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Homologous recombination deficiency in ovarian cancer: Global expert consensus on testing and a comparison of companion diagnostics
S. Quesada, F. Penault-Llorca, X. Matias-Guiu, S. Banerjee, M. Barberis, RL. Coleman, N. Colombo, A. DeFazio, IA. McNeish, A. Nogueira-Rodrigues, A. Oaknin, S. Pignata, É. Pujade-Lauraine, É. Rouleau, A. Ryška, N. Van Der Merwe, T. Van Gorp, I....
Language English Country England, Great Britain
Document type Journal Article, Comparative Study
- MeSH
- Delphi Technique MeSH
- Homologous Recombination MeSH
- Consensus * MeSH
- Humans MeSH
- Biomarkers, Tumor genetics MeSH
- Ovarian Neoplasms * genetics diagnosis drug therapy MeSH
- Poly(ADP-ribose) Polymerase Inhibitors * therapeutic use MeSH
- Check Tag
- Humans MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Comparative Study MeSH
BACKGROUND: Poly (ADP ribose) polymerase inhibitors (PARPis) are a treatment option for patients with advanced high-grade serous or endometrioid ovarian carcinoma (OC). Recent guidelines have clarified how homologous recombination deficiency (HRD) may influence treatment decision-making in this setting. As a result, numerous companion diagnostic assays (CDx) have been developed to identify HRD. However, the optimal HRD testing strategy is an area of debate. Moreover, recently published clinical and translational data may impact how HRD status may be used to identify patients likely to benefit from PARPi use. We aimed to extensively compare available HRD CDx and establish a worldwide expert consensus on HRD testing in primary and recurrent OC. METHODS: A group of 99 global experts from 31 different countries was formed. Using a modified Delphi process, the experts aimed to establish consensus statements based on a systematic literature search and CDx information sought from investigators, companies and/or publications. RESULTS: Technical information, including analytical and clinical validation, were obtained from 14 of 15 available HRD CDx (7 academic; 7 commercial). Consensus was reached on 36 statements encompassing the following topics: 1) the predictive impact of HRD status on PARPi use in primary and recurrent OC; 2) analytical and clinical validation requirements of HRD CDx; 3) resource-stratified HRD testing; and 4) how future CDx may include additional approaches to help address unmet testing needs. CONCLUSION: This manuscript provides detailed information on currently available HRD CDx and up-to-date guidance from global experts on HRD testing in patients with primary and recurrent OC.
Belgium and Luxembourg Gynaecological Oncology Group Leuven Belgium
Center for Ecological and Evolutionary Cancer Research Montpellier University Montpellier France
Centre for Cancer Research The Westmead Institute for Medical Research Sydney NSW Australia
Cours St Paul Saint Paul Réunion France
Department of Cancer Genetics University Hospital of Montpellier Montpellier France
Department of Gynaecological Oncology Westmead Hospital Sydney NSW Australia
Department of Gynecological Oncology Fudan University Shanghai Cancer Center Shanghai China
Department of Medical Oncology Institut régional du Cancer de Montpellier Montpellier France
Department of Medicine and Surgery University of Milan Bicocca Milan Italy
Division of Experimental Oncology European Institute of Oncology IRCCS Milan Italy
European Society of Pathology Belgium
Faculty of Medicine and Health The University of Sydney Sydney NSW Australia
Federal University MG Brazilian Group of Gynecologic Oncology Oncoclínicas DOM Oncologia Brazil
Groupe d'Investigateurs Nationaux pour l'Etude des cancers de l'ovaire et du sein Paris France
Gynecologic Oncology Program European Institute of Oncology IRCCS Milan Italy
Institute of Pathology School of Medicine and Health Technical University Munich Munich Germany
Medical Oncology Centre Léon Bérard and Université Claude Bernard Lyon Lyon France
Société Française de Médecine Prédictive et Personnalisée Montpellier France
Texas Oncology US Oncology Network The Woodlands TX USA
The Royal Marsden NHS Foundation Trust and Institute of Cancer Research London UK
References provided by Crossref.org
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- $a Quesada, Stanislas $u Department of Medical Oncology, Institut régional du Cancer de Montpellier (ICM), Montpellier, France; Department of Cancer Genetics, University Hospital of Montpellier, Montpellier, France; Groupe d'Investigateurs Nationaux pour l'Etude des cancers de l'ovaire et du sein (GINECO), Paris, France; Société Française de Médecine Prédictive et Personnalisée (SFMPP), Montpellier, France
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- $a BACKGROUND: Poly (ADP ribose) polymerase inhibitors (PARPis) are a treatment option for patients with advanced high-grade serous or endometrioid ovarian carcinoma (OC). Recent guidelines have clarified how homologous recombination deficiency (HRD) may influence treatment decision-making in this setting. As a result, numerous companion diagnostic assays (CDx) have been developed to identify HRD. However, the optimal HRD testing strategy is an area of debate. Moreover, recently published clinical and translational data may impact how HRD status may be used to identify patients likely to benefit from PARPi use. We aimed to extensively compare available HRD CDx and establish a worldwide expert consensus on HRD testing in primary and recurrent OC. METHODS: A group of 99 global experts from 31 different countries was formed. Using a modified Delphi process, the experts aimed to establish consensus statements based on a systematic literature search and CDx information sought from investigators, companies and/or publications. RESULTS: Technical information, including analytical and clinical validation, were obtained from 14 of 15 available HRD CDx (7 academic; 7 commercial). Consensus was reached on 36 statements encompassing the following topics: 1) the predictive impact of HRD status on PARPi use in primary and recurrent OC; 2) analytical and clinical validation requirements of HRD CDx; 3) resource-stratified HRD testing; and 4) how future CDx may include additional approaches to help address unmet testing needs. CONCLUSION: This manuscript provides detailed information on currently available HRD CDx and up-to-date guidance from global experts on HRD testing in patients with primary and recurrent OC.
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