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PD-1/PD-L1抑制剂单药用于一线治疗高PD-L1表达的晚期非小细胞肺癌患者:专家立场声明

PD-1/PD-L1 Inhibitors as Monotherapy in the First-Line Treatment of Advanced Non-Small Cell Lung Cancer Patients with High PD-L1 Expression: An Expert Position Statement.

作者信息

Isla Dolores, Sánchez Alfredo, Casal Joaquín, Cobo Manuel, Majem Margarita, Reguart Noemi, Zugazagoitia Jon, Bernabé Reyes

机构信息

Medical Oncology Department, University Hospital Lozano Blesa, 50009 Zaragoza, Spain.

Medical Oncology Department, Consorci Hospitalari Provincial de Castelló, 12002 Castelló, Spain.

出版信息

J Clin Med. 2023 Aug 1;12(15):5063. doi: 10.3390/jcm12155063.

DOI:10.3390/jcm12155063
PMID:37568465
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10420126/
Abstract

INTRODUCTION

There are currently three first-line immunotherapy options used as monotherapy in advanced non-small cell lung cancer (NSCLC) patients with high programmed death ligand 1 (PD-L1) expression (≥50%). This manuscript aims to evaluate the available data on atezolizumab (AT), cemiplimab (CEMI), and pembrolizumab (PEMBRO) and to study the results obtained during pivotal trials, especially regarding patient subgroups.

METHODS

Nominal group and Delphi techniques were used. Eight Spanish experts in lung cancer (the scientific committee of the project) analyzed the use of immunotherapy monotherapy as first-line treatment in patients with NSCLC and high PD-L1 expression. The expert scientific committee formulated several statements based on a scientific review and their own clinical experience. Subsequently, 17 additional Spanish lung cancer experts were selected to appraise the committee's statements through two Delphi rounds. They completed a Delphi round via an online platform and voted according to a scale from 1 (strongly disagree) to 10 (strongly agree). The statements were approved if ≥70% of experts voted 7 or more.

RESULTS

A total of 20 statements were proposed covering the following areas: (1) general characteristics of pivotal clinical trials; (2) overall main outcomes of pivotal clinical trials; and (3) subgroup analysis. All statements reached consensus in the first round.

CONCLUSIONS

AT, CEMI, and PEMBRO as monotherapy can be considered the standard of care in patients with advanced NSCLC and high PD-L1 expression (≥50%). Moreover, some differences noted among the drugs analyzed in this document might facilitate treatment decision-making, especially in clinically relevant patient subgroups, when using PD-1/PD-L1 inhibitors. The high level of agreement reached among experts supports the proposed statements.

摘要

引言

目前,有三种一线免疫疗法可作为单药疗法用于程序性死亡配体1(PD-L1)高表达(≥50%)的晚期非小细胞肺癌(NSCLC)患者。本手稿旨在评估阿替利珠单抗(AT)、西米普利单抗(CEMI)和帕博利珠单抗(PEMBRO)的现有数据,并研究关键试验期间获得的结果,特别是关于患者亚组的结果。

方法

采用名义组法和德尔菲技术。八位西班牙肺癌专家(项目科学委员会)分析了免疫疗法单药作为NSCLC和高PD-L1表达患者一线治疗的使用情况。专家科学委员会根据科学综述和他们自己的临床经验制定了若干声明。随后,又挑选了17位西班牙肺癌专家,通过两轮德尔菲法对委员会的声明进行评估。他们通过在线平台完成一轮德尔菲法,并根据从1(强烈不同意)到10(强烈同意)的量表进行投票。如果≥70%的专家投票为7或更高,则声明获得批准。

结果

共提出20项声明,涵盖以下领域:(1)关键临床试验的一般特征;(2)关键临床试验的总体主要结果;(3)亚组分析。所有声明在第一轮中达成共识。

结论

AT、CEMI和PEMBRO作为单药疗法可被视为晚期NSCLC和高PD-L1表达(≥50%)患者的标准治疗。此外,本文分析的药物之间存在的一些差异可能有助于治疗决策,特别是在使用PD-1/PD-L1抑制剂时,对于临床相关的患者亚组。专家们达成的高度共识支持了所提出的声明。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0921/10420126/373d1be8ff09/jcm-12-05063-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0921/10420126/373d1be8ff09/jcm-12-05063-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0921/10420126/373d1be8ff09/jcm-12-05063-g001.jpg

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