可切除性肺淋巴上皮瘤样癌患者围手术期免疫治疗联合化疗与单纯化疗的比较
Perioperative immunotherapy plus chemotherapy versus chemotherapy alone for patients with resectable pulmonary lymphoepithelioma-like carcinoma.
作者信息
Lei Mengjie, Zhang Xuanye, Hu Li-Na, Fu Sha, Xiao Meihua, Long Zhiqing, Zhu Honglin, Zhou Yixin, Hong Shaodong
机构信息
State Key Laboratory of Oncology in South China, Guangzhou, China; Collaborative Innovation Center for Cancer Medicine, Guangzhou, China; Department of Experimental Research, Sun Yat-sen University Cancer Center, Guangzhou, China; The First Affiliated Hospital, Hengyang Medical School, University of South China, Hengyang, Hunan, China.
State Key Laboratory of Oncology in South China, Guangzhou, China; Collaborative Innovation Center for Cancer Medicine, Guangzhou, China; Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.
出版信息
Lung Cancer. 2025 Jan;199:108057. doi: 10.1016/j.lungcan.2024.108057. Epub 2024 Dec 18.
BACKGROUND
Primary pulmonary lymphoepithelioma-like carcinoma (PLELC) is a rare subtype of non-small-cell lung cancer. This study aims to compare the efficacy and safety of perioperative PD-1/PD-L1 inhibitor plus chemotherapy versus chemotherapy alone in stage II-IIIB PLELC patients.
PATIENTS AND METHODS
This retrospective study included stage II-IIIB PLELC patients. Patients received either perioperative immuno-chemotherapy (IO-Chemo) or chemotherapy alone (Chemo). Data on patient characteristics, treatments, efficacy, toxicities, and pathology were collected. Primary endpoints were major pathological response (MPR) and event-free survival (EFS). Secondary endpoints included objective response rate (ORR), overall survival (OS), and adverse events (AEs).
RESULTS
A total of 72 patients were included in this retrospective study. The ORR was 75.0 % in the IO-Chemo group and 58.3 % in the Chemo group (odds ratio [OR] 0.47 [95 % CI 0.15-1.42]; P = 0.200). The percentage of patients achieving major pathological response (MPR) was 54.2 % in the IO-Chemo group and 12.5 % in the Chemo group (OR 1.91 [95 % CI 1.22-2.99]; P < 0.001). Pathological complete response (pCR) was achieved by 33.3 % of patients in the IO-Chemo group compared to 4.2 % in the Chemo group (OR 1.44 [95 % CI 1.08-1.92]; P = 0.002). The median EFS was not reached in the IO-Chemo group, whereas it was 35.0 months in the Chemo group (95 % CI 14.2-55.8; hazard ratio [HR] 0.42 [95 % CI 0.19-0.93]; P = 0.031). Median overall survival (OS) was not reached after a median follow-up of 47.0 months. Multivariate analysis indicated that the PD-1/PD-L1 inhibitor combination was independently associated with longer EFS (HR = 0.32 [95 % CI 0.11-0.95]; P = 0.043). AEs of any grade occurred in 91.7 % of the patients in the IO-Chemo group versus 89.6 % in the Chemo group.
CONCLUSIONS
In patients with resectable PLELC, perioperative PD-1/PD-L1 inhibitor plus chemotherapy resulted in significantly longer EFS and a higher percentage of patients achieving MPR and pCR than chemotherapy alone, with a tolerable safety profile.
背景
原发性肺淋巴上皮瘤样癌（PLELC）是一种罕见的非小细胞肺癌亚型。本研究旨在比较围手术期PD-1/PD-L1抑制剂联合化疗与单纯化疗在II-IIIB期PLELC患者中的疗效和安全性。
患者与方法
本回顾性研究纳入II-IIIB期PLELC患者。患者接受围手术期免疫化疗（IO-Chemo）或单纯化疗（Chemo）。收集患者特征、治疗、疗效、毒性和病理数据。主要终点为主要病理缓解（MPR）和无事件生存期（EFS）。次要终点包括客观缓解率（ORR）、总生存期（OS）和不良事件（AE）。
结果
本回顾性研究共纳入72例患者。IO-Chemo组的ORR为75.0%，Chemo组为58.3%（优势比[OR]0.47[95%CI 0.15-1.42]；P = 0.200）。IO-Chemo组达到主要病理缓解（MPR）的患者百分比为54.2%，Chemo组为12.5%（OR 1.91[95%CI 1.22-2.99]；P < 0.001）。IO-Chemo组33.3%的患者实现了病理完全缓解（pCR），而Chemo组为4.2%（OR 1.44[95%CI 1.08-1.92]；P = 0.002）。IO-Chemo组未达到中位EFS，而Chemo组为35.0个月（95%CI 14.2-55.8；风险比[HR]0.42[95%CI 0.19-0.93]；P = 0.031）。中位随访47.0个月后，未达到中位总生存期（OS）。多因素分析表明，PD-1/PD-L1抑制剂联合治疗与更长的EFS独立相关（HR = 0.32[95%CI 0.11-0.95]；P = 0.043）。IO-Chemo组91.7%的患者发生了任何级别的AE，而Chemo组为89.6%。
结论
在可切除的PLELC患者中，围手术期PD-1/PD-L1抑制剂联合化疗导致的EFS显著长于单纯化疗，实现MPR和pCR的患者百分比更高，且安全性可耐受。
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