大多数人表皮生长因子受体 2 (HER2) 阴性胃食管腺癌患者的标准一线化疗会在一年内导致疾病进展和死亡.在随机、全球 CheckMate 649 3 期试验（程序性死亡配体-1 (PD-L1) 联合阳性评分≥5 和所有随机患者）.

基于这些结果，纳武利尤单抗加化疗现已在许多国家被批准为这些患者的一线治疗 6.Nivolumab 和细胞毒性 T 淋巴细胞抗原 4 (CTLA-4) 抑制剂 ipilimumab 具有不同但互补的作用机制，有助于恢复抗肿瘤 T 细胞功能和诱导从头抗肿瘤 T 细胞反应，分别为7-11.1 mg kg-1 nivolumab 与 3 mg kg-1 ipilimumab 联合治疗在接受大量预处理的晚期胃食管癌患者中显示出具有临床意义的抗肿瘤活性和可控的安全性

在这里，我们报告比较 nivolumab 加化疗与单独化疗的长期随访结果以及比较来自 CheckMate 649 的 nivolumab 加 ipilimumab 与单独化疗的第一个结果.24个月之后.在 PD-L1 联合阳性评分≥5（风险比 0.70; 95% 置信区间 0.61, 0.81）和所有随机患者（风险比 0.79; 95% 置信区间 0.71, 0.88).PD-L1 联合阳性评分 ≥ 5 的 nivolumab 加 ipilimumab 与单独化疗的患者的总生存期未达到预先设定的显着性界限.未发现新的安全信号.我们的结果支持继续使用纳武利尤单抗加化疗作为晚期胃食管腺癌的标准一线治疗

Abstract

Standard first-line chemotherapy results in disease progression and death within one year in most patients with human epidermal growth factor receptor 2 (HER2)-negative gastro-oesophageal adenocarcinoma1-4. Nivolumab plus chemotherapy demonstrated superior overall survival versus chemotherapy at 12-month follow-up in gastric, gastro-oesophageal junction or oesophageal adenocarcinoma in the randomized, global CheckMate 649 phase 3 trial5 (programmed death ligand-1 (PD-L1) combined positive score ≥5 and all randomized patients). On the basis of these results, nivolumab plus chemotherapy is now approved as a first-line treatment for these patients in many countries6. Nivolumab and the cytotoxic T-lymphocyte antigen-4 (CTLA-4) inhibitor ipilimumab have distinct but complementary mechanisms of action that contribute to the restoration of anti-tumour T-cell function and induction of de novo anti-tumour T-cell responses, respectively7-11. Treatment combining 1 mg kg-1 nivolumab with 3 mg kg-1 ipilimumab demonstrated clinically meaningful anti-tumour activity with a manageable safety profile in heavily pre-treated patients with advanced gastro-oesophageal cancer12. Here we report both long-term follow-up results comparing nivolumab plus chemotherapy versus chemotherapy alone and the first results comparing nivolumab plus ipilimumab versus chemotherapy alone from CheckMate 649. After the 24.0-month minimum follow-up, nivolumab plus chemotherapy continued to demonstrate improvement in overall survival versus chemotherapy alone in patients with PD-L1 combined positive score ≥5 (hazard ratio 0.70; 95% confidence interval 0.61, 0.81) and all randomized patients (hazard ratio 0.79; 95% confidence interval 0.71, 0.88). Overall survival in patients with PD-L1 combined positive score ≥ 5 for nivolumab plus ipilimumab versus chemotherapy alone did not meet the prespecified boundary for significance. No new safety signals were identified. Our results support the continued use of nivolumab plus chemotherapy as standard first-line treatment for advanced gastro-oesophageal adenocarcinoma.

原文链接

https://www.nature.com/articles/s41586-022-04508-4

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