Randomized Double-Blind Placebo-Controlled Trial of Bevacizumab Therapy for Radiation Necrosis of the Central Nervous System
Purpose To conduct a controlled trial of bevacizumab for the treatment of symptomatic radiation necrosis of the brain. Methods and Materials A total of 14 patients were entered into a placebo-controlled randomized double-blind study of bevacizumab for the treatment of central nervous system radiatio...
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| Veröffentlicht in: | International journal of radiation oncology, biology, physics biology, physics, 2011-04, Vol.79 (5), p.1487-1495 |
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| creator | Levin, Victor A., M.D Bidaut, Luc, Ph.D Hou, Ping, Ph.D Kumar, Ashok J., M.D Wefel, Jeffrey S., Ph.D Bekele, B. Nebiyou, Ph.D Prabhu, Sujit, M.D Loghin, Monica, M.D Gilbert, Mark R., M.D Jackson, Edward F., Ph.D |
| description | Purpose To conduct a controlled trial of bevacizumab for the treatment of symptomatic radiation necrosis of the brain. Methods and Materials A total of 14 patients were entered into a placebo-controlled randomized double-blind study of bevacizumab for the treatment of central nervous system radiation necrosis. All patients were required to have radiographic or biopsy proof of central nervous system radiation necrosis and progressive neurologic symptoms or signs. Eligible patients had undergone irradiation for head-and-neck carcinoma, meningioma, or low- to mid-grade glioma. Patients were randomized to receive intravenous saline or bevacizumab at 3-week intervals. The magnetic resonance imaging findings 3 weeks after the second treatment and clinical signs and symptoms defined the response or progression. Results The volumes of necrosis estimated on T2 -weighted fluid-attenuated inversion recovery and T1 -weighted gadolinium-enhanced magnetic resonance imaging scans demonstrated that although no patient receiving placebo responded (0 of 7), all bevacizumab-treated patients did so (5 of 5 randomized and 7 of 7 crossover) with decreases in T2 -weighted fluid-attenuated inversion recovery and T1 -weighted gadolinium-enhanced volumes and a decrease in endothelial transfer constant. All bevacizumab-treated patients—and none of the placebo-treated patients—showed improvement in neurologic symptoms or signs. At a median of 10 months after the last dose of bevacizumab in patients receiving all four study doses, only 2 patients had experienced a recurrence of magnetic resonance imaging changes consistent with progressive radiation necrosis; one patient received a single additional dose of bevacizumab and the other patient received two doses. Conclusion The Class I evidence of bevacizumab efficacy from the present study in the treatment of central nervous system radiation necrosis justifies consideration of this treatment option for people with radiation necrosis secondary to the treatment of head-and-neck cancer and brain cancer. |
| doi_str_mv | 10.1016/j.ijrobp.2009.12.061 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_osti_</sourceid><recordid>TN_cdi_osti_scitechconnect_21491704</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0360301610000118</els_id><sourcerecordid>1022561668</sourcerecordid><originalsourceid>FETCH-LOGICAL-c619t-2bf56d05b0fa4965d784a1bd9f03d68d44a01e14f6da4ded4b577e127c3ecb4d3</originalsourceid><addsrcrecordid>eNqFkl2L1DAUhoso7uzqPxApiOhNx5wkTdubBXfWL1hW2R3Bu5Amp0zGthmTdmAWf7ypHRW80Ktc5HnP1_smyRMgSyAgXm2XdutdvVtSQqol0CURcC9ZQFlUGcvzL_eTBWGCZCzCJ8lpCFtCCEDBHyYnlLCqygu2SL7fqN64zt6hSS_dWLeYXbS2N-mnVmmsXbZy_eBd28b_tbeqTV2TXuBeaXs3dqpO1xv0andIG-fTG2WsGqzr02vU3gUbJnrYYLrCWCWKr9Hv3RjS20MYsHuUPGhUG_Dx8T1LPr99s169z64-vvuwen2VaQHVkNG6yYUheU0axSuRm6LkCmpTNYQZURrOFQEE3gijuEHD67woEGihGeqaG3aWPJvrujBYGbQdUG-063vUg6TAKygIj9SLmdp5923EMMjOBo1tq3qMM8syL0qglLNIvvwnCYTSXIAQZUT5jE73CB4bufO2U_4QITn5KLdy9lFOPkqgMvoYZU-PHca6Q_Nb9Mu4CDw_Aipo1TZe9dqGPxwHwvKyiNz5zGG8796in9bHXqOxftreOPu_Sf4uoGM-bOz5FQ8Ytm70ffROggxRIG-nzE2RA_IzbiX7AXH40tE</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1022561668</pqid></control><display><type>article</type><title>Randomized Double-Blind Placebo-Controlled Trial of Bevacizumab Therapy for Radiation Necrosis of the Central Nervous System</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals Complete</source><creator>Levin, Victor A., M.D ; Bidaut, Luc, Ph.D ; Hou, Ping, Ph.D ; Kumar, Ashok J., M.D ; Wefel, Jeffrey S., Ph.D ; Bekele, B. Nebiyou, Ph.D ; Prabhu, Sujit, M.D ; Loghin, Monica, M.D ; Gilbert, Mark R., M.D ; Jackson, Edward F., Ph.D</creator><creatorcontrib>Levin, Victor A., M.D ; Bidaut, Luc, Ph.D ; Hou, Ping, Ph.D ; Kumar, Ashok J., M.D ; Wefel, Jeffrey S., Ph.D ; Bekele, B. Nebiyou, Ph.D ; Prabhu, Sujit, M.D ; Loghin, Monica, M.D ; Gilbert, Mark R., M.D ; Jackson, Edward F., Ph.D</creatorcontrib><description>Purpose To conduct a controlled trial of bevacizumab for the treatment of symptomatic radiation necrosis of the brain. Methods and Materials A total of 14 patients were entered into a placebo-controlled randomized double-blind study of bevacizumab for the treatment of central nervous system radiation necrosis. All patients were required to have radiographic or biopsy proof of central nervous system radiation necrosis and progressive neurologic symptoms or signs. Eligible patients had undergone irradiation for head-and-neck carcinoma, meningioma, or low- to mid-grade glioma. Patients were randomized to receive intravenous saline or bevacizumab at 3-week intervals. The magnetic resonance imaging findings 3 weeks after the second treatment and clinical signs and symptoms defined the response or progression. Results The volumes of necrosis estimated on T2 -weighted fluid-attenuated inversion recovery and T1 -weighted gadolinium-enhanced magnetic resonance imaging scans demonstrated that although no patient receiving placebo responded (0 of 7), all bevacizumab-treated patients did so (5 of 5 randomized and 7 of 7 crossover) with decreases in T2 -weighted fluid-attenuated inversion recovery and T1 -weighted gadolinium-enhanced volumes and a decrease in endothelial transfer constant. All bevacizumab-treated patients—and none of the placebo-treated patients—showed improvement in neurologic symptoms or signs. At a median of 10 months after the last dose of bevacizumab in patients receiving all four study doses, only 2 patients had experienced a recurrence of magnetic resonance imaging changes consistent with progressive radiation necrosis; one patient received a single additional dose of bevacizumab and the other patient received two doses. Conclusion The Class I evidence of bevacizumab efficacy from the present study in the treatment of central nervous system radiation necrosis justifies consideration of this treatment option for people with radiation necrosis secondary to the treatment of head-and-neck cancer and brain cancer.</description><identifier>ISSN: 0360-3016</identifier><identifier>ISSN: 1879-355X</identifier><identifier>EISSN: 1879-355X</identifier><identifier>DOI: 10.1016/j.ijrobp.2009.12.061</identifier><identifier>PMID: 20399573</identifier><identifier>CODEN: IOBPD3</identifier><language>eng</language><publisher>New York, NY: Elsevier Inc</publisher><subject>Adult ; Aged ; Antibodies, Monoclonal - therapeutic use ; Antibodies, Monoclonal, Humanized ; Antineoplastic agents ; ANTINEOPLASTIC DRUGS ; Bevacizumab ; Biological and medical sciences ; BIOLOGICAL EFFECTS ; BIOLOGICAL RADIATION EFFECTS ; Biopsy ; BODY ; BRAIN ; Brain - pathology ; Brain - radiation effects ; Brain edema ; Brain Neoplasms - radiotherapy ; Brain tumors ; Carcinoma ; CARCINOMAS ; CENTRAL NERVOUS SYSTEM ; Central Nervous System - radiation effects ; CHEMOTHERAPY ; Clinical trials ; Cross-Over Studies ; DIAGNOSTIC TECHNIQUES ; DISEASES ; Double-Blind Method ; DRUGS ; Endothelial transfer constant ; Female ; Glioma ; Glioma - radiotherapy ; GLIOMAS ; HEAD ; Head and Neck Neoplasms - radiotherapy ; Hematology, Oncology and Palliative Medicine ; Humans ; INJURIES ; Intravenous administration ; Inversion ; K trans ; Magnetic Resonance Imaging ; Male ; Medical sciences ; MEDICINE ; Meningeal Neoplasms - radiotherapy ; meningioma ; Meningioma - radiotherapy ; Middle Aged ; NECK ; NECROSIS ; Necrosis - drug therapy ; Necrosis - etiology ; NEOPLASMS ; NERVOUS SYSTEM ; NERVOUS SYSTEM DISEASES ; Neuroprotective Agents - therapeutic use ; neurotoxicity ; NMR IMAGING ; ORGANS ; PATHOLOGICAL CHANGES ; Pharmacology. Drug treatments ; Placebos ; Radiation ; RADIATION EFFECTS ; RADIATION INJURIES ; Radiation Injuries - drug therapy ; Radiology ; RADIOLOGY AND NUCLEAR MEDICINE ; THERAPY ; Volumetric magnetic resonance imaging changes</subject><ispartof>International journal of radiation oncology, biology, physics, 2011-04, Vol.79 (5), p.1487-1495</ispartof><rights>Elsevier Inc.</rights><rights>2011 Elsevier Inc.</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2011 Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c619t-2bf56d05b0fa4965d784a1bd9f03d68d44a01e14f6da4ded4b577e127c3ecb4d3</citedby><cites>FETCH-LOGICAL-c619t-2bf56d05b0fa4965d784a1bd9f03d68d44a01e14f6da4ded4b577e127c3ecb4d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0360301610000118$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,314,776,780,881,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=24103587$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20399573$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://www.osti.gov/biblio/21491704$$D View this record in Osti.gov$$Hfree_for_read</backlink></links><search><creatorcontrib>Levin, Victor A., M.D</creatorcontrib><creatorcontrib>Bidaut, Luc, Ph.D</creatorcontrib><creatorcontrib>Hou, Ping, Ph.D</creatorcontrib><creatorcontrib>Kumar, Ashok J., M.D</creatorcontrib><creatorcontrib>Wefel, Jeffrey S., Ph.D</creatorcontrib><creatorcontrib>Bekele, B. Nebiyou, Ph.D</creatorcontrib><creatorcontrib>Prabhu, Sujit, M.D</creatorcontrib><creatorcontrib>Loghin, Monica, M.D</creatorcontrib><creatorcontrib>Gilbert, Mark R., M.D</creatorcontrib><creatorcontrib>Jackson, Edward F., Ph.D</creatorcontrib><title>Randomized Double-Blind Placebo-Controlled Trial of Bevacizumab Therapy for Radiation Necrosis of the Central Nervous System</title><title>International journal of radiation oncology, biology, physics</title><addtitle>Int J Radiat Oncol Biol Phys</addtitle><description>Purpose To conduct a controlled trial of bevacizumab for the treatment of symptomatic radiation necrosis of the brain. Methods and Materials A total of 14 patients were entered into a placebo-controlled randomized double-blind study of bevacizumab for the treatment of central nervous system radiation necrosis. All patients were required to have radiographic or biopsy proof of central nervous system radiation necrosis and progressive neurologic symptoms or signs. Eligible patients had undergone irradiation for head-and-neck carcinoma, meningioma, or low- to mid-grade glioma. Patients were randomized to receive intravenous saline or bevacizumab at 3-week intervals. The magnetic resonance imaging findings 3 weeks after the second treatment and clinical signs and symptoms defined the response or progression. Results The volumes of necrosis estimated on T2 -weighted fluid-attenuated inversion recovery and T1 -weighted gadolinium-enhanced magnetic resonance imaging scans demonstrated that although no patient receiving placebo responded (0 of 7), all bevacizumab-treated patients did so (5 of 5 randomized and 7 of 7 crossover) with decreases in T2 -weighted fluid-attenuated inversion recovery and T1 -weighted gadolinium-enhanced volumes and a decrease in endothelial transfer constant. All bevacizumab-treated patients—and none of the placebo-treated patients—showed improvement in neurologic symptoms or signs. At a median of 10 months after the last dose of bevacizumab in patients receiving all four study doses, only 2 patients had experienced a recurrence of magnetic resonance imaging changes consistent with progressive radiation necrosis; one patient received a single additional dose of bevacizumab and the other patient received two doses. Conclusion The Class I evidence of bevacizumab efficacy from the present study in the treatment of central nervous system radiation necrosis justifies consideration of this treatment option for people with radiation necrosis secondary to the treatment of head-and-neck cancer and brain cancer.</description><subject>Adult</subject><subject>Aged</subject><subject>Antibodies, Monoclonal - therapeutic use</subject><subject>Antibodies, Monoclonal, Humanized</subject><subject>Antineoplastic agents</subject><subject>ANTINEOPLASTIC DRUGS</subject><subject>Bevacizumab</subject><subject>Biological and medical sciences</subject><subject>BIOLOGICAL EFFECTS</subject><subject>BIOLOGICAL RADIATION EFFECTS</subject><subject>Biopsy</subject><subject>BODY</subject><subject>BRAIN</subject><subject>Brain - pathology</subject><subject>Brain - radiation effects</subject><subject>Brain edema</subject><subject>Brain Neoplasms - radiotherapy</subject><subject>Brain tumors</subject><subject>Carcinoma</subject><subject>CARCINOMAS</subject><subject>CENTRAL NERVOUS SYSTEM</subject><subject>Central Nervous System - radiation effects</subject><subject>CHEMOTHERAPY</subject><subject>Clinical trials</subject><subject>Cross-Over Studies</subject><subject>DIAGNOSTIC TECHNIQUES</subject><subject>DISEASES</subject><subject>Double-Blind Method</subject><subject>DRUGS</subject><subject>Endothelial transfer constant</subject><subject>Female</subject><subject>Glioma</subject><subject>Glioma - radiotherapy</subject><subject>GLIOMAS</subject><subject>HEAD</subject><subject>Head and Neck Neoplasms - radiotherapy</subject><subject>Hematology, Oncology and Palliative Medicine</subject><subject>Humans</subject><subject>INJURIES</subject><subject>Intravenous administration</subject><subject>Inversion</subject><subject>K trans</subject><subject>Magnetic Resonance Imaging</subject><subject>Male</subject><subject>Medical sciences</subject><subject>MEDICINE</subject><subject>Meningeal Neoplasms - radiotherapy</subject><subject>meningioma</subject><subject>Meningioma - radiotherapy</subject><subject>Middle Aged</subject><subject>NECK</subject><subject>NECROSIS</subject><subject>Necrosis - drug therapy</subject><subject>Necrosis - etiology</subject><subject>NEOPLASMS</subject><subject>NERVOUS SYSTEM</subject><subject>NERVOUS SYSTEM DISEASES</subject><subject>Neuroprotective Agents - therapeutic use</subject><subject>neurotoxicity</subject><subject>NMR IMAGING</subject><subject>ORGANS</subject><subject>PATHOLOGICAL CHANGES</subject><subject>Pharmacology. Drug treatments</subject><subject>Placebos</subject><subject>Radiation</subject><subject>RADIATION EFFECTS</subject><subject>RADIATION INJURIES</subject><subject>Radiation Injuries - drug therapy</subject><subject>Radiology</subject><subject>RADIOLOGY AND NUCLEAR MEDICINE</subject><subject>THERAPY</subject><subject>Volumetric magnetic resonance imaging changes</subject><issn>0360-3016</issn><issn>1879-355X</issn><issn>1879-355X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkl2L1DAUhoso7uzqPxApiOhNx5wkTdubBXfWL1hW2R3Bu5Amp0zGthmTdmAWf7ypHRW80Ktc5HnP1_smyRMgSyAgXm2XdutdvVtSQqol0CURcC9ZQFlUGcvzL_eTBWGCZCzCJ8lpCFtCCEDBHyYnlLCqygu2SL7fqN64zt6hSS_dWLeYXbS2N-mnVmmsXbZy_eBd28b_tbeqTV2TXuBeaXs3dqpO1xv0andIG-fTG2WsGqzr02vU3gUbJnrYYLrCWCWKr9Hv3RjS20MYsHuUPGhUG_Dx8T1LPr99s169z64-vvuwen2VaQHVkNG6yYUheU0axSuRm6LkCmpTNYQZURrOFQEE3gijuEHD67woEGihGeqaG3aWPJvrujBYGbQdUG-063vUg6TAKygIj9SLmdp5923EMMjOBo1tq3qMM8syL0qglLNIvvwnCYTSXIAQZUT5jE73CB4bufO2U_4QITn5KLdy9lFOPkqgMvoYZU-PHca6Q_Nb9Mu4CDw_Aipo1TZe9dqGPxwHwvKyiNz5zGG8796in9bHXqOxftreOPu_Sf4uoGM-bOz5FQ8Ytm70ffROggxRIG-nzE2RA_IzbiX7AXH40tE</recordid><startdate>20110401</startdate><enddate>20110401</enddate><creator>Levin, Victor A., M.D</creator><creator>Bidaut, Luc, Ph.D</creator><creator>Hou, Ping, Ph.D</creator><creator>Kumar, Ashok J., M.D</creator><creator>Wefel, Jeffrey S., Ph.D</creator><creator>Bekele, B. Nebiyou, Ph.D</creator><creator>Prabhu, Sujit, M.D</creator><creator>Loghin, Monica, M.D</creator><creator>Gilbert, Mark R., M.D</creator><creator>Jackson, Edward F., Ph.D</creator><general>Elsevier Inc</general><general>Elsevier</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7TK</scope><scope>7X8</scope><scope>OTOTI</scope></search><sort><creationdate>20110401</creationdate><title>Randomized Double-Blind Placebo-Controlled Trial of Bevacizumab Therapy for Radiation Necrosis of the Central Nervous System</title><author>Levin, Victor A., M.D ; Bidaut, Luc, Ph.D ; Hou, Ping, Ph.D ; Kumar, Ashok J., M.D ; Wefel, Jeffrey S., Ph.D ; Bekele, B. Nebiyou, Ph.D ; Prabhu, Sujit, M.D ; Loghin, Monica, M.D ; Gilbert, Mark R., M.D ; Jackson, Edward F., Ph.D</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c619t-2bf56d05b0fa4965d784a1bd9f03d68d44a01e14f6da4ded4b577e127c3ecb4d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Antibodies, Monoclonal - therapeutic use</topic><topic>Antibodies, Monoclonal, Humanized</topic><topic>Antineoplastic agents</topic><topic>ANTINEOPLASTIC DRUGS</topic><topic>Bevacizumab</topic><topic>Biological and medical sciences</topic><topic>BIOLOGICAL EFFECTS</topic><topic>BIOLOGICAL RADIATION EFFECTS</topic><topic>Biopsy</topic><topic>BODY</topic><topic>BRAIN</topic><topic>Brain - pathology</topic><topic>Brain - radiation effects</topic><topic>Brain edema</topic><topic>Brain Neoplasms - radiotherapy</topic><topic>Brain tumors</topic><topic>Carcinoma</topic><topic>CARCINOMAS</topic><topic>CENTRAL NERVOUS SYSTEM</topic><topic>Central Nervous System - radiation effects</topic><topic>CHEMOTHERAPY</topic><topic>Clinical trials</topic><topic>Cross-Over Studies</topic><topic>DIAGNOSTIC TECHNIQUES</topic><topic>DISEASES</topic><topic>Double-Blind Method</topic><topic>DRUGS</topic><topic>Endothelial transfer constant</topic><topic>Female</topic><topic>Glioma</topic><topic>Glioma - radiotherapy</topic><topic>GLIOMAS</topic><topic>HEAD</topic><topic>Head and Neck Neoplasms - radiotherapy</topic><topic>Hematology, Oncology and Palliative Medicine</topic><topic>Humans</topic><topic>INJURIES</topic><topic>Intravenous administration</topic><topic>Inversion</topic><topic>K trans</topic><topic>Magnetic Resonance Imaging</topic><topic>Male</topic><topic>Medical sciences</topic><topic>MEDICINE</topic><topic>Meningeal Neoplasms - radiotherapy</topic><topic>meningioma</topic><topic>Meningioma - radiotherapy</topic><topic>Middle Aged</topic><topic>NECK</topic><topic>NECROSIS</topic><topic>Necrosis - drug therapy</topic><topic>Necrosis - etiology</topic><topic>NEOPLASMS</topic><topic>NERVOUS SYSTEM</topic><topic>NERVOUS SYSTEM DISEASES</topic><topic>Neuroprotective Agents - therapeutic use</topic><topic>neurotoxicity</topic><topic>NMR IMAGING</topic><topic>ORGANS</topic><topic>PATHOLOGICAL CHANGES</topic><topic>Pharmacology. Drug treatments</topic><topic>Placebos</topic><topic>Radiation</topic><topic>RADIATION EFFECTS</topic><topic>RADIATION INJURIES</topic><topic>Radiation Injuries - drug therapy</topic><topic>Radiology</topic><topic>RADIOLOGY AND NUCLEAR MEDICINE</topic><topic>THERAPY</topic><topic>Volumetric magnetic resonance imaging changes</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Levin, Victor A., M.D</creatorcontrib><creatorcontrib>Bidaut, Luc, Ph.D</creatorcontrib><creatorcontrib>Hou, Ping, Ph.D</creatorcontrib><creatorcontrib>Kumar, Ashok J., M.D</creatorcontrib><creatorcontrib>Wefel, Jeffrey S., Ph.D</creatorcontrib><creatorcontrib>Bekele, B. Nebiyou, Ph.D</creatorcontrib><creatorcontrib>Prabhu, Sujit, M.D</creatorcontrib><creatorcontrib>Loghin, Monica, M.D</creatorcontrib><creatorcontrib>Gilbert, Mark R., M.D</creatorcontrib><creatorcontrib>Jackson, Edward F., Ph.D</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Neurosciences Abstracts</collection><collection>MEDLINE - Academic</collection><collection>OSTI.GOV</collection><jtitle>International journal of radiation oncology, biology, physics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Levin, Victor A., M.D</au><au>Bidaut, Luc, Ph.D</au><au>Hou, Ping, Ph.D</au><au>Kumar, Ashok J., M.D</au><au>Wefel, Jeffrey S., Ph.D</au><au>Bekele, B. Nebiyou, Ph.D</au><au>Prabhu, Sujit, M.D</au><au>Loghin, Monica, M.D</au><au>Gilbert, Mark R., M.D</au><au>Jackson, Edward F., Ph.D</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomized Double-Blind Placebo-Controlled Trial of Bevacizumab Therapy for Radiation Necrosis of the Central Nervous System</atitle><jtitle>International journal of radiation oncology, biology, physics</jtitle><addtitle>Int J Radiat Oncol Biol Phys</addtitle><date>2011-04-01</date><risdate>2011</risdate><volume>79</volume><issue>5</issue><spage>1487</spage><epage>1495</epage><pages>1487-1495</pages><issn>0360-3016</issn><issn>1879-355X</issn><eissn>1879-355X</eissn><coden>IOBPD3</coden><abstract>Purpose To conduct a controlled trial of bevacizumab for the treatment of symptomatic radiation necrosis of the brain. Methods and Materials A total of 14 patients were entered into a placebo-controlled randomized double-blind study of bevacizumab for the treatment of central nervous system radiation necrosis. All patients were required to have radiographic or biopsy proof of central nervous system radiation necrosis and progressive neurologic symptoms or signs. Eligible patients had undergone irradiation for head-and-neck carcinoma, meningioma, or low- to mid-grade glioma. Patients were randomized to receive intravenous saline or bevacizumab at 3-week intervals. The magnetic resonance imaging findings 3 weeks after the second treatment and clinical signs and symptoms defined the response or progression. Results The volumes of necrosis estimated on T2 -weighted fluid-attenuated inversion recovery and T1 -weighted gadolinium-enhanced magnetic resonance imaging scans demonstrated that although no patient receiving placebo responded (0 of 7), all bevacizumab-treated patients did so (5 of 5 randomized and 7 of 7 crossover) with decreases in T2 -weighted fluid-attenuated inversion recovery and T1 -weighted gadolinium-enhanced volumes and a decrease in endothelial transfer constant. All bevacizumab-treated patients—and none of the placebo-treated patients—showed improvement in neurologic symptoms or signs. At a median of 10 months after the last dose of bevacizumab in patients receiving all four study doses, only 2 patients had experienced a recurrence of magnetic resonance imaging changes consistent with progressive radiation necrosis; one patient received a single additional dose of bevacizumab and the other patient received two doses. Conclusion The Class I evidence of bevacizumab efficacy from the present study in the treatment of central nervous system radiation necrosis justifies consideration of this treatment option for people with radiation necrosis secondary to the treatment of head-and-neck cancer and brain cancer.</abstract><cop>New York, NY</cop><pub>Elsevier Inc</pub><pmid>20399573</pmid><doi>10.1016/j.ijrobp.2009.12.061</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 0360-3016 |
| ispartof | International journal of radiation oncology, biology, physics, 2011-04, Vol.79 (5), p.1487-1495 |
| issn | 0360-3016 1879-355X 1879-355X |
| language | eng |
| recordid | cdi_osti_scitechconnect_21491704 |
| source | MEDLINE; Elsevier ScienceDirect Journals Complete |
| subjects | Adult Aged Antibodies, Monoclonal - therapeutic use Antibodies, Monoclonal, Humanized Antineoplastic agents ANTINEOPLASTIC DRUGS Bevacizumab Biological and medical sciences BIOLOGICAL EFFECTS BIOLOGICAL RADIATION EFFECTS Biopsy BODY BRAIN Brain - pathology Brain - radiation effects Brain edema Brain Neoplasms - radiotherapy Brain tumors Carcinoma CARCINOMAS CENTRAL NERVOUS SYSTEM Central Nervous System - radiation effects CHEMOTHERAPY Clinical trials Cross-Over Studies DIAGNOSTIC TECHNIQUES DISEASES Double-Blind Method DRUGS Endothelial transfer constant Female Glioma Glioma - radiotherapy GLIOMAS HEAD Head and Neck Neoplasms - radiotherapy Hematology, Oncology and Palliative Medicine Humans INJURIES Intravenous administration Inversion K trans Magnetic Resonance Imaging Male Medical sciences MEDICINE Meningeal Neoplasms - radiotherapy meningioma Meningioma - radiotherapy Middle Aged NECK NECROSIS Necrosis - drug therapy Necrosis - etiology NEOPLASMS NERVOUS SYSTEM NERVOUS SYSTEM DISEASES Neuroprotective Agents - therapeutic use neurotoxicity NMR IMAGING ORGANS PATHOLOGICAL CHANGES Pharmacology. Drug treatments Placebos Radiation RADIATION EFFECTS RADIATION INJURIES Radiation Injuries - drug therapy Radiology RADIOLOGY AND NUCLEAR MEDICINE THERAPY Volumetric magnetic resonance imaging changes |
| title | Randomized Double-Blind Placebo-Controlled Trial of Bevacizumab Therapy for Radiation Necrosis of the Central Nervous System |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-07T16%3A36%3A02IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_osti_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Randomized%20Double-Blind%20Placebo-Controlled%20Trial%20of%20Bevacizumab%20Therapy%20for%20Radiation%20Necrosis%20of%20the%20Central%20Nervous%20System&rft.jtitle=International%20journal%20of%20radiation%20oncology,%20biology,%20physics&rft.au=Levin,%20Victor%20A.,%20M.D&rft.date=2011-04-01&rft.volume=79&rft.issue=5&rft.spage=1487&rft.epage=1495&rft.pages=1487-1495&rft.issn=0360-3016&rft.eissn=1879-355X&rft.coden=IOBPD3&rft_id=info:doi/10.1016/j.ijrobp.2009.12.061&rft_dat=%3Cproquest_osti_%3E1022561668%3C/proquest_osti_%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1022561668&rft_id=info:pmid/20399573&rft_els_id=S0360301610000118&rfr_iscdi=true |