Abstract
The diagnostic landscape of non-small cell lung cancer (NSCLC) is changing rapidly with the availability of novel treatments. Despite high-level healthcare in the Netherlands, not all patients with NSCLC are tested with the currently relevant predictive tumor markers that are necessary for optimal decision-making for today's available targeted or immunotherapy. An expert workshop on the molecular diagnosis of NSCLC involving pulmonary oncologists, clinical chemists, pathologists, and clinical scientists in molecular pathology was held in the Netherlands on December 10, 2018. The aims of the workshop were to facilitate cross-disciplinary discussions regarding standards of practice, and address recent developments and associated challenges that impact future practice. This paper presents a summary of the discussions and consensus opinions of the workshop participants on the initial challenges of harmonization of the detection and clinical use of predictive markers of NSCLC. A key theme identified was the need for broader and active participation of all stakeholders involved in molecular diagnostic services for NSCLC, including healthcare professionals across all disciplines, the hospitals and clinics involved in service delivery, healthcare insurers, and industry groups involved in diagnostic and treatment innovations. Such collaboration is essential to integrate different technologies into molecular diagnostics practice, to increase nationwide patient access to novel technologies, and to ensure consensus-preferred biomarkers are tested.
Highlights
Worldwide, an estimated 1.2 million–1.4 million deaths occur annually from non-small cell lung cancer (NSCLC) [1, 2]
This paper presents a summary of the discussions and consensus opinions of the workshop participants on the initial challenges of harmonization of the detection and clinical use of predictive markers of NSCLC
These include tumor mutational burden and PDL1, serum tumor markers, and circulating tumor deoxyribonucleic acid (ctDNA) detected with digital polymerase chain reaction (PCR) approaches or next-generation sequencing (NGS), used either alone or as a complement to tissue diagnostics
Summary
An estimated 1.2 million–1.4 million deaths occur annually from non-small cell lung cancer (NSCLC) [1, 2]. Just 2 years after the approval of pembrolizumab in patients with a PD-L1 tumor proportion score of 50% or greater, a phase 3 study of patients with untreated metastatic disease without EGFR mutations or ALK rearrangements/fusions reported that adding pembrolizumab to standard chemotherapy improves overall survival compared with chemotherapy alone, regardless of PD-L1 status [19] The pace of these developments is evident and reveals a tension between validation and implementation of new biomarkers vs the clinical utility and drug labels that necessitate the need for implementation. Given the broad range of test methodologies relevant for predictive markers and their application, an understanding and clinical guidance are needed of the different diagnostic tests for available and emerging biomarkers These include tumor mutational burden and PDL1, serum tumor markers, and ctDNA detected with digital PCR (dPCR) approaches or NGS, used either alone or as a complement to tissue diagnostics
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