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/NEJMoa2312117

摘要内容如下：

背景

没有一种治疗方法在提高既往未经治疗的局部晚期或转移性尿路上皮癌患者的总生存率方面超过以铂为基础的化疗。

方法

我们进行了一项3期、全球、开放标签、随机试验，以比较Enfortumab Vedotin和Pembrolizumab与以铂为基础的化疗在既往未经治疗的局部晚期或转移性尿路上皮癌患者中的疗效和安全性。患者以1:1的比例被随机分配接受为期3周的Enfortumab Vedotin（剂量为1.25 mg/kg体重，第1天和第8天静脉注射）和Pembrolizumab（剂量为200 mg，第1天静脉注射）（Enfortumab Vedotin-Pembrolizumab组）或吉西他滨和顺铂或卡铂（根据接受顺铂的资格确定）（化疗组）。主要终点是通过盲法独立中心审查评估的无进展生存期和总生存期。

结果

共有886名患者接受了随机分组:442名患者进入Enfortumab vedotin-pembrolizumab组，444名患者进入化疗组。截至2023年8月8日，中位生存期为17.2个月。Enfortumab vedotin-pembrolizumab组的无进展生存期长于化疗组（中位数，12.5个月对6.3个月；疾病进展或死亡的风险比为0.45；95%置信区间[CI]，0.38至0.54；P<0.001），总生存期（中位数，31.5个月对16.1个月；死亡风险比为0.47；95%可信区间为0.38~0.58；P<0.001）。Enfortumab vedotin-pembrolizumab组的中位周期数为12（范围为1至46），化疗组的中位周期数为6（范围为1至6）。Enfortumab vedotin-pembrolizumab组和化疗组分别有55.9%和69.5%的患者发生了3级或更高级别的治疗相关不良事件。

结论

在未经治疗的局部晚期或转移性尿路上皮癌患者中，Enfortumab Vedotin和Pembrolizumab治疗的结果明显优于化疗，其安全性与先前的报道一致。（由美国安斯泰来制药公司和其他公司资助；EV-302 ClinicalTrials.gov编号，NCT04223856。）

英文原文如下：

Abstracts

BACKGROUND  No treatment has surpassed platinum-based chemotherapy in improving overall survival in patients with previously untreated locally advanced or metastatic urothelial carcinoma.

METHODS  We conducted a phase 3, global, open-label, randomized trial to compare the efficacy and safety of enfortumab vedotin and pembrolizumab with the efficacy and safety of platinum-based chemotherapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma. Patients were randomly assigned in a 1:1 ratio to receive 3-week cycles of enfortumab vedotin (at a dose of 1.25 mg per kilogram of body weight intravenously on days 1 and 8) and pembrolizumab (at a dose of 200 mg intravenously on day 1) (enfortumab vedotin-pembrolizumab group) or gemcitabine and either cisplatin or carboplatin (determined on the basis of eligibility to receive cisplatin) (chemotherapy group). The primary end points were progression-free survival as assessed by blinded independent central review and overall survival.

RESULTS  A total of 886 patients underwent randomization: 442 to the enfortumab vedotin-pembrolizumab group and 444 to the chemotherapy group. As of August 8, 2023, the median duration of follow-up for survival was 17.2 months. Progression-free survival was longer in the enfortumab vedotin-pembrolizumab group than in the chemotherapy group (median, 12.5 months vs. 6.3 months; hazard ratio for disease progression or death, 0.45; 95% confidence interval [CI], 0.38 to 0.54; P<0.001), as was overall survival (median, 31.5 months vs. 16.1 months; hazard ratio for death, 0.47; 95% CI, 0.38 to 0.58; P<0.001). The median number of cycles was 12 (range, 1 to 46) in the enfortumab vedotin-pembrolizumab group and 6 (range, 1 to 6) in the chemotherapy group. Treatment-related adverse events of grade 3 or higher occurred in 55.9% of the patients in the enfortumab vedotin-pembrolizumab group and in 69.5% of those in the chemotherapy group.

CONCLUSIONS  Treatment with enfortumab vedotin and pembrolizumab resulted in significantly better outcomes than chemotherapy in patients with untreated locally advanced or metastatic urothelial carcinoma, with a safety profile consistent with that in previous reports. (Funded by Astellas Pharma US and others; EV-302 ClinicalTrials.gov number, NCT04223856.).

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