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可切除非小细胞肺癌新辅助化疗免疫疗法与围手术期(化疗)免疫疗法的比较研究:一项真实世界回顾性队列研究

Comparative investigation of neoadjuvant chemoimmunotherapy versus perioperative (chemo)immunotherapy in resectable non-small cell lung cancer: a real-world retrospective cohort study.

作者信息

Yang Yehao, Li Sini, Zhang Qian, Zhai Wanchen, Wu Haicheng, Li Hui, Fan Yun

机构信息

Department of Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences, Hangzhou, China.

出版信息

Transl Lung Cancer Res. 2025 Aug 31;14(8):2954-2968. doi: 10.21037/tlcr-2025-301. Epub 2025 Aug 25.

DOI:10.21037/tlcr-2025-301
PMID:40948847
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12432655/
Abstract

BACKGROUND

In patients with resectable non-small cell lung cancer (NSCLC), recent clinical trials have highlighted the survival advantages conferred by chemoimmunotherapy in both the neoadjuvant and perioperative treatment settings. Despite these findings, a direct comparative analysis to discern the superior protocol between neoadjuvant and perioperative approaches remains an uncharted territory. Therefore, this study aimed to compare the efficacy of neoadjuvant chemoimmunotherapy (NT) and perioperative (chemo)immunotherapy (PT) in resectable NSCLC.

METHODS

We performed a single-center retrospective study at Zhejiang Cancer Hospital, identifying 318 patients who underwent surgical intervention for stages IB-IIIB NSCLC between 2019 and 2021, with participants stratified into two groups based on distinct treatment strategies: NT or PT. We employed propensity score matching (PSM) to adjust for confounding variables, and subsequently utilized Kaplan-Meier survival curves and Cox proportional hazards regression models to investigate the correlation between treatment regimens and survival at the postoperative mark.

RESULTS

Following PSM, 248 patients were included (NT, 124; PT, 124). Comparative analyses underscored the efficacy disparities between NT and PT. In the overall population analysis, the PT group demonstrated superior event-free survival (EFS) [hazard ratio (HR), 0.48; 95% confidence interval (CI), 0.29-0.78; P=0.003] and improved overall survival (OS) (HR, 0.43; 95% CI, 0.23-0.79; P=0.006) compared with the NT group. Notably, subgroup analyses revealed in patients without a pathological complete response (pCR), the PT group experienced significantly enhanced EFS with a 3-year EFS rate of 76.5% compared to 57.5% in the NT group (HR, 0.48; 95% CI, 0.28-0.83; P=0.008), as well as improved OS with a rate of 84.4% versus 71.7% (HR, 0.48; 95% CI, 0.24-0.94; P=0.03). However, no statistically significant differences in EFS and OS were observed between the two treatment groups among patients who achieved pCR. Additionally, PT significantly improved EFS and OS in stage IIIA-IIIB patient populations. Multivariate analyses further revealed pCR as an independent prognostic factor for longer EFS in stage IB-IIIB NSCLC patients (HR, 0.42; 95% CI, 0.22-0.80; P=0.009).

CONCLUSIONS

Our study demonstrated that in comparison with NT, the PT approach can significantly enhance the survival prognosis for patients with resectable stage IB-IIIB NSCLC. Notably, patients without a pCR after surgery may stand to benefit more from the perioperative treatment approach.

摘要

背景

在可切除的非小细胞肺癌(NSCLC)患者中,近期的临床试验凸显了新辅助化疗联合免疫治疗以及围手术期化疗联合免疫治疗在生存方面的优势。尽管有这些发现,但辨别新辅助治疗和围手术期治疗两种方法中哪种方案更优的直接对比分析仍是未知领域。因此,本研究旨在比较新辅助化疗联合免疫治疗(NT)与围手术期(化疗)免疫治疗(PT)在可切除NSCLC中的疗效。

方法

我们在浙江省肿瘤医院进行了一项单中心回顾性研究,确定了2019年至2021年间接受手术干预的318例IB-IIIB期NSCLC患者,根据不同治疗策略将参与者分为两组:NT组或PT组。我们采用倾向评分匹配(PSM)来调整混杂变量,随后利用Kaplan-Meier生存曲线和Cox比例风险回归模型来研究治疗方案与术后生存之间的相关性。

结果

经过PSM后,纳入了248例患者(NT组124例;PT组124例)。对比分析强调了NT组和PT组之间的疗效差异。在总体人群分析中,与NT组相比,PT组显示出更好的无事件生存期(EFS)[风险比(HR),0.48;95%置信区间(CI),0.29 - 0.78;P = 0.003]和更长的总生存期(OS)(HR,0.43;95% CI,0.23 - 0.79;P = 0.006)。值得注意的是,亚组分析显示,在没有病理完全缓解(pCR)的患者中,PT组的EFS显著提高,3年EFS率为76.5%,而NT组为57.5%(HR,0.48;95% CI,0.28 - 0.83;P = 0.008),OS也有所改善,分别为84.4%和71.7%(HR,0.48;95% CI,0.24 - 0.94;P = 0.03)。然而,在达到pCR的患者中,两个治疗组之间在EFS和OS方面未观察到统计学显著差异。此外,PT在IIIA-IIIB期患者群体中显著改善了EFS和OS。多变量分析进一步显示pCR是IB-IIIB期NSCLC患者更长EFS的独立预后因素(HR,0.42;95% CI,0.22 - 0.80;P = 0.009)。

结论

我们的研究表明,与NT相比,PT方法可显著改善可切除的IB-IIIB期NSCLC患者的生存预后。值得注意的是,术后未达到pCR的患者可能从围手术期治疗方法中获益更多。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8424/12432655/62a1608726b2/tlcr-14-08-2954-f6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8424/12432655/a34bf07517c3/tlcr-14-08-2954-f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8424/12432655/5f7003d68f9d/tlcr-14-08-2954-f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8424/12432655/2b8634bde3fe/tlcr-14-08-2954-f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8424/12432655/5133167eb718/tlcr-14-08-2954-f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8424/12432655/94af3d512015/tlcr-14-08-2954-f5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8424/12432655/62a1608726b2/tlcr-14-08-2954-f6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8424/12432655/a34bf07517c3/tlcr-14-08-2954-f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8424/12432655/5f7003d68f9d/tlcr-14-08-2954-f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8424/12432655/2b8634bde3fe/tlcr-14-08-2954-f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8424/12432655/5133167eb718/tlcr-14-08-2954-f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8424/12432655/94af3d512015/tlcr-14-08-2954-f5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8424/12432655/62a1608726b2/tlcr-14-08-2954-f6.jpg

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