TY - JOUR
T1 - Homologous recombination deficiency in ovarian cancer
T2 - Global expert consensus on testing and a comparison of companion diagnostics
AU - Quesada, Stanislas
AU - Penault-Llorca, Frédérique
AU - Matias-Guiu, Xavier
AU - Banerjee, Susana
AU - Barberis, Massimo
AU - Coleman, Robert L.
AU - Colombo, Nicoletta
AU - DeFazio, Anna
AU - McNeish, Iain A.
AU - Nogueira-Rodrigues, Angélica
AU - Oaknin, Ana
AU - Pignata, Sandro
AU - Pujade-Lauraine, Éric
AU - Rouleau, Étienne
AU - Ryška, Aleš
AU - Van Der Merwe, Nerina
AU - Van Gorp, Toon
AU - Vergote, Ignace
AU - Weichert, Wilko
AU - Wu, Xiaohua
AU - Ray-Coquard, Isabelle
AU - Pujol, Pascal
N1 - Publisher Copyright:
© 2024
PY - 2025/1/17
Y1 - 2025/1/17
N2 - 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.
AB - 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.
KW - BRCA
KW - Companion diagnostic assays
KW - Genomic instability
KW - Homologous recombination deficiency
KW - Ovarian cancer
KW - PARP inhibitor
UR - http://www.scopus.com/inward/record.url?scp=85212155417&partnerID=8YFLogxK
U2 - 10.1016/j.ejca.2024.115169
DO - 10.1016/j.ejca.2024.115169
M3 - Article
AN - SCOPUS:85212155417
SN - 0959-8049
VL - 215
JO - European Journal of Cancer
JF - European Journal of Cancer
M1 - 115169
ER -