Role of 3D volume growth rate for drug activity evaluation in meningioma clinical trials: the example of the CEVOREM study.


Journal

Neuro-oncology
ISSN: 1523-5866
Titre abrégé: Neuro Oncol
Pays: England
ID NLM: 100887420

Informations de publication

Date de publication:
01 07 2021
Historique:
pubmed: 9 2 2021
medline: 5 8 2021
entrez: 8 2 2021
Statut: ppublish

Résumé

We aimed to improve the assessment of the drug activity in meningioma clinical trials based on the study of the 3D volume growth rate (3DVGR) in a series of aggressive meningiomas. We secondarily aimed to correlate 3DVGR study with patient outcome. We performed a post hoc analysis based on volume data and 3DVGR extracted from CEVOREM study including 18 patients with 32 recurrent high-grade meningiomas and treated with everolimus and octreotide. The joint latent class model was used to classify tumor 3DVGR undertreatment. Class 1 includes lesions responding to treatment with decrease in volume in the first 3 months, and then a stabilization thereafter (9.5% of tumors) (mean pretreatment 3DVGR = 6.13%/month; mean undertreatment 3DVGR = -18.7%/month within 3 first months and -0.14%/month after the 3 first months). Class 2 includes lesions considered as stable or with a slight increase in volume undertreatment (65.5%) (mean pretreatment 3DVGR = 6.09%/month; undertreatment 3DVGR = -0.09% within the first 3 months). Class 3 includes lesions without 3DVGR decrease (25%) (mean pretreatment 3DVGR = 46.9%/month; mean undertreatment 3DVGR = 19.2%/month within the first 3 months). Patients with class 3 lesions had a significantly worse progression-free survival (PFS) rate than class 1 and 2 ones. Tumor 3DVGR could be helpful to detect early signal of drugs antitumoral activity or nonactivity. This volume response classification could help in the assessment of drug activity in tumors with mostly volume stabilization and rare response as aggressive meningiomas even with a low number of patients in complement to 6 months PFS.

Sections du résumé

BACKGROUND
We aimed to improve the assessment of the drug activity in meningioma clinical trials based on the study of the 3D volume growth rate (3DVGR) in a series of aggressive meningiomas. We secondarily aimed to correlate 3DVGR study with patient outcome.
METHODS
We performed a post hoc analysis based on volume data and 3DVGR extracted from CEVOREM study including 18 patients with 32 recurrent high-grade meningiomas and treated with everolimus and octreotide. The joint latent class model was used to classify tumor 3DVGR undertreatment.
RESULTS
Class 1 includes lesions responding to treatment with decrease in volume in the first 3 months, and then a stabilization thereafter (9.5% of tumors) (mean pretreatment 3DVGR = 6.13%/month; mean undertreatment 3DVGR = -18.7%/month within 3 first months and -0.14%/month after the 3 first months). Class 2 includes lesions considered as stable or with a slight increase in volume undertreatment (65.5%) (mean pretreatment 3DVGR = 6.09%/month; undertreatment 3DVGR = -0.09% within the first 3 months). Class 3 includes lesions without 3DVGR decrease (25%) (mean pretreatment 3DVGR = 46.9%/month; mean undertreatment 3DVGR = 19.2%/month within the first 3 months). Patients with class 3 lesions had a significantly worse progression-free survival (PFS) rate than class 1 and 2 ones.
CONCLUSIONS
Tumor 3DVGR could be helpful to detect early signal of drugs antitumoral activity or nonactivity. This volume response classification could help in the assessment of drug activity in tumors with mostly volume stabilization and rare response as aggressive meningiomas even with a low number of patients in complement to 6 months PFS.

Identifiants

pubmed: 33556177
pii: 6131353
doi: 10.1093/neuonc/noab019
pmc: PMC8661407
doi:

Substances chimiques

Pharmaceutical Preparations 0
Octreotide RWM8CCW8GP

Types de publication

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

Langues

eng

Sous-ensembles de citation

IM

Pagination

1139-1147

Informations de copyright

© The Author(s) 2021. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

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Auteurs

Thomas Graillon (T)

Aix Marseille Univ, APHM, INSERM, MMG, Department of Neursurgery, Hospital La Timone, Marseille, France.

Loic Ferrer (L)

SOPHiA GENETICS, Radiomics R&D Department, Cité de la Photonique, Pessac, France.

Jason Siffre (J)

SOPHiA GENETICS, Radiomics R&D Department, Cité de la Photonique, Pessac, France.

Marc Sanson (M)

Neuro-Oncology Department, Hôpital La Pitié-Salpêtrière, Paris, France.

Matthieu Peyre (M)

Neurosurgery Department, Hôpital La Pitié-Salpêtrière, Paris, France.

Hadrien Peyrière (H)

Neurosurgery Department, Hôpital La Timone, Marseille, France.

Grégory Mougel (G)

Aix Marseille Univ, APHM, INSERM, MMG Molecular Biology Department, Hôpital La Conception, Marseille, France.

Didier Autran (D)

Aix-Marseille Univ, APHM, CNRS, INP, Inst Neurophysiopathol, Neuro-Oncology Department, Hôpital La Timone, Marseille, France.

Emeline Tabouret (E)

Aix-Marseille Univ, APHM, CNRS, INP, Inst Neurophysiopathol, Neuro-Oncology Department, Hôpital La Timone, Marseille, France.

Dominique Figarella-Branger (D)

Aix-Marseille Univ, APHM, CNRS, INP, Inst Neurophysiopathol, Neuropathology department, Hôpital La Timone, Marseille, France.

Anne Barlier (A)

Aix Marseille Univ, APHM, INSERM, MMG Molecular Biology Department, Hôpital La Conception, Marseille, France.

Michel Kalamarides (M)

Neurosurgery Department, Hôpital La Pitié-Salpêtrière, Paris, France.

Henry Dufour (H)

Aix Marseille Univ, APHM, INSERM, MMG, Department of Neursurgery, Hospital La Timone, Marseille, France.

Thierry Colin (T)

SOPHiA GENETICS, Radiomics R&D Department, Cité de la Photonique, Pessac, France.

Olivier Chinot (O)

Aix-Marseille Univ, APHM, CNRS, INP, Inst Neurophysiopathol, Neuro-Oncology Department, Hôpital La Timone, Marseille, France.

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