Aims Heterogeneous implementation of molecular tests in current diagnostic algorithm at a European and international level is emerging as a major issue for efficient lung cancer molecular profiling.
Methods From May 2017 until October 2017, N=1612 patients referring to 13 Italian institutions were selected, at advanced stage non-small cell lung cancer (NSCLC), and prospectively evaluated. Principal endpoints were: the percentage of diagnoses performed on cytological and histological material, the proportion of requests for epidermal growth factor receptor (EGFR) mutational status, and resistance mutations detected on tissue and/or liquid biopsy samples after first-generation or second-generation tyrosine kinase inhibitors, the proportion of requests for anaplastic lymphoma kinase (ALK) gene rearrangements, ROS proto-oncogene 1 (ROS1) and Kirsten Rat Sarcoma (KRAS) determinations, the proportion of requests for programmed death-ligand1 (PD-L1) evaluation and, finally, the different assays used for the detection of EGFR mutations, ALK and ROS1 gene rearrangements and PD-L1 expression.
Results Of 1325 patients finally included, only 50.8% requests were related to driver mutations with target agents already available in first-line at that preplanned time, while 49.2% were associated with PD-L1, ROS1, KRAS and others. Multiplex genomic assays (such as next-generation sequencing) were considered by all participating centres.
Conclusions To the best of our knowledge, this is the first study in a ‘real-life daily practice’ involving both pathologists and oncologists evaluating routinely workflow and trends towards improvements in molecular requests. Collected data aim to describe the applied algorithms and evolution of molecular screening for stage IV NSCLC in clinical practice.
- molecular biology
- lung neoplasms
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Handling editor Runjan Chetty.
Contributors All authors concepted the design of the study, the acquisition of data, the final analysis and interpretation of data. All authors reviewed the manuscript and accepted to submit the paper in its present form.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests TV, PP, CV, VL, MP, AL, PG, RM, FB, AS, LM, SG, LB, IC, LR and OB: no competing interests. UM reports personal fees from Boehringer Ingelheim, AstraZeneca, Roche, MSD, Amgen, Merck and BMS for participation in speaker bureau and for acting in an advisory role, outside the submitted work. GT reports personal fees from Roche for participation in speaker bureau and personal fees from MSD and Pfizer for acting in an advisory role, outside the submitted work. SN reports personal fees from AstraZeneca, Boehringer Ingelheim, BMS, MSD, Eli Lilly, Takeda, Pfizer and Roche for acting in an advisory role and/or for participation in speaker bureau, outside the submitted work.
Patient consent for publication Not required.
Ethics approval The study protocol was approved by the Institutional Review Board of the Coordinating Center: Thoracic Oncology Unit, Department of Oncology, San Luigi Gonzaga University Hospital (Orbassano, Turin, Italy).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article. However, detailed datasets for this manuscript are not publicly available because of sensitive information of centres and patients. Requests to access the datasets is possible upon reasonable request.
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