AUTHOR=Feng Yongdong , Zhu Guangkuo , Lang Song , Hao Ping , Li Guanghui , Chen Fanglin , Zhuo Wenlei , Duan Yuzhong , Zhang Anmei , Chen Zhengtang , Sun Jianguo 

TITLE=The Efficacy and Safety of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Combined With Thymosin in Advanced Non-Small Cell Lung Cancer Patients Harboring Active Epidermal Growth Factor Receptor Mutations

JOURNAL=Frontiers in Oncology

VOLUME=11

YEAR=2021

URL=https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2021.659065

DOI=10.3389/fonc.2021.659065

ISSN=2234-943X

ABSTRACT=<sec><title>Objective</title><p>To explore the efficacy and safety of EGFR-TKI combined with thymosin therapy in advanced non-small cell lung cancer (NSCLC) patients harboring active EGFR mutations.</p></sec><sec><title>Methods</title><p>Patients confirmed as advanced NSCLC with active EGFR mutations were recruited from August 2008 to July 2018 retrospectively. Patients treated with EGFR-TKI were classified as the EGFR-TKI group. And those received EGFR-TKI and thymosin therapy were designated as the EGFR-TKI plus thymosin group. The primary endpoint was progression-free survival (PFS). The secondary endpoints included overall survival (OS), tumor response and adverse effects.</p></sec><sec><title>Results</title><p>The median PFS was significantly longer in EGFR-TKI plus thymosin group than that in EGFR-TKI group (14.4 months <italic>vs</italic>. 9.2 months; HR=0.433, 95% CI 0.322 - 0.582, <italic>P</italic>&lt;0.0001). The median OS was also prolonged in EGFR-TKI plus thymosin group than that in EGFR-TKI group (29.5 months <italic>vs</italic>. 19.8 months; HR=0.430, 95% CI 0.319 - 0.580, <italic>P</italic>&lt;0.0001). The objective response rate in EGFR-TKI plus thymosin group and EGFR-TKI group were 60.0% versus 60.8% (<italic>P</italic>=0.918). The disease control rate was 96.9% in EGFR-TKI plus thymosin group and 97.7% in EGFR-TKI group (<italic>P</italic>=1.000). There were no significant differences in adverse effects between the two groups. The number of CD3<sup>+</sup>T cells in peripheral blood decreased significantly after treatment including both CD3<sup>+</sup>CD4<sup>+</sup>T and CD3<sup>+</sup>CD8<sup>+</sup>T subsets in EGFR-TKI group, but not in EGFR-TKI plus thymosin group.</p></sec><sec><title>Conclusions</title><p>Combination of EGFR-TKI and thymosin can significantly prolong the PFS and OS compared with EGFR-TKI monotherapy without more adverse events, which offers a new strategy in clinic.</p></sec>