As treatment benefit in a given trial can be difficult to understand by analyzing results using a single measure of PFS, the totality of PFS data should be considered. The difference in PFS outcomes between ex19del and ex21L858R is independent of EGFR-TKI generation used and is observed with first-, second-, and third-generation EGFR-TKIs. Indeed, although both ex19del and ex21L858R mutations benefit from EGFR-TKI treatment, subgroup analyses of several landmark studies in EGFRm NSCLC indicate that patients with ex21L858R derive more modest benefit with EGFR-TKI monotherapy than patients with ex19del, as represented by its lower median progression-free survival (PFS), smaller delta PFS, and higher PFS HR ( Table 1). However, the degree of benefit may differ based on the EGFR mutation type, which has been shown to be an independent prognostic marker ( 7, 8). EGFR-activating mutations are also a major predictive factor for response to small-molecule EGFR tyrosine kinase inhibitor (TKI) therapies.
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