帕博利珠单抗联合疗法治疗非小细胞肺癌——真实世界实践中的疗效及预测因素

Pembrolizumab-combination therapy for NSCLC- effectiveness and predictive factors in real-world practice.

作者信息

Knetki-Wróblewska Magdalena, Dziadziuszko Rafał, Jankowski Tomasz, Krawczyk Paweł, Bryl Maciej, Stencel Katarzyna, Wrona Anna, Bandura Artur, Smok-Kalwat Jolanta, Rok-Knapińska Jolanta, Szydziak-Zwierzyńska Kinga, Rogoziewicz Krzysztof, Czyżewicz Grzegorz, Wójtowicz Monika, Wojtukiewicz Marek, Kalinka Ewa, Wysocki Piotr J, Łobacz Mateusz, Milanowski Janusz, Pawlik Hubert, Kowalski Dariusz M, Krzakowski Maciej

机构信息

Department of Lung Cancer and Chest Tumours, The Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.

Department of Oncology and Radiotherapy, Medical University of Gdansk, Gdansk, Poland.

出版信息

Front Oncol. 2024 Jan 23;14:1341084. doi: 10.3389/fonc.2024.1341084. eCollection 2024.

DOI:10.3389/fonc.2024.1341084

PMID:38322415

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10844541/

Abstract

INTRODUCTION

Pembrolizumab combined with chemotherapy has become the standard of care for patients with non-small-cell lung cancer (NSCLC) and the expression of programmed death ligand 1 (PD-L1) in <50% of tumour cells (TC).

METHODS

We evaluated the efficacy of the treatment in real-world practice, paying attention to the predictive factors, with a special focus on low level of PD-L1 expression. This study is a multicenter retrospective analysis of patients with stage IV NSCLC.

RESULTS

A group of 339 consecutive patients was analysed, among them 51% patients with low PD-L1 expression. In the overall population, the ORR was 40.6%, median PFS and OS were 13 months (95% CI 11.4-15) and 16.8 months (95% CI 13.3-20.3), respectively. In multivariate analysis for the entire study population, performance status - ECOG 1 vs. 0 (HR 2.2, 95%CI 1.1-4.6; p=0.02), neutrophil to lymphocyte ratio (NLR)>3 (HR 2.3, 95%CI 1.3-4.2; p=0.04), presence of liver (HR 2.0, 95%CI 1-3.7; p=0. 03) and bone metastases (HR 1.3, 95%CI 1-3; p=0.04), weight loss (HR 1.8, 95%CI 1.1-2.8; p=0.01) and sum of measurable lesions diameters >110 mm (HR 1.7, 95%CI 1-2.9, p=0.049) had a negative impact on OS.

CONCLUSIONS

In the real world, patients can clinically benefit from immunochemotherapy, regardless of the expression of PD-L1 and the histological type. Other clinicopathological factors such as performance status, extent, and location of secondary lesions have prognostic significance.

摘要

引言

帕博利珠单抗联合化疗已成为非小细胞肺癌（NSCLC）患者的标准治疗方案，且程序性死亡配体1（PD-L1）在＜50%的肿瘤细胞（TC）中表达。

方法

我们评估了该治疗方案在真实世界中的疗效，关注预测因素，特别关注低水平的PD-L1表达。本研究是对IV期NSCLC患者的多中心回顾性分析。

结果

分析了一组连续的339例患者，其中51%的患者PD-L1表达水平较低。在总体人群中，客观缓解率（ORR）为40.6%，中位无进展生存期（PFS）和总生存期（OS）分别为13个月（95%置信区间11.4 - 15）和16.8个月（95%置信区间13.3 - 20.3）。在对整个研究人群的多因素分析中，体能状态 - 东部肿瘤协作组（ECOG）评分为1 vs. 0（风险比[HR] 2.2，95%置信区间1.1 - 4.6；p = 0.02）、中性粒细胞与淋巴细胞比值（NLR）＞3（HR 2.3，95%置信区间1.3 - 4.2；p = 0.04）、存在肝转移（HR 2.0，95%置信区间1 - 3.7；p = 0.03）和骨转移（HR 1.3，95%置信区间1 - 3；p = 0.04）、体重减轻（HR 1.8，95%置信区间1.1 - 2.8；p = 0.01）以及可测量病灶直径总和＞110 mm（HR 1.7，95%置信区间1 - 2.9，p = 0.049）对总生存期有负面影响。