Étude ID-MUT : mise en place de la détermination des mutations de l’EGFR par technique Idylla™ dans le cancer du poumon : évaluation chez 225 patients du CHU de Caen et du Centre de Lutte Contre le Cancer François Baclesse de Caen

In advanced non-small-cell lung carcinomas (NSCLC) and non-epidermoid, the first line of treatment should be decided only with knowledge of driver mutations (ROS1, ALK and EGFR) and PD-L1 status.In Caen, the implementation of the Idylla™ EGFR rapid technique was motivated by clinicians in order to speedup their patients care/treatment.The purpose of the prospective ID-MUT study was to develop and evaluate a rapid targeted analysis of the EGFR mutation by Idylla™ technique and compare it to the Next Generation Sequencing (NGS) ion Torrent technique on a cohort of 225 patients followed at Caen.A total of 194 tumors samples from patients with formalin-fixed and paraffin-embedded CBPNPC have been simultaneously tested using both techniques. The comparison focused on the concordance and time to analyze the two techniques. The total agreement was excellent: 98.95% (188/190). Only 6 cases were inconsistent: 2 false negatives and 4 excluded from the analysis due to a non-objectifiable mutation by the Idylla™ technique. The analysis time of the Idylla™ technique was 6.6 working days versus 15.8 working days for the NGS technique (p value <0.001).The easy-to-use Idylla™ technology allows the sensitive and rapid characterization of a majority of EGFR mutations and can be optimized by using the Idylla™ Explore tool exploiting the amplification curves or increasing the amount of initial hardware.However, the use of previously extracted DNA may be judicious in order to optimize the material, as further analysis by NGS remains essential.Dans les carcinomes broncho-pulmonaires non à petites cellules (CBPNPC) et non-épidermoïdes au stade avancé, la première ligne de traitement ne doit se décider qu’avec la connaissance des mutations drivers (ROS1, ALK et EGFR) et du statut PD-L1. Á Caen, la mise en place de la technique rapide Idylla™ EGFR a été motivée par les cliniciens pour accélérer la prise en charge de leurs patients. Le but de l’étude prospective ID-MUT était de mettre en place et d’évaluer une analyse ciblée rapide de la mutation EGFR par technique Idylla™ et de la comparer à la technique par séquençage nouvelle génération (NGS) ion Torrent sur une cohorte de 225 patients suivis à Caen. Au total, 194 échantillons tumoraux de patients atteints d’un CBPNPC fixés au formol et inclus en paraffine ont été testés simultanément par les deux techniques. La comparaison a porté sur la concordance et le délai d’analyse des deux techniques. La concordance totale était excellente : 98,95% (188/190). Seuls 6 cas étaient discordants : 2 faux négatifs et 4 exclus de l’analyse en raison d’une mutation non objectivable par la technique Idylla™. Les délais d’analyse de la technique Idylla™ était de 6,6 jours ouvrés versus 15,8 jours ouvrés pour la technique NGS (p value<0,001). La technologie Idylla™, simple d’utilisation permet la caractérisation sensible et rapide d’une majorité des mutations EGFR et peut être optimisée en exploitant les courbes d’amplification avec l’outil Idylla™ Explore ou en augmentant la quantité de matériel initial. Cependant l’utilisation d’ADN préalablement extrait peut-être judicieuse afin d’optimiser le matériel, car une analyse complémentaire par NGS reste indispensable

Contribution of the IdyllaTM System to Improving the Therapeutic Care of Patients with NSCLC through Early Screening of EGFR Mutations

International audienceEpidermal 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 EGFR genotyping tests by the IdyllaTM system guides earlier therapy decisions, EGFR mutations were assayed by both the IdyllaTM system and NGS in 223 patients with NSCLC in a bicentric prospective study. IdyllaTM demonstrated agreement with the NGS method in 187/194 cases (96.4%) and recovered 20 of the 26 (77%) EGFR mutations detected using NGS. Regarding the seven missed EGFR mutations, five were not detected by the IdyllaTM system, one was assayed in a sample with insufficient tumoral cells, and the last was in a sample not validated by the IdyllaTM system (a bone metastasis). IdyllaTM did not detect any false positives. The average time between EGFR genotyping results from IdyllaTM and the NGS method was 9.2 ± 2.2 working days (wd) (12.6 ± 4.0 calendar days (cd)). Subsequently, based on the IdyllaTM 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 (p < 0.001). We thus demonstrated here that the IdyllaTM system contributes to improving the therapeutic care of patients with NSCLC by the early screening of EGFR mutations