甲磺酸奥希替尼一线与序贯治疗EGFR突变晚期非小细胞肺癌初治患者的真实世界研究

Real world study on first-line and sequential treatment with Osimertinib of EGFR mutant patients with advanced NSCLC

目的观察甲磺酸奥希替尼一线与序贯治疗表皮生长因子受体(EGFR)突变晚期非小细胞肺癌(NSCLC)初治患者的疗效、安全性。方法选取2017年5月~2020年2月在皖南医学院附属太和医院行一代络氨酸激酶抑制剂(TKI)吉非替尼进展后序贯奥希替尼治疗(序贯组)和奥希替尼一线治疗(一线组)的EGFR突变阳性晚期NSCLC患者71例。随访截止日期为2022年1月30日。主要研究终点为疾病控制率(DCR)、客观缓解率(ORR)和无进展生存期(PFS)。对两组不良反应进行比较。结果两组ORR为70.21%vs.75.0%,DCR为89.36%vs.91.66%,序贯组略低于一线组,但差异无统计学意义(P>0.05)。序贯组中位PFS为18.6个月,一线组中位PFS为17.8个月,两年生存率序贯组为10.63%(5/47),一线组为41.66%(10/24),两组差异有统计学意义(χ^(2)=9.179,P=0.002)。一线组3级以上不良反应发生率12.5%(3/24),低于序贯组的23.4%(11/47),但组间差异无统计学意义(χ^(2)=1.193,P=0.274)。结论与一代酪氨酸激酶抑制剂序贯奥希替尼相比,奥希替尼一线治疗可提高生存率,降低不良反应使患者获益。

Objective To observe the efficacy and safety of Osimertinib mesylate in the first-line and sequential treatment of patients with EGFR mutant advanced NSCLC.Methods From May 2017 to February 2020,patients with EGFR mutation positive advanced NSCLC who underwent sequential Osimertinib treatment and first-line Osimertinib treatment after the progress of first-generation TKI in our hospital were studied.The deadline for follow-up was January 30,2022.The primary endpoints were disease control rate(DCR),objective response rate(ORR),and progression free survival(PFS).The adverse reactions of the two groups were compared.Results The ORR of the two groups was 70.21%vs 75.0%,and the DCR was 89.36%vs 91.66%,the sequential group was slightly lower than the first-line group,but there was no significant difference between the groups(P>0.05).The median PFS was 18.6 months in the sequential group and 17.8 months in the first-line group.The two-year survival rate was 10.63%(5/47)in the sequential group and 41.66%(10/24)in the first-line group.There was significant difference between the two groups(χ^(2)=9.539,P=0.002).The incidence of adverse reactions above grade 3 in the first-line Osimertinib group was 12.5%(3/24),lower than 23.4%(11/47)in the sequential group,but there was no significant difference between the groups(χ^(2)=1.193,P=0.274).Conclusion Compared with the first-generation tyrosine kinase inhibitor sequential Osimertinib,Osimertinib first-line treatment can improve the survival rate,reduce adverse reactions and benefit patients.