SCI

29 May 2024

Perioperative Nivolumab in Resectable Lung Cancer

(The New England Journal of Medicine, IF: 158.5)

  • T. Cascone, M.M. Awad, J.D. Spicer, J. He, S. Lu, B. Sepesi, F. Tanaka, J.M. Taube, R. Cornelissen, L. Havel, N. Karaseva, J. Kuzdzal, L.B. Petruzelka, L. Wu, J.-L. Pujol, H. Ito, T.-E. Ciuleanu, L. de Oliveira Muniz Koch, A. Janssens, A. Alexandru, S. Bohnet, F.V. Moiseyenko, Y. Gao, Y. Watanabe, C. Coronado Erdmann, P. Sathyanarayana, S. Meadows-Shropshire, S.I. Blum, and M. Provencio Pulla, for the CheckMate 77T Investigators

  • CORRESPONDENCE TO: tcascone@mdanderson.org

BACKGROUND 背景

Standard treatment with neoadjuvant nivolumab plus chemotherapy significantly improves outcomes in patients with resectable non–small-cell lung cancer (NSCLC). Perioperative treatment (i.e., neoadjuvant therapy followed by surgery and adjuvant therapy) with nivolumab may further improve clinical outcomes.

新辅助纳武利尤单抗加化疗的标准治疗显著改善了可切除非小细胞肺癌（NSCLC）患者的预后。围术期治疗（即新辅助治疗，然后手术和辅助治疗）应用纳武利尤单抗可以进一步改善临床结果。

 

METHODS 方法

In this phase 3, randomized, double-blind trial, we assigned adults with resectable stage IIA to IIIB NSCLC to receive neoadjuvant nivolumab plus chemotherapy or neoadjuvant chemotherapy plus placebo every 3 weeks for 4 cycles, followed by surgery and adjuvant nivolumab or placebo every 4 weeks for 1 year. The primary outcome was event-free survival according to blinded independent review. Secondary outcomes were pathological complete response and major pathological response according to blinded independent review, overall survival, and safety.

在这项3期随机双盲试验中，我们将可切除IIA-IIIB期NSCLC的成年患者分为两组，每3周接受一次新辅助纳武利尤单抗加化疗或新辅助化疗加安慰剂治疗，共4个周期，之后接受手术治疗，术后每4周进行辅助纳武利尤单抗治疗或安慰剂治疗，术后辅助治疗为期1年。主要结果为依据盲法独立评审的无事件生存率。次要结果为依据盲法独立审查的病理完全反应和主要病理反应，以及总生存率和安全性。

 

RESULTS 结果

At this prespecified interim analysis (median follow-up, 25.4 months), the percent-age of patients with 18-month event-free survival was 70.2% in the nivolumab group and 50.0% in the chemotherapy group (hazard ratio for disease progression or recurrence, abandoned surgery, or death, 0.58; 97.36% confidence interval [CI], 0.42 to 0.81; P<0.001). A pathological complete response occurred in 25.3% of the patients in the nivolumab group and in 4.7% of those in the chemotherapy group (odds ratio, 6.64; 95% CI, 3.40 to 12.97); a major pathological response occurred in 35.4% and 12.1%, respectively (odds ratio, 4.01; 95% CI, 2.48 to 6.49). Grade 3 or 4 treatment-related adverse events occurred in 32.5% of the patients in the nivolumab group and in 25.2% of those in the chemotherapy group.

在这项预先指定的中期分析（中位随访，25.4个月）中，纳武利尤单抗组18个月无事件生存期患者的年龄百分比为70.2%，化疗组为50.0%（疾病进展或复发、放弃手术或死亡的风险比为0.58；97.36%置信区间[CI]为0.42至0.81；P<0.001）。纳武利尤单抗组25.3%的患者和化疗组4.7%的患者出现病理完全缓解（比值比6.64；95%可信区间3.40至12.97）；主要病理反应发生率分别为35.4%和12.1%（比值比4.01；95%可信区间2.48至6.49）。纳武利尤单抗组32.5%的患者和化疗组25.2%的患者发生了3级或4级治疗相关不良事件。

 

CONCLUSIONS 结论

Perioperative treatment with nivolumab resulted in significantly longer event-free survival than chemotherapy in patients with resectable NSCLC. No new safety signals were observed. (Funded by Bristol Myers Squibb; CheckMate 77T ClinicalTrials.gov number, NCT04025879.)

在可切除的NSCLC患者中，纳武利尤单抗组的围术期治疗比化疗显著延长了患者无事件生存期。未观察到新的安全信号。（由Bristol Myers Squibb资助；CheckMate 77T 试验ClinicalTrials.gov编号，NCT04025879。）