新辅助化疗免疫疗法是非小细胞肺癌治疗中的最佳选择；然而，治疗周期的最佳选择仍不清楚。本研究的主要目的是确定新辅助治疗周期在非小细胞肺癌中的最佳选择。本研究是一项实际临床分析，包括2020年1月至2022年8月接受新辅助化疗免疫疗法后进行手术的患者。根据治疗周期的不同，将患者分为两组：2个周期组和3-4个周期组。主要终点是主要病理学反应（MPR）率。总共包括251名患者：2个周期组150名和3-4个周期组101名。两组间基线特征均平衡。2个周期组的MPR为57.3%，与3-4个周期组的57.4%相比没有显著差异（p=0.529）。3-4个周期组中有32名患者（31.7%）在新辅助治疗的最后一个周期后进行了超过42天的手术，明显多于2个周期组的24名患者（16.0%）（p=0.003）。与2个周期组相比，3-4个周期组与新辅助治疗相关的不良事件发生率较高（分别为72.3%和58.0%，p=0.021），然而2个周期组的术后并发症率较高（分别为28.0%和12.9%，p=0.004）。此外，在经过两个周期治疗后，直径缩小≤44.2%的患者中，3-4个周期组的MPR率较2个周期组高（分别为47.3%和29.9%，p=0.048）。对于具有编程死亡配体1表达的病例，对于肿瘤比例评分≤10%的情况，3-4个周期的新辅助治疗与2个周期相比增加了MPR率（分别为37.5%和9.5%，p=0.041）。我们的数据支持新辅助化疗免疫疗法在非小细胞肺癌新辅助治疗中的积极作用。延长至3-4个周期而不是2个周期的新辅助化疗免疫疗法可能改善手术的安全性，并导致术后并发症的发生率较低；然而，MPR率可能没有显著增加。治疗期间进行CT重新评估和初始诊断中的PD-L1表达可能是指导治疗周期选择的潜在指标。Copyright © 2023 Zhang, Guo, Jia, Wang, Wu, Chen, Li, Yang, Li, Wang and Xiao.

Neoadjuvant chemoimmunotherapy is the optimal choice in the treatment of NSCLC; however, the optimal number of therapeutic cycles remains unclear. The primary aim of this study was to determine the optimal number of neoadjuvant therapeutic cycles in NSCLC.This study was a real-world clinical analysis that included patients who received neoadjuvant chemoimmunotherapy followed by surgery from January 2020 to August 2022. Patients were divided into two groups based on the number of therapeutic cycles: 2-cycle group and 3-4-cycles group. The primary endpoint was the major pathological response (MPR) rate.A total of 251 patients were included: 150 in the 2-cycle group and 101 in the 3-4-cycles group. Baseline characteristics were well-balanced between the groups. The MPR in the 2-cycle group was 57.3% and not significantly different from that of 57.4% in the 3-4-cycles group (p=0.529). Thirty-two patients (31.7%) in the 3-4-cycles group underwent surgery > 42 days after the final cycle of neoadjuvant therapy, significantly more than the 24 patients (16.0%) in the 2-cycle group (p=0.003). The incidence of adverse events related to neoadjuvant therapy was higher in the 3-4-cycles vs 2-cycle groups (72.3% versus 58.0%, respectively; p=0.021), while the 2-cycle group had a higher rate of postoperative morbidities (28.0% versus 12.9%, respectively; p=0.004). Additionally, for patients with ≤ 44.2% regression in diameter on computed tomography after two cycles of treatment, the MPR rate was higher in the 3-4-cycles vs 2-cycle group (47.3% versus 29.9%, respectively; p=0.048). For cases with programmed death-ligand 1 expression, regarding tumor proportion score ≤ 10%, 3-4 cycles of neoadjuvant treatment increased the MPR rate compared with 2 cycles (37.5% versus 9.5%, respectively; p=0.041).Our data support the positive role of chemoimmunotherapy in the neoadjuvant treatment of NSCLC. Extending to 3-4 cycles instead of 2 cycles of neoadjuvant chemoimmunotherapy may improve the safety of surgery and result in a lower incidence of postoperative morbidities; however, the MPR rate may not increase significantly. CT re-evaluation during treatment and PD-L1 expression at initial diagnosis are potential indicators to guide the choice of the number of therapeutic cycles.Copyright © 2023 Zhang, Guo, Jia, Wang, Wu, Chen, Li, Yang, Li, Wang and Xiao.