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Resumen de Tumor mutational burden as a predictive biomarker for non‑small cell lung cancer treated with immune checkpoint inhibitors of PD‑1/PD‑L1

Min min Shao, Yue ping Xu, Jing-Jing Zhang, Mao Mao, Meng Wang

  • Background The signifcant clinical benefts of PD-1/PD-L1 immune checkpoint inhibitors (ICIP) in non-small cell lung cancer (NSCLC) have been widely recognized, emphasizing the urgent need for a reliable biomarker. In this study, we fnd the remarkable capacity of tumor mutational burden (TMB) to serve as an accessible and streamlined indicator.

    Patients and methods We designed a retrospective cohort study, consisting of 600 NSCLC patients treated with ICIP. Association between TMB and overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR) has been explored.

    Results A strong positive correlation between TMB levels and OS, PFS rates, clinical beneft has been found when TMB> =16(TMB> =16 mutations/megabase (mut/Mb)). However, when TMB<16, increasing TMB values did not exhibit a gradual stepwise increase in OS and PFS rates. The median months of OS in the TMB> =16 and<16 are 35.58, and 10.71 months respectively with average 12.39 months (p<0.0001). The median months of PFS in the TMB> =16 and<16 are not-obtained, and 2.79 months respectively with an average of 3.32 months (p<0.0001). The DCR in the TMB> =16 and<16 are 71.4% and 44.2% respectively with an average of 47.7% (p<0.0001). The ORR in the TMB> =16 and<16 are 49.4% and 20.8% respectively with an average of 24.5% (p<0.0001).

    Conclusion The TMB> =16 shows signifcantly associated with optimal ICIP treatment outcomes, including higher patient survival rates, delayed disease progression, and signifcant clinical benefts. These results present the potential of TMB as a promising biomarker candidate for NSCLC patients undergoing ICIP treatment.


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