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在真实世界环境中,EGFR-TKI 联合化疗作为一线治疗方案用于中国晚期非小细胞肺癌患者的疗效和获得性耐药。

Efficacy and acquired resistance of EGFR-TKI combined with chemotherapy as first-line treatment for Chinese patients with advanced non-small cell lung cancer in a real-world setting.

机构信息

Department of Oncology, the First Affiliated Hospital of Nanjing Medical University, 300, Guangzhou Road, Nanjing, 210029, Jiangsu, China.

Department of Cell Biology, School of Basic Medical Sciences, Nanjing Medical University, 101Longmian Avenue, Nanjing, 211166, Jiangning, China.

出版信息

BMC Cancer. 2021 May 25;21(1):602. doi: 10.1186/s12885-021-08291-9.

Abstract

BACKGROUND

To compare the benefits and explore the cause of acquired resistance of epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) and its combination with chemotherapy in advanced non-small-cell lung cancer (NSCLC) patients harboring EGFR mutation in a real-life setting.

METHODS

This retrospective analysis included 117 advanced NSCLC patients with EGFR mutation who underwent next-generation sequencing (NGS) prior to treatment. The combination group included 50 patients who received the regimen of EGFR-TKI combined with chemotherapy, while the EGFR-TKI monotherapy group included 67 patients treated with TKI only. The primary endpoint of this study was progression-free survival (PFS); the secondary endpoints were overall survival (OS), response rate, and toxicity.

RESULTS

The median PFS was significantly longer in the combination group than in the EGFR-TKI monotherapy group (19.00 months [95% CI, 14.67-23.33] vs. 11.70 months [95% CI, 10.81-12.59], p < 0.001). Subgroup analysis showed a similar trend of results. The median OS was not reached in the combination group and was 38.50 (95% CI, 35.30-41.70) months in the EGFR-TKI monotherapy group (p = 0.586). Patients in the combination group were more likely to experience adverse events, most of which showed the severity of grade 1 or 2. T790M mutation remains the main reason for acquired resistance, and the frequency of T790M mutation was similar between the two groups (p = 0.898).

CONCLUSIONS

Compared with EGFR-TKI monotherapy, EGFR-TKI combined with chemotherapy significantly improved PFS in advanced NSCLC patients with EGFR mutation, with acceptable toxicity.

摘要

背景

在真实环境中,比较表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKI)及其与化疗联合治疗携带 EGFR 突变的晚期非小细胞肺癌(NSCLC)患者的获益,并探讨获得性耐药的原因。

方法

本回顾性分析纳入了 117 例接受下一代测序(NGS)检测的 EGFR 突变的晚期 NSCLC 患者。联合组包括 50 例接受 EGFR-TKI 联合化疗的患者,而 EGFR-TKI 单药组包括 67 例仅接受 TKI 治疗的患者。本研究的主要终点是无进展生存期(PFS);次要终点是总生存期(OS)、缓解率和毒性。

结果

联合组的中位 PFS 明显长于 EGFR-TKI 单药组(19.00 个月[95%CI,14.67-23.33] vs. 11.70 个月[95%CI,10.81-12.59],p<0.001)。亚组分析也显示出相似的结果趋势。联合组的中位 OS 尚未达到,EGFR-TKI 单药组为 38.50 个月(95%CI,35.30-41.70)(p=0.586)。联合组患者更易发生不良反应,大多数为 1 级或 2 级。T790M 突变仍然是获得性耐药的主要原因,两组的 T790M 突变频率相似(p=0.898)。

结论

与 EGFR-TKI 单药治疗相比,EGFR-TKI 联合化疗可显著改善携带 EGFR 突变的晚期 NSCLC 患者的 PFS,且毒性可接受。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/10d0/8152122/fe0e338fc37e/12885_2021_8291_Fig1_HTML.jpg

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