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Gefitinib Plus Chemotherapy vs Gefitinib Alone in Untreated EGFR-Mutant Non–Small Cell Lung Cancer in Patients With Brain Metastases: The GAP BRAIN Open-Label, Randomized, Multicenter, Phase 3 Study by Xue Hou; Meichen Li; Guowu Wu; Weineng Feng; Jin Su; Honghua Jiang; Guanming Jiang; Jing Chen; Baishen Zhang; Zhixuan You; Qing Liu; Likun Chen is a Medicine article available to read on EtoBox.

What is Gefitinib Plus Chemotherapy vs Gefitinib Alone in Untreated EGFR-Mutant Non–Small Cell Lung Cancer in Patients With Brain Metastases: The GAP BRAIN Open-Label, Randomized, Multicenter, Phase 3 Study about?

Importance Use of tyrosine kinase inhibitors (TKIs) is the standard therapy for epidermal growth factor receptor (EGFR)–mutated non–small cell lung cancer (NSCLC) with brain metastases. Several studies have shown that adding chemotherapy to EGFR-TKIs could improve progression-free survival (PFS) in patients with EGFR-mutant advanced NSCLC; however, the efficacy of these agents in patients with brain metastases remains unclear. Objective To investigate the efficacy and safety of gefitinib plus chemotherapy (pemetrexed with platinum) compared with gefitinib alone in patients with untreated EGFR-mutant NSCLC brain metastases. Design, Setting, and Participants This open-label prospective, multicenter, phase 3 randomized clinical trial was conducted in 6 centers in China from January 13, 2016, to August 27, 2021. The median follow-up time was 21.1 months (IQR, 13.5-31.8 months). Patients with untreated confirmed brain metastases and EGFR-sensitive mutated NSCLC were enrolled. Interventions The eligible patients were randomly assigned (1:1) to receive gefitinib plus chemotherapy or gefitinib alone. Main Outcomes and Measures The primary end point was intracranial PFS; secondary end point

Who reads Gefitinib Plus Chemotherapy vs Gefitinib Alone in Untreated EGFR-Mutant Non–Small Cell Lung Cancer in Patients With Brain Metastases: The GAP BRAIN Open-Label, Randomized, Multicenter, Phase 3 Study?

Author

Xue Hou; Meichen Li; Guowu Wu; Weineng Feng; Jin Su; Honghua Jiang; Guanming Jiang; Jing Chen; Baishen Zhang; Zhixuan You; Qing Liu; Likun Chen

Publisher

American Medical Association (AMA)

Published

2023

Language

EN

Field

Medicine (Health Sciences)