Objective:
Anlotinib is an oral multi-target
tyrosine kinase inhibitor (TKI) with dual effects of anti-proliferation and anti-angiogenesis. Phase Ⅰ clinical trials showed
anlotinib was well tolerated and had
therapeutic effects on a variety of
tumors. The aim of this study is to explore the safety and efficacy of
anlotinib in the treatment of metastatic
renal cell carcinoma. Methods: Between January 2014 and November 2015, a single-center data was obtained from a phase Ⅱ clinical study of
anlotinib versus
sunitinib on advanced
renal cell carcinoma and a phase Ⅱ clinical study of
anlotinib on advanced
renal cell carcinoma which failed to respond to TKI treatment. Kaplan-Meier method was used for survival analysis, while Log-rank test was used to compare the survival rates. Results: A total of 36 patients with advanced
renal cell carcinoma were enrolled in this study, including 19 patients without any target drug treatment, 12 patients with
sunitinib treatment and 5 patients with
sorafenib treatment. The median number of treatment cycle was 16. Partial response (PR) was obtained in 11 patients (30.6%) and stable disease (SD) was obtained in 24 patients (66.7%). The disease control rate (DCR) was 97.2%. The median progression free survival (PFS) was 12.6 months, the 1-year survival rate was 80.6%, and the median survival time was 22.2 months. Up to the follow-up deadline, 3 patients still received treatment, the PFSs were 52.6 months, 65.0 months, and 66.7 months. The most common treatment-related adverse events of grade 3 or 4 included
hypertension (19.4%), hand-foot skin reaction (11.1%),
proteinuria (5.6%) and
anemia (5.6%). Conclusions:
Anlotinib shows good anti-
tumor activity and is generally well-tolerated in the treatment of advanced
renal cell carcinoma. The adverse reactions of
anlotinib are milder than
sunitinib or
pazopanib.