■在ADAURAIII期试验中观察到无病生存期显著改善后,主要指南推荐将奥希替尼用于EGFR突变阳性NSCLC患者的辅助治疗。由于佐剂设置中的真实数据有限,关于如何在治疗期间或完成后处理潜在的复发,目前几乎没有指导.本研究旨在就复发事件的关键治疗决策标准达成广泛共识。
■为了达成广泛共识,进行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和对关键声明的最终离线审查。NSCLC领域的国际专家小组(n=12)用于提供关于NSCLC疾病各个阶段的患者管理的临床见解,包括患者监测。诊断,以及针对特定复发情况的治疗方法。这项研究测试了在中枢神经系统(CNS)内部或外部发生的复发1),2)在NSCLC疾病的辅助-奥希替尼方案期间或之后,3)适合或不适合局部巩固治疗。
■小组成员就患者监测和诊断的各个方面达成了共识,包括使用标准技术(例如,CT,MRI)和使用组织和液体活检的肿瘤生物标志物评估。就描述特定NSCLC复发情况的治疗考虑因素的6个陈述达成共识。小组成员同意奥希替尼作为单一疗法或作为所探测复发方案中整体治疗策略的一部分的价值,并承认在针对特定患者人群提出精确建议之前需要更多的临床证据。
■本研究提供了一个定性的专家意见框架,供临床医生在奥希替尼辅助治疗期间或之后面临复发时,在其治疗决策中考虑。
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.