可切除的 III 期非小细胞肺癌患者在新辅助化疗免疫治疗后辅助免疫治疗是否必要？一项双中心真实世界研究。
Is adjuvant immunotherapy necessary after neoadjuvant chemoimmunotherapy in patients with resectable stage III NSCLC? A two-center real-world study.
作者信息
Guan Song, Wang Hui, Chen Zhaoxin, Guo Fengrui, Yi Guozhen, Du Xingyu, Yan Jingjing, Tian Cuimeng
机构信息
Department of Radiation Oncology, Beijing Chest Hospital, Capital Medical University & Beijing Tuberculosis and Thoracic Tumor Research Institute, No.9 Beiguan Street, Tongzhou District, Beijing, 101149, China.
Department of Respiratory and Critical Care, Hebei Petrochina Central Hospital, No. 51 of Xinkai Road, Guangyang District, Langfang, 065000, Hebei, China.
出版信息
Cancer Immunol Immunother. 2025 Jul 21;74(8):273. doi: 10.1007/s00262-025-04130-z.
PURPOSE
The value of adjuvant immunotherapy in patients with resectable stage III non-small cell lung cancer (NSCLC) after neoadjuvant chemoimmunotherapy remains unclear. This study aimed to evaluate the prognostic impact of additional adjuvant immunotherapy in patients with stage III NSCLC.
METHODS
Patients with stage III NSCLC who received neoadjuvant chemoimmunotherapy followed by radical surgery, with or without adjuvant immunotherapy, were retrospectively enrolled across two hospitals. Event-free survival (EFS) and overall survival (OS) were assessed from the initiation of neoadjuvant treatment and were estimated by the Kaplan‒Meier method. One-to-one propensity score matching (PSM) and inverse probability of treatment weighting (IPTW) were used to minimize confounding.
RESULTS
A total of 184 eligible patients were enrolled, of whom 105 (57.1%) received adjuvant immunotherapy and 79 (42.9%) did not. After 1:1 PSM, the addition of adjuvant immunotherapy did not significantly improve EFS (2-year EFS: 62.3% vs. 66.1%, P = 0.653) or OS (2-year OS: 92.7% vs. 89.6%, P = 0.196). Subgroup analyses, stratified by the pathological complete response (pCR) status, further confirmed that adjuvant immunotherapy did not significantly improve survival in either the pCR subgroup or the non-pCR subgroup. Similar results were obtained after IPTW. Exploratory analysis revealed that 3 cycles of neoadjuvant immunotherapy might be more beneficial than 2 (pCR: 40.8% vs. 30.6%, P = 0.292; 2-year EFS: 75.0% vs. 54.5%, P = 0.111) or 4 (pCR: 42.1% vs. 36.8%, P = 0.740; 2-year EFS: 63.2% vs. 51.5%, P = 0.343) cycles.
CONCLUSION
The addition of adjuvant immunotherapy to neoadjuvant chemoimmunotherapy may not be necessary in patients with resectable stage III NSCLC. Three cycles of neoadjuvant immunotherapy appear to be an appropriate treatment regimen for neoadjuvant chemoimmunotherapy.
目的
新辅助化疗联合免疫治疗后，辅助免疫治疗在可切除的Ⅲ期非小细胞肺癌（NSCLC）患者中的价值尚不清楚。本研究旨在评估辅助免疫治疗对Ⅲ期NSCLC患者预后的影响。
方法
回顾性纳入两家医院中接受新辅助化疗联合免疫治疗后行根治性手术的Ⅲ期NSCLC患者，这些患者接受或未接受辅助免疫治疗。从新辅助治疗开始评估无事件生存期（EFS）和总生存期（OS），并采用Kaplan-Meier法进行估计。采用一对一倾向评分匹配（PSM）和逆概率处理加权（IPTW）来减少混杂因素。
结果
共纳入184例符合条件的患者，其中105例（57.1%）接受辅助免疫治疗，79例（42.9%）未接受。1:1 PSM后，辅助免疫治疗的加入并未显著改善EFS（2年EFS：62.3% vs. 66.1%，P = 0.653）或OS（2年OS：92.7% vs. 89.6%，P = 0.196）。根据病理完全缓解（pCR）状态分层的亚组分析进一步证实，辅助免疫治疗在pCR亚组或非pCR亚组中均未显著改善生存率。IPTW后得到类似结果。探索性分析显示，3周期新辅助免疫治疗可能比2周期（pCR：40.8% vs. 30.6%，P = 0.292；2年EFS：75.0% vs. 54.5%，P = 0.111）或4周期（pCR：42.1% vs. 36.8%，P = 0.740；2年EFS：63.2% vs. 51.5%，P = 0.343）更有益。
结论
对于可切除的Ⅲ期NSCLC患者，在新辅助化疗联合免疫治疗基础上加用辅助免疫治疗可能没有必要。3周期新辅助免疫治疗似乎是新辅助化疗联合免疫治疗的合适治疗方案。
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