关于晚期非小细胞肺癌中表皮生长因子受体突变靶向治疗的真实世界全球数据：KINDLE研究结果
Real-world global data on targeting epidermal growth factor receptor mutations in stage III non-small-cell lung cancer: the results of the KINDLE study.
作者信息
Jazieh Abdul Rahman, Onal Huseyin Cem, Tan Daniel Shao-Weng, Soo Ross A, Prabhash Kumar, Kumar Amit, Huggenberger Reto, Cho Byoung Chul
机构信息
Cincinnati Cancer Advisors, Cincinnati, OH, USA.
Department of Radiation Oncology, Adana Dr. Turgut Noyan Research and Treatment Centre, Baskent University, Adana, Turkey.
出版信息
Ther Adv Med Oncol. 2022 Sep 12;14:17588359221122720. doi: 10.1177/17588359221122720. eCollection 2022.
BACKGROUND
Tyrosine kinase inhibitors (TKIs) are the standard of care for resectable and metastatic non-small-cell lung cancer (NSCLC) harbouring epidermal growth factor receptor (EGFR) mutations (EGFRm). We describe the real-world practice of EGFRm testing, prevalence, treatment and outcomes in EGFRm stage III NSCLC from a multi-country, observational study.
METHODS
The KINDLE study retrospectively captured diagnostic information, treatments and survival outcomes in patients with stage III NSCLC from January 2013 to December 2017. Baseline characteristics and treatments were described and real-world outcomes from initial therapy were analysed using Kaplan-Meier methods.
RESULTS
A total of 3151 patients were enrolled across three regions: Asia ( = 1874), Middle East and North Africa (MENA) ( = 1046) and Latin America (LA) ( = 231). Of these, 1114 patients (35%) were tested for EGFRm (46% in Asia, 17% in MENA and 32% in LA) and EGFRm was detected in 32% of tested patients (34.3% in Asia, 20.0% in MENA and 28.4% in LA). In a multi-variate analysis, overall EGFRm patients treated with EGFR-TKI monotherapy as initial treatment, without any irradiation, had twice the risk of dying (hazard ratio: 1.983, 95% confidence interval: 1.079-3.643; = 0.027) any other treatment. Finally, unresectable patients with EGFRm NSCLC who received concurrent chemoradiotherapy (cCRT) as initial therapy had longer overall survival (OS) compared with their counterparts who only received TKI monotherapy without any irradiation (48 months 24 months; < 0.001).
CONCLUSION
The KINDLE study showed that a minority of stage III NSCLC patients were tested for EGFRm. Patients with EGFRm with unresectable NSCLC had similar outcomes from cCRT as initial therapy compared with EGFR wild type with a trend in OS favouring the EGFRm group. Outcomes with EGFR-TKI monotherapy as initial therapy, without any irradiation, were worse. The ongoing LAURA study (NCT03521154) will help define the role of EGFR-TKIs in EGFRm stage III NSCLC treated with cCRT.
TRIAL REGISTRATION
NCT03725475.
背景
酪氨酸激酶抑制剂（TKIs）是携带表皮生长因子受体（EGFR）突变（EGFRm）的可切除和转移性非小细胞肺癌（NSCLC）的标准治疗方法。我们通过一项多国观察性研究描述了EGFRm检测、EGFRm III期NSCLC的患病率、治疗及结局的真实世界实践情况。
方法
KINDLE研究回顾性收集了2013年1月至2017年12月期间III期NSCLC患者的诊断信息、治疗及生存结局。描述了基线特征和治疗情况，并使用Kaplan-Meier方法分析了初始治疗的真实世界结局。
结果
三个地区共纳入3151例患者：亚洲（n = 1874）、中东和北非（MENA）（n = 1046）以及拉丁美洲（LA）（n = 231）。其中，1114例患者（35%）接受了EGFRm检测（亚洲为46%，MENA为17%，LA为32%），在接受检测的患者中，32%检测到EGFRm（亚洲为34.3%，MENA为20.0%，LA为28.4%）。在多变量分析中，总体上接受EGFR-TKI单药作为初始治疗且未接受任何放疗的EGFRm患者死亡风险是接受其他任何治疗患者的两倍（风险比：1.983，95%置信区间：1.079 - 3.643；P = 0.027）。最后，与仅接受TKI单药治疗且未接受任何放疗的患者相比，接受同步放化疗（cCRT）作为初始治疗的不可切除EGFRm NSCLC患者总生存期（OS）更长（48个月对24个月；P < 0.001）。
结论
KINDLE研究表明，少数III期NSCLC患者接受了EGFRm检测。不可切除的EGFRm NSCLC患者接受cCRT作为初始治疗的结局与EGFR野生型患者相似，OS有倾向于EGFRm组的趋势。以EGFR-TKI单药作为初始治疗且未接受任何放疗的结局较差。正在进行的LAURA研究（NCT03521154）将有助于明确EGFR-TKIs在接受cCRT治疗的EGFRm III期NSCLC中的作用。
试验注册
NCT03725475。
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