Adjuvant apatinib therapy following concurrent chemoradiotherapy in patients with high-risk nasopharyngeal carcinoma: A multicenter, prospective phase 2 study.

Chen Huang; Jinmei Huang; Yunyan Mo; Rongjun Zhang; Yixin Su; Bin Zhang; Jian Zhang; Zhenkai Ye; Rui Cai; Zhengchun Liu; Xiangyun Kong; Shufang Liao; Xiaoping Lin; Fei Mo; Jinping Xu; Kui Wang; Wei Jiang

doi:10.1016/j.tranon.2026.102963

PubMed · 42551128

Adjuvant apatinib therapy following concurrent chemoradiotherapy in patients with high-risk nasopharyngeal carcinoma: A multicenter, prospective phase 2 study.

Chen Huang·Jinmei Huang·Yunyan Mo·Rongjun Zhang·Yixin Su·Bin Zhang·Jian Zhang·Zhenkai Ye·Rui Cai·Zhengchun Liu·Xiangyun Kong·Shufang Liao·Xiaoping Lin·Fei Mo·Jinping Xu·Kui Wang·Wei Jiang

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Abstract

PURPOSE: To assess the efficacy and safety of concurrent chemoradiotherapy (CCRT) combined with apatinib in locoregionally advanced nasopharyngeal carcinoma (LA-NPC). METHODS: This multicenter, prospective, phase II study enrolled patients with newly histologically confirmed LA-NPC, who were randomly assigned to receive CCRT followed by adjuvant apatinib (investigational arm) or CCRT alone (control arm). The investigational arm received 250 mg/day of oral apatinib administered every 28 days for up to six cycles after CCRT. The primary endpoint was 3-year progression-free survival (PFS) and secondary endpoints of overall survival (OS), distant metastasis-free survival (DMFS) and local recurrence-free survival (LRFS) of 3-year, and safety. RESULTS: From July 2018 to September 2020, 44 and 44 patients were randomized into the CCRT-alone and CCRT and apatinib groups, respectively. The median follow-up duration 56 (range: 40.0-58.6) months. The survival outcomes were the 3-year PFS, OS, and DMFS rates in the adjuvant apatinib following CCRT group were significantly higher than those observed in the CCRT-alone group((PFS, 78.6%vs. 54.5%, p = 0.027; OS, 88.1% vs. 75.0%, p = 0.029; DMFS, 85.4%vs. 59.1%, p = 0.009). The 3-year LRFS was similar between the groups. The grade 3-4 treatment-related adverse events(TRAEs) were higher in the former group than in the latter. The most common grade 3-4 non-hematology-related adverse events were hypertension (14.3%), hand-foot syndrome (9.5%), increased transaminase levels (7.1%), and headache (7.1%). CONCLUSION: Apatinib significantly improved the treatment effects of CCRT for high-risk LA-NPC patients. Therefore, CCRT and adjuvant apatinib may represent a promising option for this patient population.

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Chen Huang, Jinmei Huang, Yunyan Mo, Rongjun Zhang, Yixin Su, Bin Zhang, Jian Zhang, Zhenkai Ye, Rui Cai, Zhengchun Liu, Xiangyun Kong, Shufang Liao, Xiaoping Lin, Fei Mo, Jinping Xu, Kui Wang, Wei Jiang. 2026-08-04. Adjuvant apatinib therapy following concurrent chemoradiotherapy in patients with high-risk nasopharyngeal carcinoma: A multicenter, prospective phase 2 study.. https://doi.org/10.1016/j.tranon.2026.102963

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