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A noninterventional study of everolimus in metastatic renal cell cancer after use of one VEGFR-TKI: Results of a preplanned interim analysis of a prospective study.

4552 Background: Everolimus (EVE, Afinitor) was approved for treatment of patients with metastatic renal cell cancer (mRCC) after failure of anti-VEGF therapy. Nevertheless, only limited prospective data is available on EVE after failure of 1 VEGFR-TKI. Here we report for the first time prospective data on the use of EVE after failure of the 1st VEGFR-TKI.


METHODS
A prospective, non interventional study in mRCC after failure of the 1st VEGFR-TKI was initiated to observe effectiveness of EVE. A preplanned interim analysis was performed after 100 patients had been enrolled in the study and were followed for ≥3 months.


RESULTS
59 German sites included 113 patients between 08/'09 and 07/'10, which were followed for a median of 116 days. Median age was 67 years, the median KPI was 80% and 88% had undergone nephrectomy. Most patients were previously treated with sunitinib (78%). Other prior therapies were sorafenib, cytokines and bevacizumab. Total duration of prior treatment was 15 months. Metastatic spread was detected in a median number of 2 organ systems. EVE-treatment information was available from 99 patients. At the cut-off date for interim analysis 47 of them had discontinued the study, because of disease progression (25), death (9) adverse events (7) and patient's wish (6). Median TTP for EVE was 9.7 months (95% CI: 6 mo.; n.r.). At the cut-off date the majority of patients were still on treatment, thus the median was still not reached. Safety evaluation confirmed the known profile of EVE with 230 reported adverse event. Anemia, pruritus, fatigue, dyspnea and diarrhea of any grade were the most frequent reported adverse drug reactions (>5% incidence each). 9 patients required treatment interruption of 5-39 days. Treating physicians reported a high therapy compliance of patients (80-100%) and a favorable tolerability profile of EVE.


CONCLUSIONS
This study of EVE in mRCC provides for the first time prospective data on the use of EVE after failure of the 1st VEGFR-TKI in routine use. It confirms prior reports about a longer TTP in a less pretreated population than evaluated in the pivotal trial. The results support EVE as the standard of care after failure of one VEGFR-TKI.