Summary
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.
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We thank all investigators and patients who participated in this study.
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This work was supported by the Shandong Traditional Chinese Medical Science Technology Development Projects (No. 2017–177), the Science and Technology Subject of Shandong Health Care Technology Association (SDBJKT20180047) and The Key Research and Development Program of Shandong Province (2018GSF118237).
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The research was approved by the Institutional Ethics Committee of Shandong Cancer Hospital and Institute (SDTHEC201603024).
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Zhang, L., Chen, L. & Yu, H. Phase II study of apatinib, a novel tyrosine kinase inhibitor targeting tumor angiogenesis, as second-line treatment for recurrent or advanced cervical cancer patients. Invest New Drugs 38, 1186–1191 (2020). https://doi.org/10.1007/s10637-019-00858-5
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DOI: https://doi.org/10.1007/s10637-019-00858-5