LIBELULE: A Randomized Phase III Study to Evaluate the Clinical Relevance of Early Liquid Biopsy in Patients With Suspicious Metastatic Lung Cancer
Year: 2024
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: OBJECTIVES: Genomic profiling is a major component for first-line treatment decisions in patients with NSCLC and the timeliness of biomarker testing is essential to improve time to treatment initiation (TTI) or avoid inappropriate treatment. METHODS: The phase III LIquid Biopsy for the Early detection of LUng cancer Lesion trial (NCT03721120) included patients with radiological suspicion of advanced lung cancer. They were randomized (1:1), the control arm receiving diagnostic procedures according to each center's practice, and the liquid biopsy arm with additional testing performed at the first visit using the InVisionFirst-Lung assay. Treatment initiation and type were defined according to the European Society for Medical Oncology guidelines. Primary endpoint was the time from randomization to initiation of appropriate treatment on the basis of informative genomic and pathological results in the intention-to-treat population. RESULTS: A total of 319 patients were enrolled (liquid biopsy [LB]: 161; control: 158). The median age was 68 years, 28.8% were non-smokers, 18.1% had a performance status of 2 or higher, and 56.7% had adenocarcinoma. In the LB arm, 81% of patients had circulating tumor DNA findings. The mean TTI was not significantly reduced (LB: 29.0 d; control 34 d (p = 0.26)). Sensitivity analyses found a shorter TTI in patients from the LB arm who received systemic treatment (LB: 29.1 d; control: 38.9 d, p = 0.01), in patients with advanced non-squamous NSCLC (LB: 29.5 d; control: 40.3 d, p = 0.01), and in patients with first-line targetable alterations (LB: 21d; control 37.4 d) (p = 0.004). Time to contributory genomic results was significantly reduced (LB: 17.9 d; control: 25.6 d, p < 0.001). CONCLUSION: Early liquid biopsy testing did not significantly shorten the TTI in unselected patients referred for suspected advanced lung cancer. Nevertheless, it could reduce the TTI in patients eligible for systemic treatment, particularly for those with actionable alterations.
Source: Journal of Thoracic Oncology
Authors: Aurélie Swalduz, Camille Schiffler, Hubert Curcio, Bana Ambasager, Gabriel Le Moel, Didier Debieuvre, Jean-Marc Dot, Michael Duruisseaux, Pierre Fournel, Luc Odier, Sylvie Demolombe, Acya Bizieux-Thaminy, Annie Peytier, Roland Schott, Stéphane Hominal, Claire Tissot, Pierre Bombaron, Séverine Metzger, Mathilde Donnat, Sandra Ortiz-Cuaran, Nitzan Rosenfeld, Christodoulos Pipinikas, Pierre Saintigny, Maurice Pérol
Institutions: Lyon 1 Université, Centre National de la Recherche Scientifique, Inserm, Centre Léon Bérard, Centre de Recherche en Cancérologie de Lyon, Centre François Baclesse, Centre Hospitalier Public du Cotentin, Groupe Hospitalier de la Région de Mulhouse et Sud Alsace, Hospices Civils de Lyon, Hôpital Louis Pradel, Centre Hospitalier Universitaire de Saint-Étienne, Infirmerie Protestante, Centre Hospitalier Départemental Vendée, Institut de Cancérologie Strasbourg, Centre Hospitalier Annecy Genevois, Hôpital Privé Jean Mermo, Queen Mary University of London, University of Cambridge, Cancer Research UK, Cancer Research UK Cambridge Center, Barts Cancer Institute
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,000
OpenAlex ID: W4405430873