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辅助奥希替尼治疗期间或之后非小细胞肺癌复发的治疗决策:一份国际德尔菲共识报告

Treatment decision for recurrences in non-small cell lung cancer during or after adjuvant osimertinib: an international Delphi consensus report.

作者信息

Mirza Myriam, Shrivastava Aseem, Matthews Cecile, Leighl Natasha, Ng Calvin S H, Planchard David, Popat Sanjay, Rotow Julia, Smit Egbert F, Soo Ross, Tsuboi Masahiro, Yang Fan, Stiles Brendon, Grohe Christian, Wu Yi-Long

机构信息

Charles River Associates, Munich, Germany.

Charles River Associates, Cambridge, United Kingdom.

出版信息

Front Oncol. 2024 Jan 23;13:1330468. doi: 10.3389/fonc.2023.1330468. eCollection 2023.

Abstract

INTRODUCTION

Osimertinib is recommended by major guidelines for use in the adjuvant setting in patients with EGFR mutation-positive NSCLC following the significant improvement in disease-free survival observed in the Phase III ADAURA trials. Due to limited real-world data in the adjuvant setting, little guidance exists on how to approach potential recurrences either during or after the completion of the treatment. This study aimed to reach a broad consensus on key treatment decision criteria in the events of recurrence.

METHODS

To reach a broad consensus, a modified Delphi panel study was conducted consisting of two rounds of surveys, followed by two consensus meetings and a final offline review of key statements. An international panel of experts in the field of NSCLC (n=12) was used to provide clinical insights regarding patient management at various stages of NSCLC disease including patient monitoring, diagnostics, and treatment approach for specific recurrence scenarios. This study tested recurrences occurring 1) within or outside the central nervous system (CNS), 2) during or after the adjuvant-osimertinib regimen in NSCLC disease which is 3) amenable or not amenable to local consolidative therapy.

RESULTS

Panellists agreed on various aspects of patient monitoring and diagnostics including the use of standard techniques (e.g., CT, MRI) and tumour biomarker assessment using tissue and liquid biopsies. Consensus was reached on 6 statements describing treatment considerations for the specific NSCLC recurrence scenarios. Panellists agreed on the value of osimertinib as a monotherapy or as part of the overall treatment strategy within the probed recurrence scenarios and acknowledged that more clinical evidence is required before precise recommendations for specific patient populations can be made.

DISCUSSION

This study provides a qualitative expert opinion framework for clinicians to consider within their treatment decision-making when faced with recurrence during or after adjuvant-osimertinib treatment.

摘要

引言

在III期ADAURA试验中观察到无病生存期有显著改善后,奥希替尼被主要指南推荐用于表皮生长因子受体(EGFR)突变阳性的非小细胞肺癌(NSCLC)患者的辅助治疗。由于辅助治疗环境中的真实世界数据有限,对于在治疗期间或治疗完成后如何应对潜在复发几乎没有指导意见。本研究旨在就复发事件中的关键治疗决策标准达成广泛共识。

方法

为达成广泛共识,开展了一项改良的德尔菲小组研究,包括两轮调查,随后是两次共识会议以及对关键声明的最终线下审查。使用一个NSCLC领域的国际专家小组(n = 12),就NSCLC疾病各个阶段的患者管理提供临床见解,包括患者监测、诊断以及特定复发情况的治疗方法。本研究测试了在以下情况下发生的复发:1)中枢神经系统(CNS)内或外;2)在NSCLC疾病的辅助奥希替尼治疗方案期间或之后;3)适合或不适合局部巩固治疗。

结果

小组成员在患者监测和诊断的各个方面达成了一致,包括使用标准技术(如CT、MRI)以及使用组织活检和液体活检进行肿瘤生物标志物评估。就描述特定NSCLC复发情况治疗考虑因素的6项声明达成了共识。小组成员认同奥希替尼作为单一疗法或在所探究的复发情况下作为整体治疗策略一部分的价值,并承认在能够针对特定患者群体给出精确建议之前,还需要更多临床证据。

讨论

本研究为临床医生在辅助奥希替尼治疗期间或之后面临复发时的治疗决策提供了一个定性的专家意见框架。

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Overall Survival with Osimertinib in Resected -Mutated NSCLC.奥希替尼治疗可切除突变型 NSCLC 的总生存期。
N Engl J Med. 2023 Jul 13;389(2):137-147. doi: 10.1056/NEJMoa2304594. Epub 2023 Jun 4.

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