Apatinib, a novel VEGFR-2 tyrosine kinase inhibitor, for relapsed and refractory nasopharyngeal carcinoma: data from an
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PHASE II STUDIES
Apatinib, a novel VEGFR-2 tyrosine kinase inhibitor, for relapsed and refractory nasopharyngeal carcinoma: data from an open-label, single-arm, exploratory study Ling Li 1,2 & Fei Kong 1,2 & Lei Zhang 1,2 & Xin Li 1,2 & Xiaorui Fu 1,2 & Xinhua Wang 1,2 & Jingjing Wu 1,2 & Fangwen Zhang 1,2 & Liangliang Ren 1,2 & Mingzhi Zhang 1,2 Received: 22 August 2019 / Accepted: 16 March 2020 # The Author(s) 2020
Summary Purpose 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 openlabel, 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. Keywords Apatinib . Efficacy . Nasopharyngeal carcinoma . Targeted therapy
Introduction 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]. Despite intensive treatment, 30%–40% of patients
Ling Li and Fei Kong contributed equally to the work. * Ling Li [email protected] * Mingzhi Zhang [email protected] 1
Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, Henan, China
2
Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou 450052, Henan, China
with NPC show progressive disease [3, 4], and the treatment of patients with relapsed and refractory NPC remains a major challenge. Although palliative chemotherapy can confer median progression-free survival (PFS) for 3–9 months in patients with a recurrent disease, the overall survival (OS) remains low [5]. Hence, patients with relapsed and refractory NPC are recommended to participate in clinical trials. Angiogenesis is an important step in the
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