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替雷利珠单抗治疗宫颈癌:一项回顾性研究及相关血液生物标志物分析。

Tislelizumab for cervical cancer: A retrospective study and analysis of correlative blood biomarkers.

机构信息

State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Gynecology, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, China.

State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Radiation Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, China.

出版信息

Front Immunol. 2023 Feb 15;14:1113369. doi: 10.3389/fimmu.2023.1113369. eCollection 2023.

DOI:10.3389/fimmu.2023.1113369
PMID:36875089
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9975598/
Abstract

BACKGROUND

Tislelizumab is an anti-programmed cell death 1 (PD-1) monoclonal antibody engineered to minimize binding to Fcγ receptors. It has been used to treat several solid tumors. However, its efficacy and toxicity, and the predictive and prognostic value of baseline hematological parameters in patients with recurrent or metastatic cervical cancer (R/M CC) receiving tislelizumab remain unclear.

METHODS

We reviewed 115 patients treated for R/M CC with tislelizumab from March 2020 to June 2022 in our institute. The antitumor activity of tislelizumab was assessed using RECIST v1.1. Associations between the baseline hematological parameters and efficacy of tislelizumab in these patients were analyzed.

RESULTS

With a median follow-up of 11.3 months (range, 2.2-28.7), the overall response rate was 39.1% (95% CI, 30.1-48.2) and the disease control rate was 77.4% (95% CI, 69.6-85.2). The median progression-free survival (PFS) was 19.6 months (95% CI, 10.7 to not reached). The median overall survival (OS) was not reached. Treatment-related adverse events (TRAEs) of any grade occurred in 81.7% of the patients and only 7.0% of the patients experienced grade 3 or 4 TRAEs. Univariate and multivariate regression analyses showed that the level of pretreatment serum C-reactive protein (CRP) was an independent risk factor for the response (complete or partial response) to tislelizumab and the PFS of R/M CC patients treated with tislelizumab ( = 0.0001 and = 0.002, respectively). R/M CC patients with elevated baseline CRP levels had a short PFS ( = 0.0005). Additionally, the CRP-to-albumin ratio (CAR) was an independent risk factor for the PFS and OS of R/M CC patients treated with tislelizumab ( = 0.001 and = 0.031, respectively). R/M CC patients with an elevated baseline CAR had short PFS and OS ( < 0.0001 and = 0.0323, respectively).

CONCLUSIONS

Tislelizumab showed promising antitumor activity and tolerable toxicity in patients with R/M CC. The baseline serum CRP levels and CAR showed potential for predicting the efficacy of tislelizumab and the prognosis of R/M CC patients receiving tislelizumab.

摘要

背景

替雷利珠单抗是一种抗程序性死亡受体 1(PD-1)的单克隆抗体,经过工程改造以最小化与 Fcγ 受体的结合。它已被用于治疗多种实体瘤。然而,替雷利珠单抗在接受治疗的复发性或转移性宫颈癌(R/M CC)患者中的疗效和毒性,以及基线血液学参数的预测和预后价值尚不清楚。

方法

我们回顾了 2020 年 3 月至 2022 年 6 月期间在我院接受替雷利珠单抗治疗的 115 例 R/M CC 患者的资料。使用 RECIST v1.1 评估替雷利珠单抗的抗肿瘤活性。分析这些患者的基线血液学参数与替雷利珠单抗疗效之间的关系。

结果

中位随访时间为 11.3 个月(范围:2.2-28.7),总体缓解率为 39.1%(95%CI,30.1-48.2),疾病控制率为 77.4%(95%CI,69.6-85.2)。中位无进展生存期(PFS)为 19.6 个月(95%CI,10.7-未达到)。中位总生存期(OS)尚未达到。任何等级的治疗相关不良事件(TRAEs)发生在 81.7%的患者中,仅有 7.0%的患者发生 3 级或 4 级 TRAEs。单因素和多因素回归分析表明,治疗前血清 C 反应蛋白(CRP)水平是接受替雷利珠单抗治疗的 R/M CC 患者对治疗有反应(完全或部分缓解)和 PFS 的独立危险因素( = 0.0001 和 = 0.002)。基线 CRP 水平升高的 R/M CC 患者 PFS 较短( = 0.0005)。此外,CRP 与白蛋白比值(CAR)是接受替雷利珠单抗治疗的 R/M CC 患者 PFS 和 OS 的独立危险因素( = 0.001 和 = 0.031)。基线 CAR 升高的 R/M CC 患者 PFS 和 OS 较短( < 0.0001 和 = 0.0323)。

结论

替雷利珠单抗在 R/M CC 患者中显示出有前景的抗肿瘤活性和可耐受的毒性。基线血清 CRP 水平和 CAR 具有预测替雷利珠单抗疗效和 R/M CC 患者预后的潜力。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a270/9975598/1e13b12aad64/fimmu-14-1113369-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a270/9975598/a03b857dbf31/fimmu-14-1113369-g001.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a270/9975598/7638d8491c86/fimmu-14-1113369-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a270/9975598/1e13b12aad64/fimmu-14-1113369-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a270/9975598/a03b857dbf31/fimmu-14-1113369-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a270/9975598/c86299eecb43/fimmu-14-1113369-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a270/9975598/6f1512a987f9/fimmu-14-1113369-g003.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a270/9975598/1e13b12aad64/fimmu-14-1113369-g006.jpg

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