Multicenter, single arm, phase II trial on the efficacy of ortataxel in recurrent glioblastoma.
Glioblastoma
Ortataxel
Recurrence
Taxane
Journal
Journal of neuro-oncology
ISSN: 1573-7373
Titre abrégé: J Neurooncol
Pays: United States
ID NLM: 8309335
Informations de publication
Date de publication:
May 2019
May 2019
Historique:
received:
08
11
2018
accepted:
31
01
2019
pubmed:
7
2
2019
medline:
30
8
2019
entrez:
7
2
2019
Statut:
ppublish
Résumé
Glioblastoma (GBM) is the most aggressive and frequent subtype of all malignant gliomas. At the time of recurrence, therapeutic options are lacking. Ortataxel, a second-generation taxane was reported to be effective in pre-clinical and phase I clinical studies. The aim of this study was to evaluate a potential therapeutic activity of ortataxel in patients with GBM recurring after surgery and first line treatment. In this phase II study, according to a two stage design, adult patients with histologically confirmed GBM in recurrence after surgery or biopsy, standard radiotherapy and chemotherapy with temozolomide were considered eligible. Patients included were treated with ortataxel 75 mg/m Between Nov 26, 2013 and Dec 12, 2015, 40 patients were recruited across six centres. The number of patients alive and free from progression at 6 months after the enrollment, observed in the first stage was four (11.4%), out of 35 patients included in the analysis, below the minimum number of events (7 out of 33) required to continue the study with the second stage The most important toxicities were neutropenia and hepatotoxicity that occurred in 13.2% of patients and leukopenia that occurred in 15.8% of patients. Overall ortataxel treatment fail to demonstrate a significant activity in recurrent GBM patients. However in a limited number of patients the drug produced a benefit that lasted for a long time. This study is registered with ClinicalTrials.gov, number NCT01989884.
Sections du résumé
BACKGROUND AND PURPOSE
OBJECTIVE
Glioblastoma (GBM) is the most aggressive and frequent subtype of all malignant gliomas. At the time of recurrence, therapeutic options are lacking. Ortataxel, a second-generation taxane was reported to be effective in pre-clinical and phase I clinical studies. The aim of this study was to evaluate a potential therapeutic activity of ortataxel in patients with GBM recurring after surgery and first line treatment.
METHODS
METHODS
In this phase II study, according to a two stage design, adult patients with histologically confirmed GBM in recurrence after surgery or biopsy, standard radiotherapy and chemotherapy with temozolomide were considered eligible. Patients included were treated with ortataxel 75 mg/m
RESULTS
RESULTS
Between Nov 26, 2013 and Dec 12, 2015, 40 patients were recruited across six centres. The number of patients alive and free from progression at 6 months after the enrollment, observed in the first stage was four (11.4%), out of 35 patients included in the analysis, below the minimum number of events (7 out of 33) required to continue the study with the second stage The most important toxicities were neutropenia and hepatotoxicity that occurred in 13.2% of patients and leukopenia that occurred in 15.8% of patients.
CONCLUSION
CONCLUSIONS
Overall ortataxel treatment fail to demonstrate a significant activity in recurrent GBM patients. However in a limited number of patients the drug produced a benefit that lasted for a long time.
TRIAL REGISTRATION
BACKGROUND
This study is registered with ClinicalTrials.gov, number NCT01989884.
Identifiants
pubmed: 30726533
doi: 10.1007/s11060-019-03116-z
pii: 10.1007/s11060-019-03116-z
doi:
Substances chimiques
Antineoplastic Agents
0
Bridged-Ring Compounds
0
Taxoids
0
IDN 5109
8H61Y4E29N
Banques de données
ClinicalTrials.gov
['NCT01989884']
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
455-462Investigateurs
Antonio Silvani
(A)
Andrea Salmaggi
(A)
Manuela Caroli
(M)
Enrico Marchioni
(E)
Andrea Pace
(A)
Paola Gaviani
(P)
A Silvani
(A)
P Gaviani
(P)
G Simonetti
(G)
I De Simone
(I)
E Biagioli
(E)
E Rulli
(E)
V Torri
(V)
Davide Poli
(D)
Evelina Mariotti
(E)
Grazia Caramia
(G)
Angela Pesenti Gritti
(AP)
Ilaria Pacchetti
(I)
M D'Incalci
(M)
Massimo Zucchetti
(M)
V Fregoni
(V)
E Quaquarini
(E)
Annalisa Lanza
(A)
Gianpaolo Basso
(G)
E Marchioni
(E)
Paola Bini
(P)
Giulia Berzero
(G)
Luca Diamanti
(L)
M Caroli
(M)
Andrea Di Cristofori
(A)
Andrea Manzoni
(A)
Giordano Lanfranchi
(G)
A Salmaggi
(A)
Antonio Ardizzoia
(A)
A Pace
(A)
Veronica Villani
(V)
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