新辅助免疫治疗联合化疗在真实世界中对可切除非小细胞肺癌的疗效和安全性评估
Efficacy and safety evaluation of neoadjuvant immunotherapy plus chemotherapy for resectable non-small cell lung cancer in real world.
作者信息
Fang Min, Hang Qingqing, Jiang Haitao, Cai Lei, Hu Jinlin, Ying Hangjie, Gu Qing, Yu Xiaofu, Liu Jinshi, Lai Xiaojing
机构信息
Department of Thoracic Radiotherapy, Zhejiang Cancer Hospital, Hangzhou, China.
Institute of Cancer and Basic Medicine (IBMC), Chinese Academy of Sciences, Hangzhou, China.
出版信息
Front Oncol. 2023 Jan 12;12:1055610. doi: 10.3389/fonc.2022.1055610. eCollection 2022.
OBJECTIVES
The combination of immunotherapy and chemotherapy has shown great efficacy in stage IV non-small cell lung cancer (NSCLC) and is now widely used in clinical treatment strategy. This study retrospectively analyzed the efficacy and safety of neoadjuvant immunotherapy plus chemotherapy for resectable NSCLC in real world.
METHODS
We retrospectively analyzed patients with NSCLC who received neoadjuvant immunotherapy plus chemotherapy and underwent complete tumor resection in Zhejiang Cancer Hospital between January 2019 and January 2021. Tumor staging was based on the eighth TNM classification system of the American Joint Committee on Cancer staging criteria. The safety and toxicity (including operative and postoperative complications) and the efficacy [including objective response rate (ORR), disease control rate (DCR), tumor major pathological remission (MPR), and pathological complete response (pCR)] were evaluated.
RESULTS
In total, 368 patients with NSCLC were administered with neoadjuvant immunotherapy. Of them, 211 patients were included in this retrospective study. Most patients had stage II-III disease, with 75 (35.5%) and 88 (41.7%) patients diagnosed with clinical stages IIB and IIIA, respectively. A total of 206 patients (97.6%) received at least two doses of neoadjuvant immunotherapy plus chemotherapy. In addition, 121 patients (57.3%) have achieved MPR, and 80 patients (37.9%) have achieved pCR, with ORR at 69.2% and DCR at 97.7%. Treatment-related adverse events occurred in 46.4% of patients, and the incidence rate of grade 3 or 4 treatment-related adverse events was 13.3% (13/98). Moreover, adverse events of any grade of surgical complication occurred in 15.6% of patients. One-year disease-free survival was 80.6% (170/211).
CONCLUSIONS
Neoadjuvant immunotherapy plus chemotherapy has significant efficacy with a high pCR and tolerable adverse effects for patients with resectable stage II-III NSCLC in real world.
目的
免疫治疗与化疗联合在IV期非小细胞肺癌（NSCLC）中已显示出巨大疗效，目前已广泛应用于临床治疗策略。本研究回顾性分析了新辅助免疫治疗联合化疗用于可切除NSCLC在现实世界中的疗效和安全性。
方法
我们回顾性分析了2019年1月至2021年1月期间在浙江省肿瘤医院接受新辅助免疫治疗联合化疗并接受肿瘤完全切除的NSCLC患者。肿瘤分期基于美国癌症联合委员会癌症分期标准的第八版TNM分类系统。评估了安全性和毒性（包括手术及术后并发症）以及疗效[包括客观缓解率（ORR）、疾病控制率（DCR）、肿瘤主要病理缓解（MPR）和病理完全缓解（pCR）]。
结果
共有368例NSCLC患者接受了新辅助免疫治疗。其中，211例患者纳入本回顾性研究。大多数患者为II-III期疾病，分别有７５例（35.5%）和88例（41.7%）患者诊断为临床IIB期和IIIA期。共有206例患者（97.6%）接受了至少两剂新辅助免疫治疗联合化疗。此外，121例患者（57.3%）实现了MPR，80例患者（37.9%）实现了pCR，ORR为69.2%，DCR为97.7%。46.4%的患者发生了治疗相关不良事件，3/4级治疗相关不良事件的发生率为13.3%（13/98）。此外，15.6%的患者发生了任何级别的手术并发症不良事件。一年无病生存率为80.6%（170/211）。
结论
新辅助免疫治疗联合化疗对现实世界中可切除的II-III期NSCLC患者具有显著疗效，pCR率高且不良反应可耐受。
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