新辅助免疫治疗联合化疗与手术治疗局部晚期可切除非小细胞肺癌的短期疗效比较 Translated title: Comparison of Short-term Efficacy of Neoadjuvant Immunotherapy Combined with Chemotherapy and Surgery Alone for Locally Advanced Resectable Non-small Cell Lung Cancer

Abstract

背景与目的 肺癌是中国发生率和死亡率均排名第一的癌症，非小细胞肺癌（non-small cell lung cancer, NSCLC）占所有肺恶性肿瘤的80%-85%。目前，手术治疗仍是肺癌主要的治疗方式。近年来，免疫检查点抑制剂在NSCLC中的疗效已成为共识，新辅助免疫联合化疗（neoadjuvant immunochemotherapy, nICT）在早中期NSCLC中显示出来良好的疗效和安全性。然而，nICT治疗局部晚期NSCLC的相关研究较少。本研究旨在评估程序性死亡受体1（programmed cell death 1, PD-1）抑制剂联合含铂两药新辅助治疗治疗局部晚期可切除NSCLC的有效性和安全性。 方法 纳入2021年1月至2024年4月于兰州大学第二医院胸外科就诊的85例确诊可切除IIIA、IIIB期患者，分为nICT组（n=32）和单纯手术组（n=53），比较两组患者的临床基线资料、围手术期相关指标及术后并发症，并评估nICT组的影像学缓解率、病理学缓解率、相关不良反应发生率、生活质量。 结果 两组患者临床基线资料差异均无统计学意义（P>0.05）。nICT组选择开胸方式比单纯手术组发生率高（P=0.002），两组手术时间、术中出血量、清扫淋巴结个数、带管时间、术后住院时间及R0切除率的差异无统计学意义（P>0.05）。nICT组与单纯手术组术后总并发症发生率分别为31.25%和22.64%，差异无统计学意义（P=0.380）。nICT组中客观缓解率（objective response rate, ORR）为84.38%，完全缓解（complete response, CR）5例（15.63%），部分缓解（partial response, PR）22例（68.75%），病理性完全缓解（pathological complete response, pCR）15例（46.88%），主要病理缓解（major pathological reaponse, MPR）11例（34.38%）。nICT治疗期间，3级治疗相关不良反应共12例（37.50%），无不良反应或免疫相关不良反应导致患者死亡。而且，nICT治疗后患者相关症状有所改善。 结论 nICT治疗局部晚期可切除NSCLC显示出良好的疗效，治疗相关不良事件可控，是局部晚期可切除NSCLC安全、可行的新辅助治疗模式。

Translated abstract

Background and objective Lung cancer is the cancer with the highest incidence and mortality rates in China, and non-small cell lung cancer (NSCLC) accounts for 80%-85% of all malignant lung tumors. Currently, surgical treatment remains the primary treatment modality for lung cancer. In recent years, the effectiveness of immune checkpoint inhibitors for NSCLC has become a consensus, and neoadjuvant immunochemotherapy (nICT) has shown promising efficacy and safety in early to intermediate stage NSCLC. However, there are fewer studies related to nICT for locally advanced NSCLC. This study aims to evaluate the efficacy and safety of nICT therapy in locally advanced resectable NSCLC. Methods 85 confirmed resectable stage IIIA and IIIB patients treated in the Department of Thoracic Surgery, Second Hospital of Lanzhou University, from January 2021 to April 2024, were divided into the nICT group (n=32) and the surgery alone group (n=53). Clinical baseline data, perioperative indicators, postoperative complications, imaging response rate, pathological response rate, incidence of adverse events, and quality of life were compared between the two groups. Results There were no statistically significant differences in clinical baseline data between the two groups (P>0.05). Incidence of choosing thoracotomy was higher in the nICT group than in the surgery alone group (P=0.002). There were no significant differences in surgical time, intraoperative blood loss, number of dissected lymph nodes, duration of chest tube placement, postoperative hospital stay, and R0 resection rate between the two groups (P>0.05). The overall incidence of postoperative complications was 31.25% in the nICT group and 22.64% in the surgery alone group, with no statistically significant difference (P=0.380). In the nICT group, the objective response rate (ORR) was 84.38%, with 5 cases of complete response (CR)(15.63%), 22 cases of partial response (PR)(68.75%), 15 cases of pathological response rate (pCR)(46.88%), and 11 cases of major pathological reaponse (MPR) (34.38%). During nICT treatment, 12 cases (37.50%) experienced grade 3 treatment-related adverse events, no death induced by adverse events or immune related adverse events. Moreover, the symptoms of the patients were improved after nICT treatment. Conclusion Neoadjuvant immunochemotherapy shows promising efficacy in locally advanced resectable NSCLC, with manageable treatment-related adverse events. It is a safe and feasible neoadjuvant treatment modality for locally advanced resectable NSCLC.