本文由小咖机器人翻译整理

期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2311926

摘要内容如下：

背景

新辅助Nivolumab联合化疗的标准治疗可显著改善可切除非小细胞肺癌（NSCLC）患者的预后。使用nivolumab进行围手术期治疗（即手术和辅助治疗后的新辅助治疗）可能会进一步改善临床结果。

方法

在这项3期、随机、双盲试验中，我们将可切除的IIA至IIIb期成人NSCLC患者分为两组，一组接受新辅助Nivolumab联合化疗，另一组接受新辅助化疗联合安慰剂，每3周一次，共4个周期，然后接受手术治疗，每4周一次，另一组接受辅助Nivolumab或安慰剂，共1年。根据盲法独立审查，主要结果是无事件生存率。根据盲法独立审查、总生存率和安全性，次要结果为病理完全缓解和主要病理缓解。

结果

在这一预先指定的中期分析中（中位随访时间为25.4个月），Nivolumab治疗组18个月无事件生存率的患者百分比为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]，0.42至0.81；P<0.001）。Nivolumab治疗组和化疗组的病理完全缓解率分别为25.3%和4.7%（比值比，6.64；95%可信区间为3.40~12.97）；主要病理反应的发生率分别为35.4%和12.1%（比值比，4.01；95%置信区间，2.48至6.49）。3级或4级治疗相关不良事件的发生率在nivolumab组中为32.5%，在化疗组中为25.2%。

结论

在可切除的NSCLC患者中，围手术期Nivolumab治疗的无事件生存期显著长于化疗。未观察到新的安全性信号。（由Bristol Myers Squibb资助；Checkmate 77T ClinicalTrials.gov编号，NCT04025879。）

英文原文如下：

Abstracts

BACKGROUND  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.

METHODS  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.

RESULTS  At this prespecified interim analysis (median follow-up, 25.4 months), the percentage 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.

CONCLUSIONS  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.).

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