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. 2024 Jul:206:114127.
doi: 10.1016/j.ejca.2024.114127. Epub 2024 May 23.

Harmonization of homologous recombination deficiency testing in ovarian cancer: Results from the MITO16A/MaNGO-OV2 trial

Cristin Roma  1 , Riziero Esposito Abate  1 , Alessandra Sacco  1 , Daniela Califano  2 , Laura Arenare  3 , Francesca Bergantino  1 , Carmela Pisano  4 , Sabrina Chiara Cecere  4 , Giovanni Scambia  5 , Domenica Lorusso  5 , Grazia Artioli  6 , Giulia Tasca  7 , Anna Spina  2 , Daniela Russo  2 , Angiolo Gadducci  8 , Carmine De Angelis  9 , Alessandra Bologna  10 , Sergio Marchini  11 , Ettore Domenico Capoluongo  12 , Francesco Perrone  3 , Sandro Pignata  4 , Nicola Normanno  13
Affiliations

Harmonization of homologous recombination deficiency testing in ovarian cancer: Results from the MITO16A/MaNGO-OV2 trial

Cristin Roma et al. Eur J Cancer. 2024 Jul.

Abstract

Background: Homologous Recombination Deficiency (HRD) status predicts response to treatment with poly(ADP-ribose) polymerase inhibitors in Ovarian Cancer (OC) patients. The Myriad myChoiceCDx Assay is approved by Food and Drug Agency for the HRD assessment. Here we compared the HRD status obtained by three commercial panels with the results from Myriad reference test.

Methods: The HRD analysis was performed on DNA from formalin-fixed and paraffin-embedded tumor samples of 100 untreated OC patients for which Myriad assay results were available, using TruSight Oncology 500 HRD assay (Illumina), Oncomine Comprehensive Assay Plus (Thermo Fisher Scientific) and SOPHiA DDM HRD solution panel (SOPHiA Genetics).

Results: A good overall concordance with the reference method was demonstrated at three different levels: BRCA mutational status (from 94.4 % to 97.7 %), the genomic instability value (from 88.2 % to 95.3 %) and for the HRD status (from 90.4 % to 97.6 %). Moreover, a trend in favour of HRD positive patients for response rate, progression-free survival and overall survival similar to Myriad was observed for all three tests.

Discussion: Our data suggest the feasibility of commercial testing for assessing HRD status, with a good concordance with the reference method and association with clinical outcome.

Keywords: Homologous Recombination Deficiency; Ovarian Cancer; Targeted resequencing.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Nicola Normanno declares: speaker’s fee and/or advisory boards from MSD, Bayer, Biocartis, Illumina, Incyte, Roche, BMS, Merck, Thermofisher, AstraZeneca, Eli Lilly; financial support to research projects (institutional grants) from Merck, Thermofisher, QIAGEN, Roche, AstraZeneca, Biocartis, Illumina; non-financial interests President of the International Quality Network for Pathology (IQN Path) and Past President of the Italian Cancer Society (SIC). Domenica Lorusso declares: Astrazeneca, Clovis Oncology, Corcept, Genmab, GSK, Immunogen, Incyte, MSD, Novartis, Oncoinvest, Pharmamar, Roche, Seagen, Sutro, Francesco Perrone declares: institutional grants or contracts from Roche, Bayer, AstraZeneca, Pfizer, Incyte, Tesaro/GSK, Merck; consulting fees from Bayer, Pierre Fabre, Astra Zeneca, Incyte, Ipsen, Clovis, Astellas, Sanofi, Roche, Pfizer; leadership in scientific society: President of AIOM 2023–2025. Sandro Pignata has received honoraria from Roche, MSD, AZ, GSK, and Novartis. Cristin Roma, Riziero Esposito Abate, Alessandra Sacco, Daniela Califano, Laura Arenare, Francesca Bergantino, Carmela Pisano, Sabrina Chiara Cecere, Giovanni Scambia, Grazia Artioli, Giulia Tasca, Anna Spina, Daniela Russo, Angiolo Gadducci, Carmine De Angelis, Alessandra Bologna, Sergio Marchini and Ettore Domenico Capoluongo have no conflict of interests.

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