Department of Pulmonology & Thoracic Oncology, Centre Hospitalier Universitaire de Caen, F-14000 Caen, France.
Department of Pathology, Centre François Baclesse, F-14000 Caen, France.
Curr Oncol. 2021 Nov 3;28(6):4432-4445. doi: 10.3390/curroncol28060376.
Epidermal growth factor receptor (EGFR) genotyping, a critical examen for the treatment decisions of patients with non-small cell lung cancer (NSCLC), is commonly assayed by next-generation sequencing (NGS), but this global approach takes time. To determine whether rapid genotyping tests by the Idylla system guides earlier therapy decisions, mutations were assayed by both the Idylla system and NGS in 223 patients with NSCLC in a bicentric prospective study. Idylla demonstrated agreement with the NGS method in 187/194 cases (96.4%) and recovered 20 of the 26 (77%) mutations detected using NGS. Regarding the seven missed mutations, five were not detected by the Idylla system, one was assayed in a sample with insufficient tumoral cells, and the last was in a sample not validated by the Idylla system (a bone metastasis). Idylla did not detect any false positives. The average time between genotyping results from Idylla and the NGS method was 9.2 ± 2.2 working days (wd) (12.6 ± 4.0 calendar days (cd)). Subsequently, based on the Idylla method, the timeframe from tumor sampling to the initiation of EGFR-TKI was 7.7 ± 1.2 wd (11.4 ± 3.1 cd), while it was 20.3 ± 6.7 wd (27.2 ± 8.3 cd) with the NGS method ( < 0.001). We thus demonstrated here that the Idylla system contributes to improving the therapeutic care of patients with NSCLC by the early screening of mutations.
表皮生长因子受体 (EGFR) 基因分型是评估非小细胞肺癌 (NSCLC) 患者治疗决策的关键检查,通常通过下一代测序 (NGS) 进行,但这种全面的方法需要时间。为了确定伊迪拉系统的快速基因分型测试是否能更早地指导治疗决策,在一项中心前瞻性研究中,对 223 例 NSCLC 患者同时使用伊迪拉系统和 NGS 检测突变。伊迪拉在 187/194 例(96.4%)病例中与 NGS 方法一致,并在使用 NGS 检测到的 26 个突变中的 20 个中得到了恢复。关于 7 个漏检的突变,其中 5 个未被伊迪拉系统检测到,1 个在肿瘤细胞数量不足的样本中检测到,最后 1 个在未被伊迪拉系统验证的样本中(骨转移)检测到。伊迪拉未检测到任何假阳性。伊迪拉和 NGS 方法的基因分型结果之间的平均时间为 9.2±2.2 个工作日 (wd) (12.6±4.0 个日历日 (cd))。随后,根据伊迪拉方法,从肿瘤取样到开始使用 EGFR-TKI 的时间为 7.7±1.2 wd (11.4±3.1 cd),而使用 NGS 方法则为 20.3±6.7 wd (27.2±8.3 cd)(<0.001)。因此,我们在这里证明伊迪拉系统通过早期筛选突变有助于改善 NSCLC 患者的治疗护理。