Multicenter phase 3 trial of addition of chemotherapy to gefitinib for untreated EGFR-mutant NSCLC with brain metastases

Use of EGFR-TKIs is the standard therapy for EGFR-mutated non-small cell lung cancer with brain metastases (BMs). Several studies have shown that adding chemotherapy to EGFR-TKIs could improve PFS in patients with EGFR-mutant advanced NSCLC. The efficacy of these combinations in patients with BMs is not yet clear. The multicenter phase 3 GAP BRAIN trial in China evaluated addition of chemotherapy to gefitinib for EGFR-mutant NSCLC with BMs. The study showed that addition of chemotherapy to gefitinib was associated with improved intracranial PFS, overall PFS, and OS. Grade 3 or worse adverse events were more common with gefitinib-chemotherapy compared with gefitinib alone (40.0% versus 21.0% of patients). Most of these events were manageable. The authors conclude that gefitinib plus chemotherapy could be an optional first-line treatment for EGFR-mutant NSCLC with BMs.