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信迪利单抗为基础的方案治疗晚期食管癌的真实世界疗效和安全性:一项单中心回顾性观察研究。

Real-World Efficacy and Safety of Sintilimab-Based Regimens against Advanced Esophageal Cancer: A Single-Center Retrospective Observational Study.

机构信息

Department of Radiotherapy, Anyang Tumor Hospital, The Affiliated Anyang Tumor Hospital of Henan University of Science and Technology, Henan Medical Key Laboratory of Precise Prevention and Treatment of Esophageal Cancer, Anyang 455000, China.

出版信息

Biomed Res Int. 2022 Aug 5;2022:7331687. doi: 10.1155/2022/7331687. eCollection 2022.

DOI:10.1155/2022/7331687
PMID:36033564
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9410816/
Abstract

This study is aimed at assessing the sintilimab-based regimens' safety and efficacy for advanced esophageal cancer (EC) treatment in the real world. Cases of advanced EC treated with sintilimab-based regimens in the Anyang Tumor Hospital between 1 January 2020 and 1 August 2021 were retrospectively examined. Progression-free survival (PFS), overall survival (OS), disease control rate (DCR), objective response rate (ORR), and adverse events (AEs) were evaluated. Among the 50 included patients, the median PFS was 11.3 months (95% CI: 5.0-17.6 months), and the 1-year PFS rate was 49.2%. The median OS was not reached, and the 1-year OS rate was 67.1%. Complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) were seen in 14% ( = 7), 46% ( = 23), 32% ( = 16), and 8% ( = 4) of the 50 patients, respectively. Therefore, the ORR and DCR were 60% (30/50) and 92% (46/50), respectively. The CR rate of patients with radiotherapy was higher than that without radiotherapy (25% vs. 3.8%, = 0.031). The 1-year OS rate was higher in patients with radiotherapy than in patients without radiotherapy (85.9% vs. 53.2%, = 0.020). The most observed AEs included anemia, decrease in white blood cell count, nausea/vomiting, and hypoproteinemia. Sintilimab-based regimens achieved good disease control and tolerance for treating advanced EC in the real world. Combined radiotherapy can improve the efficacy and deserves further study.

摘要

这项研究旨在评估信迪利单抗为基础的方案在真实世界中治疗晚期食管癌(EC)的安全性和疗效。回顾性分析了 2020 年 1 月 1 日至 2021 年 8 月 1 日期间安阳肿瘤医院接受信迪利单抗为基础的方案治疗的晚期 EC 病例。评估了无进展生存期(PFS)、总生存期(OS)、疾病控制率(DCR)、客观缓解率(ORR)和不良事件(AEs)。在 50 例纳入患者中,中位 PFS 为 11.3 个月(95%CI:5.0-17.6 个月),1 年 PFS 率为 49.2%。中位 OS 未达到,1 年 OS 率为 67.1%。完全缓解(CR)、部分缓解(PR)、疾病稳定(SD)和疾病进展(PD)分别见于 14%(=7)、46%(=23)、32%(=16)和 8%(=4)的 50 例患者中。因此,ORR 和 DCR 分别为 60%(30/50)和 92%(46/50)。接受放疗患者的 CR 率高于未接受放疗患者(25%比 3.8%,=0.031)。接受放疗患者的 1 年 OS 率高于未接受放疗患者(85.9%比 53.2%,=0.020)。最常见的不良反应包括贫血、白细胞计数减少、恶心/呕吐和低蛋白血症。信迪利单抗为基础的方案在真实世界中治疗晚期 EC 取得了良好的疾病控制和耐受性。联合放疗可以提高疗效,值得进一步研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9853/9410816/ace68ce42a2f/BMRI2022-7331687.003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9853/9410816/42e2c5b0d42e/BMRI2022-7331687.001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9853/9410816/d4334048118b/BMRI2022-7331687.002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9853/9410816/ace68ce42a2f/BMRI2022-7331687.003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9853/9410816/42e2c5b0d42e/BMRI2022-7331687.001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9853/9410816/d4334048118b/BMRI2022-7331687.002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9853/9410816/ace68ce42a2f/BMRI2022-7331687.003.jpg

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Sintilimab versus placebo in combination with chemotherapy as first line treatment for locally advanced or metastatic oesophageal squamous cell carcinoma (ORIENT-15): multicentre, randomised, double blind, phase 3 trial.信迪利单抗联合化疗一线治疗局部晚期或转移性食管鳞癌的随机、双盲、多中心 III 期临床研究(ORIENT-15)
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免疫检查点抑制剂联合或不联合放(化)疗用于局部晚期或复发/转移性食管鳞状细胞癌
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