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Cognition: a prospective precision oncology trial for patients with early breast cancer at high risk following neoadjuvant chemotherapy

Background - COGNITION (Comprehensive assessment of clinical features, genomics and further molecular markers to identify patients with early breast cancer for enrolment on marker driven trials) is a diagnostic registry trial that employs genomic and transcriptomic profiling to identify biomarkers i...

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Main Authors: Pixberg, Constantin Frederic (Author) , Zapatka, Marc (Author) , Hlevnjak, M. (Author) , Benedetto, S. (Author) , Suppelna, J. P. (Author) , Heil, Jörg (Author) , Smetanay, Katharina (Author) , Michel, Laura L. (Author) , Fremd, Carlo (Author) , Körber, V. (Author) , Rübsam, M. (Author) , Buschhorn, Lars (Author) , Heublein, Sabine (Author) , Schäfgen, Benedikt (Author) , Golatta, Michael (Author) , Gomez, C. (Author) , Au, Alexandra von (Author) , Wallwiener, Markus (Author) , Wolf, Sebastian Immanuel (Author) , Dikow, Nicola (Author) , Schaaf, Christian P. (Author) , Gutjahr, Ewgenija (Author) , Allgäuer, Michael (Author) , Stenzinger, Albrecht (Author) , Pfütze, K. (Author) , Kirsten, R. (Author) , Hübschmann, Daniel (Author) , Sinn, Peter (Author) , Jäger, Dirk (Author) , Trumpp, Andreas (Author) , Schlenk, Richard Friedrich (Author) , Höfer, Thomas (Author) , Thewes, V. (Author) , Schneeweiss, Andreas (Author) , Lichter, Peter (Author)
Format: Article (Journal)
Language:English
Published: 21 November 2022
In: ESMO open
Year: 2022, Volume: 7, Issue: 6, Pages: 1-12
ISSN:2059-7029
DOI:10.1016/j.esmoop.2022.100637
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.esmoop.2022.100637
Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S205970292200271X
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Author Notes:C. Pixberg, M. Zapatka, M. Hlevnjak, S. Benedetto, J.P. Suppelna, J. Heil, K. Smetanay, L. Michel, C. Fremd, V. Körber, M. Rübsam, L. Buschhorn, S. Heublein, B. Schäfgen, M. Golatta, C. Gomez, A. von Au, M. Wallwiener, S. Wolf, N. Dikow, C. Schaaf, E. Gutjahr, M. Allgäuer, A. Stenzinger, K. Pfütze, R. Kirsten, D. Hübschmann, H.-P. Sinn, D. Jäger, A. Trumpp, R. Schlenk, T. Höfer, V. Thewes, A. Schneeweiss & P. Lichter
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Summary:Background - COGNITION (Comprehensive assessment of clinical features, genomics and further molecular markers to identify patients with early breast cancer for enrolment on marker driven trials) is a diagnostic registry trial that employs genomic and transcriptomic profiling to identify biomarkers in patients with early breast cancer with a high risk for relapse after standard neoadjuvant chemotherapy (NACT) to guide genomics-driven targeted post-neoadjuvant therapy. - Patients and methods - At National Center for Tumor Diseases Heidelberg patients were biopsied before starting NACT, and for patients with residual tumors after NACT additional biopsy material was collected. Whole-genome/exome and transcriptome sequencing were applied on tumor and corresponding blood samples. - Results - In the pilot phase 255 patients were enrolled, among which 213 were assessable: thereof 48.8% were identified to be at a high risk for relapse following NACT; 86.4% of 81 patients discussed in the molecular tumor board were eligible for a targeted therapy within the interventional multiarm phase II trial COGNITION-GUIDE (Genomics-guided targeted post neoadjuvant therapy in patients with early breast cancer) starting enrolment in Q4/2022. An in-depth longitudinal analysis at baseline and in residual tumor tissue of 16 patients revealed some cases with clonal evolution but largely stable genetic alterations, suggesting restricted selective pressure of broad-acting cytotoxic neoadjuvant chemotherapies. - Conclusions - While most precision oncology initiatives focus on metastatic disease, the presented concept offers the opportunity to empower novel therapy options for patients with high-risk early breast cancer in the post-neoadjuvant setting within a biomarker-driven trial and provides the basis to test the value of precision oncology in a curative setting with the overarching goal to increase cure rates.
Item Description:Gesehen am 23.01.2023
Physical Description:Online Resource
ISSN:2059-7029
DOI:10.1016/j.esmoop.2022.100637

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