First-line treatment of EGFR-mutated nonsmall cell lung cancer: critical review on study methodology.

作者: M. Sebastian , A. Schmittel , M. Reck

DOI: 10.1183/09059180.00008413

关键词: Precision medicineEpidermal growth factor receptorErlotinibOncologyInternal medicineChemotherapyGefitinibMedicineClinical trialAfatinibPharmacologyTyrosine kinase

摘要: Recent advances in understanding the mechanisms of nonsmall cell lung cancer (NSCLC) has led to development targeted treatments, including reversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors gefitinib and erlotinib, irreversible ErbB family blocker afatinib. Several important activating EGFR mutations have now been identified, which correlate strongly with response treatment these agents. Multiple randomised controlled trials confirmed association between presence objective gefitinib, erlotinib afatinib, thus demonstrating their superiority over platinum-based chemotherapy as first-line for NSCLC patients mutation-positive tumours, resulting approval agents use this setting. It can be tempting compare outcome data across multiple clinical agents; however, substantial differences methodology studies, investigator versus independent assessment patient eligibility, makes such comparisons fraught difficulty. This critical review provides an overview evolution used eight phase III investigating NSCLC, identifies key reporting, critically assesses how should taken into account when interpreting findings from trials.

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