IB期EGFR突变非小细胞肺癌辅助EGFR-TKI降阶梯治疗：一项真实世界研究
De-escalation of Adjuvant EGFR-TKI in Stage IB EGFR-Mutated Non-small-cell Lung Cancer: A Real-World Study.
作者
作者单位
- Department of Thoracic Surgery, Sun Yat-sen University Cancer Center, Guangzhou City, Guangdong Province, People's Republic of China.
- State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou City, Guangdong Province, People's Republic of China. houxue@sysucc.org.cn.
- Department of Thoracic Surgery, Sun Yat-sen University Cancer Center, Guangzhou City, Guangdong Province, People's Republic of China. yanghx@sysucc.org.cn.
摘要
中文
IB期非小细胞肺癌(NSCLC)中辅助表皮生长因子受体-酪氨酸激酶抑制剂(EGFR-TKIs)的临床获益仍存在争议。本研究在真实世界队列中评估了辅助EGFR-TKIs对IB期NSCLC患者长期生存的影响。共纳入340例接受手术切除的IB期EGFR突变NSCLC患者，分为两组（TKI+组：接受辅助EGFR-TKI；TKI-组：未接受辅助EGFR-TKI）。采用Kaplan-Meier和Cox回归分析比较两组的总生存期、无病生存期和无复发生存期，并进行倾向性评分匹配以减少选择偏倚。在340例患者中，46.8%（159/340）接受了EGFR-TKI。辅助EGFR-TKIs显著改善了IB期NSCLC患者的5年无病生存率（TKI-组：76.1% vs. TKI+组：82.8%，P = 0.005）和5年无复发生存率（TKI-组：80.2% vs. TKI+组：86.7%，P = 0.013）。然而，5年总生存率无显著差异（TKI-组：90.4% vs. TKI+组：90.2%，P = 0.315）。亚组分析显示，在肿瘤≤3 cm、部分实性肿瘤以及无高危因素的患者中，辅助EGFR-TKIs对长期生存无影响（均P > 0.05）。此外，第一代和第三代EGFR-TKIs之间的长期生存无显著差异。尽管存在回顾性设计的局限性，我们的研究结果表明，对于肿瘤≤3 cm、部分实性肿瘤或无高危因素的IB期NSCLC患者，可考虑省略辅助EGFR-TKIs。
English
The clinical benefit of adjuvant epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) in stage IB non-small-cell lung cancer (NSCLC) remains controversial. This study evaluated the impact of adjuvant EGFR-TKIs on long-term survival in a real-world cohort of patients with stage IB NSCLC. A total of 340 patients with resected stage IB EGFR-mutated NSCLC were included in this study and divided into two groups (TKI+ group: with adjuvant EGFR-TKI; TKI- group: without adjuvant EGFR-TKI). Kaplan-Meier and Cox regression analyses were used to compare overall survival, disease-free survival, and recurrence-free survival between groups. Propensity score matching was performed to minimize selection bias. Among 340 included patients, 46.8% (159/340) received an EGFR-TKI. Adjuvant EGFR-TKIs significantly improved 5-year disease-free survival (TKI- group: 76.1% vs. TKI+ group: 82.8%, P = 0.005) and 5-year recurrence-free survival (TKI- group: 80.2% vs. TKI+ group: 86.7%, P = 0.013) in patients with stage IB NSCLC. However, no significant difference was observed in 5-year overall survival (TKI- group: 90.4% vs. TKI+ group: 90.2%, P = 0.315). Subgroup analysis showed that, in patients with tumors ≤ 3 cm, those with partial-solid tumors, and those without high-risk factors, adjuvant EGFR-TKIs had no impact on long-term survival (all P > 0.05). Furthermore, no significant difference in long-term survival was observed between first-generation and third-generation EGFR-TKIs. Despite the limitations of a retrospective design, our findings suggest that adjuvant EGFR-TKIs might be omitted in patients with stage IB NSCLC with tumors ≤ 3 cm, those with partial-solid tumors, or those without high-risk factors.
分类与指标
- 研究类型
- 临床研究
- 病种
- 肺癌
- JCR 分区
- Q1
- 影响因子
- 3.8
- 新锐分区
- 2区