The Value of Next-Generation Sequencing for Treatment in Non-Small Cell Lung Cancer Patients: The Observational, Real-World Evidence in China.

Background. Great success has been made in the targeting therapy of advanced non-small cell lung cancer (NSCLC). Nowadays, next generation sequencing (NGS) is acquirable and affordable in developed area of China. Using this feasible and accurate method of detecting therapeutic genes would help to select optimal treatments to extend patients survival. Here, we identified somatic mutations by NGS and analyzed the value for treatment of NSCLC in a real-world clinical setting. Methods. NGS was carried out on biopsy samples obtained from 66 advanced unresectable NSCLC patients who had not received any treatment. 23 patients received liquid biopsy after failure of first-line targeted treatment. The mutation profiling as well as associations between mutations and clinicopathological characters was analyzed. The study also assessed the values of NGS for choosing treatment options and predicting prognosis in NSCLC patients. Results. 152 somatic mutations were identified in 45 (68.18%) tissue samples. The most frequently mutated genes were EGFR (42.42%), TP53 (31.82%) and KRAS (15.15%). Specifically, the most frequent EGFR mutation subtypes were exon 19 deletion (60.71%) and L858R in exon 21 (46.43%). 83.33% mutated patients received targeted therapy. Among the adenocarcinoma cases, patients with EGFR exon 19 deletion mutation have longer overall survival (OS) than the wide-type (36.0 months versus 19.0 months p=0.046). In addition, in the smoking group, patients with EGFR exon 19 deletion mutation tended to have longer OS (38.0 months versus 16.5 months p<0.01). After the failure of first-line targeted therapy, 23 EGFR mutated patients received liquid biopsy, and the positive rate of T790M mutation in EGFR exon 20 was 47.83%. T790M positive patients have longer progression-free survival (PFS) than the others (15 months versus 9.5 months p=0.025). Conclusions. The observational study from real-world demonstrated that using NGS in routine clinical detection may be useful in guiding the therapy decisions and benefit more Chinese NSCLC patients.