Background & objectives Comprehensive Genomic Profiling (CGP) in cancer diagnostics is gaining interest but broad access is still limited. The nationwide BALLETT study aims to have a fully standardized CGP analysis available, potentially increasing access to innovative drugs for Belgian cancer patients. Methods BALLETT is recruiting about 900 patients with a metastatic solid tumor in 12 Belgian hospitals. CGP is weekly performed on pooled samples using the TSO500® kit (Illumina) by one of the 9 hospital labs collaborating in the BALLETT lab consortium. Results are discussed weekly in a virtual, national Molecular Tumor Board (nMTB) resulting in CGP-based treatment recommendations. Results Since June 2021, tumor samples of 630 patients with 32 different tumor types have been successfully tested by CGP, with a final test success rate of 94 %. Median turnaround time from informed consent to nMTB discussion was 25 days. For the 30 tumor types with more than 1 case, actionable genomic alterations were recorded in 55 % to 100 % of cases. The nMTB discussions resulted in a CGP-guided treatment recommendation in 441 patients (70 %): reimbursed treatments (n=46), participation to a clinical trial (n=355) or a medical need program (n=8) or off-label drug use (n=32). Follow-up on potential hereditary cancer predisposition was recommended for 74 patients (11,7 %). Conclusion BALLETT has resulted in a broad access to CGP for patients with metastatic cancer in Belgium. Clinically relevant biomarkers were identified and CGP-based treatment recommendations were made for the large majority of patients. The uptake of these treatment recommendations and the outcome of the patients will be followed up within the project. Furthermore, the BALLETT laboratory consortium combined with the nMTB is a valuable platform for reducing turnaround time, exchanging expertise and standardization of CGP methodology and treatment recommendation. ClinicalTrials.gov:NCT05058937
Maes, Brigitte ; Dedeurwaerdere, Franceska ; Vanden Bempt, Isabelle ; Van Huysse, Jacques ; Rottey, Sylvie ; et. al. Comprehensive genomic profiling for precision oncology: the Belgian Approach for Local Laboratory Extensive Tumour Testing study (BALLETT).European Congress of Pathology (Dublin, du 10/09/2023 au 13/09/2023).
Aftimos, Philippe
