DataSheet_2_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.pdf

ObjectiveTo 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.
MethodsPatients 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.
ResultsThe median PFS was significantly longer in EGFR-TKI plus thymosin group than that in EGFR-TKI group (14.4 months vs. 9.2 months; HR=0.433, 95% CI 0.322 - 0.582, P<0.0001). The median OS was also prolonged in EGFR-TKI plus thymosin group than that in EGFR-TKI group (29.5 months vs. 19.8 months; HR=0.430, 95% CI 0.319 - 0.580, P<0.0001). The objective response rate in EGFR-TKI plus thymosin group and EGFR-TKI group were 60.0% versus 60.8% (P=0.918). The disease control rate was 96.9% in EGFR-TKI plus thymosin group and 97.7% in EGFR-TKI group (P=1.000). There were no significant differences in adverse effects between the two groups. The number of CD3+T cells in peripheral blood decreased significantly after treatment including both CD3+CD4+T and CD3+CD8+T subsets in EGFR-TKI group, but not in EGFR-TKI plus thymosin group.
ConclusionsCombination 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.

研究目的：探索表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI, Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor）联合胸腺肽疗法治疗携带活动性EGFR突变的晚期非小细胞肺癌（NSCLC, Non-Small Cell Lung Cancer）患者的疗效与安全性。
研究方法：本研究于2008年8月至2018年7月期间，回顾性招募经确诊的携带活动性EGFR突变的晚期非小细胞肺癌患者。将接受EGFR-TKI单药治疗的患者归为EGFR-TKI组，接受EGFR-TKI联合胸腺肽治疗的患者归为EGFR-TKI联合胸腺肽组。本研究的主要终点为无进展生存期（PFS, Progression-Free Survival），次要终点包括总生存期（OS, Overall Survival）、肿瘤应答情况与不良反应。
研究结果：EGFR-TKI联合胸腺肽组的中位无进展生存期显著长于EGFR-TKI组（14.4个月 vs 9.2个月；风险比（HR, Hazard Ratio）=0.433，95%置信区间（CI, Confidence Interval）：0.322~0.582，P<0.0001）。EGFR-TKI联合胸腺肽组的中位总生存期亦显著长于EGFR-TKI组（29.5个月 vs 19.8个月；HR=0.430，95%CI：0.319~0.580，P<0.0001）。EGFR-TKI联合胸腺肽组与EGFR-TKI组的客观缓解率分别为60.0%与60.8%（P=0.918），疾病控制率分别为96.9%与97.7%（P=1.000）。两组患者的不良反应发生率无显著差异。EGFR-TKI组患者治疗后外周血CD3+T细胞（包含CD3+CD4+T细胞亚群与CD3+CD8+T细胞亚群）水平显著下降，但EGFR-TKI联合胸腺肽组未出现该类变化。
研究结论：相较于EGFR-TKI单药治疗，EGFR-TKI联合胸腺肽疗法可显著延长患者的无进展生存期与总生存期，且未增加不良反应发生风险，可为临床治疗提供全新策略。