全国范围内实施可切除NSCLC新辅助nivolumab为基础的化疗-免疫治疗:一项前瞻性多中心研究的手术结果
Nationwide Implementation of Neoadjuvant Nivolumab-Based Chemo-Immunotherapy for Resectable NSCLC: Surgical Outcomes from a Prospective Multicenter Study.
作者
作者单位
- 3rd Department of Surgery, First Faculty of Medicine, Charles University and University Hospital Motol and Homolka, Prague, Czech Republic. jiri.vachtenheim@fnmotol.cz.
- Pneumology and Oncology Departments, Second Faculty of Medicine, Charles University and Center for Thoracic Oncology and Surgery, University Hospital Motol and Homolka, Prague, Czech Republic.
- 3rd Department of Surgery, First Faculty of Medicine, Charles University and University Hospital Motol and Homolka, Prague, Czech Republic.
- Department of Pathology and Molecular Medicine, Second Faculty of Medicine, Charles University and University Hospital Motol and Homolka, Prague, Czech Republic.
- Department of Anesthesiology and Intensive Care Medicine, Second Faculty of Medicine, Charles University and University Hospital Motol and Homolka, Prague, Czech Republic.
- University Hospital Olomouc and Faculty of Medicine and Dentistry, Palacký University Olomouc, Olomouc, Czech Republic.
- Department of Pulmonary Diseases and Tuberculosis, University Hospital Olomouc and The Faculty of Medicine of Palacký University in Olomouc, Olomouc, Czech Republic.
- Department of Thoracic Surgery 3rd Faculty of Medicine, Charles University and Thomayer University Hospital, Prague, Czech Republic.
- Department of Pneumology, First Faculty of Medicine, Charles University and Thomayer University Hospital, Prague, Czech Republic.
- Department of Surgery, Charles University and University Hospital, Pilsen, Czech Republic.
- Department of Pneumology and Phthiseology, Faculty of Medicine in Pilsen, University Hospital in Pilsen, Charles University, Pilsen, Czech Republic.
- Department of Thoracic Surgery, Krajska zdravotni a.s. and UJEP, Ústí nad Labem, Czech Republic.
- Department of Clinical Oncology, Krajská Zdravotní Masaryk Hospital, Ústí nad Labem, Czech Republic.
- Department of Cardiac Surgery, Faculty of Medicine, Charles University in Hradec Králové and University Hospital Hradec Králové, Hradec Králové, Czech Republic.
- Department of Pneumology, Faculty of Medicine in Hradec Kralove, University Hospital Hradec Kralove, Czech Republic, Charles University, Prague, Czech Republic.
- Department of Surgery, University Hospital Brno and Faculty of Medicine, Masaryk University, Brno, Czech Republic.
- Department of Respiratory Diseases, University Hospital Brno, Department of Comprehensive Cancer Care, Masaryk Memorial Cancer Institute, Faculty of Medicine, Masaryk University, Brno, Czech Republic.
- Department of Surgery, University Hospital Ostrava, Ostrava, Czech Republic.
- Department of Oncology, University Hospital Ostrava, Ostrava, Czech Republic.
- Department of Immunology, Second Faculty of Medicine, Charles University and University Hospital Motol and Homolka, Prague, Czech Republic.
- ANOVA CRO s.r.o., Brno, Czech Republic.
- Sarah Cannon Cancer Network, Swedish Medical Center, Englewood, CO, USA.
摘要
中文
新辅助化疗-免疫治疗已改变了可切除非小细胞肺癌(NSCLC)的治疗格局。然而,来自欧洲全国队列的真实世界手术数据仍然有限。本研究评估了捷克共和国在首个全国新辅助化疗-免疫治疗(nivolumab)实施年度内的手术结果和实践模式。本前瞻性、多中心、观察性队列研究纳入了2023年8月至2024年8月间在捷克共和国全部八个认证胸部肿瘤中心按照CheckMate 816方案(铂类化疗联合nivolumab)治疗的所有连续可切除PD-L1≥1% NSCLC患者。评估手术和病理学结果。64例患者启动新辅助治疗,56例(87.5%)接受了切除术。46.4%的病例尝试了微创手术,中转开胸率为11.5%。Clavien-Dindo≥III级并发症发生率为14.3%,最高严重程度为IIIb级。30天死亡率为0%。90天死亡率为5.4%,但无一例死亡直接归因于手术。R0切除率为98.2%。在意向治疗人群中,病理学完全缓解率和主要病理学缓解率分别为40.6%和48.4%。鳞状NSCLC的病理学完全缓解率显著高于非鳞状NSCLC(66.7% vs 27.6%;p=0.003)。在这项来自欧洲国家的首个全国队列中,在PD-L1≥1%可切除NSCLC患者中早期采用nivolumab新辅助化疗-免疫治疗获得了可接受的围手术期结果、高R0切除率和显著的病理学缓解。这些结果表明,在全国医疗体系中成功采用了一种新型NSCLC治疗模式。
English
Neoadjuvant chemo-immunotherapy has transformed the treatment landscape for resectable non-small-cell lung cancer (NSCLC). However, real-world surgical data from nationwide European cohorts remain limited. This study evaluated surgical outcomes and practice patterns during the first year of nationwide implementation of neoadjuvant chemo-immunotherapy with nivolumab in the Czech Republic. This prospective, multicenter, observational cohort study included all consecutive patients with resectable programmed cell death ligand-1(PD-L1) ≥ 1% NSCLC treated according to the CheckMate 816 protocol (platinum-based chemotherapy plus nivolumab) at all eight accredited thoracic oncology centers in the Czech Republic between August 2023 and August 2024. Surgical and pathological outcomes were assessed. Sixty-four patients initiated neoadjuvant therapy and 56 (87.5%) underwent resection. Minimally invasive surgery was attempted in 46.4% of cases, with an 11.5% conversion rate. Clavien-Dindo grade ≥ III complications occurred in 14.3%, with grade IIIb representing the highest severity. 30-day mortality was 0%. Although 90-day mortality was 5.4%, none of the deaths were directly attributable to surgery. R0 resection was achieved in 98.2%. In the intention-to-treat population, pathological complete response and major pathological response rates were 40.6% and 48.4%, respectively. Pathological complete response was significantly higher in squamous than in non-squamous NSCLC (66.7% vs. 27.6%; p = 0.003). In this first nationwide cohort from a European country, early adoption of neoadjuvant chemo-immunotherapy with nivolumab in patients with resectable PD-L1 ≥ 1% NSCLC was associated with acceptable perioperative outcomes, high R0 resection rates, and substantial pathological response. These results demonstrate the successful adoption of a novel NSCLC treatment modality across a nationwide healthcare system.
分类与指标
- 研究类型
- 临床研究
- 病种
- 肺癌
- JCR 分区
- Q1
- 影响因子
- 3.8
- 新锐分区
- 2区