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中国癌症防治杂志

中国癌症防治杂志 ›› 2020, Vol. 12 ›› Issue (4): 397-402.doi: 10.3969/j.issn.1674-5671.2020.04.06

• 鼻咽癌精准诊疗专栏 • 上一篇    下一篇

转移性鼻咽癌放化疗后阿帕替尼维持治疗的前瞻性、单臂、多中心Ⅱ期临床研究

  

  1. 电子科技大学医学院附属肿瘤医院暨四川省肿瘤医院放疗科；川北医学院附属医院肿瘤科
  • 出版日期:2020-08-25 发布日期:2020-08-31
  • 通讯作者: 冯梅 E-mail：freda_fm@126.com
  • 基金资助:
    四川省科技计划项目（20CXRC0038）

A prospective,one-arm,multicenter phase Ⅱ clinical study of apatinib in maintenance therapy after chemoradiotherapy for metastatic nasopharyngeal carcinoma

  • Online:2020-08-25 Published:2020-08-31

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摘要：

 目的 探讨阿帕替尼单药作为转移性鼻咽癌化疗和（或）放疗后维持治疗的有效性和安全性。方法 纳入2017年4月至2020年4月接受化疗和（或）放疗后的转移性鼻咽癌患者，予以阿帕替尼500 mg维持治疗，观察其有效性和安全性，采用Kaplan-Meier法分析总生存期和无进展生存期。结果 共入组21例患者，中位年龄47岁，阿帕替尼中位服药时间4.7个月（范围：0.6~14.1个月）。中位随访时间16.1个月（范围：1.0~31.3个月），中位总生存期16.6个月（95%CI：6.9~26.3个月），1年生存率为53.2%；中位无进展生存期为10.8个月（95%CI：5.9~15.6个月），1年无进展生存率为31.9%。治疗相关3级不良反应主要为手足综合征（9.52%）、高血压（4.76%）、疲乏（4.76%）、口腔疼痛（4.76%）和呕吐（4.76%），未观察到4级不良反应。结论 阿帕替尼维持治疗可作为转移性鼻咽癌放化疗后的一种治疗选择，能较显著延长无进展生存期，且安全性可控，但需进一步开展前瞻性研究证实。

关键词: 鼻咽癌, 转移性, 阿帕替尼, 维持治疗

Abstract:

Objective To explore the efficacy and safety of apatinib as a maintenance treatment for metastatic nasopharyngeal carcinoma after chemotherapy and/or radiotherapy. Methods The patients with metastatic nasopharyngeal carcinoma，who received chemotherapy and/or radiotherapy from April 2017 to April 2020，were selected. All the patients received apatinib 500 mg as maintenance treatment，and the efficacy and safety were observed. The Kaplan-Meier method was used to analyze the overall survival and progression-free survival. Results A total of 21 patients were enrolled，with a median age of 47 years. The median duration of apatinib medication was 4.7（range：0.6-14.1） months，the median follow-up time was 16.1（range：1.0-31.3）months，the median overall survival was 16.6 （95%CI：6.9-26.3） months，1-year survival rate was 53.2%，and the median progression-free survival was 10.8（95%CI：5.9-15.6） months，the 1-year progression-free survival rate was 31.9%. The treatment-related grade 3 adverse reactions were mainly hand-foot syndrome （9.52%），hypertension （4.76%），tired （4.76%），mouth pain （4.76%），and vomiting （4.76%）. No grade 4 adverse reactions were observed. Conclusions Apatinib maintenance treatment can be an option for metastatic nasopharyngeal carcinoma after chemotherapy and radiotherapy. It can significantly prolong progression-free survival and has controllable safety. However，further prospective studies are needed to confirm this conclusion.

Key words: Nasopharyngeal carcinoma, Metastasis, Apatinib, Maintenance treatment

中图分类号: 

  • R739.63