Abstract: AIM: To investigate the efficacy and safety of apatinib monotherapy in the third line and further line treatment for patients with advanced colorectal cancer failed after standard therapy and the preliminary analysis of efficacy predictors.  METHODS: The required sample size in this study was calculated with the PASS 15.0 software. Advanced colorectal cancer patients failed after standard therapy from May 2017 to October 2018 were included in this study. Patients enrolled in this study were given apatinib either 750 mg or 500 mg monotherapy. The objective remission rate (ORR) and disease control rate (DCR) were evaluated after 2 cycles treatment. The progression-free survival (PFS) and overall survival (OS) were evaluated at the follow-up period, and adverse events during treatment were recorded. The prognosis of patients with or without hypertension was analyzed. The primary endpoint of this study was PFS, and second endpoint was ORR, DCR, OS, safety evaluation and efficacy predictor analysis.RESULTS: Of the 51 patients included, 45 patients were available for efficacy and safety evaluation. Of the 45 advanced colorectal cancer received apatinib monotherapy, the objective response rate (ORR) was 11.11%, and the DCR was 77.78%, the median PFS was 3.95 months, the median OS was 10.3 months. And the common adverse reactions were hypertension, hand-foot syndrome, proteinuria and diarrhea. And the adverse reactions above grade 3 with higher incidence were hand-foot syndrome 6 cases (13.33%), hypertension 5 cases (11.11%), proteinuria 3 cases (6.67%) and diarrhea 3 cases (6.67%). PFS of patients with hypertension was significantly longer than that of patients without hypertension, which was statistical difference (P=0.01). CONCLUSION: Patients with advanced colorectal cancer failed the standard therapy and received apatinib treatment had potential clinical benefits, and the overall toxicity profile was manageable. Patients with hypertension might confer a better prognosis.

Key words: colorectal cancer, apatinib, efficacy, safety, efficacy predictor