The value of disease-free survival (DFS) and osimertinib in adjuvant non-small-cell lung cancer (NSCLC): an international Delphi consensus report

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M.C. Hardenberg¹  B. Patel¹  C. Matthews¹  R. Califano²  R. Garcia Campelo³  C. Grohe⁴  M.H. Hong⁵  G. Liu⁶  S. Lu⁷  F. de Marinis⁸  M. Pérol⁹  R.A. Soo^1,10  B.M. Stiles^1,11  M. Tiseo^1,12  M. Tsuboi^1,13 

[1] Charles River Associates;Department of Medical Oncology, The Christie NHS Foundation Trust and Division of Cancer Sciences, The University of Manchester;Coruña University Hospital;Department of Respiratory Diseases, ELK Thorax Center;Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Severance Hospital, Yonsei University College of Medicine;University of Toronto, Princess Margaret Cancer Centre;Department of Shanghai Lung Cancer Center, Shanghai Jiao Tong University, Shanghai Chest Hospital;European Institute of Oncology;Medical Oncology Department, Léon Bérard Cancer Center;Department of Haematology-Oncology, National University Cancer Institute;Albert Einstein College of Medicine, Montefiore Health System;University of Parma, Department of Medicine and Surgery and Medical Oncology Unit, University Hospital of Parma;Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East

关键词: NSCLC;    DFS;    early stage;    adjuvant treatment;    EGFRm;    ADAURA;   

DOI  :  10.1016/j.esmoop.2022.100572

学科分类：社会科学、人文和艺术（综合）

来源: BMJ Publishing Group

【 摘 要 】

Background Rates of disease recurrence and death following surgery remain high in early-stage non-small-cell lung cancer (NSCLC), despite adjuvant treatment and curative intent. Recently, osimertinib showed overwhelming evidence for disease-free survival (DFS), as demonstrated by an overall reduction in the risk of disease recurrence or death in the adjuvant setting of 80% versus control in the ADAURA study (stage IB-IIIA; hazard ratio 0.20; 99.12% confidence interval 0.14-0.30; P < 0.001). However, due to the early unblinding of ADAURA and lack of mature overall survival data, there is a need to qualitatively confirm consensus on the clinical and patient relevance of DFS.Materials and methods We conducted a modified Delphi panel study consisting of two rounds of surveys, followed by a consensus meeting. An international panel of experts in the field of NSCLC and epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) (n = 13) was asked to rate agreement and comment on a list of pre-defined statements covering key consensus gaps. Statements were eliminated or updated between surveys, depending on the level of agreement. A final list of agreed-upon statements was drafted in the consensus meeting.Results Consensus was reached on 32 qualitative statements, with topics including unmet needs in early-stage NSCLC, the value of DFS, and the value of osimertinib. Crucially, DFS was agreed to be a clinically and patient-relevant endpoint in adjuvant NSCLC. The relevance of DFS was found to relate to the ability of an adjuvant therapy, such as osimertinib, to keep patients in the clinically valuable curative intent setting, while preventing the burden associated with distant and locoregional recurrence, and progressive disease.Conclusions Addressing the need for measures that reflect clinical benefit is essential to continue improving outcomes for NSCLC patients. To that end, this work provides a qualitative framework for clinicians to consider the clinical and patient relevance of DFS in adjuvant NSCLC and the benefit demonstrated in ADAURA thus far.

【 授权许可】

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