Alternative academic approaches for testing homologous recombination deficiency in ovarian cancer in the MITO16A/MaNGO-OV2 trial.


Journal

ESMO open
ISSN: 2059-7029
Titre abrégé: ESMO Open
Pays: England
ID NLM: 101690685

Informations de publication

Date de publication:
10 2022
Historique:
received: 23 03 2022
revised: 28 07 2022
accepted: 16 08 2022
pubmed: 27 9 2022
medline: 25 10 2022
entrez: 26 9 2022
Statut: ppublish

Résumé

The detection of homologous recombination deficiency (HRD) can identify patients who are more responsive to platinum and poly ADP ribose polymerase inhibitors (PARPi). MyChoice CDx (Myriad) is the most used HRD test in ovarian cancer (OC). However, some limitations of commercial tests exist, because of the high rate of inconclusive results, costs, and the impossibility of evaluating functional resistance mechanisms. Two academic genomic tests and a functional assay, the RAD51 foci, were evaluated to detect HRD. One hundred patients with high-grade OC enrolled in the MITO16A/MaNGO-OV2 trial and treated with first-line therapy with carboplatin, paclitaxel, and bevacizumab were analyzed. The failure rate of the two genomic assays was 2%. The sensitivity in detecting HRD when compared with Myriad was 98.1% and 90.6%, respectively. The agreement rate with Myriad was 0.92 and 0.87, with a Cohen's κ coefficient corresponding to 0.84 and 0.74, respectively. For the RAD51 foci assay, the failure rate was 30%. When the test was successful, discordant results for deficient and proficient tumors were observed, and additional HRD patients were identified compared to Myriad; sensitivity was 82.9%, agreement rate was 0.65, and Cohen's κ coefficient was 0.18. The HRD detected by genomic assays and residual tumor at primary surgery and stage was correlated with progression-free survival at multivariate analysis. Results suggest the feasibility of academic tests for assessing HRD status that show robust concordance with Myriad and correlation with clinical outcome. The contribution of the functional information related to the RAD51 foci test to the genomic data needs further investigation.

Sections du résumé

BACKGROUND
The detection of homologous recombination deficiency (HRD) can identify patients who are more responsive to platinum and poly ADP ribose polymerase inhibitors (PARPi). MyChoice CDx (Myriad) is the most used HRD test in ovarian cancer (OC). However, some limitations of commercial tests exist, because of the high rate of inconclusive results, costs, and the impossibility of evaluating functional resistance mechanisms.
PATIENTS AND METHODS
Two academic genomic tests and a functional assay, the RAD51 foci, were evaluated to detect HRD. One hundred patients with high-grade OC enrolled in the MITO16A/MaNGO-OV2 trial and treated with first-line therapy with carboplatin, paclitaxel, and bevacizumab were analyzed.
RESULTS
The failure rate of the two genomic assays was 2%. The sensitivity in detecting HRD when compared with Myriad was 98.1% and 90.6%, respectively. The agreement rate with Myriad was 0.92 and 0.87, with a Cohen's κ coefficient corresponding to 0.84 and 0.74, respectively. For the RAD51 foci assay, the failure rate was 30%. When the test was successful, discordant results for deficient and proficient tumors were observed, and additional HRD patients were identified compared to Myriad; sensitivity was 82.9%, agreement rate was 0.65, and Cohen's κ coefficient was 0.18. The HRD detected by genomic assays and residual tumor at primary surgery and stage was correlated with progression-free survival at multivariate analysis.
CONCLUSIONS
Results suggest the feasibility of academic tests for assessing HRD status that show robust concordance with Myriad and correlation with clinical outcome. The contribution of the functional information related to the RAD51 foci test to the genomic data needs further investigation.

Identifiants

pubmed: 36156447
pii: S2059-7029(22)00215-0
doi: 10.1016/j.esmoop.2022.100585
pmc: PMC9512829
pii:
doi:

Substances chimiques

Bevacizumab 2S9ZZM9Q9V
Carboplatin BG3F62OND5
Paclitaxel P88XT4IS4D
Platinum 49DFR088MY
Poly(ADP-ribose) Polymerases EC 2.4.2.30

Types de publication

Clinical Trial Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

100585

Informations de copyright

Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Auteurs

E D Capoluongo (ED)

Department of Molecular Medicine and Medical Biotechnology, Università degli Studi di Napoli Federico II, Naples; Azienda Ospedaliera per L'Emergenza, Cannizzaro, Catania.

B Pellegrino (B)

Department of Medicine and Surgery, University of Parma, Parma; Medical Oncology and Breast Unit, University Hospital of Parma, Parma; Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC), Parma.

L Arenare (L)

Clinical Trial Unit, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Naples.

D Califano (D)

Microenvironment Molecular Targets Unit, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, Naples.

G Scambia (G)

Department of Women and Child Health, Division of Gynecologic Oncology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome; Department of Life Science and Public Health, Catholic University of Sacred Heart Largo Agostino Gemelli, Rome.

L Beltrame (L)

Molecular Pharmacology laboratory., Group of Cancer Pharmacology IRCCS Humanitas Research Hospital, Rozzano, Italy.

V Serra (V)

Vall d'Hebron Institute of Oncology, Barcelona, Spain.

G L Scaglione (GL)

Advanced Biotechnology, Università Federico II-CEINGE, Naples; IDI-IRCSS, Rome.

A Spina (A)

Microenvironment Molecular Targets Unit, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, Naples.

S C Cecere (SC)

Uro-Gynecologic Oncology Unit, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples.

R De Cecio (R)

Pathology Unit, Istituto Nazionale Tumori 'Fondazione Giovanni Pascale', IRCCS, Napoli.

N Normanno (N)

Cell Biology and Biotherapy Unit, Istituto Nazionale Tumori 'Fondazione Giovanni Pascale', IRCCS, Napoli.

N Colombo (N)

University of Milan-Bicocca and European Institute of Oncology IRCCS, Milan.

D Lorusso (D)

Department of Women and Child Health, Division of Gynecologic Oncology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome; Department of Life Science and Public Health, Catholic University of Sacred Heart Largo Agostino Gemelli, Rome.

D Russo (D)

Microenvironment Molecular Targets Unit, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, Naples.

C Nardelli (C)

Department of Molecular Medicine and Medical Biotechnology, Università degli Studi di Napoli Federico II, Naples; Advanced Biotechnology, Università Federico II-CEINGE, Naples.

M D'Incalci (M)

Molecular Pharmacology laboratory., Group of Cancer Pharmacology IRCCS Humanitas Research Hospital, Rozzano, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan.

A Llop-Guevara (A)

Vall d'Hebron Institute of Oncology, Barcelona, Spain.

C Pisano (C)

Uro-Gynecologic Oncology Unit, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples.

G Baldassarre (G)

Molecular Oncology Unit, Centro di Riferimento Oncologico di Aviano (CRO), IRCCS, National Cancer Institute, Aviano.

D Mezzanzanica (D)

Molecular Therapies Unit, Department of Research, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan.

G Artioli (G)

Oncologia Medica, ULSS2 Marca Trevigiana, Treviso.

M Setaro (M)

Advanced Biotechnology, Università Federico II-CEINGE, Naples.

G Tasca (G)

Division of Oncology 2, Istituto Oncologico Veneto IRCCS, Padova.

C Roma (C)

Cell Biology and Biotherapy Unit, Istituto Nazionale Tumori 'Fondazione Giovanni Pascale', IRCCS, Napoli.

N Campanini (N)

Unit of Pathological Anatomy, Department of Medicine and Surgery, University Hospital of Parma, Parma.

S Cinieri (S)

Oncologia Medica, Ospedale Senatore Antonio Perrino, Brindisi.

A Sergi (A)

Molecular Pharmacology laboratory., Group of Cancer Pharmacology IRCCS Humanitas Research Hospital, Rozzano, Italy; Department of Electronics, Information and Bioengineering, Politecnico di Milano, Milan.

A Musolino (A)

Department of Medicine and Surgery, University of Parma, Parma; Medical Oncology and Breast Unit, University Hospital of Parma, Parma; Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC), Parma.

F Perrone (F)

Clinical Trial Unit, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Naples.

P Chiodini (P)

Department of Mental Health and Public Medicine, Section of Statistics, Università degli Studi della Campania Luigi Vanvitelli, Napoli, Italy.

S Marchini (S)

Molecular Pharmacology laboratory., Group of Cancer Pharmacology IRCCS Humanitas Research Hospital, Rozzano, Italy.

S Pignata (S)

Uro-Gynecologic Oncology Unit, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples. Electronic address: s.pignata@istitutotumori.na.it.

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Classifications MeSH