Abstract 99P
Background
Rates of disease recurrence following surgery remain high in early-stage NSCLC, despite adjuvant treatment and curative intent. Recently, osimertinib demonstrated an overall reduction in the risk of disease recurrence or death in the adjuvant setting of 80% vs control in the ADAURA study (Stage IB-IIIA; HR 0.20; 99.12% CI, 0.14 to 0.30; P<0.001). Despite the overwhelming evidence for disease-free survival (DFS) shown in ADAURA, consensus on its clinical and patient relevance remained unclear. As such, this study sought to validate the value of DFS as an endpoint in the context of adjuvant treatments in NSCLC.
Methods
To validate the value of DFS and the impact of osimertinib in adjuvant NSCLC, we conducted a modified Delphi panel study consisting of two rounds of surveys. An international panel of medical oncologists and thoracic surgeons, with expertise in the field of NSCLC and EGFR-TKIs (n=13), commented on a set of pre-defined statements, covering key consensus gaps. These were then discussed in a consensus meeting, which resulted in a final list of agreed-upon statements.
Results
Consensus was reached on 32 key statements, with topics including unmet needs in early-stage NSCLC, the value of DFS, and the value of osimertinib in adjuvant NSCLC. Crucially, it was agreed that DFS is a clinically and patient relevant endpoint in adjuvant NSCLC.
Conclusions
Addressing the need for measures that reflect clinical benefit is essential to continue improving outcomes for NSCLC patients. To that end, this study shows that DFS is a relevant endpoint in adjuvant NSCLC, both clinically and from a patient perspective. The relevance of DFS relates 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 recurrence and progressive disease.
Editorial acknowledgement
The following consensus study pannellists provided their support: Raffaele Califano, Rosario García Campelo, Christian Grohe, Min Hee Hong, Geoffrey Liu, Shun Lu, Filippo de Marinis, Maurice Pérol, Ross A. Soo, Brandon M. Stiles, Marcello Tiseo, and Masahiro Tsuboi.
Legal entity responsible for the study
The authors.
Funding
AstraZeneca.
Disclosure
All authors have declared no conflicts of interest.