China Medical University, Shenyang, China.
Department of Oncology, Shengjing Hospital of China Medical University, Shenyang, China.
Technol Cancer Res Treat. 2024 Jan-Dec;23:15330338241258164. doi: 10.1177/15330338241258164.
This study aimed to analyze the efficacy and safety of neoadjuvant and adjuvant immunotherapies for non-small cell lung cancer (NSCLC). Electronic literature searches were conducted in PubMed, OVID, Web of SCI, Embase, Cochrane Library, and the Chinese National Knowledge Infrastructure databases. The deadline for literature update and retrieval is February 16, 2024. Studies presented at meetings were also screened. Randomized controlled trials (RCTs) and single-arm trials were included, and the data were extracted according to the inclusion and exclusion criteria. Data analysis was performed using Stata (16.0) software. A total of 5850 patients in 11 RCTs and 6 single-arm trial studies involving neoadjuvant and/or adjuvant immune checkpoint inhibitor (ICI)-based therapies were included. Regarding neoadjuvant therapy, the overall complication rate after surgery reached 35% (95% CI, 0.21-0.49). Higher rates of pathological complete response (OR = 7.83; 95% CI, 5.95-10.31; < .001) and major pathological response (OR = 5.13; 95% CI, 3.56-7.40; < .001) were found in the resectable NSCLC patients who received neoadjuvant therapy with ICIs combined with chemotherapy compared with patients treated with chemotherapy alone. Of note, compared with chemotherapy, neoadjuvant ICIs combined with chemotherapy significantly improved the overall survival (OS) (HR = 0.65; 95% CI, 0.52-0.82; < .001) and event-free survival (EFS) (HR = 0.59; 95% CI, 0.52-0.67; < .001) in patients with resectable NSCLC. Regarding adjuvant therapy, a lower risk of disease progression or death (HR = 0.78; 95% CI, 0.69-0.90; < .001) was found in the adjuvant ICI group compared with the adjuvant chemotherapy-alone group. In terms of safety, perioperative immunotherapy combined with chemotherapy did not increase toxicity compared with chemotherapy alone. In patients with resectable NSCLC, perioperative immunotherapy was safe and efficacious. Perioperative immunotherapy combined with chemotherapy improved the pathologic response and EFS/DFS/OS over chemotherapy alone without increasing toxicity.
这项研究旨在分析新辅助和辅助免疫治疗非小细胞肺癌(NSCLC)的疗效和安全性。我们在 PubMed、OVID、Web of SCI、Embase、Cochrane Library 和中国国家知识基础设施数据库中进行了电子文献检索。文献更新和检索的截止日期为 2024 年 2 月 16 日。还筛选了会议上报告的研究。纳入了随机对照试验(RCT)和单臂试验,根据纳入和排除标准提取数据。使用 Stata(16.0)软件进行数据分析。共有 11 项 RCT 和 6 项新辅助和/或辅助免疫检查点抑制剂(ICI)为基础的治疗单臂试验的 5850 名患者纳入研究。对于新辅助治疗,手术后的总体并发症发生率达到 35%(95%CI,0.21-0.49)。与单独化疗相比,接受新辅助免疫联合化疗的可切除 NSCLC 患者的病理完全缓解率(OR=7.83;95%CI,5.95-10.31; < .001)和主要病理缓解率(OR=5.13;95%CI,3.56-7.40; < .001)更高。值得注意的是,与化疗相比,新辅助ICI 联合化疗显著改善了可切除 NSCLC 患者的总生存(OS)(HR=0.65;95%CI,0.52-0.82; < .001)和无事件生存(EFS)(HR=0.59;95%CI,0.52-0.67; < .001)。对于辅助治疗,与辅助化疗相比,辅助 ICI 组的疾病进展或死亡风险(HR=0.78;95%CI,0.69-0.90; < .001)较低。在安全性方面,与单独化疗相比,围手术期免疫治疗联合化疗并未增加毒性。在可切除 NSCLC 患者中,围手术期免疫治疗是安全有效的。与单独化疗相比,围手术期免疫治疗联合化疗改善了病理反应和 EFS/DFS/OS,而不增加毒性。