信迪利单抗联合SOX化疗方案治疗晚期食管癌临床观察
Observation of the clinical efficacy of Xindilizumab combined with SOX chemotherapy in the treatment of advanced esophageal cancer
秦雷 1曾平 1汪毅1
作者信息
- 1. 合肥市第一人民医院南区肿瘤科 安徽 合肥 230011
- 折叠
摘要
目的 观察信迪利单抗联合SOX(替吉奥联合奥沙利铂)化疗方案治疗晚期食管癌的临床疗效.方法 前瞻性选取2019年1月至2022年12月合肥市第一人民医院收治的晚期食管癌患者90例.按照随机数字表法将90例患者分为联合组与对照组,每组各45例.联合组予SOX化疗方案治疗[第1天静脉滴注奥沙利铂130mg/m2,滴注2h;第1～14天口服替吉奥胶囊(体表面积＜1.25 m2,早晚均口服40 mg;体表面积在1.25～1.50 m2之间,早口服40 mg,晚口服60 mg;体表面积＞1.50 m2,早晚均口服60 mg),21 d为一个周期],在此基础上于每周期第1天化疗前静脉输注信迪利单抗200 mg,持续输注30～60 min,1次/21 d,持续用药至疾病进展或治疗不耐受.对照组仅采用SOX化疗方案治疗.比较两组患者治疗2个周期的临床疗效,观察两组患者治疗前、治疗2个周期后血清鳞状上皮细胞癌相关抗原(SCC)、血清细胞角蛋白19片段抗原(CYFRA21-1)、癌胚抗原水平;记录两组自治疗开始随访1年期间总生存率、总生存期(OS)及治疗期间药物毒副作用发生情况.结果 两组患者治疗期间,联合组1例主动要求退出研究,1例失访,对照组1例未进行肿瘤评估,2例失访,最终联合组43例、对照组42例完成研究.治疗2个周期,联合组患者的疾病控制率及客观缓解率分别为88.37％、58.14％,均明显高于对照组(69.05％、28.57％),差异均有统计学意义(P＜0.05);治疗2个周期,两组患者的血清SCC、CYFRA21-1、癌胚抗原水平均较治疗前明显下降,且联合组血清SCC、癌胚抗原、CYFRA21-1 水平分别为(1.59±0.22)、(5.96±0.93)、(13.42±4.30)μg/L,均明显低于对照组[(2.13±0.32)、(8.03±1.41)、(17.59±4.11)μg/L],差异均有统计学意义(P＜0.05).两组患者治疗期间胃肠道反应、肝肾损伤、骨髓移植、神经系统损伤发生率比较,差异均无统计学意义(P＞0.05).结论 与单纯SOX化疗方案治疗相比,信迪利单抗联合SOX化疗方案治疗晚期食管癌可显著提高临床疗效,提高患者短期生存率并延长生存时间,降低血清肿瘤标志物水平,且不会明显增加毒副作用,有良好的耐受性.
Abstract
Objective To observe the clinical efficacy of the combination of Xindilizumab and SOX(Tegio combined with Oxaliplatin)chemotherapy regimen in the treatment of advanced esophageal cancer.Methods A total of 90 patients with advanced esophageal cancer admitted to the First People's Hospital of Hefei from January 2019 to December 2022 were prospectively selected.According to the random number table method,90 patients were divided into the combined group and the control group,with 45 cases in each group.The combination group was treated with SOX chemotherapy regimen[intravenous infusion of oxaliplatin 130 mg/m2 for 2 hours on day 1;oral administration of tigio capsules(body surface area＜1.25 m2,40 mg orally in the morning and evening;body surface area between 1.25 m2 and 1.50 m2,40 mg orally early and 60 mg orally in the evening;body surface area＞1.50 m2,60 mg orally in the morning and evening)on day 1 for 21 days as a cycle],continuous infu-sion for 30-60 minutes,once/21 days,until disease progression or treatment intolerance.The control group was only treated with SOX chemo-therapy.The clinical efficacy of two treatment cycles were compared,and the levels of serum squamous cell carcinoma associated antigen(SCC),serum cytokeratin 19 fragment antigen(CYFRA21-1),and carcinoembryonic antigen before and after treatment for two cycles in both groups were observed.The overall survival rate,overall survival(OS)and drug side effects during treatment were recorded in the two groups during the 1-year follow-up period.Results During the treatment of the two groups,one case in the combination group voluntarily requested to withdraw from the study,one case was lost to follow-up,one case in the control group did not undergo tumor evaluation,and two cases were lost to follow-up.Finally,43 cases in the combination group and 42 cases in the control group completed the study.After two cycles of treatment,the disease control rate(88.37％)and objective response rate(58.14％)of patients in the combined group were significantly higher than those in the control group(69.05％,28.57％),and the differences were statistically significant(P＜0.05).After two cycles of treatment,the serum levels of SCC,CYFRA21-1,and carcinoembryonic antigen in both groups of patients were significantly lower than those before treatment,and the levels of serum SCC,carcinoembryonic antigen and CYFRA21-1 in the combined group were(1.59±0.22),(5.96±0.93)and(13.42±4.30)µg/L,respectively,which were significantly lower than those in the control group[(2.13±0.32),(8.03±1.41)and(17.59±4.11)μg/L],and the differences were statistically significant(P＜0.05).The overall one-year survival rate of patients in the combined group was 74.41％,which was significantly higher than that in the control group(52.38％),and the median survival time(10.5 months)was significantly longer than that in the control group(8.9 months),and the differences were statistically significant(P＜0.05).There was no statistical significant difference in the incidence of gastrointestinal reactions,liver and kidney damage,bone marrow transplantation,and neurological damage between the two groups of patients during treatment(P＞0.05).Conclusion Compared with the simple SOX chemotherapy regimen,the combination of Xindilimab and SOX chemotherapy regimen can significantly improve clinical efficacy,improve short-term survival rate and prolong survival time of patients with advanced esophageal cancer,reduce serum tumor marker levels,and do not significantly increase toxic side effects.It has good tol-erance.
关键词
食管癌/信迪利单抗/替吉奥/奥沙利铂/鳞状上皮细胞癌相关抗原/细胞角蛋白19片段抗原/癌胚抗原Key words
Esophageal cancer/Xindilizumab/Tegio/Oxaliplatin/Serum squamous cell carcinoma associated antigen/Cytokeratin 19 fragment antigen,Carcinoembryonic antigen引用本文复制引用
基金项目
2022年安徽省重点研究与开发计划项目(2022e07020067)
出版年
2024
NETL
NSTL
万方数据