文章：

新辅助免疫疗法在非小细胞肺癌患者中的疗效与安全性评估

The Efficacy and Safety of Neoadjuvant Immunotherapy in Patients with Non-Small Cell Lung Cancer

原文发布日期：28 December 2023

DOI: 10.3390/cancers16010156

类型: Article

开放获取: 是

英文摘要：

Background: After the success of immunotherapy in the treatment of advanced non-small cell lung cancer (NSCLC), the benefit of neoadjuvant chemoimmunotherapy was compared with chemotherapy for localized NSCLC in several trials. However, the available studies had variable study designs, and study cohorts had limited follow-up times. Therefore, we conducted a systematic review and meta-analysis to evaluate the benefit of adding immunotherapy to neoadjuvant chemotherapy in patients with localized NSCLC. Methods: We conducted a systematic review using Pubmed, Web of Science, and Scopus databases for studies published until 5 December 2023. This protocol was registered in the PROSPERO database (Registration Number: CRD42023466337). We performed the meta-analyses with the generic inverse-variance method with a fixed effects model. Results: Overall, 7 studies encompassing 2993 patients were included in the analyses. The use of neoadjuvant chemoimmunotherapy was associated with a 41% reduction in the risk of progression or death compared to neoadjuvant chemotherapy (HR: 0.59, 95% CI: 0.52–0.66,p< 0.0001) and a lower risk of death (HR: 0.67, 95% CI: 0.55–0.82,p< 0.0001). The neoadjuvant chemoimmunotherapy improved pCR rates compared to chemotherapy (21.8% vs. 3.8%, OR: 7.04, 95% CI: 5.23–9.47,p< 0.0001), while high-grade adverse events were higher with neoadjuvant chemoimmunotherapy (OR: 1.18, 95% CI: 1.02–1.36,p= 0.0300). Conclusions: The available evidence demonstrates a statistically significant and clinically meaningful event-free survival benefit and possibly an overall survival benefit with neoadjuvant chemoimmunotherapy with a slight increase in high-grade toxicities.

摘要翻译： 

背景：免疫疗法在晚期非小细胞肺癌（NSCLC）治疗取得成效后，多项试验对局部晚期NSCLC患者中新辅助化疗联合免疫疗法与单纯化疗的疗效进行了比较。然而现有研究设计方案各异，且队列随访时间有限。为此，我们开展系统综述与荟萃分析，旨在评估局部晚期NSCLC患者在新辅助化疗基础上联合免疫治疗的临床获益。 方法：我们系统检索了截至2023年12月5日收录于Pubmed、Web of Science和Scopus数据库的相关研究。本方案已在PROSPERO数据库注册（注册号：CRD42023466337）。采用固定效应模型的通用逆方差法进行荟萃分析。 结果：共纳入7项研究，涵盖2993例患者。与单纯新辅助化疗相比，新辅助化疗联合免疫治疗可使疾病进展或死亡风险降低41%（HR：0.59，95% CI：0.52–0.66，p<0.0001），同时降低死亡风险（HR：0.67，95% CI：0.55–0.82，p<0.0001）。新辅助化疗联合免疫治疗较单纯化疗显著提高病理完全缓解率（21.8% vs. 3.8%，OR：7.04，95% CI：5.23–9.47，p<0.0001），但高级别不良事件发生率更高（OR：1.18，95% CI：1.02–1.36，p=0.0300）。 结论：现有证据表明，新辅助化疗联合免疫治疗在无事件生存期方面具有统计学显著且临床意义的获益，可能改善总生存期，但会轻微增加高级别毒性反应。

原文链接：

The Efficacy and Safety of Neoadjuvant Immunotherapy in Patients with Non-Small Cell Lung Cancer