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新辅助化疗免疫治疗或新辅助化疗后 I-III 期非小细胞肺癌的真实世界疗效和预后因素分析。

Real-World Effectiveness and Prognostic Factors Analysis of Stages I-III Non-Small Cell Lung Cancer Following Neoadjuvant Chemo-Immunotherapy or Neoadjuvant Chemotherapy.

机构信息

Department of Lung Cancer, Tianjin Lung Cancer Center, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.

Department of Thoracic Surgery, Binzhou People's Hospital, Binzhou, China.

出版信息

Ann Thorac Cardiovasc Surg. 2022 Apr 20;28(2):111-120. doi: 10.5761/atcs.oa.21-00143. Epub 2021 Nov 15.

Abstract

PURPOSE

Immune checkpoint inhibitors (ICIs) have been successfully used in many clinical trials related to immunotherapy. This study aimed to investigate the clinical efficacy of ICIs and prognostic factors in patients with resectable non-small cell lung cancer (NSCLC) following neoadjuvant therapy in the real world.

METHODS

A total of 170 consecutive patients were finally selected and divided into two groups: the preoperative chemotherapy group (n = 91) and the chemo-immunotherapy group (n = 79). The primary endpoint was disease-free survival (DFS). The secondary endpoints were pathological response, clinical response, pathological nodal disease, and ability of multivariate Cox regression analysis to predict survival. Survival was estimated using Kaplan-Meier method and compared using log-rank test.

RESULTS

There was a statistically significant difference in DFS between the two groups (log-rank test, P = 0.019). Multivariate Cox regression analysis showed that maximum tumor diameter (P = 0.016), higher lymph node stage (ypN1, P = 0.016; ypN2, P <0.001), and major pathological response not achieved (non-major pathological response [MPR], P = 0.011) were independent prognostic factors for worse DFS.

CONCLUSION

Neoadjuvant chemo-immunotherapy yields better effects in pathological and clinical response than chemotherapy alone, which is also associated with longer DFS in the treatment of locally advanced NSCLC. Moreover, a larger tumor specimen diameter, higher ypN staging, and non-MPR after neoadjuvant therapy were associated with worse prognosis.

摘要

目的

免疫检查点抑制剂(ICI)已在许多与免疫疗法相关的临床试验中成功应用。本研究旨在探讨新辅助治疗后可切除非小细胞肺癌(NSCLC)患者接受 ICI 治疗的临床疗效和预后因素。

方法

共纳入 170 例连续患者,最终分为两组:术前化疗组(n=91)和化疗免疫组(n=79)。主要终点是无病生存期(DFS)。次要终点是病理反应、临床反应、病理淋巴结疾病以及多变量 Cox 回归分析预测生存能力。采用 Kaplan-Meier 法估计生存情况,并用对数秩检验比较。

结果

两组 DFS 差异有统计学意义(log-rank 检验,P=0.019)。多变量 Cox 回归分析显示,最大肿瘤直径(P=0.016)、较高的淋巴结分期(ypN1,P=0.016;ypN2,P<0.001)和未达到主要病理反应(非主要病理反应[MPR],P=0.011)是 DFS 较差的独立预后因素。

结论

新辅助化疗免疫治疗在病理和临床反应方面优于单纯化疗,也与局部晚期 NSCLC 患者的 DFS 延长有关。此外,新辅助治疗后肿瘤标本直径较大、ypN 分期较高和非 MPR 与预后较差相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2546/9081467/8e8e408bac54/atcs-28-111-g001.jpg

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