Anlotinib in metastatic renal cell carcinoma (mRCC) with a previous anti-VEGFR TKI: Preliminary results from a multicenter, phase II trial.

e16082Background: Fibroblast growth factor (FGF) signaling regulates tumor growth and vascularization and partly mediates antiangiogenic escape from VEGFR inhibitors. Sequential TKI treatment has been proved to be effective in some patients with mRCC failed with a previous TKI. Anlotinib is a potent oral, small molecular TKI with a favorable safety profile in phase I trial which mainly targets VEGFR1/2/3, FGFR2. This multicenter phase II trial (NCT02072044) evaluated the efficacy of anlotinib in mRCC patients with clear cell being the predominant component who failed with a previous anti-VEGFR TKI. Methods: Patients who progressed on or were intolerant to sorafenib or sunitinib were enrolled. Anlotinib was administered orally at dose of 12 mg daily for 2 weeks followed by 1 week rest. The primary endpoint was PFS. Secondary end points included OS, ORR, safety. Results: Of 43 patients enrolled, 1 patient withdrawn his informed consent before treatment started. Of 42 patients received anlotinib, 30 patients...