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.

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.
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表皮生长因子受体酪氨酸激酶抑制剂联合胸腺肽治疗表皮生长因子受体活性突变的晚期非小细胞肺癌患者的疗效和安全性

DOI:
10.3389/fonc.2021.659065
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发表时间:
2021
影响因子:
4.7
通讯作者:
Sun J
Sun J
中科院分区:
医学3区
文献类型:
--
作者:
Feng Y;Zhu G;Lang S;Hao P;Li G;Chen F;Zhuo W;Duan Y;Zhang A;Chen Z;Sun J

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目的探讨EGFR-TKI联合胸腺素治疗活动性EGFR突变的晚期非小细胞肺癌(NSCLC)的疗效和安全性。方法对2008年8月至2018年7月确诊为晚期非小细胞肺癌且EGFR基因突变活跃的患者进行回顾性研究。接受EGFR-TKI治疗的患者分为EGFR-TKI组。而接受EGFR-TKI和胸腺肽治疗的患者被指定为EGFR-TKI加胸腺球蛋白治疗组。主要终点是无进展生存期(PFS)。次要终点包括总生存期(OS)、肿瘤反应和不良反应。结果EGFR-TKI联合胸腺球蛋白组的中位PFS明显长于EGFR-TKI组(14.4月vs.9.2月;HR=0.433,95%CI 0.322~0.582,P&lt;0.0001)。EGFR-TKI联合胸腺肽治疗组的中位OS明显长于EGFR-TKI组(29.5个月比19.8个月;HR=0.430,95%CI 0.319~0.580,P<0.0001)。EGFR-TKI联合胸腺球蛋白组和EGFR-TKI组的客观有效率分别为60.0%和60.8%(P=0.918)。EGFR-TKI联合胸腺球蛋白组和EGFR-TKI组的疾病控制率分别为96.9%和97.7%(P=1.000)。两组不良反应发生率差异无统计学意义。EGFR-TKI组治疗后外周血中CD3+T细胞明显减少,包括CD3+CD4+T细胞和CD3+CD8+T细胞亚群,而EGFR-TKI+胸腺球蛋白组治疗后CD3+T细胞数无明显变化。结论EGFR-TKI与胸腺肽联合应用较单用EGFR-TKI可显著延长PFS和OS,且不良反应少,为临床提供了新的治疗策略。
Objective 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. Methods 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. Results The 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. Conclusions 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.
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