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High‐throughput molecular assays for inclusion in personalised oncology trials – State‐of‐the‐art and beyond

Journal of internal medicine, 2024-06, Vol.295 (6), p.785-803 [Peer Reviewed Journal]

2024 The Authors. published by John Wiley & Sons Ltd on behalf of Association for Publication of The . ;2024 The Authors. Journal of Internal Medicine published by John Wiley & Sons Ltd on behalf of Association for Publication of The Journal of Internal Medicine. ;2024. This article is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. ;ISSN: 0954-6820 ;ISSN: 1365-2796 ;EISSN: 1365-2796 ;DOI: 10.1111/joim.13785 ;PMID: 38698538

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Title:
High‐throughput molecular assays for inclusion in personalised oncology trials – State‐of‐the‐art and beyond
Author: Edsjö, Anders ; Russnes, Hege G. ; Lehtiö, Janne ; Tamborero, David ; Hovig, Eivind ; Stenzinger, Albrecht ; Rosenquist, Richard ; Janowska, Agnieszka ; Rioja, Alba López ; Stenzinger, Albrecht ; Razzak, Ali ; Edsjö, Anders ; Lepland, Anni ; Marra, Antonio ; Planken, Anu ; Helland, Åslaug ; Patocs, Attila ; Mainoli, Beatrice ; Ryll, Bettina ; Brasiuniene, Birute ; Kazdal, Daniel ; Tamborero, David ; Cerina, Dora ; Hult, Ebba Hallersjö ; Baltruškevičienė, Edita ; Vrdoljak, Eduard ; Hovig, Eivind ; Chavarria, Elena ; Garralda, Elena ; Aas, Eline ; Bjørgo, Elisa ; Voest, Emile ; Curigliano, Giuseppe ; Fagereng, Gro Live ; Gelderblom, Hans ; Russnes, Hege G. ; Verheul, Henk ; Timmer, Hans ; Brana, Irene ; Lugowska, Iwona ; Lehtiö, Janne ; Blay, Jean‐Yves ; Oliveira, Julio ; Rekker, Kadri ; Toome, Kadri ; Jalkanen, Katriina ; Taskén, Kjetil ; Smeland, Knut ; Ojamaa, Kristiina ; Rohrberg, Kristoffer Staal ; Verlingue, Loic ; Antouly, Manon ; Mustonen, Mika ; Zagami, Paola ; Nagy, Péter ; Nygren, Peter ; Asplund, Peter ; Sabaliauskaite, Rasa ; Rosenquist, Richard ; Henrique, Rui ; Waalwijk van Doorn‐Khosrovani, Sahar Barjesteh ; Brabrand, Sigmund ; Ekman, Simon ; Mohammad, Soemeya Haj ; Jarmalaite, Sonata ; Juslin, Tanja ; Kahre, Tiina ; Kringelbach, Tina ; Guren, Tormod ; Lassen, Ulrik ; Grolmusz, Vince Kornél ; Alberu, Xenia Villabour
Subjects: Assaying ; Biomarkers ; Biomarkers, Tumor ; Cancer ; Cancer and Oncology ; Cancer och onkologi ; Clinical Medicine ; Clinical trials ; Clinical Trials as Topic ; Customization ; DNA sequencing ; Drug sensitivity testing ; Drugs ; Gene sequencing ; Genomes ; High-Throughput Nucleotide Sequencing ; Homologous recombination ; Humans ; Immunotherapy ; In vivo methods and tests ; Klinisk medicin ; Medical and Health Sciences ; Medical Oncology - methods ; Medical Oncology - trends ; Medical sciences ; Medicin och hälsovetenskap ; Microsatellite instability ; Microsatellites ; Neoplasms ; Neoplasms - diagnosis ; Neoplasms - drug therapy ; Neoplasms - genetics ; Neoplasms - therapy ; omics technologies ; Oncology ; personalised oncology ; precision cancer medicine ; precision diagnostics ; Precision Medicine - methods ; Proteomics ; Recombination ; Sensitivity analysis ; Sequencing ; Transcriptomes ; Tumors
Is Part Of: Journal of internal medicine, 2024-06, Vol.295 (6), p.785-803
Description: In the last decades, the development of high‐throughput molecular assays has revolutionised cancer diagnostics, paving the way for the concept of personalised cancer medicine. This progress has been driven by the introduction of such technologies through biomarker‐driven oncology trials. In this review, strengths and limitations of various state‐of‐the‐art sequencing technologies, including gene panel sequencing (DNA and RNA), whole‐exome/whole‐genome sequencing and whole‐transcriptome sequencing, are explored, focusing on their ability to identify clinically relevant biomarkers with diagnostic, prognostic and/or predictive impact. This includes the need to assess complex biomarkers, for example microsatellite instability, tumour mutation burden and homologous recombination deficiency, to identify patients suitable for specific therapies, including immunotherapy. Furthermore, the crucial role of biomarker analysis and multidisciplinary molecular tumour boards in selecting patients for trial inclusion is discussed in relation to various trial concepts, including drug repurposing. Recognising that today's exploratory techniques will evolve into tomorrow's routine diagnostics and clinical study inclusion assays, the importance of emerging technologies for multimodal diagnostics, such as proteomics and in vivo drug sensitivity testing, is also discussed. In addition, key regulatory aspects and the importance of patient engagement in all phases of a clinical trial are described. Finally, we propose a set of recommendations for consideration when planning a new precision cancer medicine trial.
Publisher: England: Blackwell Publishing Ltd
Language: English
Identifier: ISSN: 0954-6820
ISSN: 1365-2796
EISSN: 1365-2796
DOI: 10.1111/joim.13785
PMID: 38698538
Source: SWEPUB Freely available online

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High‐throughput molecular assays for inclusion in personalised oncology trials – State‐of‐the‐art and beyond

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