Abstract
SummaryPurpose Apatinib, a new tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor-2, has shown promising efficacy against several solid cancers, but evidence of its efficacy against relapsed and refractory nasopharyngeal carcinoma is limited. We investigated the efficacy and safety of apatinib for relapsed and refractory nasopharyngeal carcinoma in an open-label, single-arm, phase II clinical trial. Fifty-one patients with relapsed and refractory nasopharyngeal carcinoma in the First Affiliated Hospital, Zhengzhou University, who met the inclusion criteria were enrolled in the study. All patients received apatinib at an initial dose of 500 mg daily (1 cycle = 28 days). The primary and secondary endpoints were overall response rate, progression-free survival, and overall survival. We evaluated treatment effects and recorded apatinib-related adverse events by performing regular follow-ups and workup. The overall response rate (complete and partial responses) was 31.37% (16/51). The median overall survival and progression-free survival were 16 (95% CI, 9.32–22.68) and 9 months (95% CI, 5.24–12.76), respectively. Most patients tolerated treatment-related adverse events of grades 1 and 2; hypertension (29, 56.86%), proteinuria (25, 49.02%), and hand–foot syndrome (27, 52.94%) were the most common adverse events. There were no treatment-related deaths. Apatinib showed good efficacy and safety in patients with relapsed and refractory NPC.
Highlights
Nasopharyngeal carcinoma (NPC) is a common malignant tumor of the head and neck with a distinct regional and racial prevalence in southern China, especially among people of Cantonese ancestry
Co-expression of tumor VEGF and hypoxiarelated growth factors in NPC is associated with poor prognosis, and it serves as potential evidence to explore the effectiveness of apatinib against relapsed and recurrent NPC
The inclusion criteria were as follows: 1) patients aged between 18 and 70 years with an Eastern Cooperative Oncology Group (ECOG) performance status of 0–3; 2) patients with histologically confirmed NPC who did not respond to the first-line platinum-containing chemotherapy and second-line single or combined chemotherapy before apatinib treatment according to the National Comprehensive Cancer Network guideline; and 3) patients with at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) and with acceptable hematologic, hepatic, and renal functions
Summary
Nasopharyngeal carcinoma (NPC) is a common malignant tumor of the head and neck with a distinct regional and racial prevalence in southern China, especially among people of Cantonese ancestry. Radiotherapy is the main treatment for NPC [1, 2]. A new vascular endothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor, selectively targets intracellular ATP-binding site and has shown efficacy against various solid tumors, especially advanced gastric carcinoma [5,6,7,8]. In a previous study [9], VEGF was overexpressed in more than 60% of clinical biopsy samples of NPC. Co-expression of tumor VEGF and hypoxiarelated growth factors in NPC is associated with poor prognosis, and it serves as potential evidence to explore the effectiveness of apatinib against relapsed and recurrent NPC. Clinical data to help assess the antitumor activity against
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