曲妥珠单抗联合FLOT方案围手术期治疗可手术HER-2阳性进展期胃癌的疗效和安全性  

Efficacy and safety of trastuzumab with FLOT regimen in perioperative treatment of resectable HER-2+advanced gastric cancer

作　　者：童刚领[1] 程勃然 吴烜[1] 何立锐[2] 王丽[1] 吕国庆[2] 王树滨[1] TONG Gangling;CHENG Boran;WU Xuan;HE Lirui;WANG Li;LYU Guoqing;WANG Shubin(Department of Oncology,Peking University Shenzhen Hospital,Shenzhen Key Laboratory of Gastrointestinal Cancer Translational Research,Cancer Institute of Shenzhen-PKU-HKUST Medical Center,Guangdong Shenzhen 518036,China;Gastrointestinal Surgery,Peking University Shenzhen Hospital,Guangdong Shenzhen 518036,China)

机构地区：[1]北京大学深圳医院肿瘤科,深圳市胃肠肿瘤转化研究重点实验室,深圳北京大学香港科技大学肿瘤研究所,广东深圳518036 [2]北京大学深圳医院胃肠外科,广东深圳518036

出　　处：《现代肿瘤医学》2021年第4期616-620,共5页Journal of Modern Oncology

基　　金：广东省自然科学基金(编号:2018A0303100026);深圳市科技创新委员会基金(编号:GJHZ20180420180754917,ZDSYS20190902092855097;JCYJ20190809100005672);深圳市三名工程项目(编号:SZSM201612041)。

摘　　要：目的:评估曲妥珠单抗联合FLOT方案作为可手术HER-2阳性进展期胃癌围手术期治疗的有效性和安全性。方法:FLOT方案具体为:多西他赛50 mg/m~2,奥沙利铂85 mg/m~2,亚叶酸钙200 mg/m~2,5-FU 2 600 mg/m~2(24小时持续静脉泵入),第一日,2周重复,术前和术后各4周期,曲妥珠单抗具体为:首次剂量8 mg/kg,后续6 mg/kg,第1、22、43日,3周重复,术前和术后各3周期,手术与化疗间隔3周。主要观察患者的客观缓解率、疾病控制率、肿瘤退缩程度、安全性和总生存时间。结果:共有31例患者入组,中位随访时间24.5个月。通过治疗,疗效为CR、PR、SD和PD的患者分别为:5例(16.1%)、18例(58.1%)、5例(16.1%)和3例(9.7%),ORR为74.2%(23/31),DCR为90.3%(28/31),R0切除率96.8%(30/31)。有5例(16.1%)患者获得TRG1a,8例(25.8%)患者获得TRG1b,均未见复发。最常见的3-4级副作用为粒细胞缺乏症(19.4%)和呕吐(3.2%)。2年OS 78.6%。结论:曲妥珠单抗联合FLOT方案作为可手术HER-2阳性进展期胃癌围手术期的治疗具有很好的疗效和安全性。Objective:To test efficacy and safety of the perioperative FLOT regimen given in combination with trastuzumab(T)in patients with resectable human epidermal growth factor receptor-2 positive(HER-2+)advanced GC.Methods:FLOT regimen consisting of docetaxel(50 mg/m 2),oxaliplatin(85 mg/m 2),leucovorin(200 mg/m 2),and 5-FU(2600 mg/m 2 as a 24 h infusion),all given on day 1 and administered every 2 weeks,for 4 cycles of 3 weeks before and after surgery,plus T(8 mg/kg loading dose,followed by 6 mg/kg every 3 weeks)on day 1,22 and 43,independent of the chemotherapy regimen chosen,for 3 cycles of 3 weeks before and after surgery.The objective response rate(ORR),disease control rate(DCR),tumor regression grade(TRG),safety and overall survival(OS)were observed.Results:Thirty-one patients were included in this retrospective study.Median follow-up of patients was 24.5 months.After the therapy,the patients of complete response(CR),partial response(PR),stable response(SD)and progression disease(PD)were 5(16.1%),18(58.1%),5(16.1%)and 3(9.7%).The ORR was 74.2%(23/31),and DCR was 90.3%(28/31).R0 resection was obtained in 30(96.8%)patients.Five patients(16.1%)had TRG1a and 8(25.8%)patients had TRG1b.No relapse was observed in patients with TRG1a/b.The most common grade 3-4 adverse events were neutropenia(19.4%)and vomiting(3.23%).The 2-year OS was 78.6%.Conclusion:Trastuzumab combined with FLOT regimen could be efficient and safely administrated in perioperative treatment of resectable HER-2+advanced GC.

关 键 词：胃癌 HER-2 围手术期化疗 曲妥珠单抗 

分 类 号：R735.2[医药卫生—肿瘤]