Yu Shaofu, Zhai Shasha, Gong Qian, Xiang Chunhong, Gong Jianping, Wu Lin, Pu Xingxiang
Department of Clinical Pharmacy, the Second People's Hospital of Huaihua.
The Second Department of Thoracic Medical Oncology, Hunan Cancer Hospital, Changsha.
Am J Clin Oncol. 2023 Nov 1;46(11):517-528. doi: 10.1097/COC.0000000000001046. Epub 2023 Sep 26.
To systematically evaluate the effectiveness and safety of neoadjuvant immunotherapy for patients with non-small cell lung cancer (NSCLC).
Randomized controlled trials of neoadjuvant immunotherapy in treating patients with NSCLC were comprehensively retrieved from electronic databases, eligible studies, previous systematic reviews and meta-analyses, guidelines, and conference abstracts. The meta-analysis was performed by the Stata/SE 12.0 software.
Eleven randomized controlled trials were eventually included. The results of the meta-analysis showed that neoadjuvant immunochemotherapy significantly improved the objective response rate compared with neoadjuvant chemotherapy (CT; 62.46% vs 41.88%, P = 0.003), but the objective response rate of neoadjuvant double-immunotherapy was roughly comparable to that of neoadjuvant single-immunotherapy (15.74% vs 10.45%, P = 0.387). Major pathologic response (MPR) rate and pathologic complete response (pCR) rate of neoadjuvant immunochemotherapy and neoadjuvant double-immunotherapy were significantly superior to neoadjuvant CT alone and neoadjuvant single-immunotherapy, respectively. Compared with neoadjuvant CT alone, neoadjuvant immunochemotherapy increased the down-staging rate (40.16% vs 26.70%, P = 0.060), the surgical resection rate (83.69% vs 73.07%, P = 0.231), and R0 resection rate (86.19% vs 77.98%, P = 0.502), but there were no statistically significant differences. Neoadjuvant immunochemotherapy did not increase the postoperative complications rate than neoadjuvant CT alone (40.20% vs 41.30%, P = 0.920). In terms of safety, neoadjuvant immunochemotherapy and neoadjuvant double-immunotherapy did not increase the incidence of treatment-related adverse events (TRAEs) and the grade 3 or higher TRAEs.
In summary, neoadjuvant immunochemotherapy had better clinical efficacy than neoadjuvant CT for patients with NSCLC. MPR rate and pCR rate of neoadjuvant immunochemotherapy and neoadjuvant double-immunotherapy were significantly superior to neoadjuvant CT and neoadjuvant single-immunotherapy, respectively, for patients with NSCLC, showing that MPR rate and pCR rate were probably considered as alternative endpoints for survival benefit. TRAEs were comparable between the corresponding groups. The long-term survival outcome of neoadjuvant immunotherapy for patients with NSCLC needs to be further confirmed to better guide clinical practice.
系统评价新辅助免疫治疗对非小细胞肺癌（NSCLC）患者的有效性和安全性。
从电子数据库、符合条件的研究、既往系统评价和荟萃分析、指南及会议摘要中全面检索新辅助免疫治疗用于NSCLC患者的随机对照试验。采用Stata/SE 12.0软件进行荟萃分析。
最终纳入11项随机对照试验。荟萃分析结果显示，与新辅助化疗（CT）相比，新辅助免疫化疗显著提高了客观缓解率（62.46%对41.88%，P = 0.003），但新辅助双免疫治疗的客观缓解率与新辅助单免疫治疗大致相当（15.74%对10.45%，P = 0.387）。新辅助免疫化疗和新辅助双免疫治疗的主要病理缓解（MPR）率和病理完全缓解（pCR）率分别显著优于单纯新辅助CT和新辅助单免疫治疗。与单纯新辅助CT相比，新辅助免疫化疗提高了降期率（40.16%对26.70%，P = 0.060）、手术切除率（83.69%对73.07%，P = 0.231）和R0切除率（86.19%对77.98%，P = 0.502），但差异无统计学意义。新辅助免疫化疗与单纯新辅助CT相比，并未增加术后并发症发生率（40.20%对41.30%，P = 0.920）。在安全性方面，新辅助免疫化疗和新辅助双免疫治疗并未增加治疗相关不良事件（TRAEs）的发生率以及3级或更高等级TRAEs的发生率。
综上所述，对于NSCLC患者，新辅助免疫化疗的临床疗效优于新辅助CT。对于NSCLC患者，新辅助免疫化疗和新辅助双免疫治疗的MPR率和pCR率分别显著优于新辅助CT和新辅助单免疫治疗，表明MPR率和pCR率可能被视为生存获益的替代终点。相应组之间TRAEs相当。NSCLC患者新辅助免疫治疗的长期生存结果需要进一步证实，以更好地指导临床实践。
