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信迪利单抗联合化疗作为转移性食管鳞癌一线治疗的疗效和安全性。

The efficacy and safety of sintilimab combined with chemotherapy as the first-line treatment for metastatic esophageal squamous cell carcinoma.

机构信息

Department of Oncology, Henan Provincial People's Hospital & People's Hospital of Henan University, Zhengzhou, Henan, P.R. China.

出版信息

Medicine (Baltimore). 2023 Aug 18;102(33):e34794. doi: 10.1097/MD.0000000000034794.

Abstract

Immunotherapy is a new treatment option for patients with esophageal squamous cell carcinoma (ESCC). However, no study has investigated the efficacy and safety of sintilimab combined with nanoparticle albumin-bound paclitaxel (Nab-PTX) and platinum as first-line treatment for metastatic ESCC. In this retrospective study, eligible patients with metastatic ESCC were administered sintilimab plus Nab-PTX, cisplatin, or nedaplatin for up to 4 to 6 cycles. Subsequently, patients without progressive disease (PD) continued to receive sintilimab every 3 weeks as maintenance treatment until unacceptable toxicity, PD, withdrawal of consent, or for up to 2 years. The primary endpoint was the objective response rate (ORR) and the secondary endpoints were progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety. A total of 22 patients diagnosed with metastatic ESCC were enrolled, 1 patient reached a complete response (CR), 15 patients achieved a partial response (PR), 4 patients had stable disease, and 2 had PD. The ORR was 72.7% (16/22) and the DCR was 90.9% (20/22). The time to response was 1.9 months (95% confidence interval [CI]:1.7-2.2 months). The median PFS was 8.9 months (95% CI, 7.1-10.7 months), and the median OS was 19.0 months. Exploratory biomarker analysis revealed that lactic dehydrogenase (LDH) was a potential marker for OS, and patients with high LDH levels had shorter mOS (13.0 months, 95% CI:7.5-18.5 months). Treatment-related adverse events (AEs) occurred in 21 patients (95.5%), most of which were grade 1 or 2. No treatment-related deaths occurred in this study. The results of this study suggested that sintilimab combined with Nab-PTX and platinum in patients with metastatic ESCC had a significantly high ORR and encouraging mPFS and mOS. LDH was a potential marker for OS, and the safety profile was manageable.

摘要

免疫疗法是一种治疗食管鳞癌(ESCC)患者的新选择。然而,目前尚无研究探讨信迪利单抗联合白蛋白结合型紫杉醇(Nab-PTX)和铂类药物作为转移性 ESCC 一线治疗的疗效和安全性。在这项回顾性研究中,符合条件的转移性 ESCC 患者接受信迪利单抗联合 Nab-PTX、顺铂或奈达铂治疗,最多 4 至 6 个周期。随后,无疾病进展(PD)的患者继续每 3 周接受信迪利单抗维持治疗,直至出现不可接受的毒性、PD、患者撤回同意或治疗时间最长达 2 年。主要终点是客观缓解率(ORR),次要终点是无进展生存期(PFS)、总生存期(OS)、疾病控制率(DCR)和安全性。共纳入 22 例转移性 ESCC 患者,1 例患者达到完全缓解(CR),15 例患者达到部分缓解(PR),4 例患者病情稳定,2 例患者病情进展。ORR 为 72.7%(16/22),DCR 为 90.9%(20/22)。缓解时间为 1.9 个月(95%CI:1.7-2.2 个月)。中位 PFS 为 8.9 个月(95%CI:7.1-10.7 个月),中位 OS 为 19.0 个月。探索性生物标志物分析显示,乳酸脱氢酶(LDH)是 OS 的潜在标志物,高 LDH 水平的患者 OS 更短(mOS:13.0 个月,95%CI:7.5-18.5 个月)。21 例(95.5%)患者发生治疗相关不良事件(AE),多数为 1 级或 2 级。本研究无治疗相关死亡。该研究结果表明,信迪利单抗联合 Nab-PTX 和铂类药物治疗转移性 ESCC 患者的 ORR 较高,mPFS 和 mOS 有显著改善。LDH 是 OS 的潜在标志物,安全性可管理。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7059/10443762/0af1b5e887f0/medi-102-e34794-g001.jpg

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