可切除非小细胞肺癌患者接受新辅助免疫化疗的治疗模式和临床结局：一项大规模、多中心、真实世界研究（NeoR-World）。
Treatment patterns and clinical outcomes of patients with resectable non-small cell lung cancer receiving neoadjuvant immunochemotherapy: A large-scale, multicenter, real-world study (NeoR-World).
机构信息
Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
出版信息
J Thorac Cardiovasc Surg. 2024 Oct;168(4):1245-1258.e17. doi: 10.1016/j.jtcvs.2024.02.006. Epub 2024 Feb 10.
BACKGROUND
Neoadjuvant immunotherapy has ushered in a new era of perioperative treatment for resectable non-small cell lung cancer (NSCLC). However, large-scale data for verifying the efficacy and optimizing the therapeutic strategies of neoadjuvant immunochemotherapy in routine clinical practice are scarce.
METHODS
NeoR-World (NCT05974007) was a multicenter, retrospective cohort study involving patients who received neoadjuvant immunotherapy plus chemotherapy or chemotherapy alone in routine clinical practice from 11 medical centers in China between January 2010 and March 2022. Propensity score matching was performed to address indication bias.
RESULTS
A total of 408 patients receiving neoadjuvant immunochemotherapy and 684 patients receiving neoadjuvant chemotherapy were included. The pathologic complete response (pCR) and major pathologic response (MPR) rates of the real-world neoadjuvant immunochemotherapy cohort were 32.8% and 58.1%, respectively. Notably, patients with squamous cell carcinoma exhibited significantly higher pCR and MPR rates than those with adenocarcinoma (pCR, 39.2% vs 16.5% [P < .001]; MPR, 66.6% vs 36.5% [P < .001]), whereas pCR and MPR rates were comparable among patients receiving different neoadjuvant cycles. In addition, the 2-year rates of disease-free survival (DFS) and overall survival (OS) rate were 82.0% and 93.1%, respectively. Multivariate analyses identified adjuvant therapy as an independent prognostic factor for DFS (hazard ratio [HR], 0.51; 95% confidence interval [CI], 0.29-0.89; P = .018) and OS (HR, 0.28; 95% CI, 0.13-0.58; P < .001). A significantly longer DFS with adjuvant therapy was observed in patients with non-pCR or 2 neoadjuvant cycles. We observed significant benefits in pCR rate (32.4% vs 6.4%; P < .001), DFS (HR, 0.50; 95% CI, 0.38-0.68; P < .001) and OS (HR, 0.61; 95% CI, 0.40-0.94; P = .024) with immunotherapy plus chemotherapy compared to chemotherapy alone both in the primary propensity-matched cohort and across most key subgroups.
CONCLUSIONS
The study validates the superior efficacy of neoadjuvant immunochemotherapy over chemotherapy alone for NSCLC. Adjuvant therapy could prolong DFS in patients receiving neoadjuvant immunochemotherapy, and patients with non-pCR or those who underwent 2 neoadjuvant cycles were identified as potential beneficiaries of adjuvant therapy.
背景
新辅助免疫治疗为可切除非小细胞肺癌（NSCLC）的围手术期治疗开创了新纪元。然而，在常规临床实践中，验证新辅助免疫化疗疗效和优化治疗策略的大规模数据仍然匮乏。
方法
NeoR-World（NCT05974007）是一项多中心、回顾性队列研究，纳入了 2010 年 1 月至 2022 年 3 月期间中国 11 家医疗中心的 408 例接受新辅助免疫化疗和 684 例接受新辅助化疗的患者。采用倾向评分匹配来解决指示偏差。
结果
共纳入 408 例接受新辅助免疫化疗和 684 例接受新辅助化疗的患者。真实世界新辅助免疫化疗队列的病理完全缓解（pCR）和主要病理缓解（MPR）率分别为 32.8%和 58.1%。值得注意的是，与腺癌相比，鳞状细胞癌患者的 pCR 和 MPR 率显著更高（pCR，39.2%比 16.5%[P<0.001]；MPR，66.6%比 36.5%[P<0.001]），而接受不同新辅助周期的患者的 pCR 和 MPR 率相似。此外，2 年无病生存率（DFS）和总生存率（OS）率分别为 82.0%和 93.1%。多变量分析确定辅助治疗是 DFS（风险比[HR]，0.51；95%置信区间[CI]，0.29-0.89；P=0.018）和 OS（HR，0.28；95%CI，0.13-0.58；P<0.001）的独立预后因素。在未达到 pCR 或接受 2 个新辅助周期的患者中，辅助治疗可显著延长 DFS。与单独化疗相比，新辅助免疫化疗联合化疗可显著提高 pCR 率（32.4%比 6.4%；P<0.001）、DFS（HR，0.50；95%CI，0.38-0.68；P<0.001）和 OS（HR，0.61；95%CI，0.40-0.94；P=0.024），在主要倾向评分匹配队列和大多数关键亚组中均观察到这一结果。
结论
该研究证实了新辅助免疫化疗较单独化疗在 NSCLC 中的疗效优势。辅助治疗可延长接受新辅助免疫化疗患者的 DFS，未达到 pCR 或接受 2 个新辅助周期的患者可能是辅助治疗的潜在获益者。
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