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安罗替尼用于局部晚期鼻咽癌放化疗后辅助治疗的疗效观察OACSTPCD

Effect of anlotinib in adjuvant therapy of locally advanced nasopharyngeal carcinoma after radiotherapy and chemotherapy

中文摘要英文摘要

目的 分析局部晚期鼻咽癌患者行诱导化疗+同步放化疗后予口服安罗替尼辅助治疗的临床疗效及不良反应,为存在高危复发因素的局部晚期鼻咽癌患者找到一种有效的辅助治疗方法.方法 选择2018年1月至2019年12月广西科技大学第二附属医院(n=73)和来宾市人民医院(n=32)收治的局部晚期初治鼻咽癌患者进行研究.这些患者均为经2个周期TPF方案(多西他赛+氟尿嘧啶+顺铂)诱导化疗+顺铂单药同步放化疗后,有≥1项复发高危因素:治疗后未达完全缓解(complete response,CR)、Epstein-Barr 病毒(Epstein-Barr virus,EBV)-DNA>100 copies/mL 或者初始治疗前分期为 T4 或 N3.105 例患者随机分为安罗替尼辅助治疗组51例和观察组54例.安罗替尼辅助治疗组于同步放化疗结束后3周开始使用安罗替尼辅助治疗(餐前口服安罗替尼12 mg,1次/d,连续服用2周,停药1周;3周为1个周期),总共8个周期.观察组予观察.随访2年,比较两组患者2年生存情况,并分析安罗替尼辅助治疗组放化疗和安罗替尼相关不良反应.结果 安罗替尼辅助治疗组和观察组2年无失败生存(failure-free survival,FFS)率为94.1%和83.3%(P=0.023),2年无远处转移生存(distant metastasis-free survival,DMFS)率为 98.1%和 88.9%(P=0.015),2 年总生存(overall survival,OS)率为 98.1%和 94.4%(P=0.081),2年无局部区域复发生存(locoregional relapse-free survival,LRFS)率为96.1%和92.5%(P=0.072).安罗替尼相关不良反应主要为Ⅰ~Ⅱ级的高血压、疲乏、食欲下降、手足综合征、口腔咽喉痛以及皮疹.经对症处理后,患者不良反应明显缓解.结论 对于局部晚期鼻咽癌患者,行诱导化疗+同步放化疗后再口服安罗替尼辅助治疗可提高患者2年FFS率,减少局部复发和转移率.部分患者出现安罗替尼相关不良反应,大多可耐受,可通过治疗缓解.

Objective To analyze the efficacy and adverse reactions of anlotinib in adjuvant therapy of patients with locally advanced nasopharyngeal carcinoma after induction chemotheary and concurrent chemoradiotherapy,so as to find an effective treatment of local-ly advanced nasopharyngeal carcinoma patients with high-risk factors for recurrence.Methods From January 2018 to December 2019,105 cases of locally advanced nasopharyngeal carcinoma undergoing initial treatment were selected from the Second Affiliated Hospital of Guangxi University of Science and Technology(n=73)and People's Hospital of Laibin(n=32).These patients all had at least one high-risk factor for recurrence after 2 cycles of TPF regimen(docetaxel+fluorouracil+cisplatin)induction chemotherapy+cisplatin single-agent concurrent chemoradiotherapy.High-risk factors for recurrence included complete response(CR)unachieved after treatment,Epstein-Barr-virus(EBV)-DNA>100 copies/mL,and stage T4 or N3 before initial treatment.The patients were randomly assigned to anlotinib adjuvant therapy group(n=51)and observation group(n=54).The anlotinib adjuvant therapy group began to have anlotinib adjuvant therapy(anlotinib 12 mg orally once a day before meals for two consecutive weeks and discontinued for one week,three weeks as a cycle)three weeks after the end of the concurrent chemoradiotherapy,for a total of 8 cycles.The observation group was observed only.The 2-year survival of the two groups was compared,and the adverse reactions related to chemoradiotherapy and anlotinib adjuvant therapy were analyzed.Results For the anlotinib adjuvant therapy group and the observation group,the 2-year failure-free survival(FFS)rates were 94.1%and 83.3%(P=0.023),the 2-year distant metastasis-free survival(DMFS)rates were 98.1%and 88.9%(P=0.015),the 2-year overall survival(OS)rates were 98.1%and 94.4%(P=0.081),and the 2-year locoregional relapse-free survival(LRFS)rates were 96.1%and 92.5%(P=0.072).The main adverse reactions of anlotinib were grade Ⅰ and Ⅱ hypertension,fatigue,loss of appetite,hand-foot syndrome,oropharyngeal pain,and rash.After symptomatic treatment,the adverse reactions were significantly relieved.Conclusions For patients with locally ad-vanced nasopharyngeal carcinoma,induction chemotherapy and concurrent chemoradiotherapy followed by anlotinib adjuvant therapy can enhance the 2-year FFS rate of patients,and reduce the probability of recurrence and metastasis.The increased side effects related to an-lotinib can be tolerated by most patients and can be alleviated by treatment.

赵迎喜;蓝柳;韦婷婷;龙亚秀;梁立莉

广西科技大学第二附属医院肿瘤放射治疗三病区,广西 柳州 545006来宾市人民医院肿瘤科,广西来宾 546100

局部晚期鼻咽癌同步放化疗辅助治疗安罗替尼

locally advanced nasopharyngeal carcinomaconcurrent chemoradiotherapyadjuvant therapyanlotinib

《实用肿瘤杂志》 2024 (003)

258-265 / 8

广西卫生健康委员会自筹经费科研项目(Z20200922)

10.13267/j.cnki.syzlzz.2024.039

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