420O Erlotinib plus bevacizumab (EB) versus erlotinib alone (E) as first-line treatment for advanced non-squamous non–small-cell lung cancer (NSCLC) with activating EGFR mutation (mt): JO25567 exploratory subgroup analysis

Abstract

Aim/Background: Recent studies suggest that some clinical factors are associated with shorter progression-free survival (PFS) of EGFR-TKI alone. In patients ( pts) with these factors, more effective strategies with EGFR-TKI are awaited. JO25567 demonstrated clinical benefit of EB in NSCLC pts with activating EGFR mt. To explore pts for whom EB could be applied as more beneficial strategy, we conducted exploratory subgroup analysis. (Table presented) Methods: JO25567 was open-label randomized trial. Pts with stage IIIB, IV or recurrent, non-squamous NSCLC, activating EGFR mt, ECOG performance status (PS) 0 or 1, and no previous chemotherapy were randomized either EB or E. We conducted subgroup analysis by baseline age, sex, smoking status, ECOG PS, clinical stage, EGFR mt type, the sum of longest diameter (SLD) of target lesions, the number of affected organs and pleural and/or cardiac effusion (PCE). Median PFS was estimated by Kaplan-Meier methods. Results: PFS were shown in table. Especially in pts with PCE, in which PFS with E was shorter than the other subgroups, PFS exceeded 15 months in EB group. PCE progression were seen in 11 (30.6%) pts in E group and 5 (16.7%) pts in EB group with PCE at baseline. No new safety signals of EB and E were observed even in pts with PCE. Conclusions: EB showed consistent clinical benefit regardless patient characteristics. EB could be beneficial strategy to the pts with baseline PCE. Further investigation in this population is warranted.