Anlotinib versus sunitinib as first line treatment for metastatic renal cell carcinoma (mRCC): Preliminary results from a randomized phase II clinical trial.

4565Background: Anlotinib is a potent oral, small molecular TKI with a favorable safety profile in phase I clinical trial which mainly targets VEGFR1/2/3, FGFR2. This multicenter randomized phase II trial (NCT02072031) compared efficacy and safety of anlotinib and sunitinib as first line treatment in mRCC patients with clear cell being the predominant component. Methods: Patients were randomized in 2:1 to receive anlotinib or sunitinib. Anlotinib was administered at dose of 12 mg once daily for 2 weeks followed by 1 week rest, sunitinib at dose of 50mg once daily for 4 weeks followed by 2 weeks off. The primary endpoint was progression free survival (PFS). Secondary end points included overall survival (OS), overall response rate (ORR), safety. Results: 133 (93 with anlotinib, 40 with sunitinib) patients were enrolled. Data cutoff was May 15, 2015. Both group had similar PFS (11.3 vs. 11.0 months (p = 0.30), ORR (24.4% vs. 23.3%), 6-week disease controll rate (97.8% vs. 93.0%, p = 0.33). OS for both group...