安罗替尼联合信迪利单抗对晚期非小细胞肺癌的临床疗效分析

Clinical efficacy of anlotinib combined with sintilimab in treatment of advanced non-small cell lung cancer

摘要:

目的 研究安罗替尼联合信迪利单抗治疗晚期非小细胞肺癌（NSCLC）的临床疗效，并作生存分析。方法 回顾性分析2018年12月—2020年12月同济大学附属上海市肺科医院收治的82例晚期NSCLC患者的临床资料，根据治疗方案分为对照组40例和实验组42例。对照组口服盐酸安罗替尼胶囊，12 mg/次，1次/d，连续14 d，21 d为1个周期；实验组在对照组基础上静脉滴注信迪利单抗注射液，200 mg/次，每21天给药1次。两组均治疗至病情进展或不可耐受药物副作用为止。比较两组的临床疗效、血清肿瘤标志物、免疫功能指标及治疗期间药物不良反应情况，记录随访1年期间患者的生存情况，Kaplan-Meier法绘制生存曲线，比较两组的累积生存率。结果 研究开展期间共3例脱落。治疗后，实验组和对照组的客观缓解率分别为30.95%和12.50%，疾病控制率分别为85.71%和65.00%，两组比较，实验组均高于对照组（P <0.05）。实验组治疗前后血清CA125、CYFRA21-1差值均高于对照组（P <0.05）。实验组治疗前后CD3⁺、CD4⁺、CD4⁺/CD8⁺、NK差值均高于对照组（P <0.05）。治疗期间，实验组Ⅲ级血小板减少症1例、Ⅲ级高血压1例，对照组Ⅲ级出血1例、Ⅳ级高血压1例，其余不良反应均为Ⅰ、Ⅱ级；两组的各项药物不良反应发生率比较，差异均无统计学意义（P >0.05）。截至随访结束，实验组和对照组累积生存率分别为64.29%和47.50%，两组的累积生存率比较，实验组高于对照组（P <0.05）。结论 安罗替尼联合信迪利单抗治疗晚期NSCLC临床疗效确切，可降低患者的血清肿瘤标志物水平、有效改善患者免疫功能，不良反应可耐受，使患者生存获益。

Abstract:

Objective To analyze the clinical efficacy and survival of Anlotinib combined with Sintilimab in the treatment of advanced non-small cell lung cancer (NSCLC).Methods The clinical data of eighty-two patients with advanced NSCLC admitted to the department of respiratory medicine of Shanghai pulmonary hospital from December 2018 to December 2020 were reviewed., and they were divided into an experimental group of 42 cases and a control group of 40 cases according to the treatment plan. The control group was given oral Anlotinib, 12 mg each time, once a day, for 14 consecutive days, with a cycle of 21 days, and the experimental group was given intravenous infusion of Sintilimab injection on the basis of the control group, 200 mg each time, 1 dose every 21 days. Both groups were treated until disease progression or intolerable drug side effects. The clinical efficacy, serum tumor markers, and immune function index levels were evaluated and compared between the two groups, the adverse drug reactions during the treatment period were counted, and the patients' survival was recorded during the 1-year follow-up.Results During the study period, 3 cases dropped out. After treatment, the objective remission rates of the experimental group and the control group were 30.95% and 12.50%, and the disease control rates were 85.71% and 65.00%. The experimental group was higher than the control group (P < 0.05). The differences of serum CA125 and CYFRA21-1 levels in the experimental group before and after treatment were higher than those in the control group (P < 0.05). The differences of CD3⁺, CD4⁺, CD4⁺/CD8⁺, and NK in the experimental group before and after treatment were higher than those in the control group (P < 0.05). During the treatment, there were 1 case of grade Ⅲthrombocytopenia and 1 case of grade Ⅲ hypertension in the experimental group, 1 case of grade Ⅲ bleeding and 1 case of grade Ⅳ hypertension in the control group, and the rest of the adverse reactions were grades Ⅰ to Ⅱ. There was no significant difference in the incidence of adverse drug reactions (P > 0.05). By the end of the follow-up, the cumulative survival rates of the experimental group and the control group were 64.29% and 47.50%. The cumulative survival rate curves of the two groups were compared, and the experimental group was higher than the control group (P < 0.05).Conclusion Anlotinib combined with Sintilimab has definite clinical efficacy in the treatment of advanced NSCLC, which can effectively improve the immune function of patients, with tolerable adverse reactions and improved prognosis.