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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Prolonged survival for patients with newly diagnosed, inoperable glioblastoma with 3-times daily ultrafractionated radiation therapy</title>
<author><name sortKey="Beauchesne, Patrick" sort="Beauchesne, Patrick" uniqKey="Beauchesne P" first="Patrick" last="Beauchesne">Patrick Beauchesne</name>
</author>
<author><name sortKey="Bernier, Valerie" sort="Bernier, Valerie" uniqKey="Bernier V" first="Valerie" last="Bernier">Valerie Bernier</name>
</author>
<author><name sortKey="Carnin, Charlotte" sort="Carnin, Charlotte" uniqKey="Carnin C" first="Charlotte" last="Carnin">Charlotte Carnin</name>
</author>
<author><name sortKey="Taillandier, Luc" sort="Taillandier, Luc" uniqKey="Taillandier L" first="Luc" last="Taillandier">Luc Taillandier</name>
</author>
<author><name sortKey="Djabri, Mohamed" sort="Djabri, Mohamed" uniqKey="Djabri M" first="Mohamed" last="Djabri">Mohamed Djabri</name>
</author>
<author><name sortKey="Martin, Laurent" sort="Martin, Laurent" uniqKey="Martin L" first="Laurent" last="Martin">Laurent Martin</name>
</author>
<author><name sortKey="Michel, Xavier" sort="Michel, Xavier" uniqKey="Michel X" first="Xavier" last="Michel">Xavier Michel</name>
</author>
<author><name sortKey="Maire, Jean Philippe" sort="Maire, Jean Philippe" uniqKey="Maire J" first="Jean-Philippe" last="Maire">Jean-Philippe Maire</name>
</author>
<author><name sortKey="Khalil, Toufic" sort="Khalil, Toufic" uniqKey="Khalil T" first="Toufic" last="Khalil">Toufic Khalil</name>
</author>
<author><name sortKey="Kerr, Christine" sort="Kerr, Christine" uniqKey="Kerr C" first="Christine" last="Kerr">Christine Kerr</name>
</author>
<author><name sortKey="Gorlia, Thierry" sort="Gorlia, Thierry" uniqKey="Gorlia T" first="Thierry" last="Gorlia">Thierry Gorlia</name>
</author>
<author><name sortKey="Stupp, Roger" sort="Stupp, Roger" uniqKey="Stupp R" first="Roger" last="Stupp">Roger Stupp</name>
</author>
<author><name sortKey="Pedeux, Remy" sort="Pedeux, Remy" uniqKey="Pedeux R" first="Remy" last="Pedeux">Remy Pedeux</name>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">PMC</idno>
<idno type="pmid">20511183</idno>
<idno type="pmc">2940649</idno>
<idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2940649</idno>
<idno type="RBID">PMC:2940649</idno>
<idno type="doi">10.1093/neuonc/noq008</idno>
<date when="2010">2010</date>
<idno type="wicri:Area/Pmc/Corpus">000191</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Prolonged survival for patients with newly diagnosed, inoperable glioblastoma with 3-times daily ultrafractionated radiation therapy</title>
<author><name sortKey="Beauchesne, Patrick" sort="Beauchesne, Patrick" uniqKey="Beauchesne P" first="Patrick" last="Beauchesne">Patrick Beauchesne</name>
</author>
<author><name sortKey="Bernier, Valerie" sort="Bernier, Valerie" uniqKey="Bernier V" first="Valerie" last="Bernier">Valerie Bernier</name>
</author>
<author><name sortKey="Carnin, Charlotte" sort="Carnin, Charlotte" uniqKey="Carnin C" first="Charlotte" last="Carnin">Charlotte Carnin</name>
</author>
<author><name sortKey="Taillandier, Luc" sort="Taillandier, Luc" uniqKey="Taillandier L" first="Luc" last="Taillandier">Luc Taillandier</name>
</author>
<author><name sortKey="Djabri, Mohamed" sort="Djabri, Mohamed" uniqKey="Djabri M" first="Mohamed" last="Djabri">Mohamed Djabri</name>
</author>
<author><name sortKey="Martin, Laurent" sort="Martin, Laurent" uniqKey="Martin L" first="Laurent" last="Martin">Laurent Martin</name>
</author>
<author><name sortKey="Michel, Xavier" sort="Michel, Xavier" uniqKey="Michel X" first="Xavier" last="Michel">Xavier Michel</name>
</author>
<author><name sortKey="Maire, Jean Philippe" sort="Maire, Jean Philippe" uniqKey="Maire J" first="Jean-Philippe" last="Maire">Jean-Philippe Maire</name>
</author>
<author><name sortKey="Khalil, Toufic" sort="Khalil, Toufic" uniqKey="Khalil T" first="Toufic" last="Khalil">Toufic Khalil</name>
</author>
<author><name sortKey="Kerr, Christine" sort="Kerr, Christine" uniqKey="Kerr C" first="Christine" last="Kerr">Christine Kerr</name>
</author>
<author><name sortKey="Gorlia, Thierry" sort="Gorlia, Thierry" uniqKey="Gorlia T" first="Thierry" last="Gorlia">Thierry Gorlia</name>
</author>
<author><name sortKey="Stupp, Roger" sort="Stupp, Roger" uniqKey="Stupp R" first="Roger" last="Stupp">Roger Stupp</name>
</author>
<author><name sortKey="Pedeux, Remy" sort="Pedeux, Remy" uniqKey="Pedeux R" first="Remy" last="Pedeux">Remy Pedeux</name>
</author>
</analytic>
<series><title level="j">Neuro-Oncology</title>
<idno type="ISSN">1522-8517</idno>
<idno type="eISSN">1523-5866</idno>
<imprint><date when="2010">2010</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass></textClass>
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<front><div type="abstract" xml:lang="en"><p>Ultrafractionation of radiation therapy is a novel regimen consisting of irradiating tumors several times daily, delivering low doses (<0.75 Gy) at which hyperradiosensitivity occurs. We recently demonstrated the high efficiency of ultrafractionated radiotherapy (RT) on glioma xenografts and report here on a phase II clinical trial to determine the safety, tolerability, and efficacy of an ultrafractionation regimen in patients with newly and inoperable glioblastoma (GBM). Thirty-one patients with histologically proven, newly diagnosed, and unresectable supratentorial GBM (WHO grade IV) were enrolled. Three daily doses of 0.75 Gy were delivered at least 4 hours apart, 5 days per week over 6–7 consecutive weeks (90 fractions for a total of 67.5 Gy). Conformal irradiation included the tumor bulk with a margin of 2.5 cm. The primary end points were safety, toxicity, and tolerability, and the secondary end points were overall survival (OS) and progression-free survival (PFS). Multivariate analysis was used to compare the OS and PFS with the EORTC-NCIC trial 26981-22981/CE.3 of RT alone vs radiation therapy and temozolomide (TMZ). The ultrafractionation radiation regimen was safe and well tolerated. No acute Grade III and/or IV CNS toxicity was observed. Median PFS and OS from initial diagnosis were 5.1 and 9.5 months, respectively. When comparing with the EORTC/NCIC trial, in both PFS and OS multivariate analysis, ultrafractionation showed superiority over RT alone, but not over RT and TMZ. The ultrafractionation regimen is safe and may prolong the survival of patients with GBM. Further investigation is warranted and a trial associating ultra-fractionation and TMZ is ongoing.</p>
</div>
</front>
</TEI>
<pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Neuro Oncol</journal-id>
<journal-id journal-id-type="publisher-id">neuonc</journal-id>
<journal-id journal-id-type="hwp">neuonc</journal-id>
<journal-title-group><journal-title>Neuro-Oncology</journal-title>
</journal-title-group>
<issn pub-type="ppub">1522-8517</issn>
<issn pub-type="epub">1523-5866</issn>
<publisher><publisher-name>Oxford University Press</publisher-name>
</publisher>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">20511183</article-id>
<article-id pub-id-type="pmc">2940649</article-id>
<article-id pub-id-type="doi">10.1093/neuonc/noq008</article-id>
<article-id pub-id-type="publisher-id">noq008</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Clinical Investigations</subject>
</subj-group>
</article-categories>
<title-group><article-title>Prolonged survival for patients with newly diagnosed, inoperable glioblastoma with 3-times daily ultrafractionated radiation therapy</article-title>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Beauchesne</surname>
<given-names>Patrick</given-names>
</name>
<xref ref-type="corresp" rid="cor1"></xref>
</contrib>
<contrib contrib-type="author"><name><surname>Bernier</surname>
<given-names>Valerie</given-names>
</name>
</contrib>
<contrib contrib-type="author"><name><surname>Carnin</surname>
<given-names>Charlotte</given-names>
</name>
</contrib>
<contrib contrib-type="author"><name><surname>Taillandier</surname>
<given-names>Luc</given-names>
</name>
</contrib>
<contrib contrib-type="author"><name><surname>Djabri</surname>
<given-names>Mohamed</given-names>
</name>
</contrib>
<contrib contrib-type="author"><name><surname>Martin</surname>
<given-names>Laurent</given-names>
</name>
</contrib>
<contrib contrib-type="author"><name><surname>Michel</surname>
<given-names>Xavier</given-names>
</name>
</contrib>
<contrib contrib-type="author"><name><surname>Maire</surname>
<given-names>Jean-Philippe</given-names>
</name>
</contrib>
<contrib contrib-type="author"><name><surname>Khalil</surname>
<given-names>Toufic</given-names>
</name>
</contrib>
<contrib contrib-type="author"><name><surname>Kerr</surname>
<given-names>Christine</given-names>
</name>
</contrib>
<contrib contrib-type="author"><name><surname>Gorlia</surname>
<given-names>Thierry</given-names>
</name>
</contrib>
<contrib contrib-type="author"><name><surname>Stupp</surname>
<given-names>Roger</given-names>
</name>
</contrib>
<contrib contrib-type="author"><name><surname>Pedeux</surname>
<given-names>Remy</given-names>
</name>
</contrib>
</contrib-group>
<aff><institution>Neuro-Oncologie, CHU de Nancy</institution>
(P.B., C.C., L.T.);<institution>Radiothérapie, Centre A Vautrin</institution>
(V.B.);<institution>Radiothérapie, CHG de Metz</institution>
(X.M.);<institution>Radiothérapie, CHU de Bordeaux</institution>
(J.-P.M.);<institution>Radiothérapie, CHG de Thionville</institution>
(M.D.);<institution>Neurochirurgie, CHU de Clermont-Ferrand</institution>
(T.K.);<institution>Radiothérapie, Centre G Le Conquérant</institution>
,<addr-line>Le Havre</addr-line>
(L.M.);<institution>Radiothérapie, Centre Val d'Aurelle-P Lamarque</institution>
,<addr-line>Montpellier</addr-line>
,<country>France</country>
(C.K.);<institution>EORTC Data Center</institution>
,<addr-line>Brussels</addr-line>
,<country>Belgium</country>
(T.G.);<institution>Neurochirurgie, CHU Vaudois (CHUV) and University of Lausanne</institution>
,<addr-line>Lausanne</addr-line>
,<country>Switzerland</country>
(R.S.);<institution>INSERM U917</institution>
,<addr-line>Rennes</addr-line>
,<country>France</country>
(R.P.)</aff>
<author-notes><corresp id="cor1"><bold>Corresponding Author:</bold>
Patrick Beauchesne, MD, PhD, <institution>Neuro-Oncologie – Neurologie, CHU de Nancy, Hôpital Central</institution>
, <addr-line>CO no 34, 54035 Nancy Cedex</addr-line>
, <country>France</country>
(<email>beauchesnep@wanadoo.fr</email>
, <email>beaupatt@orange.fr</email>
)</corresp>
</author-notes>
<pub-date pub-type="ppub"><month>6</month>
<year>2010</year>
</pub-date>
<pub-date pub-type="epub"><day>11</day>
<month>2</month>
<year>2010</year>
</pub-date>
<volume>12</volume>
<issue>6</issue>
<fpage>595</fpage>
<lpage>602</lpage>
<history><date date-type="received"><day>6</day>
<month>5</month>
<year>2009</year>
</date>
<date date-type="accepted"><day>25</day>
<month>10</month>
<year>2009</year>
</date>
</history>
<permissions><copyright-statement>© The Author(s) 2010. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oxfordjournals.org.</copyright-statement>
<copyright-year>2010</copyright-year>
</permissions>
<abstract><p>Ultrafractionation of radiation therapy is a novel regimen consisting of irradiating tumors several times daily, delivering low doses (<0.75 Gy) at which hyperradiosensitivity occurs. We recently demonstrated the high efficiency of ultrafractionated radiotherapy (RT) on glioma xenografts and report here on a phase II clinical trial to determine the safety, tolerability, and efficacy of an ultrafractionation regimen in patients with newly and inoperable glioblastoma (GBM). Thirty-one patients with histologically proven, newly diagnosed, and unresectable supratentorial GBM (WHO grade IV) were enrolled. Three daily doses of 0.75 Gy were delivered at least 4 hours apart, 5 days per week over 6–7 consecutive weeks (90 fractions for a total of 67.5 Gy). Conformal irradiation included the tumor bulk with a margin of 2.5 cm. The primary end points were safety, toxicity, and tolerability, and the secondary end points were overall survival (OS) and progression-free survival (PFS). Multivariate analysis was used to compare the OS and PFS with the EORTC-NCIC trial 26981-22981/CE.3 of RT alone vs radiation therapy and temozolomide (TMZ). The ultrafractionation radiation regimen was safe and well tolerated. No acute Grade III and/or IV CNS toxicity was observed. Median PFS and OS from initial diagnosis were 5.1 and 9.5 months, respectively. When comparing with the EORTC/NCIC trial, in both PFS and OS multivariate analysis, ultrafractionation showed superiority over RT alone, but not over RT and TMZ. The ultrafractionation regimen is safe and may prolong the survival of patients with GBM. Further investigation is warranted and a trial associating ultra-fractionation and TMZ is ongoing.</p>
</abstract>
<kwd-group><kwd>glioblastoma</kwd>
<kwd>inoperable</kwd>
<kwd>low doses</kwd>
<kwd>radiation therapy</kwd>
<kwd>ultrafractionated regimen</kwd>
</kwd-group>
</article-meta>
</front>
</pmc>
</record>
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