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    The prognostic impact of tumor mutational burden (TMB) in the first-line management of advanced non-oncogene addicted non-small-cell lung cancer (NSCLC): a systematic review and meta-analysis of randomized controlled trials

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    Author
    Galvano, A
    Gristina, V
    Malapelle, U
    Pisapia, P
    Pepe, F
    Barraco, N
    Castiglia, M
    Perez, A
    Rolfo, C
    Troncone, G
    Russo, A
    Bazan, V
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    Date
    2021-04-30
    Journal
    ESMO Open
    Publisher
    Elsevier Ltd.
    Type
    Article
    
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    See at
    https://doi.org/10.1016/j.esmoop.2021.100124
    Abstract
    BACKGROUND: The role of tumor mutational burden (TMB) is still debated for selecting advanced non-oncogene addicted non-small-cell lung cancer (NSCLC) patients who might benefit from immune checkpoint inhibitors (ICIs). Of note, TMB failed to predict a benefit in overall survival (OS) among such patients. MATERIALS AND METHODS: The purpose of this meta-analysis was to compare efficacy outcomes among first-line immune-oncology (IO) agents versus standard platinum-based chemotherapy (CT) within two subgroups (TMB-low and TMB-high on either tissue or blood). We collected hazard ratios (HRs) to evaluate the association for progression-free survival (PFS) and OS, with the relative 95% confidence intervals (CIs). Risk ratios (RRs) were used as an association measure for objective response rate (ORR). RESULTS: Eight different cohorts of five randomized controlled phase III studies (3848 patients) were analyzed. In TMB-high patients, IO agents were associated with improved ORR (RRs 1.37, 95% CI 1.13-1.66), PFS (HR 0.69, 95% CI 0.61-0.79) and OS (HR 0.67, 95% CI 0.59-0.77) when compared with CT, thus suggesting a possible predictive role of high TMB for IO regimens. In TMB-low patients, the IO strategy did not lead to any significant benefit in survival and activity, whereas the pooled results of both ORR and PFS were intriguingly associated with a statistical significance in favor of CT. CONCLUSIONS: This meta-analysis resulted in a proven benefit in OS in favor of IO agents in the TMB-high population. Although more prospective data are warranted, we postulated the hypothesis that monitoring TMB, in addition to the existing programmed death-ligand 1 (PD-L1) expression level, could represent the preferable option for future clinical research in the first-line management of advanced non-oncogene addicted NSCLC patients.
    Rights/Terms
    Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.
    Keyword
    ICIs
    NSCLC
    TMB
    meta-analysis
    prognostic
    Identifier to cite or link to this item
    http://hdl.handle.net/10713/15583
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.esmoop.2021.100124
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