Dong Yichen, Xu Long, Wen Jialiang, Si Haojie, Yu Juemin, Chen Tao, Xie Huikang, Li Xinjian, Yang Minglei, Fan Junqiang, Wu Junqi, She Yunlang, Zhao Deping, Chen Chang
Department of Thoracic Surgery, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, People's Republic of China.
Department of Pathology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, People's Republic of China.
JTO Clin Res Rep. 2024 Nov 12;6(1):100763. doi: 10.1016/j.jtocrr.2024.100763. eCollection 2025 Jan.
The potential survival benefits of adjuvant immunotherapy for resectable NSCLC after neoadjuvant chemoimmunotherapy, and the optimal number of adjuvant immunotherapy cycles, remain uncertain. This study aims to evaluate the prognostic impact of adjuvant immunotherapy and determine the optimal number of cycles.
A total of 438 patients who received neoadjuvant chemoimmunotherapy between August 2019 and June 2022 across four hospitals were enrolled in this study, with a median follow-up time of 31.3 months. Recurrence-free survival (RFS) and overall survival (OS) were estimated using Kaplan-Meier methods and tested by log-rank test. Unstratified Cox proportional hazards models were fitted to the subgroups.
In this multi-center cohort, 29.7% of patients (n = 130) achieved a pathologic complete response. Patients who received adjuvant immunotherapy experienced significant survival benefits compared with those who did not (RFS: hazard ratio [HR] = 0.63, 95% confidence interval: 0.41-0.98, = 0.037; OS: hazard ratio = 0.27, 95% confidence interval: 0.13-0.57, < 0.001). Subgroup analyses found that patients with a squamous histologic type, positive PD-L1 expression, and those with a major pathologic response particularly benefited from adjuvant immunotherapy. In addition, we found that six cycles of adjuvant immunotherapy served as a threshold for better prognostic differentiation, suggesting that six or more cycles may be more beneficial.
Our study found that the addition of adjuvant immunotherapy to neoadjuvant chemoimmunotherapy is significantly associated with improved RFS and OS in patients with resectable NSCLC. We also identified that six cycles of adjuvant immunotherapy may be the optimal regimen for these patients.
新辅助化疗联合免疫治疗后，辅助免疫治疗对可切除非小细胞肺癌（NSCLC）的潜在生存益处以及辅助免疫治疗的最佳疗程数仍不确定。本研究旨在评估辅助免疫治疗的预后影响并确定最佳疗程数。
本研究纳入了2019年8月至2022年6月期间在四家医院接受新辅助化疗联合免疫治疗的438例患者，中位随访时间为31.3个月。采用Kaplan-Meier方法估计无复发生存期（RFS）和总生存期（OS），并通过对数秩检验进行检验。对亚组拟合未分层的Cox比例风险模型。
在这个多中心队列中，29.7%的患者（n = 130）达到了病理完全缓解。接受辅助免疫治疗的患者与未接受辅助免疫治疗的患者相比，生存获益显著（RFS：风险比[HR]=0.63，95%置信区间：0.41-0.98，P = =0.037；OS：风险比 = 0.27，95%置信区间：0.13-0.57，P < 0.001）。亚组分析发现，鳞状组织学类型、PD-L1表达阳性以及有主要病理反应的患者尤其从辅助免疫治疗中获益。此外，我们发现六个周期的辅助免疫治疗是更好的预后区分阈值，表明六个或更多周期可能更有益。
我们的研究发现，在新辅助化疗联合免疫治疗基础上加用辅助免疫治疗与可切除NSCLC患者的RFS和OS改善显著相关。我们还确定六个周期的辅助免疫治疗可能是这些患者的最佳方案。
