Molecular pathology testing for non-small cell lung cancer: an observational study of elements currently present in request forms and result reports and the opinion of different stakeholders

Kelly Dufraing, Kaat Van Casteren, Joke Breyne, Nicky D'Haene, Claude Van Campenhout, Sara Vander Borght, Karen Zwaenepoel, Etienne Rouleau, Ed Schuuring, Jan von der Thüsen, Elisabeth Dequeker, Kelly Dufraing, Kaat Van Casteren, Joke Breyne, Nicky D'Haene, Claude Van Campenhout, Sara Vander Borght, Karen Zwaenepoel, Etienne Rouleau, Ed Schuuring, Jan von der Thüsen, Elisabeth Dequeker

Abstract

Background: For patients with non-small cell lung cancer (NSCLC), targeted therapies are becoming part of the standard treatment. It is of question which information the clinicians provide on test requests and how the laboratories adapt test conclusions to this knowledge and regulations.

Methods: This study consisted of two components; 1) checking the presence of pre-defined elements (administrative and key for therapy-choice) on completed requests and corresponding reports in Belgian laboratories, both for tissue- and liquid biopsy (LB)-testing and b) opinion analysis from Belgian pathologists/molecular biologists and clinicians during national pathology/oncology meetings.

Results: Data from 4 out of 6 Belgian laboratories with ISO-accreditation for LB-testing were analyzed, of which 75% were university hospitals. On the scored requests (N = 4), 12 out of 19 ISO-required elements were present for tissue and 11 for LB-testing. Especially relevant patient history, such as line of therapy (for LB), tumor histology and the reason for testing were lacking. Similarly, 11 and 9 out of 18 elements were present in the reports (N = 4) for tissue and LB, respectively. Elements that pathologists/molecular biologists (N = 18) were missing on the request were the initial activating mutation, previous therapies, a clinical question and testing-related information. For reporting, an item considered important by both groups is the clinical interpretation of the test result. In addition, clinicians (N = 28) indicated that they also wish to read the percentage of neoplastic cells.

Conclusions: Communication flows between the laboratory and the clinician, together with possible pitfalls were identified. Based on the study results, templates for complete requesting and reporting were proposed.

Keywords: Molecular pathology; Non-small-cell lung cancer; Post-analytical phase; Pre-analytical phase; Test report; Test requesting.

Conflict of interest statement

ES received honoraria for consultancy/advisory board from AstraZeneca, Roche, Pfizer, Bayer, Novartis, BMS, MSD/Merck, BioRad, Illumina, Ageno BioSciences, Janssen Cilag (Johnson&Johnson), BioCartis; speaker’s fee AstraZeneca, Roche, Pfizer, Novartis, BioRad, Illumina, Ageno BioSciences, BioCartis; (unrestricted) grants from Boehringer Ingelheim, BMS, Biocartis, BioRad, Ageno BioSciences and Roche (All outside the submitted work and fees to UMCG). JvdT is a member of the advisory boards of BMS, MSD and Roche. EDQ received a research grant from AstraZeneca. KD, KvC, JB, NDH, CVC, SVB, ER and KZ have nothing to declare.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Communication flows and their pitfalls between pathologists/molecular biologists and clinician in Belgium. Legend: Option 1: the anatomic pathology- and molecular pathology laboratory are part of the same unit and located at the same place. Option 2: the anatomic pathology- and molecular pathology laboratory are distinct units and might have separate locations, LIS: laboratory information system, H&E: hematoxylin and eosin, NCP: neoplastic cell percentage, IHC: immunohistochemistry, FISH: fluorescent in-situ hybridization, NGS: next-generation sequencing, PCR: polymerase chain reaction

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