Phase II study of apatinib, a novel tyrosine kinase inhibitor targeting tumor angiogenesis, as second-line treatment for recurrent or advanced cervical cancer patients.

This study was designed to evaluate the efficacy and safety of apatinib, a novel tyrosine kinase inhibitor targeting tumor angiogenesis, as second-line treatment in recurrent or advanced cervical cancer patients. Twenty patients who failed cisplatin/paclitaxel ± bevacizumab treatment received a 4-week cycle of apatinib, with a daily dosage of 500 mg or 250 mg. The follow-up period ranged from 5.9 to 21.3 months (median, 14.0 months). None of the patients achieved a complete response (CR). Nevertheless, a partial response (PR), stable disease (SD) and progressive disease (PD) were observed in three, four and thirteen patients, respectively. The objective response rate (ORR) was 15.0% (95% CI, 2.1%-32.1%), and the disease control rate (DCR) was 35.0% (95% CI, 12.1%-57.9%). Among the 12 patients who were treated with bevacizumab in first-line treatment, two achieved PR and two achieved SD. The ORR and DCR were 16.7% (95% CI, 8.1%-41.4%) and 33.3% (95% CI, 2.0%-64.6%), respectively. The median progression-free survival (PFS) was 5.13 months (95% CI, 2.94-7.32 months), and the median overall survival (OS) was 12.3 months (95% CI, 10.13-14.47 months). The one-year PFS rate was 28.1%, and the one-year OS rate was 44.6%. The most common adverse events were hand-foot syndrome, hypertension, proteinuria, fatigue, nausea, vomiting, anaemia, and neutropenia. Most of the adverse events were of grades 1 and 2. The most frequent grade 3 and 4 adverse events were fatigue, hypertension, and hand-foot syndrome. In summary, apatinib is an effective and well-tolerated second-line treatment for patients with recurrent or advanced cervical cancer.