Second-line everolimus treatment is effective in RCC patients with poor progression-free survival (PFS) in first-line VEGF-targeted therapies.

e15028 Background: Everolimus is a standard second line treatment after failure of a VEGF targeted agent in patients (pts.) with metastatic renal carcinoma (mRCC) and was associated with a median progression free survival (PFS) of 4.9 months (mo.) in the pivotal trial. It remains unknown whether everolimus efficacy is similar in pts. who failed to respond to tyrosine kinase inhibitors (TKIs) or had a PFS ≤6 mo. in first line therapy compared to others. Methods: Fifty-six pts. who received everolimus as second line therapy after failure of either sunitinib (n=45) or sorafenib (n=11) were identified retrospectively at 2 German academic centres. Everolimus was applied between April 2007 and January 2011. Nine pts. are still ongoing. MSKCC-Score was considered as high in 1 patient, intermediate in 29 and low in 12 patients, respectively. In 14 patients MSKCC could not be evaluated. Disease control was defined by the fraction of patients achieving either objective response or stable disease as best response. Results: First line therapy achieved a median PFS of 10.7 months and was associated with a median overall survival (OS) of 37.6 mo. in first line therapy. Disease control was achieved in 46 pts. (82%). Three patients did not have tumor evaluation and 8 patients showed PD as best response. A PFS ≤6 mo. was detected in 13 pts. (23%) and considered as unfavourable. The median PFS of everolimus treatment is 5.5 mo., with disease control in 33 pts. (60%) and progressive disease in 19 pts. (35%) as best response. 4 pts. were not evaluable for response. The median OS from start of first TKI treatment in pts. with PFS ≤6 or >6 mo. of first line TKI treatment was 16.9 and 40 mo., respectively (P=0.001). However, PFS of everolimus treatment remained similar in both groups and achieved 3.6 and 5.8 mo., respectively (P=0.968). Conclusions: PFS ≤6 mo. in first line TKI treatment is associated with a poor prognosis in mRCC. However, 2nd line antitumor activity of everolimus remains unaffected irrespective of the previous therapeutic activity.