk according to Motzer, the DR according to the proposed stratification was 0. 08, likewise 0. 38 and 0. 72, for the 9 patients without any risk factor, the 26 with one risk factor and the 20 with two risk factors, respectively.