Clinical validation of the CE-IVD marked Therascreen MGMT kit in a cohort of glioblastoma patients

Véronique Quillien; Audrey Lavenu; François Ducray; David Meyronet; Olivier Chinot; Frédéric Fina; Marc Sanson; Catherine Carpentier; Lucie Karayan-Tapon; Pierre Rivet; Natacha Entz-Werle; Michèle Legrain; Emmanuèle Lechapt Zalcman; Guenaelle Levallet; Fabienne Escande; Carole Ramirez; Dan Chiforeanu; Elodie Vauleon; Dominique Figarella-Branger

doi:10.3233/CBM-170191

Journal articles

Clinical validation of the CE-IVD marked Therascreen MGMT kit in a cohort of glioblastoma patients

Véronique Quillien ^{1, 2, *} Audrey Lavenu ³ François Ducray ⁴ David Meyronet ⁵ Olivier Chinot ⁶ Frédéric Fina ^{7, 8} Marc Sanson ^{9, 10, 11} Catherine Carpentier ⁹ Lucie Karayan-Tapon ^{12, 13} Pierre Rivet ¹³ Natacha Entz-Werle ¹⁴ Michèle Legrain ^{15, 16} Emmanuèle Lechapt Zalcman ¹⁷ Guenaelle Levallet ¹⁷ Fabienne Escande ¹⁸ Carole Ramirez ¹⁸ Dan Chiforeanu ¹⁹ Elodie Vauleon ^{20, 1} Dominique Figarella-Branger ^{8, 21}

* Corresponding author

1 COSS - Chemistry, Oncogenesis, Stress and Signaling

2 CRLCC - Centre Eugène Marquis

3 CIC - Centre d'Investigation Clinique [Rennes]

4 UNICANCER/CRCL - Centre de Recherche en Cancérologie de Lyon

5 CHLS - Centre Hospitalier Lyon Sud [CHU - HCL]

6 Département de neurooncologie

7 TIMONE - Hôpital de la Timone [CHU - APHM]

8 ACPNP - Service d'Anatomo-Cyto-Pathologie et de NeuroPathologie [Hôpital de la Timone - APHM]

9 ICM - Institut du Cerveau et de la Moëlle Epinière = Brain and Spine Institute

10 SU - Sorbonne Université

11 Service de neurologie 2 [CHU Pitié-Salpêtrière]

12 LNEC - Laboratoire de neurosciences expérimentales et cliniques

13 CHU Poitiers - Centre hospitalier universitaire de Poitiers

14 Département d'Oncologie Pédiatrique [CHU Hautepierre, Strasbourg]

15 Hôpital de Hautepierre [Strasbourg]

16 Progression tumorale et microenvironnement. Approches translationnelles et épidémiologie

17 Département de Pathologie [CHU Caen]

18 CHRU Lille - Centre Hospitalier Régional Universitaire [Lille]

19 CHU Pontchaillou [Rennes]

20 CRLCC - CRLCC Eugène Marquis

21 CRO2 - Centre de Recherches en Oncologie biologique et Oncopharmacologie

Abstract : BACKGROUND: Pyrosequencing is recognized as a strong technique to analyze the MGMT status of glioblastoma patients. The most commonly used assay, quantifies the methylation levels of CpGs 74 to 78. A more recent CE-marked In Vitro Diagnostic Medical Device (CE-IVD) assay, Therascreen, analyzes CpGs 76-79.METHODS: We performed a comparison of these two assays to evaluate the potential impact of this shift in analyzed CpGs. Therascreen analysis was centrally performed for 102 glioblastoma patients, who were part of a prospective multicenter trial.RESULTS: A strong correlation was observed for the mean values of the 4 or 5 analyzed CpGs, with lower values recorded using the Therascreen assay, especially for values greater than 20%. When considering a classification in 3 categories (> 12%: methylated; ⩽ 8%: unmethylated; 9-12%: grey zone), 93% of patients were identically classified between the two assays. Using a binary classification, 95% and 97% of patients were identically classified with cut-offs of 8% and 12%, respectively. A strong prognostic significance was observed for both assays: median overall survival were 15.9 months and 34.9 months for respectively unmethylated and methylated patients with either test. CONCLUSION: The results demonstrate that these assays may be used interchangeably.

Keywords : pyrosequencing CE-IVD kit Glioblastoma MGMT methylation

Document type :

Journal articles

Domain :

Life Sciences [q-bio] / Cancer

Life Sciences [q-bio] / Neurons and Cognition [q-bio.NC] / Neurobiology

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Submitted on : Wednesday, January 31, 2018 - 12:00:46 PM
Last modification on : Friday, January 7, 2022 - 3:48:51 AM
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Clinical validation of the CE-IVD marked Therascreen MGMT kit in a cohort of glioblastoma patients

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Clinical validation of the CE-IVD marked Therascreen MGMT kit in a cohort of glioblastoma patients

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