Final Analysis of Neoadjuvant Sintilimab Plus Chemotherapy in IB–IIIA Non-Small-Cell Lung Cancer: Phase 2 neoSCORE Trial

IF 4.9 2区医学 Q1 ONCOLOGY

Cancer Science Pub Date : 2026-09-01 Epub Date: 2026-06-07 DOI:10.1111/cas.70442

Miner Shao, Jie Yao, Lufeng Zhao, Ling Zhu, Baizhou Li, Lili Li, Bangyi Zhou, Yixin Zhang, Huiying Liu, Xiaoke Chen, Zuqun Wu, Zexin Chen, Junqiang Fan, Fuming Qiu

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引用次数: 0

Abstract

The optimal number of neoadjuvant chemoimmunotherapy cycles for resectable non-small cell lung cancer (NSCLC) remains uncertain. The randomized phase 2 neoSCORE trial (NCT04459611) conducted a comprehensive final analysis, comparing the outcomes of two versus three cycles of neoadjuvant sintilimab combined with platinum-doublet chemotherapy in 60 stage IB–IIIA NSCLC patients, among whom 55 underwent surgery. After a median follow-up period of 56.9 months, no statistically significant differences in disease-free survival (DFS) or overall survival (OS) were observed between the two-cycle and three-cycle groups. Specifically, the 4-year DFS rates stood at 53.8% and 55.2% while the 4-year OS rates were 76.9% and 75.9%, respectively. Major pathological response (MPR) was strongly associated with improved DFS (HR = 0.26, 95% CI: 0.08–0.85, p = 0.026) and OS (HR = 0.15, 95% CI: 0.03–0.81, p = 0.028) on multivariable Cox analysis. Exploratory analysis revealed that maintenance immunotherapy was associated with longer DFS among patients who achieved MPR, whereas no clear DFS or OS advantage was observed among patients without MPR. In summary, no superiority of three cycles over two cycles was demonstrated in this study. MPR stands out as an independent prognostic indicator, and maintenance immunotherapy seems to be associated with long-term prognosis in patients who achieved MPR, necessitating further prospective validation.

Trial Registration: ClinicalTrials.gov identifier: NCT04459611

查看原文本刊更多论文

新辅助辛替单抗联合化疗治疗IB-IIIA型非小细胞肺癌的最终分析：2期neoSCORE试验。

对于可切除的非小细胞肺癌（NSCLC），新辅助化疗免疫治疗周期的最佳次数仍不确定。随机2期neoSCORE试验（NCT04459611）对60例IB-IIIA期NSCLC患者进行了2个周期与3个周期新辅助辛替单抗联合铂双药化疗的结果进行了全面的最终分析，其中55例患者接受了手术。中位随访期56.9个月后，两周期组和三周期组无病生存期（DFS）或总生存期（OS）无统计学差异。具体而言，4年DFS率分别为53.8%和55.2%，4年OS率分别为76.9%和75.9%。多变量Cox分析显示，主要病理反应（MPR）与改善的DFS （HR = 0.26, 95% CI: 0.08 ~ 0.85, p = 0.026）和OS （HR = 0.15, 95% CI: 0.03 ~ 0.81, p = 0.028）密切相关。探索性分析显示，维持性免疫治疗与实现MPR的患者更长的DFS相关，而在没有MPR的患者中，没有观察到明显的DFS或OS优势。总之，在本研究中没有证明三个周期优于两个周期。MPR是一个独立的预后指标，维持免疫治疗似乎与实现MPR的患者的长期预后相关，需要进一步的前瞻性验证。试验注册：ClinicalTrials.gov标识符：NCT04459611。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Cancer Science 医学-肿瘤学

自引率

3.50%

发文量

406

审稿时长

2 months

期刊介绍： Cancer Science (formerly Japanese Journal of Cancer Research) is a monthly publication of the Japanese Cancer Association. First published in 1907, the Journal continues to publish original articles, editorials, and letters to the editor, describing original research in the fields of basic, translational and clinical cancer research. The Journal also accepts reports and case reports. Cancer Science aims to present highly significant and timely findings that have a significant clinical impact on oncologists or that may alter the disease concept of a tumor. The Journal will not publish case reports that describe a rare tumor or condition without new findings to be added to previous reports; combination of different tumors without new suggestive findings for oncological research; remarkable effect of already known treatments without suggestive data to explain the exceptional result. Review articles may also be published.