PDF(Pubmed)
Abstract：
Tyrosine kinase inhibitors (TKIs) are standard first-line treatments for advanced non-small-cell lung cancer (NSCLC) with driver gene mutations. The Response Evaluation Criteria in Solid Tumors (RECIST) are limited in predicting long-term patient benefits. A tumour marker-based evaluation criteria, RecistTM, was used to investigate the potential for assessing targeted-therapy efficacy in lung cancer treatment.
We retrospectively analysed patients with stage IIIA-IV NSCLC and driver gene mutations, whose baseline tumour marker levels exceeded the pre-treatment cut-off value three-fold and who received TKI-targeted therapy as a first-line treatment. We compared efficacy, progression-free survival (PFS), and overall survival (OS) between RecistTM and RECIST.
The median PFS and OS differed significantly among treatment-response subgroups based on RecistTM but not RECIST. The predicted 1-, 2-, and 3-year disease-progression risk, according to area under the receiver operating characteristic curve, as well as the 1-, 3-, and 5-year mortality risk, differed significantly between RecistTM and RECIST. The median PFS and OS of tmCR according to RecistTM, was significantly longer than (CR+PR) according to RECIST. Imaging analysis revealed that the ΔPFS was 11.27 and 6.17 months in the intervention and non-intervention groups, respectively, suggesting that earlier intervention could extend patients\' PFS.
RecistTM can assess targeted-therapy efficacy in patients with advanced NSCLC and driver gene mutations, along with tumour marker abnormalities. RecistTM surpasses RECIST in predicting short- and long-term patient benefits, and allows the early identification of patients resistant to targeted drugs, enabling prompt intervention and extending the imaging-demonstrated time to progression.
We retrospectively analysed patients with stage IIIA-IV NSCLC and driver gene mutations, whose baseline tumour marker levels exceeded the pre-treatment cut-off value three-fold and who received TKI-targeted therapy as a first-line treatment. We compared efficacy, progression-free survival (PFS), and overall survival (OS) between RecistTM and RECIST.
The median PFS and OS differed significantly among treatment-response subgroups based on RecistTM but not RECIST. The predicted 1-, 2-, and 3-year disease-progression risk, according to area under the receiver operating characteristic curve, as well as the 1-, 3-, and 5-year mortality risk, differed significantly between RecistTM and RECIST. The median PFS and OS of tmCR according to RecistTM, was significantly longer than (CR+PR) according to RECIST. Imaging analysis revealed that the ΔPFS was 11.27 and 6.17 months in the intervention and non-intervention groups, respectively, suggesting that earlier intervention could extend patients\' PFS.
RecistTM can assess targeted-therapy efficacy in patients with advanced NSCLC and driver gene mutations, along with tumour marker abnormalities. RecistTM surpasses RECIST in predicting short- and long-term patient benefits, and allows the early identification of patients resistant to targeted drugs, enabling prompt intervention and extending the imaging-demonstrated time to progression.
摘要：
背景：酪氨酸激酶抑制剂（TKIs）是具有驱动基因突变的晚期非小细胞肺癌（NSCLC）的标准一线治疗方法。实体瘤的反应评估标准（RECIST）在预测长期患者益处方面受到限制。基于肿瘤标志物的评估标准，RecistTM,用于研究评估肺癌治疗中靶向治疗疗效的潜力。
方法：我们回顾性分析了IIIA-IV期非小细胞肺癌和驱动基因突变的患者，其基线肿瘤标志物水平超过治疗前临界值3倍，并接受TKI靶向治疗作为一线治疗。我们比较了疗效,无进展生存期（PFS），RecistTM和RECIST之间的总生存期（OS）。
结果：基于RecristTM而非RECIST的治疗反应亚组的中位PFS和OS差异显著。预测的1-，2-,和3年的疾病进展风险，根据接收器工作特性曲线下的面积，以及1-，3-,和5年死亡风险，RecystTM和RECIST之间存在显着差异。根据RecistTM，tmCR的PFS和OS中位数，根据RECIST，显著长于(CR+PR)。影像学分析显示，干预组和非干预组的ΔPFS分别为11.27和6.17个月，分别,这表明早期干预可以延长患者的PFS。
结论：RecristTM可以评估晚期NSCLC和驱动基因突变患者的靶向治疗疗效，以及肿瘤标志物异常。RecystTM在预测短期和长期患者获益方面超过RECIST，并允许早期识别对靶向药物耐药的患者，能够及时干预并延长影像学显示的进展时间。
方法：我们回顾性分析了IIIA-IV期非小细胞肺癌和驱动基因突变的患者，其基线肿瘤标志物水平超过治疗前临界值3倍，并接受TKI靶向治疗作为一线治疗。我们比较了疗效,无进展生存期（PFS），RecistTM和RECIST之间的总生存期（OS）。
结果：基于RecristTM而非RECIST的治疗反应亚组的中位PFS和OS差异显著。预测的1-，2-,和3年的疾病进展风险，根据接收器工作特性曲线下的面积，以及1-，3-,和5年死亡风险，RecystTM和RECIST之间存在显着差异。根据RecistTM，tmCR的PFS和OS中位数，根据RECIST，显著长于(CR+PR)。影像学分析显示，干预组和非干预组的ΔPFS分别为11.27和6.17个月，分别,这表明早期干预可以延长患者的PFS。
结论：RecristTM可以评估晚期NSCLC和驱动基因突变患者的靶向治疗疗效，以及肿瘤标志物异常。RecystTM在预测短期和长期患者获益方面超过RECIST，并允许早期识别对靶向药物耐药的患者，能够及时干预并延长影像学显示的进展时间。
