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期刊来源：Nat Med

原文链接：https://doi.org/10.1038/s41591-023-02721-w

摘要内容如下：

围手术期化疗是局部晚期胃癌或胃食管结合部癌的标准治疗方法，目前正在研究增加程序性细胞死亡1（PD-1）抑制剂。在这项随机、开放标签的2期研究（NeoSummit-01）中，临床分期为CT3-4AN+M0的可切除胃癌或胃食管结合部癌患者随机（1:1）接受3个术前和5个术后3周周期的Sox/XELOX（化疗组，n=54）或PD-1抑制剂Toripalimab联合Sox/XELOX，然后接受Toripalimab单药治疗长达6个月（Toripalimab联合化疗组，n=54主要终点是病理完全缓解或接近完全缓解率（肿瘤消退分级（TRG）0/1）。结果显示，Toripalimab+化疗组患者TRG 0/1的比例高于化疗组（44.4%（24/54，95%可信区间（CI）:30.9%-58.6%）对20.4%（11/54，95%CI:10.6%-33.5%））。Toripalimab联合化疗组与单纯化疗组TRG0/1的风险差异为22.7%（95%CI:5.8%~39.6%；P=0.009），满足预先指定的终点。此外，Toripalimab联合化疗组的病理完全缓解率（YpT0N0）较高（22.2%（12/54，95%CI:12.0%-35.6%）对7.4%（4/54，95%CI:2.1%-17.9%）；P=0.030），两个治疗组的手术发病率（Toripalimab+化疗组为11.8%，化疗组为13.5%）和死亡率（1.9%和0%）以及治疗相关的3-4级不良事件（35.2%和29.6%）具有可比性。总之，与单独化疗相比，在化疗中加入Toripalimab显著增加了达到TRG 0/1的患者比例，并显示出可控的安全性。ClinicalTrials.gov注册：NCT04250948。

英文原文如下：

Abstracts

Perioperative chemotherapy is the standard treatment for locally advanced gastric or gastro-esophageal junction cancer, and the addition of programmed cell death 1 (PD-1) inhibitor is under investigation. In this randomized, open-label, phase 2 study (NEOSUMMIT-01), patients with resectable gastric or gastro-esophageal junction cancer clinically staged as cT3-4aN + M0 were randomized (1:1) to receive either three preoperative and five postoperative 3-week cycles of SOX/XELOX (chemotherapy group, n = 54) or PD-1 inhibitor toripalimab plus SOX/XELOX, followed by toripalimab monotherapy for up to 6 months (toripalimab plus chemotherapy group, n = 54). The primary endpoint was pathological complete response or near-complete response rate (tumor regression grade (TRG) 0/1). The results showed that patients in the toripalimab plus chemotherapy group achieved a higher proportion of TRG 0/1 than those in the chemotherapy group (44.4% (24 of 54, 95% confidence interval (CI): 30.9%-58.6%) versus 20.4% (11 of 54, 95% CI: 10.6%-33.5%)), and the risk difference of TRG 0/1 between toripalimab plus chemotherapy group and chemotherapy group was 22.7% (95% CI: 5.8%-39.6%; P = 0.009), meeting a prespecified endpoint. In addition, a higher pathological complete response rate (ypT0N0) was observed in the toripalimab plus chemotherapy group (22.2% (12 of 54, 95% CI: 12.0%-35.6%) versus 7.4% (4 of 54, 95% CI: 2.1%-17.9%); P = 0.030), and surgical morbidity (11.8% in the toripalimab plus chemotherapy group versus 13.5% in the chemotherapy group) and mortality (1.9% versus 0%), and treatment-related grade 3-4 adverse events (35.2% versus 29.6%) were comparable between the treatment groups. In conclusion, the addition of toripalimab to chemotherapy significantly increased the proportion of patients achieving TRG 0/1 compared to chemotherapy alone and showed a manageable safety profile. ClinicalTrials.gov registration: NCT04250948 .

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