摘要
目的分析信迪利单抗联合白蛋白结合型紫杉醇化疗治疗晚期胃癌患者的临床疗效及生存获益。方法将晚期胃癌患者按队列法分为试验组和对照组,对照组接受白蛋白结合型紫杉醇为基础的化疗方案(静滴白蛋白结合型紫杉醇125 mg·m^(-2),第1~8天,21 d为1个周期;口服替吉奥胶囊40 mg·m^(-2)·d^(-1),第1~14天,连续治疗1个周期;注射用曲妥珠单抗,每3周静滴1次,初始负荷剂量8 mg·kg^(-1),后续每隔3周按6 mg·kg^(-1)剂量进行维持治疗),试验组在对照组基础上于每周期第1天静脉滴注信迪利单抗注射液,每次200 mg,21 d为1个周期,均持续治疗6个周期后改为维持治疗,并随访8个月。对比2组患者临床疗效、治疗前后血清糖类抗原242(CA242)、糖类抗原724(CA724)及癌胚抗原(CEA)与组织多肽特异性抗原(TPS)、可溶性细胞间黏附因子-1(sICAM-1)、E-钙黏蛋白(E-cadherin)、生存,并进行安全性评价。结果本研究对照组和试验组分别入组39例和41例。治疗结束,试验组和对照组客观缓解率(ORR)分别为56.10%和33.33%,疾病控制率(DCR)分别为78.05%和48.71%,在统计学上差异均有统计学意义(均P<0.05);治疗后,试验组和对照组血清CA242分别为(57.64±5.82)和(68.95±7.23)mg·L^(-1),CA724分别为(36.58±3.79)和(43.65±4.48)U·mL^(-1),CEA分别为(17.33±1.78)和(20.16±2.35)ng·mL^(-1),TPS分别为(21.35±2.44)和(37.65±3.84)U·L^(-1),sICAM-1分别为(216.77±22.53)和(275.34±28.63)ng·mL^(-1),E-cadherin分别为(12.15±1.36)和(9.87±1.45)ng·mL^(-1)。试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(均P<0.05)。试验组和对照组的平均无进展生存时间(PFS)分别为7.55和7.17个月,PFS率分别为65.78%和56.42%,试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(均P<0.05)。试验组和对照组的药物不良反应主要有骨髓抑制、恶心呕吐、肝功能损害、周围神经感觉异常、甲状腺�
Objective To analyze the therapeutic effects and survival benefits of sintilimab combined with albumin-bound paclitaxel chemotherapy in the treatment of patients with advanced gastric cancer.Methods Patients with advanced gastric cancer were divided into the treatment group and the control group by cohort method.The control group was treated with albumin-bound paclitaxel-based chemotherapy[intravenous infusion of albumin-bound paclitaxel at 125 mg·m^(-2)from day 1 to day 8,for a cycle(21 days as a cycle);Tiggio capsule 40 mg·m^(-2)·d^(-1)was taken orally for 1-14 days for 1 consecutive cycle;Trastuzumab was administered once every 3 weeks at an initial loading dose of 8 mg·kg^(-1),followed by maintenance treatment at a dose of 6 mg·kg^(-1)every 3 weeks].On this basis,the treatment group was treated with intravenous infusion of sintilimab injection at a dose of 200 mg·time^(-1)on the first day of each cycle,with 21 d as a cycle.After 6 cycles of continuous treatment,both groups were given maintenance treatment and were followed up for 8 months.The two groups were compared in terms of clinical efficacy,the levels of serum tumor markers[carbohydrate antigen 242(CA242),carbohydrate antigen 724(CA724),carcinoembryonic antigen(CEA),tissue polypeptide-specific antigen(TPS),soluble intercellular cell adhesion molecule-1(sICAM-1)and E-cadherin],survival and evaluated the safety.Results In this study,39 and 41patients were enrolled in the control group and the treatment group,respectively.At the end of treatment,the objective response rates(ORR)in the treatment group and the control group were 56.10%and 33.33%;the disease control rates(DCR)were 78.05%and 48.71%.The differences were statistically significant(all P<0.05).After treatment,serum CA242 levels in the treatment group and the control group were(57.64±5.82)and(68.95±7.23)mg·L^(-1);CA724 levels were(36.58±3.79)and(43.65±4.48)U·mL^(-1);CEA levels were(17.33±1.78)and(20.16±2.35)ng·mL^(-1);TPS levels were(21.35±2.44)and(37.65±3.84)U·L^(-1);sICAM-1 leve
作者
王正冬
潘成
周爱明
徐光辉
WANG Zheng-dong;PAN Cheng;ZHOU Ai-ming;XU Guang-hui(Department of Gastrointestinal Surgery,The First Affiliated Hospital of Kangda College,Nanjing Medical University(The First People's Hospital of Lianyungang),Lianyungang 222000,Jiangsu Province,China;Department of Tumor Chemotherapy,The First Affiliated Hospital of Kangda College,Nanjing Medical University(The First People's Hospital of Lianyungang),Lianyungang 222000,Jiangsu Province,China)
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2024年第20期2968-2972,共5页
The Chinese Journal of Clinical Pharmacology
关键词
信迪利单抗注射液
白蛋白结合型紫杉醇
晚期胃癌
化疗
生存获益
sindilizumab injection
albumin-bound paclitaxel
advanced gastric cancer
chemotherapy
survival benefit
