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[IB-IIIB期非小细胞肺癌患者新辅助免疫化疗的疗效与安全性分析]

[Analysis of Efficacy and Safety of Neoadjuvant Immunochemotherapy in Patients
with Stage IB-IIIB Non-small Cell Lung Cancer].

作者信息

Li Zihao, Wang Xin, Wang Yulong, Cui Zhuoer, Wang Xin, Li Xiao, Jiang Guanchao, Wang Xun

机构信息

Department of Thoracic Surgery, China Thoracic Oncology Institute, Peking University People's Hospital, Research Unit of Intelligence Diagnosis and Treatment in Early Non-small Cell Lung Cancer, Chinese Academy of Medical Sciences, Beijing 100044, China.

Department of Thoracic Surgery, Tianjin Chest Hospital, Tianjin 300222, China.

出版信息

Zhongguo Fei Ai Za Zhi. 2025 Jun 20;28(6):415-426. doi: 10.3779/j.issn.1009-3419.2025.106.16.

Abstract

BACKGROUND

Neoadjuvant immunochemotherapy has emerged as an indispensable therapeutic modality for non-small cell lung cancer (NSCLC). However, its clinical application experience remains limited, and the associations between various clinical factors and treatment benefits remain undefined. This study aims to evaluate the efficacy and safety of neoadjuvant immunochemotherapy in patients with stage IB-IIIB NSCLC in a real-world setting, analyze survival outcomes among subgroups with diverse clinical characteristics, and identify potential clinical predictive factors for pathological response.

METHODS

This study included patients with stage IB-IIIB NSCLC who underwent radical lung resection after 2-4 cycles of neoadjuvant immunochemotherapy at Peking University People's Hospital between August 2019 and March 2024. Medical records and follow-up information were collected to analyze therapeutic response, adverse events and survival outcomes. Logistic analysis was used to identify clinical predictors of pathological response.

RESULTS

Among 183 enrolled patients, 116 (63.4%) were stage III. Grade 3-4 immune-related adverse events (irAEs) occurred in 39 (21.3%) patients. Radiographic complete response (CR) or partial response (PR) was achieved in 118 (64.5%) patients. R0 resection was achieved in 180 (98.4%) patients. Major pathologic response (MPR) was observed in 107 (58.5%) patients, with 78 (42.6%) achieving pathologic complete response (pCR). Squamous cell carcinoma and radiographic objective response were associated with pathological response (pCR/MPR). With a median follow-up of 22.1 [interquartile range (IQR): 18.3-32.2] months, the 2-year event-free survival (EFS) and overall survival (OS) rates were 82.5% and 90.4%, respectively. Achievement of pathological response (pCR/MPR) was correlated with prolonged survival outcomes.

CONCLUSIONS

Neoadjuvant immunochemotherapy is safe and effective for patients with stage IB-IIIB NSCLC. Patients achieving pCR or MPR exhibit significantly better survival benefits from neoadjuvant immunochemotherapy. Squamous cell carcinoma and radiographic objective response can serve as clinical predictors of pathological response.

摘要

背景

新辅助免疫化疗已成为非小细胞肺癌(NSCLC)不可或缺的治疗方式。然而,其临床应用经验仍然有限,各种临床因素与治疗获益之间的关联仍不明确。本研究旨在评估新辅助免疫化疗在真实世界中对IB-IIIB期NSCLC患者的疗效和安全性,分析不同临床特征亚组的生存结局,并确定病理反应的潜在临床预测因素。

方法

本研究纳入了2019年8月至2024年3月期间在北京大学人民医院接受2-4周期新辅助免疫化疗后接受根治性肺切除术的IB-IIIB期NSCLC患者。收集病历和随访信息以分析治疗反应、不良事件和生存结局。采用逻辑分析确定病理反应的临床预测因素。

结果

在183例入组患者中,116例(63.4%)为III期。39例(21.3%)患者发生3-4级免疫相关不良事件(irAEs)。118例(64.5%)患者获得影像学完全缓解(CR)或部分缓解(PR)。180例(98.4%)患者实现R0切除。107例(58.5%)患者观察到主要病理反应(MPR),其中78例(42.6%)实现病理完全缓解(pCR)。鳞状细胞癌和影像学客观反应与病理反应(pCR/MPR)相关。中位随访22.1[四分位间距(IQR):18.3-32.2]个月,2年无事件生存(EFS)率和总生存(OS)率分别为82.5%和90.4%。实现病理反应(pCR/MPR)与延长生存结局相关。

结论

新辅助免疫化疗对IB-IIIB期NSCLC患者安全有效。实现pCR或MPR的患者从新辅助免疫化疗中获得的生存获益显著更好。鳞状细胞癌和影像学客观反应可作为病理反应的临床预测因素。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3c3c/12257159/6b90580f0046/img_1.jpg

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