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美国复发性/转移性头颈部鳞状细胞癌(R/M HNSCC)中的程序性死亡受体配体1(PD-L1)检测模式

PD-L1 testing patterns in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) in the U.S.

作者信息

Hanna Glenn J, Zheng Dandan, Gao Wei, Hair Gleicy M, Ai Lei, Song Yan, Lerman Nati, Bidadi Behzad, Zion Abigail, Zou Lin, Tang Yuexin, Wang Liya, Merchant Sanjay, Black Christopher M

机构信息

Center for Head and Neck Oncology, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA 02215, USA.

Value and Implementation, Outcomes Research, Merck & Co., Inc., 126 East Lincoln Avenue, Rahway, NJ 07065, USA.

出版信息

Oral Oncol. 2025 Feb;161:107146. doi: 10.1016/j.oraloncology.2024.107146. Epub 2025 Jan 3.

DOI:10.1016/j.oraloncology.2024.107146
PMID:39754998
Abstract

BACKGROUND

Pembrolizumab with/without platinum + 5-FU is approved for the first-line (1L) treatment of R/M HNSCC, and its monotherapy use requires PD-L1 Combined Positive Score (CPS) ≥ 1. We aimed to understand PD-L1 testing patterns and associations with patient characteristics and treatment choice in R/M HNSCC.

METHODS

Adults with R/M HNSCC initiating 1L systemic therapy were included from a U.S. nationwide database primarily compromised of community practices (07/01/2019-12/31/2023). PD-L1 testing patterns, treatment sequence, and time gaps related to testing and treatment initiation were summarized. Logistic regression was used to test associations between patient characteristics and PD-L1 testing patterns, and between CPS scores and 1L pembrolizumab monotherapy use.

RESULTS

Of 2,207 patients, 32.7 % received PD-L1 testing before 1L therapy initiation, 17.4 % after 1L therapy initiation, and 50.0 % were never tested. Most patients (55.9 %) who tested positive before 1L therapy received pembrolizumab monotherapy while those who tested negative received pembrolizumab + platinum + 5-FU most commonly (31.6 %). Among patients untested before 1L therapy, the most common 1L treatment was pembrolizumab monotherapy (24.3 %). Patients with an ECOG ≥ 2 had higher odds of being tested before 1L therapy (OR: 1.42, p < 0.01). CPS scores were associated with higher odds of receiving 1L pembrolizumab monotherapy (OR: 4.11 and 4.96 for CPS 1-19 and ≥ 20, respectively; both p < 0.0001).

CONCLUSIONS

This study revealed low utilization of PD-L1 testing to guide treatment choice and impactful gaps between specimen collection, the receipt of results, and 1L therapy initiation. There is a need to improve clinician awareness of the importance of PD-L1 testing and an opportunity for updated guidelines on testing.

摘要

背景

帕博利珠单抗联合或不联合铂类+5-氟尿嘧啶被批准用于复发/转移性头颈部鳞状细胞癌(R/M HNSCC)的一线(1L)治疗,其单药治疗要求程序性死亡受体配体1(PD-L1)联合阳性评分(CPS)≥1。我们旨在了解R/M HNSCC中PD-L1检测模式及其与患者特征和治疗选择的关联。

方法

纳入来自美国一个主要由社区医疗机构组成的全国性数据库中开始接受1L全身治疗的成年R/M HNSCC患者(2019年7月1日至2023年12月31日)。总结了PD-L1检测模式、治疗顺序以及与检测和治疗开始相关的时间间隔。采用逻辑回归分析来检验患者特征与PD-L1检测模式之间以及CPS评分与1L帕博利珠单抗单药治疗使用之间的关联。

结果

在2207例患者中,32.7%在开始1L治疗前接受了PD-L1检测,17.4%在开始1L治疗后接受了检测,50.0%从未接受检测。大多数在1L治疗前检测呈阳性的患者(55.9%)接受了帕博利珠单抗单药治疗,而检测呈阴性的患者最常接受帕博利珠单抗+铂类+5-氟尿嘧啶治疗(31.6%)。在1L治疗前未接受检测的患者中,最常见的1L治疗是帕博利珠单抗单药治疗(24.3%)。东部肿瘤协作组(ECOG)评分≥2的患者在1L治疗前接受检测的几率更高(比值比:1.42,p<0.01)。CPS评分与接受1L帕博利珠单抗单药治疗的较高几率相关(CPS 1-19和≥20时的比值比分别为4.11和4.96;p均<0.0001)。

结论

本研究显示,PD-L1检测在指导治疗选择方面的利用率较低,在标本采集、结果接收和1L治疗开始之间存在显著差距。有必要提高临床医生对PD-L1检测重要性的认识,并且有机会更新检测指南。

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