安罗替尼和厄洛替尼治疗晚期非鳞非小细胞肺癌的临床疗效与安全性分析

Analysis of the Clinical Efficacy and Safety of Anlotinib and Erlotinib in the Treatment of Advanced Non-squamous Non-small Cell Lung Cancer

关键词:  安罗替尼  厄洛替尼  非小细胞肺癌  非鳞  临床疗效  安全性

Key words:  anlotinib  erlotinib  non-small-cell lung cancer  non-squamous  clinical efficacy  safety

摘要:

目的 比较安罗替尼和厄洛替尼治疗晚期非鳞非小细胞肺癌（non-small cell lung cancer，NSCLC）患者的临床疗效与安全性。方法 回顾性分析并筛选南通大学附属医院2018年10月—2019年9月期间诊治的表皮生长因子受体（epidermal growth factor receptor，EGFR）基因敏感突变阳性的晚期非鳞NSCLC的患者106例。根据患者的用药情况分成安罗替尼组53例和厄洛替尼组53例，患者口服剂量为安罗替尼12 mg·d^-1，厄洛替尼150 mg·d^-1，直到病情出现进展、死亡或者出现不能耐受的不良反应，观察患者的治疗效果和生存时间。结果 安罗替尼组完全缓解2例（3.8%），部分缓解4例（7.5%），疾病稳定34例（64.2%），疾病进展13例（24.5%）；计算有效率为11.3%，疾病控制率为75.5%；中位总生存期为10.3个月，1年生存率为45.1%。厄洛替尼组完全缓解2例（3.8%），部分缓解2例（3.8%），疾病稳定31例（58.5%），疾病进展18例（33.9%）。计算有效率为7.6%，疾病控制率为66.1%；中位总生存期为8.6个月，1年生存率为38.2%，两者无统计学差异。多因素分析显示安罗替尼组生存期与PS评分、淋巴结是否转移相关（P=0.002和0.003）。2组患者高血压、转氨酶升高、腹泻不良反应存在显著差异性（P<0.05），安罗替尼组总体的不良反应和3~4级不良反应低于厄洛替尼。结论 安罗替尼治疗晚期非鳞NSCLC的临床疗效不劣于一线治疗用药厄洛替尼，且耐受性优于厄洛替尼。

Abstract:

OBJECTIVE To compare the clinical efficacy and safety of anlotinib and erlotinib in the patients with advanced non-squamous non-small cell lung cancer(NSCLC) patients. METHODS Retrospective analysis and screening of 106 patients with advanced non-squamous NSCLC with positive epidermal growth factor receptor(EGFR) gene sensitive mutation diagnosed and treated in the Affiliated Hospital of Nantong University from October 2018 to September 2019. According to the medication situation of the patients, 53 patients were divided into the anlotinib group and the erlotinib group. The oral doses of the patients were 12 mg·d^-1 of anlotinib and 150 mg·d^-1 of erlotinib until progress, death or intolerance of adverse reactions occurred. The therapeutic effect and survival time of the patients were observed. RESULTS In the anlotinib group, complete response was observed in 2 patient(3.8%), partial response was observed in 4 patients(7.5%), stable disease was observed in 34 patients(64.2%), and progressive disease was observed in 13 patients(24.5%), response rate was 11.3% and disease control rate was 75.5%. The median overall survival was 10.3 months and the 1-year survival rate was 45.1%. In the erlotinib group, complete response was observed in 2 patient(3.8%), partial response was observed in 2 patient(3.8%), stable disease was observed in 31 patients(58.5%), and progressive disease was observed in 18 patients(33.9%), response rate was 7.6% and disease control rate was 66.1%. The median overall survival was 8.6 months and the 1-year survival rate was 38.2%. There was no significant difference between the two groups. The multivariate analysis showed that the survival time was associated with PS score and lymph node metastasis(P=0.002 and 0.003). There were significant differences in hypertension, elevated transaminase and diarrhea between the two groups(P<0.05). The overall adverse reactions and grade 3-4 adverse reactions in the anlotinib group were lower than that of erlotinib. CONCLUSION The clinical efficacy of anlotinib in the patients with advanced non-squamous NSCLC is not inferior to erlotinib, and its tolerability is better than erlotinib.