阿帕替尼联合同步放化疗治疗化疗耐药局部晚期宫颈癌的临床观察  

A clinical observation on apatinib combined with concurrent chemoradiotherapy in the treatment of patients with advanced chemotherapy-resistant cervical cancer

作　　者：甘媚 陈敏[1] 梁雷锋[2] 杨春旭[1] 曾伟[1] 梅自洁 孙绍星[1] 杨慧 王淼[1] 江耀飞 邱惠 GAN Mei;CHEN Min;LIANG Leifeng;YANG Chunxu;ZENG Wei;MEI Zijie;SUN Shaoxing;YANG Hui;WANG Miao;JIANG Yaofei;QIU Hui(Dept.of Radiation and Medical Oncology,Hubei Key Laboratory of Tumor Biological Behaviors,Zhongnan Hospital of Wuhan University,Wuhan 430071,Hubei,China;Dept.of Oncology,The First People’s Hospital of Yulin City,Yulin 537000,GuangXi,China)

机构地区：[1]武汉大学中南医院肿瘤放化疗科/湖北省肿瘤生物学行为重点实验室,湖北武汉430071 [2]玉林市第一人民医院肿瘤科,广西玉林537000

出　　处：《武汉大学学报（医学版）》2021年第6期954-959,共6页Medical Journal of Wuhan University

摘　　要：目的:观察在标准放化疗同步治疗的基础上,加用抗血管生成的小分子药物阿帕替尼能否逆转或增加对化疗耐药的宫颈癌细胞的放疗敏感性、提高临床疗效,同时观察其使用的安全性。方法:选取的研究对象为2016年1月至2018年9月就诊的Ⅱb~Ⅳa期宫颈癌患者,经2周期新辅助化疗且疗效评估为疾病稳定(SD)或疾病进展(PD),共40例,其中观察组(20例),先口服阿帕替尼7 d,继而行根治性同步放化疗联合服用阿帕替尼。对照组(20例)患者仅接受同步放化疗。按照实体瘤RECIST1.1标准评估治疗短期疗效,比较两组患者的总生存(OS)率、无进展生存(PFS)率进行远期疗效的评价。按照CTCAE(不良事件通用术语标准)记录患者的不良事件。结果:短期疗效:放化疗结束时,观察组与对照组完全缓解(CR)差别有统计学意义(75%vs 40%,P=0.03);部分缓解(PR)率无统计学差异(20%vs 30%,P>0.05)。客观缓解率(ORR)有统计学差异(95%vs 75%,P=0.03),疾病控制率(DCR)无统计学差异(95%vs 80%,P=0.15)。短期疗效观察CR率及ORR均优于对照组,有统计学差异。远期疗效:至2020年8月,对照组与观察组PFS率分别为:50%、40%,中位PFS分别为:33月、25月,差别无统计学意义(P=0.40)。OS率分别为65%、50%(P=0.45),观察组的PFS率及OS率高于对照组,但两组间无显著性差异(P>0.05)。放疗过程中不良事件主要为骨髓抑制、急性放射性肠炎、高血压、手足综合征,未出现4级急慢性放射反应,不良反应耐受。结论:针对化疗耐药晚期宫颈癌患者,阿帕替尼联合同步放化疗完全缓解率及客观缓解率较高,短期疗效较佳,且不良反应可耐受,有望成为一种安全有效的治疗手段,但长期疗效有待进一步临床试验证实。Objective:To observe the radiotherapy sensitivity,clinical efficacy,and safety of concurrent chemoradiotherapy combined with apatinib on the patients with advanced chemotherapy-resistant cervical cancer.Methods:From January 2016 to September 2018,after two periods of the neoadjuvant chemotherapy,40 Ⅱb-Ⅳa cervical cancer patients were concluded as PD(progressive disease)/SD(stable disease).The observation group(20 cases) received oral apatinib targeted therapy for 7 days,followed by radical concurrent chemoradiotherapy combined with oral apatinib targeted therapy.The control group(20 cases) received concurrent chemoradiotherapy.The therapeutic efficacy was evaluated according to the solid tumor RECIST criteria.The OS rate and PFS rate of the two groups were compared to evaluate the long-term efficacy.Adverse events were recorded according to the CTCAE.Results:In short-term efficacy,when the chemoradiotherapy was finished,the difference between the observation group and control group was statistically significant in CR(75% vs 40%,P=0.03)and ORR(95% vs 75%,P=0.03),while no difference was found in PR(20% vs 30%,P>0.05) and DCR(95% vs 80%,P=0.15).The complete and objective remission rates in observation group were superior to those in control group,with statistically significant differences.In the long-term curative effect,by August 2020,the PFS rates of the two groups were 50% vs 40%,the median PFS were 33 months vs 25 months,and OS rates were 65% vs 50%,respectively,and no signifcant difference was shown.The disease-free survival rate and overall survival rate in observation group were higher than those in control group,but no signifcant difference was found(P>0.05).The main adverse events were grade 1-3 bone marrow suppression,acute radiation enteritis,hypertension,and hand and foot syndrome,without grade 4 acute or chronic radiological reaction.These adverse reactions were tolerable.Conclusion:For patients with advanced cervical cancer resistant to chemotherapy,apatinib combined with concurrent chemoradiothera

关 键 词：晚期宫颈癌 化疗耐药 同步放化疗 阿帕替尼 联合治疗 

分 类 号：R737.6[医药卫生—肿瘤]