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Bevacizumab and fotemustine for recurrent glioblastoma: a phase II study of AINO (Italian Association of Neuro-Oncology)

The optimal combination of bevacizumab with cytotoxic or cytostatic drugs in recurrent glioblastoma is unknown. We performed a phase 2 trial of combined bevacizumab and fotemustine for patients with glioblastoma at first relapse after radiotherapy and temozolomide. The primary endpoint was 6-month p...

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Autores principales: Soffietti, Riccardo, Trevisan, Elisa, Bertero, Luca, Cassoni, Paola, Morra, Isabella, Fabrini, Maria Grazia, Pasqualetti, Francesco, Lolli, Ivan, Castiglione, Anna, Ciccone, Giovannino, Rudà, Roberta
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3905193/
https://www.ncbi.nlm.nih.gov/pubmed/24293233
http://dx.doi.org/10.1007/s11060-013-1317-x
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author Soffietti, Riccardo
Trevisan, Elisa
Bertero, Luca
Cassoni, Paola
Morra, Isabella
Fabrini, Maria Grazia
Pasqualetti, Francesco
Lolli, Ivan
Castiglione, Anna
Ciccone, Giovannino
Rudà, Roberta
author_facet Soffietti, Riccardo
Trevisan, Elisa
Bertero, Luca
Cassoni, Paola
Morra, Isabella
Fabrini, Maria Grazia
Pasqualetti, Francesco
Lolli, Ivan
Castiglione, Anna
Ciccone, Giovannino
Rudà, Roberta
author_sort Soffietti, Riccardo
collection PubMed
description The optimal combination of bevacizumab with cytotoxic or cytostatic drugs in recurrent glioblastoma is unknown. We performed a phase 2 trial of combined bevacizumab and fotemustine for patients with glioblastoma at first relapse after radiotherapy and temozolomide. The primary endpoint was 6-month progression-free survival (PFS), while secondary endpoints were overall survival (OS), response rate based on RANO criteria and toxicity. Fifty-four patients with recurrent GBM were enrolled. The authors observed a 6-month PFS rate of 42.6 % (95 % CI 29.3–55.2) and a median PFS of 5.2 months (95 % CI 3.8–6.6). The median OS was 9.1 months (95 % CI 7.3–10.3). Twenty-eight patients (52 %) had a radiographic response, and a significant neurological improvement with steroid reduction was observed in 25/42 symptomatic patients (60 %). MGMT promoter methylation was significantly associated with improved PFS in univariate analysis. Most unifocal tumors at baseline had a focal enhancing progression (76 %), while the diffuse non-enhancing progression accounted for 9.5 %. Response or survival were not associated with any pattern of progression. Survival after failure of treatment was short. Twelve out of 54 patients (22 %) discontinued fotemustine for grade 3/4 myelotoxicity, while 4/54 (7.4 %) discontinued bevacizumab. This study failed to demonstrate a superiority of the combination of bevacizumab and fotemustine over either bevacizumab or fotemustine alone as historical controls. Future studies should explore alternative regimens of combination of the two drugs.
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spelling pubmed-39051932014-01-30 Bevacizumab and fotemustine for recurrent glioblastoma: a phase II study of AINO (Italian Association of Neuro-Oncology) Soffietti, Riccardo Trevisan, Elisa Bertero, Luca Cassoni, Paola Morra, Isabella Fabrini, Maria Grazia Pasqualetti, Francesco Lolli, Ivan Castiglione, Anna Ciccone, Giovannino Rudà, Roberta J Neurooncol Clinical Study The optimal combination of bevacizumab with cytotoxic or cytostatic drugs in recurrent glioblastoma is unknown. We performed a phase 2 trial of combined bevacizumab and fotemustine for patients with glioblastoma at first relapse after radiotherapy and temozolomide. The primary endpoint was 6-month progression-free survival (PFS), while secondary endpoints were overall survival (OS), response rate based on RANO criteria and toxicity. Fifty-four patients with recurrent GBM were enrolled. The authors observed a 6-month PFS rate of 42.6 % (95 % CI 29.3–55.2) and a median PFS of 5.2 months (95 % CI 3.8–6.6). The median OS was 9.1 months (95 % CI 7.3–10.3). Twenty-eight patients (52 %) had a radiographic response, and a significant neurological improvement with steroid reduction was observed in 25/42 symptomatic patients (60 %). MGMT promoter methylation was significantly associated with improved PFS in univariate analysis. Most unifocal tumors at baseline had a focal enhancing progression (76 %), while the diffuse non-enhancing progression accounted for 9.5 %. Response or survival were not associated with any pattern of progression. Survival after failure of treatment was short. Twelve out of 54 patients (22 %) discontinued fotemustine for grade 3/4 myelotoxicity, while 4/54 (7.4 %) discontinued bevacizumab. This study failed to demonstrate a superiority of the combination of bevacizumab and fotemustine over either bevacizumab or fotemustine alone as historical controls. Future studies should explore alternative regimens of combination of the two drugs. Springer US 2013-12-01 2014 /pmc/articles/PMC3905193/ /pubmed/24293233 http://dx.doi.org/10.1007/s11060-013-1317-x Text en © Springer Science+Business Media New York 2013
spellingShingle Clinical Study
Soffietti, Riccardo
Trevisan, Elisa
Bertero, Luca
Cassoni, Paola
Morra, Isabella
Fabrini, Maria Grazia
Pasqualetti, Francesco
Lolli, Ivan
Castiglione, Anna
Ciccone, Giovannino
Rudà, Roberta
Bevacizumab and fotemustine for recurrent glioblastoma: a phase II study of AINO (Italian Association of Neuro-Oncology)
title Bevacizumab and fotemustine for recurrent glioblastoma: a phase II study of AINO (Italian Association of Neuro-Oncology)
title_full Bevacizumab and fotemustine for recurrent glioblastoma: a phase II study of AINO (Italian Association of Neuro-Oncology)
title_fullStr Bevacizumab and fotemustine for recurrent glioblastoma: a phase II study of AINO (Italian Association of Neuro-Oncology)
title_full_unstemmed Bevacizumab and fotemustine for recurrent glioblastoma: a phase II study of AINO (Italian Association of Neuro-Oncology)
title_short Bevacizumab and fotemustine for recurrent glioblastoma: a phase II study of AINO (Italian Association of Neuro-Oncology)
title_sort bevacizumab and fotemustine for recurrent glioblastoma: a phase ii study of aino (italian association of neuro-oncology)
topic Clinical Study
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3905193/
https://www.ncbi.nlm.nih.gov/pubmed/24293233
http://dx.doi.org/10.1007/s11060-013-1317-x
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