Gefitinib plus chemotherapy versus gefitinib alone in untreated patients with EGFR-mutated non–small cell lung cancer and brain metastases (GAP Brain): An open-label, randomized, multicenter, phase 3 study.

• DOI: 10.1200/jco.2022.40.16_suppl.9095
• Publication Date: 2022-06-06T18:04:22Z
• Authors: Likun Chen; Xue Hou; Meichen Li; Guowu Wu; Weineng Feng; Jin Su; Honghua Jiang; Guanming Jiang; Baishen Zhang; Jing Chen; Zhixuan You
• Keywords: Pemetrexed; Clinical endpoint; Performance status

9095 Background: Combination of tyrosine kinase inhibitor (TKI) and chemotherapy has shown improved clinical outcomes in advanced epidermal growth factor receptor ( EGFR) mutated non-small cell lung cancer (NSCLC) patients. We conducted this phase 3, randomized, controlled trial to further investigate the efficacy safety gefitinib combined with EGFR NSCLC patients brain metastases. Methods: Treatment-naïve, confirmed metastases sensitive were screened from six centers China. The eligible randomly assigned (1:1) receive alone or plus pemetrexed-platinum until intracranial progressive diseases, unacceptable adverse, any cause death. Theprimary endpoint was progression-free survival (iPFS), secondary endpoints PFS, overall survival, objective response rate, safety. This study is registered at ClinicalTrials. gov, number NCT01951469. Results: From January 2017 June 2021, 161 (n = 81) 80), median follow-up time 18.2 (IQR 11.8-29.7) months. PFS 15.6 (14.3-16.9) months group versus 9.1 (8.0-10.2) (HR 0.36, 95% CI, 0.25-0.53, P < 0.001). Similarly, also significantly longer than (16.3 vs 9.5 months, In addition, had better rate (85.0% 63.0%, 0.002) (80.0% 64.2%, 0.035) alone. At data cutoff, 50.3% (35 46 group) died. 3-year OS higher (47.4%, CI 36.3-58.7) (24.9%, 15.1-34.3, 0.003). And 35.0 (95% 28.8-41.3 months) 28.9 23.4-34.4 0.66, 0.42-1.03, 0.065). Grade 3 worse adverse events more common (40.0% 21.0%, 0.010), but most them manageable. Conclusions: Inuntreated metastases, a tendency alone, could be optional first-line treatment. Clinical information: