中国老年晚期非小细胞肺癌患者使用奥希替尼不良反应分析

Analysis of adverse reactions of osimertinib among elderly patients with advanced non-small cell lung cancer in China

目的分析老年晚期非小细胞肺癌(NSCLC)患者使用奥希替尼的实际临床特征和不良反应(ADR),为其临床安全用药提供参考。方法从医疗记录中获取2019年第一季度使用奥希替尼中国患者,入组条件为NSCLC,表皮生长因子受体(EGFR)突变并且年龄≥75岁,对使用奥希替尼治疗线无限制。统计入组患者性别、年龄、诊断、吸烟等临床情况,对ADR发生的时间分布、临床表现、治疗措施及转归情况等进行回顾性分析。结果共纳入30例患者,男女各15例,年龄75~89岁,中位数80岁;最常见的EGFR突变是外显子21(L858R),使用EGFR的酪氨酸酶抑制剂(TKI)耐药后激发T790M突变占26.7%,>50%患者接受奥希替尼治疗前,曾接受一线或二线ERGFR-TKIs治疗;用药3个月内ADR发生率为30.0%,有1例发生间质性肺病需停用奥希替尼,常规激素和抗菌治疗疗效欠佳;食欲下降为最常见,发生率为20.0%,有4例(13.3%)患者发生2~3级腹泻,其中1例患者既往有肠易激综合征病史,服用奥希替尼后激发严重的腹泻。结论临床NSCLC患者应用甲磺酸奥希替尼前3个月应特别注意ADR的发生,尤其应注意呼吸、消化系统的ADR,其中食欲下降是老年人特有的不良反应。

Objective To analyze the actual clinical characteristics and adverse reactions(ADR)of elderly advanced non-small cell lung cancer(NSCLC)patients using osimertinib,providing a reference for its clinical safety.Methods Obtained Chinese patients using osimertinib in the first quarter of 2019 from medical records.The enrollment conditions were NSCLC,epidermal growth factor receptor(EGFR)mutation and age≥75 years,and there were no restriction on the use of osimertinib.Calculated the clinical status of the patients included in the group including gender,age,diagnosis,smoking status,etc.The time distribution,clinical manifestations,treatment measures and outcomes of ADR were analyzed retrospectively.Results A total of 30 patients were enrolled,15 patients were male and female,the median age was 80 years old and the range was 75 to 89 years old.The most common EGFR mutation was exon 21(L858R).26.7%of T790M mutations were stimulated by EGFR tyrosinase inhibitor(TKI)resistance.More than 50%of the patients received first-line or second-line ERGFR-TKIstreatment.The incidence of ADR within 3 months of medication was 30.0%.One case of interstitial lung disease required cessation of osimertinib,and conventional hormone and antibacterial treatments were not effective.Decreased appetite was the most common,with an incidence rate of 20.0%,and 4 patients(13.3%)had grade 2 to 3 diarrhea,of which 1 patient had a history of irritable bowel syndrome,which caused severe diarrhea after taking osimertinib.Conclusion In the first 3 months of clinical application of oxitinib mesylate,special attention should be paid to the occurrence of ADR,especially the ADR of the respiratory and digestive systems,in which decreased appetite is a unique adverse reaction of the elderly.