Dr Pellini on the Clinical Utility of ctDNA Assays in NSCLC

Bruna Pellini, MD, assistant member, Department of Thoracic Oncology, Moffitt Cancer Center; assistant professor, Morsani College of Medicine, University of South Florida, discusses the potential utility of circulating tumor DNA (ctDNA) assays in clinical practice for non–small cell lung cancer, as well as highlights the need for ongoing research to make this a more accurate, sensitive, and potentially predictive tool for treatment selection.

Pellini begins by noting that ctDNA is a promising prognostic biomarker in oncology. Although ctDNA holds potential for guiding treatment decisions and risk stratification, concerns persist regarding the reliability and clinical utility of current assays due to limitations in assay sensitivity and suitability for longitudinal monitoring, Pellini states, explaining that ctDNA is not ready for use in clinical practice.

Current assays lack the necessary sensitivity to reliably detect minimal residual disease (MRD), Pellini says. False negatives are prevalent in current ctDNA assays, compromising their effectiveness in guiding treatment decisions and longitudinal monitoring, she explains.

Due to these limitations, Pellini opts not to integrate ctDNA testing into her clinical decision-making process. She highlights the need for improved assay technologies to enhance ctDNA sensitivity and accuracy, acknowledging ongoing developments in this area. Testing for ctDNA may be useful for indicating a high risk of disease recurrence in patients, but it may be less useful in guiding adjuvant immunotherapy decisions following chemoimmunotherapy and surgery.

Although many are eager to integrate ctDNA testing into clinical practice, others are hesitant due to the risk of false negatives, Pellini notes. She emphasizes that the current technology does not meet the necessary standards for making treatment decisions, particularly in assessing MRD and predicting disease outcomes accurately. 

Ultimately, it is vital to develop enhanced treatment strategies in the adjuvant setting for patients with micro-metastatic disease detected by ctDNA, Pellini adds. Further research and technological advancements are needed to enhance the sensitivity and accuracy of ctDNA assays to realize their full potential as valuable tools in cancer management, Pellini concludes.