108P Biomarkers and personalized cancer therapy: A study of trial discontinuation and unpublished rates

Background: The TOPAZ-1 trial showed improved overall survival (OS) and progression-free survival (PFS) for pts with advanced BTC.However, we still lack predictive biomarkers for immunotherapy benefits and have limited data on the clinical significance of genomic features. Methods:The study involved pts with unresectable, locally advanced, or metastatic BTC receiving CGD at 39 clinical sites in 11 countries from July 2021 to December 2023.Genomic analyses of primary tumors were conducted locally using various nextgeneration sequencing assays.Additionally, to test the impact of the prognostic index, outcomes from the CGD cohort were compared to a historical cohort receiving only CG.The data was collected prospectively from 17 centers in Italy between March 2006 and December 2022.

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Publication Details

Journal
ESMO Open
Published
2025-03-01
DOI
https://doi.org/10.1016/j.esmoop.2025.104269
Primary Topic
Cancer Genomics and Diagnostics
Type
article
Field-Weighted Citation Impact
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article

108P Biomarkers and personalized cancer therapy: A study of trial discontinuation and unpublished rates

Wael Soliman, Alyaa Dawoud, Ahmed S. Shehata, Mohammed Hamouda et al.
ESMO Open
Cancer Genomics and Diagnostics
article

108P Biomarkers and personalized cancer therapy: A study of trial discontinuation and unpublished rates

Wael Soliman, Alyaa Dawoud, Ahmed S. Shehata, Mohammed Hamouda, Amira S. Ashour, A. Benali, Anis Syamimi Mohamed, Amr Elnemr, F.A. Mahmoud, Mohamed Ellebedy, Israa Ahmed Qutob, B.M. El-Khalifa, A.R.A.O.A. Elareef
article en

Abstract

Background: The TOPAZ-1 trial showed improved overall survival (OS) and progression-free survival (PFS) for pts with advanced BTC.However, we still lack predictive biomarkers for immunotherapy benefits and have limited data on the clinical significance of genomic features. Methods:The study involved pts with unresectable, locally advanced, or metastatic BTC receiving CGD at 39 clinical sites in 11 countries from July 2021 to December 2023.Genomic analyses of primary tumors were conducted locally using various nextgeneration sequencing assays.Additionally, to test the impact of the prognostic index, outcomes from the CGD cohort were compared to a historical cohort receiving only CG.The data was collected prospectively from 17 centers in Italy between March 2006 and December 2022.

ESMO OpenVol. 10
Ain Shams University (EG), Damietta University (EG), Misr University for Science and Technology (EG), Mansoura University (EG), Al-Azhar University (EG), South Valley University (EG), Mansoura University Hospital (EG), Centre Hospitalo-Universitaire Mohammed VI d'Oujda (MA), Alexandria University (EG), Sohag University (EG)
Openalex Percentile: Top 95%
Cancer Genomics and Diagnostics
DOIOpen Access PDFOpenAlex
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