Gefitinib (an EGFR tyrosine kinase inhibitor) plus anlotinib (an multikinase inhibitor) for untreated, EGFR-mutated, advanced non-small cell lung cancer (FL-ALTER): a multicenter phase III trial

Autor: Hua-Qiang Zhou, Ya-Xiong Zhang, Gang Chen, Qi-Tao Yu, Hua Zhang, Guo-Wu Wu, Di Wu, Ying-Cheng Lin, Jun-Fei Zhu, Jian-Hua Chen, Xiao-Hua Hu, Bin Lan, Ze-Qiang Zhou, Hai-Feng Lin, Zi-Bing Wang, Xiao-Lin Lei, Suo-Ming Pan, Li-Ming Chen, Jian Zhang, Tian-Dong Kong, Ji-Cheng Yao, Xin Zheng, Feng Li, Li Zhang, Wen-Feng Fang
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Signal Transduction and Targeted Therapy, Vol 9, Iss 1, Pp 1-12 (2024)
Druh dokumentu: article
ISSN: 2059-3635
DOI: 10.1038/s41392-024-01927-9
Popis: Abstract Dual inhibition of vascular endothelial growth factor and epidermal growth factor receptor (EGFR) signaling pathways offers the prospect of improving the effectiveness of EFGR-targeted therapy. In this phase 3 study (ClinicalTrial.gov: NCT04028778), 315 patients with treatment-naïve, EGFR-mutated, advanced non-small cell lung cancer (NSCLC) were randomized (1:1) to receive anlotinib or placebo plus gefitinib once daily on days 1–14 per a 3-week cycle. At the prespecified final analysis of progression-free survival (PFS), a significant improvement in PFS was observed for the anlotinib arm over the placebo arm (hazards ratio [HR] = 0.64, 95% CI, 0.48–0.80, P = 0.003). Particularly, patients with brain metastasis and those harboring EGFR amplification or high tumor mutation load gained significant more benefits in PFS from gefitinib plus anlotinib. The incidence of grade 3 or higher treatment-emergent adverse events was 49.7% of the patients receiving gefitinib plus anlotinib versus 31.0% of the patients receiving gefitinib plus placebo. Anlotinib plus gefitinib significantly improves PFS in patients with treatment-naïve, EGFR-mutated, advanced NSCLC, with a manageable safety profile.
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