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一线帕博利珠单抗治疗晚期非小细胞肺癌且PD-L1高表达患者:来自西班牙一项多中心研究的真实世界数据

First-line pembrolizumab in patients with advanced non-small cell lung cancer and high PD-L1 expression: real-world data from a Spanish multicenter study.

作者信息

Piedra Aida, Martínez-Recio Sergio, Hernández Ainhoa, Morán Teresa, Arriola Edurne, Recuero-Borau Jordi, Cobo Manuel, Cordeiro Patricia, Mosquera Joaquín, Fernández Manuel, García-Campelo Rosario, Calles Antonio, Álvarez Rosa, Zapata-García María, Isla Dolores, Callejo Ana, Iranzo Patricia, Serra-López Jorgina, Barba Andrés, Sullivan Ivana, Felip Enriqueta, Majem Margarita

机构信息

Medical Oncology Department. Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.

Department of Medicine, Universitat Autònoma de Barcelona (UAB), Barcelona, Spain.

出版信息

Front Oncol. 2024 Dec 17;14:1510278. doi: 10.3389/fonc.2024.1510278. eCollection 2024.

Abstract

INTRODUCTION

Pembrolizumab stands as a first-line option for patients with advanced non-small cell lung cancer (NSCLC) and high programmed death-ligand 1 (PD-L1) expression (PD-L1 ≥50%). Several factors such as antibiotic exposure, low body mass index (BMI), certain metastatic location or poor performance status may influence outcomes.

METHODS

We conducted a multicenter retrospective analysis in a cohort of patients with advanced high PD-L1 expression NSCLC treated with first-line pembrolizumab in clinical practice. We sought to evaluate clinical outcomes according to several factors.

RESULTS

Among the 494 included patients, median age was 67.29 years, 77% were male, 54% and 38% were former or current smokers, respectively; 84% had an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1, and 48% had a BMI of <25. 32% of patients had bone metastases, 32% brain metastases and 16% liver metastases. 35% of patients had exposure to antibiotics (AB), 44% to corticosteroids and 62% to proton pump inhibitors (PPi). With a median follow-up of 14.3 months, the median overall survival (OS) and progression-free survival (PFS) were 15.9m (95% CI 13.1 to 18.8) and 9.9m (95% CI 7.7 to 12.1), and the overall response rate (ORR) was 43%. After univariate analysis, median OS in patients with ECOG-PS 0 vs. 1 vs. 2 was 36.7m vs. 14.8m vs. 2.7m (p<0.001). Median OS in patients who received treatment with corticosteroids vs. patients without exposure was 11.4m vs. 22.3m (p<0.001). After multivariate analysis, corticosteroid exposure (HR 1.41) and ECOG-PS (HR 2.40) maintained a prognostic impact.

DISCUSSION

First-line pembrolizumab outcomes in advanced high PD-L1 expression NSCLC patients could be negatively influenced by corticosteroid exposure or poor ECOG-PS.

摘要

引言

帕博利珠单抗是晚期非小细胞肺癌(NSCLC)且程序性死亡配体1(PD-L1)高表达(PD-L1≥50%)患者的一线治疗选择。抗生素暴露、低体重指数(BMI)、某些转移部位或体能状态差等多种因素可能会影响治疗结果。

方法

我们对临床实践中接受一线帕博利珠单抗治疗的晚期高PD-L1表达NSCLC患者队列进行了多中心回顾性分析。我们试图根据多种因素评估临床结果。

结果

在纳入的494例患者中,中位年龄为67.29岁,77%为男性,既往或当前吸烟者分别占54%和38%;84%的东部肿瘤协作组(ECOG)体能状态(PS)为0-1,48%的BMI<25。32%的患者有骨转移,32%有脑转移,16%有肝转移。35%的患者曾使用抗生素(AB),44%使用过皮质类固醇,62%使用过质子泵抑制剂(PPi)。中位随访时间为14.3个月,中位总生存期(OS)和无进展生存期(PFS)分别为15.9个月(95%CI 13.1至18.8)和9.9个月(95%CI 7.7至12.1),总缓解率(ORR)为43%。单因素分析后,ECOG-PS为0、1、2的患者中位OS分别为36.7个月、14.8个月、2.7个月(p<0.001)。接受皮质类固醇治疗的患者与未暴露患者的中位OS分别为11.4个月和22.3个月(p<0.001)。多因素分析后,皮质类固醇暴露(HR 1.41)和ECOG-PS(HR 2.40)仍具有预后影响。

讨论

晚期高PD-L1表达NSCLC患者一线使用帕博利珠单抗的治疗结果可能会受到皮质类固醇暴露或ECOG-PS差的负面影响。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dfe6/11686446/94f114effc76/fonc-14-1510278-g001.jpg

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