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新辅助免疫检查点抑制剂联合化疗、EGFR-TKI与单纯化疗的非小细胞肺癌患者围手术期结局比较:一项真实世界证据研究

Comparison of perioperative outcomes among non-small cell lung cancer patients with neoadjuvant immune checkpoint inhibitor plus chemotherapy, EGFR-TKI, and chemotherapy alone: a real-world evidence study.

作者信息

Zhao Deping, Xu Long, Wu Junqi, She Yunlang, Su Hang, Hou Likun, E Haoran, Zhang Lei, Grossi Francesco, Subramanian Melanie P, Kim Anthony W, Zhu Yuming, Chen Chang

机构信息

Department of Thoracic Surgery, Shanghai Pulmonary Hospital, Tongji University, School of Medicine, Shanghai, China.

Department of Pathology, Shanghai Pulmonary Hospital, Tongji University, School of Medicine, Shanghai, China.

出版信息

Transl Lung Cancer Res. 2022 Jul;11(7):1468-1478. doi: 10.21037/tlcr-22-476.

DOI:10.21037/tlcr-22-476
PMID:35958337
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9359956/
Abstract

BACKGROUND

The utilization of neoadjuvant immune checkpoint inhibitor (ICI) plus chemotherapy has increased significantly for resectable non-small cell lung cancer (NSCLC). It is still unclear whether such a treatment paradigm affects perioperative outcomes compared with other neoadjuvant treatment. We aimed to evaluate the perioperative outcomes of pulmonary resection after neoadjuvant ICI plus chemotherapy and to compare them with neoadjuvant epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKI) and neoadjuvant chemotherapy alone for resectable NSCLC.

METHODS

A retrospective cohort including 194 stage IB-IIIB NSCLC underwent surgical resection after neoadjuvant treatment between 2018 and 2020 were reviewed. Perioperative complications were evaluated using the Common Terminology Criteria for Adverse Events, and were compared using one-way analysis of variance for continuous variables and Pearson chi-square test.

RESULTS

There were 42, 54, and 98 patients in the neoadjuvant ICI plus chemotherapy, EGFR-TKI, and chemotherapy alone groups, respectively. The tumor size before neoadjuvant treatment was well balanced among the three groups (P=0.122). A shorter median surgical time was observed in the EGFR-TKI group than ICI plus chemotherapy group and chemotherapy group alone (120 150 146 min, P=0.041). Video-assisted thoracoscopic surgery was performed in 37 (88.1%), 49 (90.7%), and 57 (58.7%) patients in the three groups, respectively (P<0.001). A higher incidence of pneumonia (P=0.014) was found in the chemotherapy group. Perioperative mortality was observed in 1 patient (2.4%) in the ICI plus chemotherapy group and in 3 patients (3.1%) in the chemotherapy alone group (P=0.440). Patients in the ICI plus chemotherapy group had higher proportions of pathological complete response (40.5% 11.1% 6.1%, P<0.001) and downstaging of clinical N2 status (68.6% 42.9% 31.7%, P=0.012) than patients in EGFR-TKI group and chemotherapy alone group.

CONCLUSIONS

Surgical resection for NSCLC following neoadjuvant ICI plus chemotherapy was safe and feasible, the perioperative outcomes were similar with neoadjuvant EGFR-TKI and chemotherapy alone without unexpected perioperative complications. Additional prospective studies are necessary to validate our findings.

摘要

背景

新辅助免疫检查点抑制剂(ICI)联合化疗在可切除非小细胞肺癌(NSCLC)中的应用显著增加。与其他新辅助治疗相比,这种治疗模式是否会影响围手术期结局仍不清楚。我们旨在评估新辅助ICI联合化疗后肺切除的围手术期结局,并将其与新辅助表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKI)及单纯新辅助化疗用于可切除NSCLC的情况进行比较。

方法

回顾性分析2018年至2020年间194例IB-IIIB期NSCLC患者在新辅助治疗后接受手术切除的队列。使用不良事件通用术语标准评估围手术期并发症,并对连续变量采用单因素方差分析,对分类变量采用Pearson卡方检验进行比较。

结果

新辅助ICI联合化疗组、EGFR-TKI组和单纯化疗组分别有42例、54例和98例患者。新辅助治疗前肿瘤大小在三组间分布均衡(P=0.122)。EGFR-TKI组的中位手术时间短于ICI联合化疗组和单纯化疗组(分别为120、150和146分钟,P=0.041)。三组分别有37例(88.1%)、49例(90.7%)和57例(58.7%)患者接受了电视辅助胸腔镜手术(P<0.001)。单纯化疗组肺炎发生率更高(P=0.014)。ICI联合化疗组有1例患者(2.4%)发生围手术期死亡,单纯化疗组有3例患者(3.1%)发生围手术期死亡(P=0.440)。与EGFR-TKI组和单纯化疗组相比,ICI联合化疗组患者的病理完全缓解率更高(分别为40.5%、11.1%和6.1%,P<0.001),临床N2分期降期比例更高(分别为68.6%、42.9%和31.7%,P=0.012)。

结论

新辅助ICI联合化疗后行NSCLC手术切除安全可行,围手术期结局与新辅助EGFR-TKI及单纯化疗相似,未出现意外的围手术期并发症。需要进一步的前瞻性研究来验证我们的发现。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/23b1/9359956/a4ab2ea15399/tlcr-11-07-1468-f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/23b1/9359956/60a831ad1545/tlcr-11-07-1468-vid1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/23b1/9359956/a4ab2ea15399/tlcr-11-07-1468-f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/23b1/9359956/60a831ad1545/tlcr-11-07-1468-vid1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/23b1/9359956/a4ab2ea15399/tlcr-11-07-1468-f1.jpg

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