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新辅助化疗免疫治疗后可切除非小细胞肺癌患者完全或主要病理缓解后的无事件生存期改善,无论辅助治疗如何:一项系统评价和个体患者数据荟萃分析

Improved Event-Free Survival After Complete or Major Pathologic Response in Patients With Resectable NSCLC Treated With Neoadjuvant Chemoimmunotherapy Regardless of Adjuvant Treatment: A Systematic Review and Individual Patient Data Meta-Analysis.

作者信息

Marinelli Daniele, Nuccio Antonio, Di Federico Alessandro, Ambrosi Francesca, Bertoglio Pietro, Faccioli Eleonora, Ferrara Roberto, Ferro Alessandra, Giusti Raffaele, Guerrera Francesco, Mammana Marco, Pittaro Alessandra, Sepulcri Matteo, Viscardi Giuseppe, Gallina Filippo Tommaso

机构信息

Department of Experimental Medicine, Sapienza University, Rome, Italy.

Medical Oncology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) San Raffaele Scientific Institute, Milan, Italy; Università Vita-Salute San Raffaele, Milan, Italy.

出版信息

J Thorac Oncol. 2025 Mar;20(3):285-295. doi: 10.1016/j.jtho.2024.09.1443. Epub 2024 Oct 9.

Abstract

INTRODUCTION

Neoadjuvant chemoimmunotherapy has reshaped the treatment landscape for resectable NSCLC, yet the prognostic significance of pathologic response remains unclear. We conducted a systematic review and individual patient data (IPD) meta-analysis to evaluate the impact of achieving pathologic complete response (pCR) or major pathologic response (MPR) on event-free survival (EFS) and assessed the influence of adjuvant immunotherapy.

METHODS

We performed an IPD meta-analysis of prospective clinical trials on neoadjuvant or perioperative anti-programmed death-ligand 1 in combination with platinum-based chemotherapy in patients with resectable NSCLC. The IPD was extracted from Kaplan-Meier curves for pCR and MPR from the included studies. Survival outcomes were compared between patients achieving pCR or MPR and those who did not, considering both intention-to-treat and resected populations.

RESULTS

Achieving pCR or MPR was associated with improved EFS in the intention-to-treat population (pCR, hazard ratio = 0.13; MPR, hazard ratio = 0.18, respectively) with a 24 months EFS rate of 94% and 88% for patients who achieved pCR and MPR, respectively. Independently from pCR status, patients who were treated in an experimental arm that included adjuvant immunotherapy had similar EFS.

CONCLUSIONS

Our study reported a strong EFS improvement in patients who achieved either pCR or MPR after neoadjuvant chemoimmunotherapy. The use of adjuvant immunotherapy after tumor resection was not associated with improved EFS.

摘要

引言

新辅助化疗免疫疗法重塑了可切除非小细胞肺癌(NSCLC)的治疗格局,但病理反应的预后意义仍不明确。我们进行了一项系统评价和个体患者数据(IPD)荟萃分析,以评估达到病理完全缓解(pCR)或主要病理反应(MPR)对无事件生存期(EFS)的影响,并评估辅助免疫疗法的作用。

方法

我们对可切除NSCLC患者新辅助或围手术期抗程序性死亡配体1联合铂类化疗的前瞻性临床试验进行了IPD荟萃分析。IPD从纳入研究的pCR和MPR的Kaplan-Meier曲线中提取。比较达到pCR或MPR的患者与未达到的患者的生存结果,同时考虑意向性治疗人群和切除人群。

结果

在意向性治疗人群中,达到pCR或MPR与改善EFS相关(pCR的风险比=0.13;MPR的风险比=0.18),达到pCR和MPR的患者24个月EFS率分别为94%和88%。与pCR状态无关,在包括辅助免疫疗法的试验组中接受治疗的患者EFS相似。

结论

我们的研究报告,新辅助化疗免疫疗法后达到pCR或MPR的患者EFS有显著改善。肿瘤切除后使用辅助免疫疗法与EFS改善无关。

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