盐酸安罗替尼治疗晚期非小细胞肺癌临床疗效及影响因素分析

Analysis of the clinical effect of Anlotinib hydrochloride capsules in the treatment of advanced non-small cell lung cancer patients

目的探讨盐酸安罗替尼治疗晚期非小细胞肺癌(NSCLC)的疗效及不良反应。方法纳入海军军医大学附属长海医院2018年6月至2019年1月接受安罗替尼靶向治疗的35例ⅢB~Ⅳ期局部晚期或转移性NSCLC患者,所有入组患者既往接受过标准一、二线治疗,随访时间截止至2019年3月31日。结果35例患者中,无完全缓解及部分缓解,稳定19例(54.3%),进展16例(45.7%),客观缓解率为0%,疾病控制率为54.3%。EGFR、ROS1突变及PD1、PDL1、p53、KI67表达对疾病控制率无明显影响,性别、病理类型、分期、年龄、PS评分等因素对治疗效果均无明显影响。吸烟患者无进展生存期(PFS)M(QR)为2.0(1.5)个月,不吸烟患者PFS为3.3(2.0)个月,2组之间差异有显著意义(Z=1.23,P<0.05)。有脑转移患者PFS为3.7(2.9)个月,无脑转移患者PFS为6.5(2.0)月,2组之间差异有显著意义(Z=-2.21,P<0.05)。不良反应阳性组PFS为3.6(1.9)月,不良反应阴性组PFS为2.3(1.7)个月,2组之间差异有显著意义(Z=-2.07,P<0.05)。不良反应显示,高血压4例(11.42%),手足综合征6例(17.14%),胃肠道反应5例(14.28%),肾功能不全1例(2.85%),气胸1例(2.85%),口腔黏膜反应3例(8.57%),声音嘶哑4例(11.42%)。结论盐酸安罗替尼对晚期NSCLC患者有一定疗效,不吸烟患者、无脑转移患者及药物不良反应阳性患者获益明显,且药物不良反应经处理后可耐受,具有一定的临床应用价值。

Objective To observe the curative effects and toxic side effects of Anlotinib hydrochloride capsules in the treatment of advanced non-small cell lung cancer(NSCLC).Methods Clinical data was collected from 35 patients who were diagnosed of phaseⅢB toⅣadvanced NSCLC and were treated with Anlotinib hydrochloride capsules during June 2018 to March 2019 in Changhai Hospital Affiliated to Naval Medical University.All these patients had been treated with one or two lines of standard prior treatments and the follow-up time was cut off until March 31st,2019.Results No case achieved complete response or partial response,19 cases(54.3%)achieved stable disease and 16(45.7%)achieved progressive disease in 35 cases.The ORR was 0%and the DCR was 54.3%.The clinical effect was not related with the following factors including the mutation of EGFR and ROS1,the expression status of PD1,PDL1,p53 and KI67,gender,pathology type,stage,age and PS score.The median PFS of non-smoking group was higher than that of the smoking group[M(QR):3.3(2.0)months vs 2.0(1.5)months]and the difference was statistically significant(Z=1.23,P<0.05).The median PFS of group with brain metastasis was lower than that of group without brain metastasis[M(QR):3.7(2.9)months vs 6.5(2.0)months]and the difference was statistically significant(Z=-2.21,P<0.05).The median PFS of group with adverse reactions was higher than that of group without adverse reactions[M(QR):3.6(1.9)months vs 2.3(1.7)months]and the difference was statistically significant(Z=-2.07,P<0.05).Adverse reactions included 4 cases of hypertension(11.42%),6 case of hand-foot syndrome(17.14%),5 case of gastrointestinal reaction(14.28%),1 case of renal deficiency(2.85%),1 case of pneumothorax(2.85%),3 cases of oral ulcer(8.57%)and 4 cases of hoarseness(11.42%).Conclusions Anlotinib hydrochloride in the treatment of advanced NSCLC has certain therapeutic effect,which is superior in non-smoking patients,group without brain metastasis and patients suffering adverse reactions.The adverse reactions can be tolerated after symptomatic treatment.Anlotinib hydrochloride has special clinical application value in patients with advanced NSCLC.