放疗联合化疗和免疫治疗对HER2阴性局部晚期或晚期胃癌的临床疗效和安全性  

Clinical efficacy and safety of radiotherapy combined with chemotherapy and immunotherapy for HER2-negative locally advanced or advanced gastric cancer

作　　者：刘前怡 董洪敏 王文玲 王刚 陈望花 Liu Qianyi;Dong Hongmin;Wang Wenling;Wang Gang;Chen Wanghua(Department of Oncology,Clinical Medical College of Guizhou Medical University,Guiyang 550004,China;Department of Abdominal Oncology,Affiliated Cancer Hospital of Guizhou Medical University,Guiyang 550008,China;Department of Oncology,Affiliated Hospital of Guizhou Medical University,Guiyang 550001,China)

机构地区：[1]贵州医科大学临床医学院肿瘤学教研室,贵阳550004 [2]贵州医科大学附属肿瘤医院腹部肿瘤科,贵阳550008 [3]贵州医科大学附属医院肿瘤科,贵阳550001

出　　处：《国际肿瘤学杂志》2025年第4期209-216,共8页Journal of International Oncology

摘　　要：目的探讨放疗联合化疗和免疫治疗在人表皮生长因子2(HER2)阴性局部晚期或晚期胃癌中的临床疗效和安全性。方法选取2021年9月至2024年3月贵州医科大学附属肿瘤医院收治的34例不可手术切除的HER2阴性局部晚期或晚期胃/胃食管结合部(G/GEJ)腺癌患者作为研究对象,接受1周期XELOX方案(卡培他滨+奥沙利铂)或SOX方案(替吉奥+奥沙利铂)联合免疫治疗(信迪利单抗或纳武利尤单抗)后,进行G/GEJ原发灶及转移区域淋巴结放疗,部分患者序贯远处转移灶放疗。主要研究终点为客观缓解率(ORR),次要研究终点为疾病控制率(DCR)、临床症状缓解情况、Karnofsky功能状态(KPS)评分变化、无进展生存期(PFS)、不良反应。采用实体瘤临床疗效评价标准1.1版评估临床疗效,按照美国国立癌症研究所通用不良反应术语标准5.0版、中国临床肿瘤学会免疫检查点抑制剂相关的毒性管理指南进行不良反应评价和分级。中位随访时间7个月(范围:2.3~30个月),以随访过程中出现的最佳疗效定为最终疗效评价。采用Kaplan-Meier法绘制生存曲线。结果至随访结束,全组患者ORR达58.8%(20/34),DCR达70.6%(24/34);放疗病灶ORR达73.8%(48/65)、DCR达92.3%(60/65)。单因素分析显示,女性患者的ORR(84.6%,11/13)高于男性患者(42.9%,9/21),远处淋巴结转移患者的ORR(83.3%,15/18)高于远处淋巴结转移合并器官转移或单独器官转移患者(18.2%,2/11),差异均具有统计学意义(P=0.030;P=0.010)。不同年龄(P=0.487)、KPS评分(P=0.198)、原发肿瘤部位(P=0.280)、组织学分化程度(P=0.668)、化疗方案(P=0.728)、免疫治疗方案(P>0.999)患者的ORR差异均无统计学意义。23例上腹疼痛患者缓解22例(95.7%),21例食欲下降患者缓解10例(47.6%),17例上腹饱胀患者缓解15例,14例黑便患者缓解13例,7例进食梗阻患者缓解6例,4例转移部位疼痛患者缓解3例,2例呕血患者均缓解。KPS评分好转率82.4%(28/34)Objective To explore the clinical efficacy and safety of a multimodal treatment regimen integrating radiotherapy,chemotherapy,and immunotherapy in patients with human epidermal growth factor receptor 2(HER2)-negative locally advanced or advanced gastric cancer.Methods A total of 34 patients with unresectable,HER2-negative,locally advanced or metastatic gastric/gastroesophageal junction(G/GEJ)adenocarcinoma admitted to the Affiliated Cancer Hospital of Guizhou Medical University from September 2021 to March 2024 were selected as study objects.Participants received one cycle of either XELOX regimen(capecitabine+oxaliplatin)or SOX regimen(S-1+oxaliplatin)with immunotherapy(sintilimab or nivolumab).The process was succeeded by radiotherapy targeted at the primary G/GEJ tumor and regional lymph nodes.In selected cases,sequential radiotherapy was also administered for distant metastases.The primary endpoint was Objective response rate(ORR),and secondary endpoints were disease control rate(DCR),clinical symptom response,changes in Karnofsky performance status(KPS)score,progression-free survival(PFS),and adverse reactions.Clinical efficacy was assessed in accordance with Response Evaluation Criteria in Solid Tumors version 1.1.Adverse reactions were assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 and the Chinese Society of Clinical Oncology guidelines for management of immune checkpoint inhibitor-related toxicity.With a median follow-up of 7 months(range:2.3 to 30 months),the final evaluation considered the best response documented throughout follow-up.Survival curves were constructed utilizing Kaplan-Meier analysis.Results By the end of follow-up,an overall ORR of 58.8%(20/34)and DCR of 70.6%(24/34)were observed.The ORR of lesions by radiotherapy reached 73.8%(48/65)and the DCR reached 92.3%(60/65).Univariate analysis showed that the ORR of female patients(84.6%,11/13)was higher than that of male patients(42.9%,9/21),and the ORR of patients with d

关 键 词：胃肿瘤 化放疗 免疫疗法 药物相关性副作用和不良反应 近期疗效 

分 类 号：R735.2[医药卫生—肿瘤]