摘要
目的观察信迪利单抗联合化疗一线治疗程序性死亡受体配体1(PD-L1)阳性晚期胃癌的近期疗效及安全性。方法采用回顾性队列研究设计,纳入2019年1月—2021年12月溧阳市人民医院收治的90例PD-L1阳性晚期胃癌患者,依据治疗方案不同分为联合组(信迪利单抗+化疗)与单纯化疗组(单纯化疗),各45例。比较2组近期疗效,治疗前后实验室指标[外周血淋巴细胞计数、中性粒细胞与淋巴细胞比值(NLR)、癌胚抗原(CEA)]、生活质量[欧洲癌症研究与治疗组织生活质量核心问卷(EORTC QLQ-C30)评分]及治疗相关不良事件。结果末次疗效评估时,联合组客观缓解率、疾病控制率分别为64.44%、91.11%,均高于单纯化疗组的37.78%、73.33%(χ^(2)=6.403,P=0.011;χ^(2)=4.865,P=0.028)。治疗后,联合组外周血淋巴细胞计数高于治疗前和同期单纯化疗组,NLR及CEA(经ANCOVA校正治疗前基线)水平低于治疗前和同期单纯化疗组(P<0.01);治疗后,联合组生活质量各项评分升高,且高于同期单纯化疗组(P<0.01),而单纯化疗组治疗前后比较无统计学差异(P>0.05)。联合组≥3级治疗相关不良事件总发生率为57.78%,单纯化疗组为53.33%,组间比较无统计学差异(χ^(2)=0.180,P=0.671)。联合组特有的免疫相关不良事件发生率为26.67%,均为1~2级,经对症处理后短期缓解。结论对于PD-L1阳性晚期胃癌患者,一线采用信迪利单抗联合化疗方案较单纯化疗能显著提高近期疗效,改善部分免疫炎性相关指标,提高患者生活质量,且安全性可控,未显著增加严重治疗相关毒性。
Objective To observe the short-term efficacy and safety of sintilimab combined with chemotherapy as first-line treatment for patients with PD-L1 positive advanced gastric cancer.Methods A retrospective cohort study design was used to include 90 patients with PD-L1 positive advanced gastric cancer admitted to Liyang People′s Hospital from January 2019 to December 2021,according to different treatment regimens,patients were divided into combination group(sintilimab+chemotherapy)and chemotherapy alone group(chemotherapy alone),with 45 cases in each group.The short-term efficacy,l aboratory indexes(peripheral blood lymphocyte count,NLR,CEA),quality of life(EORTC QLQ-C30 score)before and after treatment,and treat-related adverse events were compared between the two groups.Results At the last efficacy evaluation,the objective response rate and disease control rate of the combination group were 64.44%and 91.11%respectively,which were higher than 37.78%and 73.33%of the chemotherapy alone group(χ^(2)=6.403,P=0.011;χ^(2)=4.865,P=0.028).After treatment,peripheral blood lymphocyte count in the combination group were higher than pre-treatment and concurrent c hemotherapy alone group,NLR and carcinoembryonic antigen(pre-treatment baseline corrected by ANCOVA)levels were lower than pre-treatment and c oncurrent chemotherapy alone groups(P<0.01).After treatment,the scores of quality of life in the combination group increased,and were higher than those in the concurrent chemotherapy alone group(P<0.01),while there was no significant difference in the c hemotherapy alone group before and after treatment(P>0.05).The total incidence of treatment-related adverse events of grade≥3 was 57.78%in the combination group and 53.33%in the chemotherapy a lone group,and there was no s ignificant difference between the two groups(χ^(2)=0.180,P=0.671).The incidence of s pecific i mmu ne-related adverse e vents in the combination group was 26.67%,all of which were grade 1-2 and relieved after s ymptomati c treatment.Conclusion For patients with PD-L1 positive advanced gastric cancer,the first-line use of sintilimab combined with c hemotherapy can significantly improve the short-term efficacy,improve some immune-inflammatory related i ndicators,and improve the quality of life of patients compared with chemotherapy alone,with controllable safety and no s ignificant increase in severe treatment-related toxicity.
作者
石贤清
SHI Xianqing(Department of Oncology,Liyang People′s Hospital,Jiangsu P rovince,Liyang 213300,China)
出处
《临床合理用药》
2026年第6期9-12,共4页
Chinese Journal of Clinical Rational Drug Use
基金
2024年度南京医科大学康达学院科研发展基金项目(KD2024KYJJ277)。
关键词
晚期胃癌
PD-L1阳性
信迪利单抗
化疗
客观缓解率
疾病控制率
癌胚抗原
免疫相关不良事件
Advanced gastric cancer
PD-L1 positive
Sintilimab
Chemotherapy
Objective response rate
Disease control rate
Carcinoembryonic antigen
Immune-related adverse events
