本文由小咖机器人翻译整理

期刊来源：Nat Med

原文链接：https://doi.org/10.1038/s41591-024-02797-y

摘要内容如下：

虽然抗程序性死亡1抗体联合化疗最近已被批准用于一线食管鳞状细胞癌（ESCC），但抗程序性死亡配体1抗体可能在这种情况下提供另一种组合选择。在这项多中心、随机、双盲的第3阶段试验中，共有540名患有不可切除、局部晚期、复发或转移性ESCC且未接受系统治疗的成人（年龄18-75岁）入选。所有患者按2:1随机分组，每3周接受sugemalimab（一种抗PD-L1抗体；1，200mg）或安慰剂，持续24个月，每3周接受化疗（第1天顺铂80mg-2，第1-4天5-氟尿嘧啶800mg-2，第1-4天），持续6个周期。在预先指定的中期分析中，该研究达到了两个主要终点。中位随访时间为15.2个月，与安慰剂加化疗相比，sugemalimab加化疗的无进展生存期延长具有统计学意义（中位时间分别为6.2个月和5.4个月，风险比0.67（95%置信区间0.54-0.82），P=0.0002），通过盲法独立中心评价进行评估。sugemalimab化疗的总生存率也更高（中位数15.3个月对11.5个月，风险比0.70（95%置信区间0.55-0.90，P=0.0076）。通过盲法独立中心审查评估，观察到sugemalimab化疗的客观缓解率显著较高（60.1%对45.2%）。两组3级或以上治疗相关不良事件的发生率（51.3%对48.4%）具有可比性。Sugemalimab联合化疗可显著延长未经治疗的晚期ESCC患者的无进展生存期和总生存期，且无意外的安全性信号。ClinicalTrials.gov标识符为NCT04187352。

英文原文如下：

Abstracts

Although antiprogrammed death 1 antibody plus chemotherapy has recently been approved for first-line esophageal squamous cell carcinoma (ESCC), antiprogrammed death-ligand 1 antibody may offer another combination option in this setting. In this multicenter, randomized, double-blinded phase 3 trial a total of 540 adults (aged 18-75 years) with unresectable, locally advanced, recurrent or metastatic ESCC and who had not received systemic treatment were enrolled. All patients were randomized at 2:1 to receive either sugemalimab (an anti-PD-L1 antibody; 1,200 mg) or placebo every 3 weeks for up to 24 months, plus chemotherapy (cisplatin 80 mg m-2 on day 1 plus 5-fluorouracil 800 mg m-2 day-1 on days 1-4) every 3 weeks for up to six cycles. At the prespecified interim analysis this study had met dual primary endpoints. With a median follow-up of 15.2 months, the prolongation of progression-free survival was statistically significant with sugemalimab plus chemotherapy compared with placebo plus chemotherapy (median 6.2 versus 5.4 months, hazard ratio 0.67 (95% confidence interval 0.54-0.82), P = 0.0002) as assessed by blinded independent central review. Overall survival was also superior with sugemalimab chemotherapy (median 15.3 versus 11.5 months, hazard ratio 0.70 (95% confidence interval 0.55-0.90, P = 0.0076). A significantly higher objective response rate (60.1 versus 45.2%) as assessed by blinded independent central review was observed with sugemalimab chemotherapy. The incidence of grade 3 or above treatment-related adverse events (51.3 versus 48.4%) was comparable between the two groups. Sugemalimab plus chemotherapy significantly prolonged progression-free survival and overall survival in treatment-naïve patients with advanced ESCC, with no unexpected safety signal. The ClinicalTrials.gov identifier is NCT04187352 .

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