The efficacy and safety of apatinib plus capecitabine in platinum-refractory metastatic and/or recurrent nasopharyngeal carcinoma: a prospective, phase II trial
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Published:2023-03-16
Issue:1
Volume:21
Page:
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ISSN:1741-7015
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Container-title:BMC Medicine
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language:en
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Short-container-title:BMC Med
Author:
Tang Lin-Quan,Li Xiao-Yun,Li Zhi-Ming,Liu Zhi-Gang,Lin Miao-Zhen,Zhou Huan,Yu Qi-Wen,Zhou Jian,Zhao Chong,Chen Ze-Bin,Wang Xi-Cheng,Peng Jia-Yu,Chen Qiu-Yan,Fang Wen-Feng,Yang Yun-Peng,Zhang Bei,Xia Liang-Ping,Hu Pi-Li,Hu Wei-Han,Li Yi-Jie,Mai Hai-Qiang,Cai Xiu-Yu
Abstract
Abstract
Background
Previous studies have shown that monotherapy with apatinib, an oral tyrosine kinase inhibitor, has promising efficacy for treating recurrent or metastatic (RM) nasopharyngeal carcinoma (NPC) patients. In this study, we aimed to assess the efficacy and safety of apatinib combined with capecitabine as a second-line therapy or beyond for treating RM-NPC patients who failed the first-line platinum-based chemotherapy.
Methods
In this single-arm, phase II study, we enrolled RM-NPC patients who had at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). The sample size was determined using Simon’s two-stage design. All patients were administered with apatinib 500 mg once daily and capecitabine 1000 mg/m2 twice per day on days 1–14 of each 21-day cycle. The primary endpoint was the objective response rate (ORR), and the secondary endpoints comprised disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety.
Results
We enrolled 64 patients from September 2018 to August 2020. The ORR and DCR were 39.1% (95% CI, 27.1–52.1) and 85.9% (95% CI, 75.0–93.4), respectively. The median DoR was 14.4 months (95% CI, 7.8–21.0). As of April 20, 2021, the median follow-up duration was 12.0 months. The median PFS was 7.5 months (95% CI, 5.0–10.0) and the median OS was 15.7 months (95% CI, 11.3–20.1). The most common toxicities of any grade were anemia (75.0%), hand-foot syndrome (65.6%), and proteinuria (64.0%). Grade 3–4 toxicities were observed in 36 (56.3%) patients, with hypertension (14.1%), mucositis (12.4%), and fatigue (10.9%) most commonly observed.
Conclusions
Apatinib plus capecitabine shows promising efficacy as a second-line treatment option in pretreated platinum-refractory RM-NPC patients. Dose selection of this combination needs further investigation considering the toxicity.
Trial registration
Chi-CTR1800017229.
Funder
Chinese Society of Clinical Oncology the National Key R&D Program of China National Natural Science Foundation of China Guangzhou Municipal Science and Technology Project the Sun Yat-sen University Clinical Research 5010 Program Innovative research team of high-level local universities in Shanghai Natural Science Foundation of Guangdong Province for Distinguished Young Scholars Natural Science Foundation of Guangdong Province Health Medical Collaborative Innovation Program of Guangzhou Pearl River S and T Nova Program of Guangzhou Science and Technology Planning Project of Guangdong Province Young Teacher Foundation of Sun Yat-sen University
Publisher
Springer Science and Business Media LLC
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