Gefitinib alone vs gefitinib plus chemotherapy for non–small-cell lung cancer with mutated epidermal growth factor receptor: NEJ009 study
Journal of Clinical Oncology Nov 20, 2019
Hosomi Y, Morita S, Sugawara S, et al. - Researchers examined the efficacy and safety of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor combined with cytotoxic chemotherapy vs standard therapy with EGFR- tyrosine kinase inhibitors alone for the treatment of advanced non–small-cell lung cancer (NSCLC) with EGFR mutations. Three hundred forty-five patients with newly diagnosed metastatic NSCLC with EGFR mutations were randomly assigned to gefitinib combined with carboplatin plus pemetrexed or gefitinib alone. The combination group vs the gefitinib group demonstrated a better objective response rate (ORR) and progression-free survival (PFS) (ORR, 84% v 67%; PFS, 20.9 v 11.9 months; hazard ratio for death or disease progression, 0.490), although no significant differences were observed in PFS2 (20.9 v 18.0 months). The combination therapy had an acceptable toxicity profile, although further validation is recommended for its overall survival benefit.
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