The efficacy and safety of apatinib plus capecitabine in platinum-refractory metastatic and/or recurrent nasopharyngeal carcinoma: a prospective, phase II trial
Lin-Quan Tang,
Xiao-Yun Li,
Zhi-Ming Li,
Zhi-Gang Liu,
Miao-Zhen Lin,
Huan Zhou,
Qi-Wen Yu,
Jian Zhou,
Chong Zhao,
Ze-Bin Chen,
Xi-Cheng Wang,
Jia-Yu Peng,
Qiu-Yan Chen,
Wen-Feng Fang,
Yun-Peng Yang,
Bei Zhang,
Liang-Ping Xia,
Pi-Li Hu,
Wei-Han Hu,
Yi-Jie Li,
Hai-Qiang Mai,
Xiu-Yu Cai
Affiliations
Lin-Quan Tang
Department of Nasopharyngeal Carcinoma, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy
Xiao-Yun Li
Department of Nasopharyngeal Carcinoma, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy
Zhi-Ming Li
Department of Medical Oncology, Sun Yat-Sen University Cancer Center
Zhi-Gang Liu
The Cancer Center of the Fifth Affiliated Hospital of Sun Yat-Sen University
Miao-Zhen Lin
Department of VIP Inpatient, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy
Huan Zhou
Department of Oncology, The First Affiliated Hospital of Guangdong Pharmaceutical University
Qi-Wen Yu
Department of Oncology, The First Affiliated Hospital of Guangdong Pharmaceutical University
Jian Zhou
Department of Medical Imaging, Sun Yat-Sen University Cancer Center
Chong Zhao
Department of Nasopharyngeal Carcinoma, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy
Ze-Bin Chen
Department of Oncology, The First Affiliated Hospital of Guangdong Pharmaceutical University
Xi-Cheng Wang
Department of Oncology, The First Affiliated Hospital of Guangdong Pharmaceutical University
Jia-Yu Peng
Department of Oncology, The First Affiliated Hospital of Guangdong Pharmaceutical University
Qiu-Yan Chen
Department of Nasopharyngeal Carcinoma, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy
Wen-Feng Fang
Department of Medical Oncology, Sun Yat-Sen University Cancer Center
Yun-Peng Yang
Department of Medical Oncology, Sun Yat-Sen University Cancer Center
Bei Zhang
Department of VIP Inpatient, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy
Liang-Ping Xia
Department of VIP Inpatient, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy
Pi-Li Hu
Department of VIP Inpatient, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy
Wei-Han Hu
Department of Radiation Oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine
Yi-Jie Li
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Hai-Qiang Mai
Department of Nasopharyngeal Carcinoma, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy
Xiu-Yu Cai
Department of VIP Inpatient, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy
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.
