缓解深度与一线TKI类药物疗效相关性的单中心研究

A single center study on the relationship between the depth of remission and the efficacy of first-line TKI drugs

目的探索肺腺癌患者缓解深度与酪氨酸激酶抑制剂(TKI)类药物疗效的相关性。方法收集2015年至2016年就诊于本院的初治且携带表皮生长因子受体(EGFR)经典突变(19del或21L858R)的局部晚期或转移性(Ⅲb或Ⅳ期)肺腺癌患者的临床病理资料及转归信息,通过RECIST1.1标准衡量肿瘤缓解深度[稳定(SD),部分缓解(PR),完全缓解(CR)],通过Kaplan-Meier法绘制生存曲线并进行Log-rank检验。结果研究期间,共204例初治携带19del或21L858R突变的晚期肺腺癌患者接受了一代TKI类药物治疗,其中,24例患者失访或无法进行疗效评估,20例患者最佳疗效评估为进展(PD),62例患者评估为SD,98例患者评估为CR或PR,疾病控制率(DCR)及客观缓解率(ORR)分别为88.9%和54.4%。评估为SD的患者和评估为CR或PR的患者中位无进展生存时间(PFS)分别为12.6个月(95%CI:10.9~14.4)和13.2个月(95%CI:11.6~14.7),差异无统计学意义(P=0.27)。亚组分析发现,评估为SD的患者中,携带EGFR 19del和21L858R突变的患者的中位PFS分别为12.5个月(95%CI:9.9~15.4)和12.7个月(95%CI:9.4~16.1),差异无统计学意义(P=0.66);评估为CR或PR的患者中,携带EGFR 19del和21L858R突变的患者中位PFS分别为13.9个月(95%CI:12.3~15.5)和12.3个月(95%CI:9.5~15.1),差异亦无统计学意义(P=0.41)。结论携带EGFR 19del或21L858R突变的晚期非腺癌患者,其一线接受TKI的疗效与肿瘤缓解深度无相关性。

Objective The aim of the study was to investigate association of response depth and prognosis in epidermal growth factor receptor(EGFR)-mutant non-small cell lung cancer(NSCLC)patients treated with first-line tyrosine kinase inhibitors(TKIs).Methods The clinicopathological data and prognosis information of patients with locally advanced or metastatic(ⅢB orⅣ)lung adenocarcinoma with EGFR classical(19del or 21L858R)mutation who were treated in our hospital from 2015 to 2016 were collected.The tumor remission depth[stable disease(SD),partial response(PR),complete response(CR)]was measured by recist 1.1 standard.The survival curve was drawn by Kaplan-Meier method and log rank test was performed.Results During the study period,204 advanced lung adenocarcinoma patients with 19del or 21L858R mutation were treated with TKI drugs of the first generation.Among them,24 patients were lost or unable to evaluate the efficacy,20 patients were evaluated as progression disease(PD),62 patients as SD,98 patients as CR or PR.Disease control rate(DCR)and objective remission rate(ORR)were 88.9%and 54.4%,respectively.The median progression free survival time(PFS)was 12.6 months(95%CI:10.9-14.4 months)and 13.1 months(95%CI:11.6-14.7)for patients assessed as SD(group A)and CR or PR(group B),respectively,with no significant difference(P=0.27).Subgroup analysis showed that the median overall survival of patients with EGFR 19del and 21L858R mutations was 12.5 months(95%CI:9.9-15.4)and 12.7 months(95%CI:9.4-16.1),respectively,with no significant difference(P=0.66);Similar result was also observed in Group B with a median PFS of 13.9 months(95%CI:12.3-15.5 months)and 12.3 months(95%CI:9.5-15.1 months)in patients who had EGFR 19del or 21L858R mutations(P=0.41).Conclusions Response depth was not a positive predictor for prognosis in EGFR-mutant NSCLC patients treated with first-line TKIs.