安罗替尼联合多西他赛治疗TP/PDL1靶向失败NSCLC老年患者的疗效分析  

Therapeutic effect of antolini hydrochloride combined with docetaxel for elderly patients with NSCLC who took TP/PDL1 targeted chemotherapy and failed

作　　者：白小航 常振东[2] 穆艳艳[2] Bai Xiaohang;Chang Zhendong;Mu Yanyan(Department of Western Medicine and Pharmacy,Nanyang Central Hospital,Nanyang 473000,China;Department of Emergency Internal Medicine,Nanyang Central Hospital,Nanyang 473000,China)

机构地区：[1]南阳市中心医院西药药学部,南阳473000 [2]南阳市中心医院急诊内科,南阳473000

出　　处：《国际医药卫生导报》2023年第24期3551-3556,共6页International Medicine and Health Guidance News

基　　金：河南省医学科技攻关联合共建项目(LHGJ20191450)。

摘　　要：目的探讨盐酸安罗替尼联合多西他赛对“紫杉醇、顺铂、替雷利珠单抗联合方案”(TP/PD-L1)治疗失败后非小细胞肺癌(NSCLC)老年患者的临床疗效及安全性影响。方法前瞻性选取2019年1月至2022年1月于南阳市中心医院接受TP/PD-L1失败NSCLC老年患者,采用随机数字表法分为对照组[46例,男20例,女26例,年龄(68.50±0.81)岁]与对照组[47例,男22例,女25例,年龄(68.97±0.77)岁],所有研究对象正式挽救前均给予醋酸地塞米松片(1.0 mg/次,2次/d,持续应用3 d撤除),正式化疗给药前均输注0.9%氯化钠500 ml作为水化治疗。对照组给予80 mg/m^(2)多西他赛行挽救治疗,静脉给药持续静滴1 h以上,1次/d,以21 d为一个治疗周期。试验组在对照组的基础上联合安罗替尼(0.15 mg·kg^(-1))清晨口服,1次/d,每使用14 d后停药7 d,设定每周期持续21 d。两组均持续治疗4个周期,随访1年。采用t检验、χ^(2)检验比较两组实体瘤临床疗效、外周血T淋巴细胞亚群CD4^(+)/CD8^(+)比例及药物不良反应率。绘制1年期Kaplan-Meier生存曲线比较两组无进展生存期的差异。结果共筛选入组97例,因失访、主动退出4例,共成功入组93例,其中对照组46例,试验组47例。治疗后,试验组和对照组的客观缓解率分别为57.45%(27/47)、34.78%(16/46),疾病控制率分别为78.72%(37/47)、58.70%(27/46),差异均有统计学意义(均P<0.05)。试验组与对照组CD4^(+)分别为(587.69±13.98)/μl、(369.06±10.85)/μl,CD8^(+)分别为(401.71±8.51)/μl、(477.71±9.53)/μl,CD4^(+)/CD8^(+)分别为(1.49±0.04)、(0.79±0.03),差异均有统计学意义(均P<0.05)。试验组与对照组中位无进展生存期分别为9.9个月[HR(95%CI):1.493(0.837~2.664)]和8.8个月[HR(95%CI):1.120(0.622~2.017)],差异有统计学意义(P<0.05)。两组共发现不良反应有骨髓抑制、发热、胃肠功能受损、恶心及皮肤过敏,试验组及对照组的药物不良反应率分别为36.17%(17/47)、34.78%(16/46),Objective To investigate the clinical efficacy and safety of antolini hydrochloride combined with docetaxel for elderly patients with non-small cell lung cancer(NSCLC)who took paclitaxel,cisplatin,and toralizumab combination regimen(TP/PD-L1)and failed.Methods The elderly patients with NSCLC who who took TP/PD-L1 and failed at Nanyang Central Hospital from January 2019 to January 2022 were prospectively selected and divided into control a group(46 cases)and an experimental group(47 cases)by the random number table method.There were 20 males and 26 females in the control group;they were(68.50±0.81)years old.There were 22 males and 25 females in the experimental group;they were(68.97±0.77)years old.All the patients were given dexamethasone acetate tablets before formal salvage 1.0 mg/time,2 times/day,for 3 days,and withdrawn;500 ml 0.9%NaCl was infused as hydration treatment before the formal chemotherapy administration.The control group intravenously dripped docetaxel 80 mg/m^(2)for more than 1 h,once a day,for 21 d;21 d was set as a treatment cycle.In addition,the experimental group orally took antolini hydrochloride 0.15 mg·kg^(-1)in the early morning,1 time/d,and stopped 7 d after every 14 d;21 d was set as a treatment cycle.Both groups were treated for 4 cycles and followed up 1 year.The clinical efficacies,peripheral blood CD4^(+)/CD8^(+)T lymphocyte subpopulation distribution,and incidences of adverse drug reaction rates were compared between the two groups by t and χ^(2) tests.The Kaplan-Meier survival curves were plotted at 1 year to compare the difference in progression-free survival between the two groups.Results A total of 97 cases were screened for enrollment in this project,and 4 cases were withdrawn due to lost visit and initiative quitting,and a total of 93 cases were successfully enrolled,including 46 cases in the control group and 47 cases in the experimental group.After the treatment,the objective remission rates were 57.45%(27/47)and 34.78%(16/46)and the disease control rates were 78.72%(37/

关 键 词：非小细胞肺癌 安罗替尼 多西他赛 老年 化疗失败 挽救治疗 程序性细胞死亡蛋白-1配体 

分 类 号：R734.2[医药卫生—肿瘤]