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Phase II trial of upfront bevacizumab and temozolomide for unresectable or multifocal glioblastoma

Patients with unresectable glioblastomas have a poor prognosis, with median survival of 6–10 months. We conducted a phase II trial of upfront 5-day temozolomide (TMZ) and bevacizumab (BV) in patients with newly diagnosed unresectable or multifocal glioblastoma. Patients received up to four cycles of...

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Autores principales: Lou, Emil, Peters, Katherine B, Sumrall, Ashley L, Desjardins, Annick, Reardon, David A, Lipp, Eric S, Herndon, James E, Coan, April, Bailey, Leighann, Turner, Scott, Friedman, Henry S, Vredenburgh, James J
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Blackwell Publishing Ltd 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3639657/
https://www.ncbi.nlm.nih.gov/pubmed/23634286
http://dx.doi.org/10.1002/cam4.58
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author Lou, Emil
Peters, Katherine B
Sumrall, Ashley L
Desjardins, Annick
Reardon, David A
Lipp, Eric S
Herndon, James E
Coan, April
Bailey, Leighann
Turner, Scott
Friedman, Henry S
Vredenburgh, James J
author_facet Lou, Emil
Peters, Katherine B
Sumrall, Ashley L
Desjardins, Annick
Reardon, David A
Lipp, Eric S
Herndon, James E
Coan, April
Bailey, Leighann
Turner, Scott
Friedman, Henry S
Vredenburgh, James J
author_sort Lou, Emil
collection PubMed
description Patients with unresectable glioblastomas have a poor prognosis, with median survival of 6–10 months. We conducted a phase II trial of upfront 5-day temozolomide (TMZ) and bevacizumab (BV) in patients with newly diagnosed unresectable or multifocal glioblastoma. Patients received up to four cycles of TMZ at 200 mg/m(2) on days 1–5, and BV at 10 mg/kg on days 1 and 15 of a 28-day cycle. Brain magnetic resonance imaging (MRI) was performed monthly. Therapy was continued as long as there was no tumor progression, grade 4 nonhematologic toxicity, or recurrent grade 4 hematologic toxicity after dose reduction. The primary end point was best tumor response as measured on MRI. Forty-one patients were accrued over 12 months; 39 had a full set of MRI scans available for evaluation. Assessment for best radiographic responses was as follows: partial responses in 24.4%, stable disease in 68.3%, and progressive disease in 2.4%. Treatment-related toxicities included seven grade 4 toxicities and one grade 5 toxicity (myocardial infarction). From this study, it was concluded that an upfront regimen of TMZ and BV for unresectable glioblastoma was well tolerated and provided a significant level of disease stabilization. Therapeutic toxicities were consistent with those seen in the adjuvant setting using these agents. The upfront approach to treatment of glioblastoma in the unresectable population warrants further investigation in randomized controlled phase III trials.
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spelling pubmed-36396572013-04-30 Phase II trial of upfront bevacizumab and temozolomide for unresectable or multifocal glioblastoma Lou, Emil Peters, Katherine B Sumrall, Ashley L Desjardins, Annick Reardon, David A Lipp, Eric S Herndon, James E Coan, April Bailey, Leighann Turner, Scott Friedman, Henry S Vredenburgh, James J Cancer Med Clinical Cancer Research Patients with unresectable glioblastomas have a poor prognosis, with median survival of 6–10 months. We conducted a phase II trial of upfront 5-day temozolomide (TMZ) and bevacizumab (BV) in patients with newly diagnosed unresectable or multifocal glioblastoma. Patients received up to four cycles of TMZ at 200 mg/m(2) on days 1–5, and BV at 10 mg/kg on days 1 and 15 of a 28-day cycle. Brain magnetic resonance imaging (MRI) was performed monthly. Therapy was continued as long as there was no tumor progression, grade 4 nonhematologic toxicity, or recurrent grade 4 hematologic toxicity after dose reduction. The primary end point was best tumor response as measured on MRI. Forty-one patients were accrued over 12 months; 39 had a full set of MRI scans available for evaluation. Assessment for best radiographic responses was as follows: partial responses in 24.4%, stable disease in 68.3%, and progressive disease in 2.4%. Treatment-related toxicities included seven grade 4 toxicities and one grade 5 toxicity (myocardial infarction). From this study, it was concluded that an upfront regimen of TMZ and BV for unresectable glioblastoma was well tolerated and provided a significant level of disease stabilization. Therapeutic toxicities were consistent with those seen in the adjuvant setting using these agents. The upfront approach to treatment of glioblastoma in the unresectable population warrants further investigation in randomized controlled phase III trials. Blackwell Publishing Ltd 2013-04 2013-01-24 /pmc/articles/PMC3639657/ /pubmed/23634286 http://dx.doi.org/10.1002/cam4.58 Text en © 2013 Published by John Wiley & Sons Ltd. http://creativecommons.org/licenses/by/2.5/ This is an open access article under the terms of the Creative Commons Attribution Non-Commercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Clinical Cancer Research
Lou, Emil
Peters, Katherine B
Sumrall, Ashley L
Desjardins, Annick
Reardon, David A
Lipp, Eric S
Herndon, James E
Coan, April
Bailey, Leighann
Turner, Scott
Friedman, Henry S
Vredenburgh, James J
Phase II trial of upfront bevacizumab and temozolomide for unresectable or multifocal glioblastoma
title Phase II trial of upfront bevacizumab and temozolomide for unresectable or multifocal glioblastoma
title_full Phase II trial of upfront bevacizumab and temozolomide for unresectable or multifocal glioblastoma
title_fullStr Phase II trial of upfront bevacizumab and temozolomide for unresectable or multifocal glioblastoma
title_full_unstemmed Phase II trial of upfront bevacizumab and temozolomide for unresectable or multifocal glioblastoma
title_short Phase II trial of upfront bevacizumab and temozolomide for unresectable or multifocal glioblastoma
title_sort phase ii trial of upfront bevacizumab and temozolomide for unresectable or multifocal glioblastoma
topic Clinical Cancer Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3639657/
https://www.ncbi.nlm.nih.gov/pubmed/23634286
http://dx.doi.org/10.1002/cam4.58
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