一代TKIs治疗不可切除的EGFR突变阳性NSCLC患者的研究

Study on First-Generation TKIs in the Treatment of Patients with Unresectable EGFR-Mutation-Positive Non-Small-Cell Lung Cancer

摘要: 目的：探索一代TKIs治疗晚期或局部晚期不可手术切除的EGFR (Epidermal Growth Factor Receptor, EGFR)突变阳性肺腺癌患者的疗效和安全性的真实世界研究。方法：回顾性分析了80名EGFR突变阳性不可手术肺腺癌患者一线接受埃克替尼治疗的临床数据，主要研究终点为：无进展生存期(Progression free survival, PFS)和总生存期(Overall survival, OS)。结果：不可手术的(IIIB~IV期) 80例患者接受一线埃克替尼治疗后疾病控制率为97.5%，客观缓解率为77.5%。中位无进展生存期为36.5个月(95% CI: 22~54.8)，中位总生存期为69个月(95% CI: 55.3~90)，联合放疗组患者的中位PFS显著高于联合化疗组或单药TKI治疗组(P = 0.018)；总体人群5年OS率为72.5%。结论：真实世界研究中一代TKIs在晚期或局部晚期不可手术切除的EGFR突变阳性肺腺癌患者的治疗中有效且安全，联合放疗可显著提高疗效，延长无进展生存期，提高晚期患者生存质量。

Abstract: Purpose: To investigate the efficacy and safety of first-generation TKIs in treating patients with advanced or locally advanced unresectable EGFR mutation positive lung adenocarcinoma. Methods: Clinical data of 80 patients with unresectable lung adenocarcinoma with EGFR mutation positive who received first-line treatment with Icotinib were retrospectively analyzed. The primary endpoint was progression free survival (PFS) and overall survival (OS). Results: DCR and ORR of 80 patients with unresectable EGFR-mutation-positive non-small-cell lung cancer (stage IIIB~IV) who received first-generation Icotinib was 97.5% and 77.5%. The median PFS was 36.5 (95% CI: 22~54.8) months and the median OS was 69 (95% CI: 55.3~90) months. The median PFS in the TKIs combined radiotherapy group was significantly higher than that in the TKIs combined chemotherapy group or TKI single group (P = 0.018). The 5-year OS rate in the general population was 72.5%. Conclusion: In real world studies, first-generation TKIs are effective and safe in the treatment of patients with advanced or locally advanced unresectable EGFR-mutation-positive lung adenocarcinoma. TKIs combined with radiotherapy can significantly improve the efficacy, prolong progression-free survival and improve the quality of life of advanced patients.