摘要
目的评价程序性细胞死亡受体1(PD-1)抑制剂联合化疗在Ⅲ期非小细胞肺癌(NSCLC)术前新辅助治疗中的有效性和安全性。方法纳入2019年6月至2020年10月在我院行术前新辅助治疗的68例Ⅲ期NSCLC患者。根据随机数字表法将患者分为两组:对照组34例,男19例、女15例,年龄(59.41±4.77)岁;观察组34例,男21例、女13例,年龄(61.15±6.24)岁。对照组采用注射用白蛋白结合型紫杉醇+顺铂,观察组在对照组基础上加用卡瑞利珠单抗,所有患者均行2周期术前新辅助治疗。比较两组患者的影像学临床疗效、T淋巴细胞亚群、药物毒副反应、手术切除率、主要病理缓解(MPR)、完全病理缓解(pCR)和术后并发症,同时分析影响MPR的因素。结果观察组影像学临床疗效:客观缓解率(ORR,70.6%)优于对照组(38.2%),差异均有统计学意义(P<0.05)。观察组治疗后CD_(3)^(+)细胞阳性率、CD_(4)^(+)细胞阳性率、CD_(8)^(+)细胞阳性率和CD_(4)^(+)/CD_(8)^(+)细胞比值高于对照组,差异均有统计学意义(P<0.05)。观察组药物毒副反应在反应性皮肤毛细血管增生症(RCCEP)/皮疹、甲状腺功能异常、心肌酶异常方面高于对照组,差异均有统计学意义(P<0.05)。手术患者中观察组的MPR(66.7%)和pCR(51.9%)高于对照组的MPR(19.2%)和pCR(7.7%),差异均有统计学意义(P<0.05);观察组的电视辅助胸腔镜手术(VATS,55.6%)比例高于对照组(19.2%),差异有统计学意义(P<0.05);两组患者在手术切除率和术后并发症方面差异均无统计学意义(P>0.05)。单因素分析结果显示美国东部肿瘤协作组(ECOG)评分、病理类型、新辅助治疗方案和手术切除方式与MPR相关(P<0.05)。二元logistic回归分析结果显示ECOG评分和新辅助治疗方案是影响MPR的独立危险因素(P<0.05)。结论 PD-1抑制剂联合化疗在Ⅲ期NSCLC患者术前新辅助治疗中的临床疗效确切,可明显提高患者MPR、pCR和细胞免疫功能,但免疫治疗药物
Objective To evaluate the efficacy and safety of programmed cell death receptor 1(PD-1)inhibitor combined with chemotherapy in the preoperative neoadjuvant treatment of stageⅢnon-small cell lung cancer(NSCLC).Methods The clinical data of 68 patients with stageⅢNSCLC who underwent preoperative neoadjuvant treatment in our hospital from June 2019 to October 2020 were analyzed and divided into two groups according to a random number table.There were 34 patients in the control group including 19 males and 15 females with an average age of 59.41±4.77 years.In the observation group,there were 34 patients including 21 males and 13 females with an average age of 61.15±6.24 years.The patients in the control group were treated with albumin-bound paclitaxel and cisplatin for injection,and the patients in the observation group were treated with carrelizumab on the basis of the control group,and both groups received 2 cycles of preoperative neoadjuvant therapy.We compared the clinical efficacy of imaging,T lymphocyte subsets,drug side effects,surgical resection rate,major pathological remission(MPR),complete pathological remission(pCR)and postoperative complications of the two groups of patients,and analyzed the influencing factors for MPR.Results The objective response rate(ORR)of imaging in the observation group(70.6%)was higher than that in the control group(38.2%,P<0.05).The positive rate of CD_(3)^(+) cells,the positive rate of CD_(4)^(+) cells,the positive rate of CD_(8)^(+) cells and the ratio of CD_(4)^(+)/CD_(8)^(+) cells in the observation group after treatment were higher than those in the control group(P<0.05).The drug toxicity of the observation group was higher than that of the control group in the reactive cutaneouscapillary endothelial proliferation(RCCEP)/rash,abnormal thyroid function,and abnormal myocardial enzymes(P<0.05).The MPR(66.7%)and pCR(51.9%)of the surgical observation group were higher than those of the surgical control group(MPR:19.2%,pCR:7.7%,P<0.05).There was no statistical difference in
作者
白悦
孙大强
张逊
朱公建
郎丽丽
曹群
BAI Yue;SUN Daqiang;ZHANG Xun;ZHU Gongjian;LANG Lili;CAO Qun(Graduate School of Tianjin Medical University,Tianjin,300070,P.R.China;Department of Thoracic Surgery,Tianjin Chest Hospital,Tianjin,300222,P.R.China;Department of Thoracic Surgery,Gansu Cancer Hospital,Lanzhou,730050,P.R.China)
出处
《中国胸心血管外科临床杂志》
CSCD
北大核心
2021年第8期963-971,共9页
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery
基金
甘肃省卫生健康行业科研计划项目(GSWSKY2020-40)。
