Abstract:
Objective To investigate the efficacy and safety of apatinib monotherapy as subsequent-line therapy on patients with advanced ESCC.
Methods We included 56 patients with advanced ESCC who were administered with apatinib monotherapy. The initial dosage of apatinib was 500mg or 250mg daily. Clinicopathological characteristics, adverse reaction and prognosis of the patients were analyzed. The primary endpoint of this study was PFS, the secondary endpoints were ORR, DCR, OS and safety of apatinib administration.
Results All the 56 patients with ESCC corresponded with the eligibility criteria and were available for the evaluation of efficacy and adverse reaction. The ORR of the 56 patients who received apatinib monotherapy was 8.9% (95%CI: 3.0%-19.6%) and DCR was 64.3% (95%CI: 50.4%-76.6%). The median PFS was 3.7 months (95%CI: 3.19-4.21) and the median OS was 6.3 months (95%CI: 3.53-9.08). The common adverse reactions were hypertension (50.0%), fatigue (41.1%), loss of appetite (35.7%), hand-foot syndrome (30.4%) and diarrhea (26.8%).
Conclusion Apatinib monotherapy demonstrates potential efficacy and tolerable safety as the further-line treatment for the patients with advanced ESCC. And the conclusion should be validated in prospective clinical studies subsequently.