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

TL;DR

This study shows that combining immunotherapy with chemotherapy before surgery is safe and effective for non-small cell lung cancer patients, with better survival for those achieving major or complete pathologic responses.

Contribution

The study provides real-world evidence on the efficacy and safety of neoadjuvant immunochemotherapy in IB-IIIB NSCLC patients and identifies predictors of pathologic response.

Findings

64.5% of patients achieved complete or partial radiological response after treatment.

58.5% of patients achieved major pathologic response, with 42.6% achieving pathologic complete response.

Patients with major or complete pathologic responses had significantly longer survival times.

Abstract

背景与目的 新辅助免疫治疗联合化疗已成为非小细胞肺癌（non-small cell lung cancer, NSCLC）的重要治疗手段。然而其实际应用经验尚不充分，许多临床因素与治疗获益的关系尚无定论。本研究旨在分析真实世界中新辅助免疫治疗联合化疗对IB-IIIB期NSCLC患者的有效性和安全性，评估不同临床特征下患者的生存情况，并识别病理学缓解的临床预测因素。方法 本研究纳入2019年8月至2024年3月在北京大学人民医院接受2-4个周期新辅助免疫治疗联合化疗后行肺癌根治术的IB-IIIB期NSCLC患者，通过收集病历资料及随访信息，分析其治疗反应、不良事件和生存情况。通过Logistic回归分析病理学缓解的临床预测因素。结果 共纳入183例患者，其中III期患者116例（63.4%）。39例（21.3%）患者出现3级及以上免疫相关不良事件（immune-related adverse events, irAEs）。118例（64.5%）患者达到影像学完全缓解（complete response, CR）或部分缓解（partial response, PR）。180例（98.4%）患者实现R0切除。107例（58.5%）患者达到主要病理缓解（major pathologic response, MPR），其中78例（42.6%）患者实现病理学完全缓解 （pathologic complete response, pCR）。鳞状细胞癌、影像学客观缓解（CR/PR）与病理缓解（pCR/MPR）有关。中位随访时间为22.1（四分位间距：18.3-32.2）个月，2年无事件生存（event-free survival, EFS）率和总生存（overall survival, OS）率分别为82.5%和90.4%。达到病理缓解（pCR/MPR）与生存期延长有关联。结论 在真实世界中，新辅助免疫治疗联合化疗对IB-IIIB期NSCLC患者安全有效；达到病理缓解（pCR/MPR）的患者从新辅助免疫治疗联合化疗中得到的生存获益更佳；鳞状细胞癌、影像学客观缓解（CR/PR）对病理缓解（pCR/MPR）存在预测作用。

Baseline characteristics of the NSCLC patients treated with neoadjuvant immunochemotherapy

The usage of different immune checkpoint inhibitors and chemotherapy regimens

Clinical and pathological response after neoadjuvant immunochemotherapy

Surgical outcomes after neoadjuvant immunochemotherapy

A: EFS; B: OS. EFS: event-free survival; OS: overall survival.

A: EFS: MPR vs non-MPR; B: OS: MPR vs non-MPR; C: EFS: pCR vs non-pCR; D: OS: pCR vs non-pCR. HR: hazard ratio.

A: EFS: ADC vs SCC; B: OS: ADC vs SCC; C: EFS: Stage IB-IIB vs Stage IIIA-IIIB; D: OS: Stage IB-IIB vs Stage IIIA-IIIB.

Univariate and multivariate Logistic analysis of predictive factors for achieving MPR and pCR

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