A phase II study of bevacizumab and erlotinib after radiation and temozolomide in MGMT unmethylated GBM patients
Survival for glioblastoma (GBM) patients with an unmethyated MGMT promoter in their tumor is generally worse than methylated MGMT tumors, as temozolomide (TMZ) response is limited. How to better treat patients with unmethylated MGMT is unknown. We performed a trial combining erlotinib and bevacizuma...
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Veröffentlicht in: | Journal of neuro-oncology 2016-01, Vol.126 (1), p.185-192 |
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creator | Raizer, J. J. Giglio, P. Hu, J. Groves, M. Merrell, R. Conrad, C. Phuphanich, S. Puduvalli, V. K. Loghin, M. Paleologos, N. Yuan, Y. Liu, D. Rademaker, A. Yung, W. K. Vaillant, B. Rudnick, J. Chamberlain, M. Vick, N. Grimm, S. Tremont-Lukats, I. W. De Groot, J. Aldape, K. Gilbert, M. R. |
description | Survival for glioblastoma (GBM) patients with an unmethyated
MGMT
promoter in their tumor is generally worse than methylated
MGMT
tumors, as temozolomide (TMZ) response is limited. How to better treat patients with unmethylated
MGMT
is unknown. We performed a trial combining erlotinib and bevacizumab in unmethylated GBM patients after completion of radiation (RT) and TMZ. GBM patients with an unmethylated
MGMT
promoter were trial eligible. Patient received standard RT (60 Gy) and TMZ (75 mg/m
2
× 6 weeks) after surgical resection of their tumor. After completion of RT they started erlotinib 150 mg daily and bevacizumab 10 mg/kg every 2 weeks until progression. Imaging evaluations occurred every 8 weeks. The primary endpoint was overall survival. Of the 48 unmethylated patients enrolled, 46 were evaluable (29 men and 17 women); median age was 55.5 years (29–75) and median KPS was 90 (70–100). All patients completed RT with TMZ. The median number of cycles (1 cycle was 4 weeks) was 8 (2–47). Forty-one patients either progressed or died with a median progression free survival of 9.2 months. At a follow up of 33 months the median overall survival was 13.2 months. There were no unexpected toxicities and most observed toxicities were categorized as CTC grade 1 or 2. The combination of erlotinib and bevacizumab is tolerable but did not meet our primary endpoint of increasing survival. Importantly, more trials are needed to find better therapies for GBM patients with an unmethylated
MGMT
promoter. |
doi_str_mv | 10.1007/s11060-015-1958-z |
format | Article |
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MGMT
promoter in their tumor is generally worse than methylated
MGMT
tumors, as temozolomide (TMZ) response is limited. How to better treat patients with unmethylated
MGMT
is unknown. We performed a trial combining erlotinib and bevacizumab in unmethylated GBM patients after completion of radiation (RT) and TMZ. GBM patients with an unmethylated
MGMT
promoter were trial eligible. Patient received standard RT (60 Gy) and TMZ (75 mg/m
2
× 6 weeks) after surgical resection of their tumor. After completion of RT they started erlotinib 150 mg daily and bevacizumab 10 mg/kg every 2 weeks until progression. Imaging evaluations occurred every 8 weeks. The primary endpoint was overall survival. Of the 48 unmethylated patients enrolled, 46 were evaluable (29 men and 17 women); median age was 55.5 years (29–75) and median KPS was 90 (70–100). All patients completed RT with TMZ. The median number of cycles (1 cycle was 4 weeks) was 8 (2–47). Forty-one patients either progressed or died with a median progression free survival of 9.2 months. At a follow up of 33 months the median overall survival was 13.2 months. There were no unexpected toxicities and most observed toxicities were categorized as CTC grade 1 or 2. The combination of erlotinib and bevacizumab is tolerable but did not meet our primary endpoint of increasing survival. Importantly, more trials are needed to find better therapies for GBM patients with an unmethylated
MGMT
promoter.</description><identifier>ISSN: 0167-594X</identifier><identifier>EISSN: 1573-7373</identifier><identifier>DOI: 10.1007/s11060-015-1958-z</identifier><identifier>PMID: 26476729</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Adult ; Antineoplastic Agents - therapeutic use ; Bevacizumab - therapeutic use ; Brain Neoplasms - drug therapy ; Clinical Study ; Dacarbazine - adverse effects ; Dacarbazine - analogs & derivatives ; Disease-Free Survival ; DNA Methylation ; DNA Modification Methylases - genetics ; Erlotinib Hydrochloride - therapeutic use ; Female ; Glioblastoma - drug therapy ; Humans ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Neurology ; Oncology ; Prognosis ; Radiotherapy - adverse effects ; Temozolomide ; Treatment Outcome ; Young Adult</subject><ispartof>Journal of neuro-oncology, 2016-01, Vol.126 (1), p.185-192</ispartof><rights>Springer Science+Business Media New York 2015</rights><rights>Springer Science+Business Media New York 2016</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c573t-df6b89f3ff614e99ff4b86475408eccbe0489d0bcaa5b493549fcb52d30eb2ae3</citedby><cites>FETCH-LOGICAL-c573t-df6b89f3ff614e99ff4b86475408eccbe0489d0bcaa5b493549fcb52d30eb2ae3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s11060-015-1958-z$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s11060-015-1958-z$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>230,314,780,784,885,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26476729$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Raizer, J. J.</creatorcontrib><creatorcontrib>Giglio, P.</creatorcontrib><creatorcontrib>Hu, J.</creatorcontrib><creatorcontrib>Groves, M.</creatorcontrib><creatorcontrib>Merrell, R.</creatorcontrib><creatorcontrib>Conrad, C.</creatorcontrib><creatorcontrib>Phuphanich, S.</creatorcontrib><creatorcontrib>Puduvalli, V. K.</creatorcontrib><creatorcontrib>Loghin, M.</creatorcontrib><creatorcontrib>Paleologos, N.</creatorcontrib><creatorcontrib>Yuan, Y.</creatorcontrib><creatorcontrib>Liu, D.</creatorcontrib><creatorcontrib>Rademaker, A.</creatorcontrib><creatorcontrib>Yung, W. K.</creatorcontrib><creatorcontrib>Vaillant, B.</creatorcontrib><creatorcontrib>Rudnick, J.</creatorcontrib><creatorcontrib>Chamberlain, M.</creatorcontrib><creatorcontrib>Vick, N.</creatorcontrib><creatorcontrib>Grimm, S.</creatorcontrib><creatorcontrib>Tremont-Lukats, I. W.</creatorcontrib><creatorcontrib>De Groot, J.</creatorcontrib><creatorcontrib>Aldape, K.</creatorcontrib><creatorcontrib>Gilbert, M. R.</creatorcontrib><creatorcontrib>Brain Tumor Trials Collaborative</creatorcontrib><creatorcontrib>Brain Tumor Trials Collaborative</creatorcontrib><title>A phase II study of bevacizumab and erlotinib after radiation and temozolomide in MGMT unmethylated GBM patients</title><title>Journal of neuro-oncology</title><addtitle>J Neurooncol</addtitle><addtitle>J Neurooncol</addtitle><description>Survival for glioblastoma (GBM) patients with an unmethyated
MGMT
promoter in their tumor is generally worse than methylated
MGMT
tumors, as temozolomide (TMZ) response is limited. How to better treat patients with unmethylated
MGMT
is unknown. We performed a trial combining erlotinib and bevacizumab in unmethylated GBM patients after completion of radiation (RT) and TMZ. GBM patients with an unmethylated
MGMT
promoter were trial eligible. Patient received standard RT (60 Gy) and TMZ (75 mg/m
2
× 6 weeks) after surgical resection of their tumor. After completion of RT they started erlotinib 150 mg daily and bevacizumab 10 mg/kg every 2 weeks until progression. Imaging evaluations occurred every 8 weeks. The primary endpoint was overall survival. Of the 48 unmethylated patients enrolled, 46 were evaluable (29 men and 17 women); median age was 55.5 years (29–75) and median KPS was 90 (70–100). All patients completed RT with TMZ. The median number of cycles (1 cycle was 4 weeks) was 8 (2–47). Forty-one patients either progressed or died with a median progression free survival of 9.2 months. At a follow up of 33 months the median overall survival was 13.2 months. There were no unexpected toxicities and most observed toxicities were categorized as CTC grade 1 or 2. The combination of erlotinib and bevacizumab is tolerable but did not meet our primary endpoint of increasing survival. Importantly, more trials are needed to find better therapies for GBM patients with an unmethylated
MGMT
promoter.</description><subject>Adult</subject><subject>Antineoplastic Agents - therapeutic use</subject><subject>Bevacizumab - therapeutic use</subject><subject>Brain Neoplasms - drug therapy</subject><subject>Clinical Study</subject><subject>Dacarbazine - adverse effects</subject><subject>Dacarbazine - analogs & derivatives</subject><subject>Disease-Free Survival</subject><subject>DNA Methylation</subject><subject>DNA Modification Methylases - genetics</subject><subject>Erlotinib Hydrochloride - therapeutic use</subject><subject>Female</subject><subject>Glioblastoma - drug therapy</subject><subject>Humans</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Neurology</subject><subject>Oncology</subject><subject>Prognosis</subject><subject>Radiotherapy - adverse effects</subject><subject>Temozolomide</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>0167-594X</issn><issn>1573-7373</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNqNkcFrFDEUxoModrv6B3iRgBcvo0kmM5lchLboutDFSwVvIZl56abMJGuSKez-9abdWqogeArh_d733vc-hN5Q8oESIj4mSklLKkKbisqmqw7P0II2oq5ELernaEFoK6pG8h8n6DSlG0IIFzV9iU5Yy0UrmFyg3RnebXUCvF7jlOdhj4PFBm517w7zpA3WfsAQx5Cdd-VnM0Qc9eB0dsHfVzNM4RDGMLkBsPN4s9pc4dlPkLf7UWcY8Op8g3elAXxOr9ALq8cErx_eJfr-5fPVxdfq8ttqfXF2WfXFQK4G25pO2tralnKQ0lpuurJ1w0kHfW-A8E4OxPRaN4bLuuHS9qZhQ03AMA31En066u5mM8HQl9lRj2oX3aTjXgXt1J8V77bqOtwq3rGWSV4E3j8IxPBzhpTV5FIP46g9hDkpKoTsOsIo-w-0ZXXxQZqCvvsLvQlz9OUSheJSEiGLmyWiR6qPIaUI9nFvStRd9OoYvSrRq7vo1aH0vH1q-LHjd9YFYEcglZK_hvhk9D9VfwHAPLvN</recordid><startdate>20160101</startdate><enddate>20160101</enddate><creator>Raizer, J. 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K. ; Loghin, M. ; Paleologos, N. ; Yuan, Y. ; Liu, D. ; Rademaker, A. ; Yung, W. K. ; Vaillant, B. ; Rudnick, J. ; Chamberlain, M. ; Vick, N. ; Grimm, S. ; Tremont-Lukats, I. W. ; De Groot, J. ; Aldape, K. ; Gilbert, M. 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J.</au><au>Giglio, P.</au><au>Hu, J.</au><au>Groves, M.</au><au>Merrell, R.</au><au>Conrad, C.</au><au>Phuphanich, S.</au><au>Puduvalli, V. K.</au><au>Loghin, M.</au><au>Paleologos, N.</au><au>Yuan, Y.</au><au>Liu, D.</au><au>Rademaker, A.</au><au>Yung, W. K.</au><au>Vaillant, B.</au><au>Rudnick, J.</au><au>Chamberlain, M.</au><au>Vick, N.</au><au>Grimm, S.</au><au>Tremont-Lukats, I. W.</au><au>De Groot, J.</au><au>Aldape, K.</au><au>Gilbert, M. R.</au><aucorp>Brain Tumor Trials Collaborative</aucorp><aucorp>Brain Tumor Trials Collaborative</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A phase II study of bevacizumab and erlotinib after radiation and temozolomide in MGMT unmethylated GBM patients</atitle><jtitle>Journal of neuro-oncology</jtitle><stitle>J Neurooncol</stitle><addtitle>J Neurooncol</addtitle><date>2016-01-01</date><risdate>2016</risdate><volume>126</volume><issue>1</issue><spage>185</spage><epage>192</epage><pages>185-192</pages><issn>0167-594X</issn><eissn>1573-7373</eissn><abstract>Survival for glioblastoma (GBM) patients with an unmethyated
MGMT
promoter in their tumor is generally worse than methylated
MGMT
tumors, as temozolomide (TMZ) response is limited. How to better treat patients with unmethylated
MGMT
is unknown. We performed a trial combining erlotinib and bevacizumab in unmethylated GBM patients after completion of radiation (RT) and TMZ. GBM patients with an unmethylated
MGMT
promoter were trial eligible. Patient received standard RT (60 Gy) and TMZ (75 mg/m
2
× 6 weeks) after surgical resection of their tumor. After completion of RT they started erlotinib 150 mg daily and bevacizumab 10 mg/kg every 2 weeks until progression. Imaging evaluations occurred every 8 weeks. The primary endpoint was overall survival. Of the 48 unmethylated patients enrolled, 46 were evaluable (29 men and 17 women); median age was 55.5 years (29–75) and median KPS was 90 (70–100). All patients completed RT with TMZ. The median number of cycles (1 cycle was 4 weeks) was 8 (2–47). Forty-one patients either progressed or died with a median progression free survival of 9.2 months. At a follow up of 33 months the median overall survival was 13.2 months. There were no unexpected toxicities and most observed toxicities were categorized as CTC grade 1 or 2. The combination of erlotinib and bevacizumab is tolerable but did not meet our primary endpoint of increasing survival. Importantly, more trials are needed to find better therapies for GBM patients with an unmethylated
MGMT
promoter.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>26476729</pmid><doi>10.1007/s11060-015-1958-z</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Adult Antineoplastic Agents - therapeutic use Bevacizumab - therapeutic use Brain Neoplasms - drug therapy Clinical Study Dacarbazine - adverse effects Dacarbazine - analogs & derivatives Disease-Free Survival DNA Methylation DNA Modification Methylases - genetics Erlotinib Hydrochloride - therapeutic use Female Glioblastoma - drug therapy Humans Male Medicine Medicine & Public Health Middle Aged Neurology Oncology Prognosis Radiotherapy - adverse effects Temozolomide Treatment Outcome Young Adult |
title | A phase II study of bevacizumab and erlotinib after radiation and temozolomide in MGMT unmethylated GBM patients |
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