卡瑞利珠单抗用于Ⅲa期NSCLC患者术前新辅助化疗的临床研究OA北大核心CSTPCD
Clinical trial of carrelizumab for preoperative neoadjuvant chemotherapy in patients with stage Ⅲa NSCLC
目的 观察卡瑞利珠单抗联合白蛋白紫杉醇、顺铂用于Ⅲa期非小细胞肺癌(NSCLC)患者术前新辅助化疗的临床疗效和安全性.方法 将Ⅲa期NSCLC患者分为试验组和对照组.对照组第1、8天静脉滴注注射用紫杉醇130 mg·m-2,第1天静脉滴注注射用顺铂75 mg·m-2,试验组在对照组治疗基础上第1天静脉滴注注射用卡瑞利珠单抗200 mg,2组均治疗2周期.比较2组患者的临床疗效、肿瘤标志物、肿瘤转移标志物、T淋巴细胞亚群,以及进行安全性评价.结果 试验组和对照组分别纳入56和59例.治疗后,试验组和对照组的客观缓解率(ORR)分别为69.64％(39例/56例)和38.98％(23例/59例),疾病控制率(DCR)分别为89.29％(50例/56例)和72.88％(43例/59例),细胞角蛋白 19 片段(Cyfra21-1)分别为(3.47±0.86)和(4.01±1.24)ng·mL-1,癌胚抗原(CEA)分别为(4.55±0.93)和(5.26±1.04)ng·mL-1,神经元特异性烯醇化酶(NSE)分别为(16.38±2.51)和(19.02±2.95)ng·mL-1,成纤维细胞生长因子(bFGF)分别为(15.82±2.34)和(18.64±2.59)μg·L-1,糖类抗原 15-3(CA15-3)分别为(22.54±3.10)和(29.41±3.82)ng·mL-1,CD4+/CD8+分别为1.42±0.51和1.30±0.32.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中性粒细胞减少、血小板减少、脱发、胃肠道反应、放射性肺炎,2组患者的上述各药物不良反应发生率比较,在统计学上差异均无统计学意义(均P＞0.05).结论 卡瑞利珠单抗联合含铂双药治疗Ⅲ a期NSCLC患者疗效显著.
Objective To observe the clinical effect and safety of camrelizumab combined with albumin-bound paclitaxel and cisplatin in preoperative neoadjuvant chemotherapy for patients with stage Ⅲa non-small cell lung cancer(NSCLC).Methods Patients with stage Ⅲ a NSCLC were divided into the treatment group and the control group.The control group was treated with intravenous infusion of 130 mg·m-2 of paclitaxel injection on day 1 and day 8,and intravenous infusion of 75 mg·m-2 of cisplatin injection on day 1.In addition to the treatment of control group,the treatment group was treated with intravenous infusion of 200 mg of camrelizumab injection on day 1.Both groups were given 2 cycles of treatment.Clinical efficacy,tumor markers,tumor metastasis markers,T lymphocyte subsets,and safety were compared between the two groups.Results After treatment,the objective remission rate(ORR)of the treatment group and the control group was 69.64％(39 cases/56 cases)and 38.98％(23 cases/59 cases),respectively;the disease control rate(DCR)was 89.29％(50 cases/56 cases)and 72.88％(43 cases/59 cases),respectively;cytokeratin-19-fragment(Cyfra21-1)levels were(3.47±0.86)and(4.01±1.24)ng·mL-1;carcinoembryonic antigen(CEA)levels were(4.55±0.93)and(5.26±1.04)ng·mL-1;neuron-specific enolase(NSE)levels were(16.38±2.51)and(19.02±2.95)ng·mL-1;basic fibroblast growth factor(bFGF)levels were(15.82±2.34)and(18.64±2.59)μg·L-1;carbohydrate antigen 15-3(CA15-3)levels were(22.54±3.10)and(29.41±3.82)ng·mL-1;CD4+/CD8+were 1.42±0.51 and 1.30±0.32.The above indexes were significantly different between the control group and the treatment group(all P＜0.05).The adverse drug reactions in the treatment group and the control group were mainly neutropenia,thrombocytopenia,alopecia,gastrointestinal reaction and radiation pneumonia.There were no significant difference in the incidence of adverse drug reactions between the two groups(all P＞0.05).Conclusion Camrelizumab combined with albumin-bound paclitaxel and cisplatin is effective in the treatment of patients with stage Ⅲa NSCLC.
闫红江;李铁志;焦晓丹;高少林
河北医科大学第二医院,胸外科,河北石家庄 050000河北医科大学第二医院,呼吸与危重症,河北石家庄 050000
药学
注射用卡瑞利珠单抗注射用紫杉醇注射用顺铂非小细胞肺癌术前新辅助化疗疗效
carrelizumab injectionpaclitaxel injectioncisplatin injectionnon-small cell lung cancerpreoperative neoadjuvant chemotherapycurative effect
《中国临床药理学杂志》 2024 (017)
2469-2473 / 5
评论