早期治疗中C反应蛋白及其动力学预测接受一线pembrolizumab治疗的癌症复发和/或转移患者的生存率和反应。

IF 3 3区 医学 Q2 ONCOLOGY Investigational New Drugs Pub Date : 2023-10-01 Epub Date: 2023-08-21 DOI:10.1007/s10637-023-01388-x
Markus Haas, Alexander Lein, Thorsten Fuereder, Julia Schnoell, Faris F Brkic, David T Liu, Lorenz Kadletz-Wanke, Gregor Heiduschka, Bernhard J Jank
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引用次数: 0

摘要

目的:一线免疫检查点阻断可以改善复发和/或转移性头颈部鳞状细胞癌(R/M HNSCC)的预后,但有效率仍然很低。在本研究中,我们旨在研究CRP及其早期动力学对预测R/M HNSCC的反应和生存率的预后价值。方法:对87例接受一线pembrolizumab治疗R/M HNSCC的患者进行分析。使用三重交叉验证来估计基线和治疗时(第40天)CRP的临界点 ± 10) 。根据早期CRP动力学分析治疗反应和生存率。中性粒细胞与淋巴细胞比率(NLR)被用作CRP预后表现的基准。结果:治疗时CRP低于2 mg/dl(正常上限(ULN)的4倍)与总生存率(OS)增加相关,而治疗时CRP高于3 mg/dl(ULN的6倍)与疾病控制率(DCR)和无进展生存率(PFS)增加相关。与CRP无应答者相比,CRP突发应答者和CRP应答者表现出更高的DCR和更长的PFS。NLR高于6是进展的负面预测因素。在多变量分析中,治疗时CRP是OS的唯一显著预测因素(HR:4.97,CI95%CI:2.18-11.32,p 结论:在接受一线pembrolizumab治疗的R/M HNSCC患者中,治疗中CRP被确定为客观反应和生存率的预后生物标志物,并且可以很容易地作为一种广泛可用且具有成本效益的生物标志物纳入临床实践。
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Early on-treatment C-reactive protein and its kinetics predict survival and response in recurrent and/or metastatic head and neck cancer patients receiving first-line pembrolizumab.

Purpose: First-line immune checkpoint blockade has improved the prognosis of recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC), but response rates remain low. In this study, we aimed to investigate the prognostic value of CRP and its early kinetics to predict response and survival in R/M HNSCC.

Methods: A total of 87 patients who received first-line pembrolizumab for R/M HNSCC were analyzed. Three-fold cross-validation was used to estimate cut-off points of CRP at baseline and on-treatment (day 40 ± 10). Treatment response and survival were analyzed according to early CRP kinetics. The neutrophil-to-lymphocyte ratio (NLR) was used as a benchmark for the prognostic performance of CRP.

Results: On-treatment CRP below 2 mg/dl, 4x the upper limit of normal (ULN), was associated with increased overall survival (OS), while on-treatment CRP below 3 mg/dl (6x ULN) was correlated with a higher disease control rate (DCR) and increased progression-free survival (PFS). CRP flare-responders and CRP responders showed a higher DCR and longer PFS than CRP non-responders. An NLR above 6 was a negative prognosticator for progression. In multivariable analysis, on-treatment CRP prevailed as the only significant prognosticator for OS (HR: 4.97, CI95%: 2.18-11.32, p < 0.001) and PFS (HR: 2.07, CI95%: 1.07-3.99, p = 0.030).

Conclusion: On-treatment CRP was identified as a prognostic biomarker for objective response and survival in R/M HNSCC patients receiving first-line pembrolizumab and could be easily incorporated into clinical practice as a widely available and cost-effective biomarker.

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来源期刊
CiteScore
7.60
自引率
0.00%
发文量
121
审稿时长
1 months
期刊介绍: The development of new anticancer agents is one of the most rapidly changing aspects of cancer research. Investigational New Drugs provides a forum for the rapid dissemination of information on new anticancer agents. The papers published are of interest to the medical chemist, toxicologist, pharmacist, pharmacologist, biostatistician and clinical oncologist. Investigational New Drugs provides the fastest possible publication of new discoveries and results for the whole community of scientists developing anticancer agents.
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