甲磺酸阿帕替尼片联合放化疗对比单独放化疗治疗食管鳞癌:平行对照、探索性Ⅱ期临床研究  

Apatinibmesylate Combined with Chemoradiotherapy Versus Chemoradio therapy Alone for Esophageal Squamous Cell Carcinoma: AParallel Controlled, Exploratory Phase Ⅱ Clinical Study

作　　者：黄志宇[1] 吴海山[1] 姚奇伟 郑步宏[1] 李建成[1] HUANG Zhi-yu;WU Hai-shan;YAO Qi-wei;ZHENG Bu-hong;LI Jian-cheng(Department of Thoracic Radiation Oncology,Fujian Cancer Hospital&Fujian Medical University Cancer Hospital,Fuzhou,Fujian Province,350014 China)

机构地区：[1]福建省肿瘤医院&福建医科大学附属肿瘤医院胸部放疗科,福建福州350014

出　　处：《中外医疗》2020年第6期9-14,共6页China & Foreign Medical Treatment

摘　　要：目的探讨甲磺酸阿帕替尼片联合放化疗治疗食管鳞癌的临床疗效及安全性。方法方便选取该院收治的经病理学确诊的Ⅱ、Ⅲ、Ⅳ期食管鳞癌初治患者,随机分为单纯放化疗组、甲磺酸阿帕替尼片联合放化疗组,随访至疾病进展,统计分析所有患者无进展生存时间、临床疗效及安全性。结果该研究共纳入2017年1月-2018年8月在该院接受治疗的37例食管鳞癌初治患者,其中单纯放化疗组(对照组)有19例,甲磺酸阿帕替尼片联合放化疗组(实验组)有18例。单纯放化疗组中位无进展生存时间为3个月(范围1-9),甲磺酸阿帕替尼片联合放化疗组中位无进展生存时间为5个月(范围1-17),差异无统计学意义(χ~2=1.143,P=0.285)。单纯放化疗组肿瘤缓解深度(Depth of Response,DPR)≥50%者3例,DPR<50%者16例;甲磺酸阿帕替尼片联合放化疗组DPR≥50%者9例,DPR<50%者9例,差异有统计学意义(χ~2=4.937,P=0.026)。实验组中,高血压、肝功能损害、手足综合征、腹泻的发生率分别为11.11%(2/18)、5.56%(1/18)、11.11%(2/18)和5.56%(1/18)。对照组中乏力、腹泻、高血压的发生率均为5.26%(1/19)。结论甲磺酸阿帕替尼片联合放化疗对比单独放化疗治疗食管鳞癌可提高肿瘤缓解深度、改善肿瘤近期疗效,并有提高无进展生存时间的趋势。不良反应主要表现为高血压、肝功能损害、手足综合征、腹泻。Objective To explore the clinical efficacy and safety of apatinibmesylate combined with chemoradiotherapy in the treatment of esophageal squamous cell carcinoma. Methods Convenient select the newly diagnosed patients with stage Ⅱ, Ⅲ and Ⅳ esophageal squamous cell carcinoma who were diagnosed by pathology were randomly divided into chemoradiotherapy alone group, apatinibmesylate combined with chemoradiotherapy group and follow-up to disease progression. Progression-free survival, clinical efficacy, and safety were all evaluated in all patients. Results Between January 2017 and August 2018, a total of 37 patients fulfilled the inclusion criteria, 19 of whom receivedchemoradiotherapy alone(control group), while 18 received apatinibmesylate combined with chemoradiotherapy(experimental group). The median progression-free survival time was 3 months(range,1-9) in the chemoradiotherapy alone group and 5 months(range,1-17) in the combination of apatinibmesylate group, the difference was not statistically significant(χ~2=1.143, P=0.285). In the chemoradiotherapy alone group, there were 3 patients with DPR(depth of response) ≥50% and 16 patients with DPR<50%, whereas there were 9 patients with DPR≥50% and 9 patients with DPR<50% in the combination of apatinibmesylate group, the difference was statistically significant(χ~2=4.937, P =0.026). In the experimental group, the incidence of hypertension, liver function damage, hand-foot syndrome, and diarrhea were 11.11%(2/18), 5.56%(1/18), 11.11%(2/18),and 5.56%(1/18). And the rate of fatigue, diarrhea, and hypertension in the control group was 5.26%(1/19). Conclusion Apatinibmesylate combined with chemoradiotherapy for esophageal squamous cell carcinoma can improve the tumor deepness of response and response rate, and exhibited the trend in increasing the progression-free survival time. Adverse reactions mainly reported as hypertension, liver damage,hand-foot syndrome, and diarrhea.

关 键 词：阿帕替尼 放化疗 食管鳞癌 

分 类 号：R5[医药卫生—内科学]