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Temozolomide chemotherapy versus radiotherapy in high-risk low-grade glioma

Identifieur interne : 001663 ( Main/Exploration ); précédent : 001662; suivant : 001664

Temozolomide chemotherapy versus radiotherapy in high-risk low-grade glioma

Auteurs : Brigitta G. Baumert [Allemagne] ; Monika E. Hegi [Suisse] ; Martin J. Van Den Bent [Pays-Bas] ; Andreas Von Deimling [Allemagne] ; Thierry Gorlia [Belgique] ; Khê Hoang-Xuan [France] ; Alba A. Brandes [Italie] ; Guy Kantor [France] ; Martin J. B. Taphoorn [Pays-Bas] ; Mohamed Ben Hassel [France] ; Christian Hartmann [Allemagne] ; Gail Ryan [Australie] ; David Capper [Allemagne] ; Johan M. Kros [Pays-Bas] ; Sebastian Kurscheid [Suisse, Australie] ; Wolfgang Wick [Allemagne] ; Roelien Enting [Pays-Bas] ; Michele Reni [Italie] ; Brian Thiessen [Canada] ; Frederic Dhermain [France] ; Jacoline E. Bromberg [Pays-Bas] ; Loic Feuvret [France] ; Jaap C. Reijneveld [Pays-Bas] ; Olivier Chinot [France] ; Johanna M. M. Gijtenbeek [Pays-Bas] ; John P. Rossiter [Canada] ; Nicolas Dif [Belgique] ; Carmen Balana [Espagne] ; Jose Bravo-Marques [Portugal] ; Paul M. Clement [Belgique] ; Christine Marosi [Autriche] ; Tzahala Tzuk-Shina [Israël] ; Robert A. Nordal [Canada] ; Jeremy Rees [Royaume-Uni] ; Denis Lacombe [Belgique] ; Warren P. Mason [Canada] ; Roger Stupp [Suisse]

Source :

RBID : PMC:5124485

Descripteurs français

English descriptors

Abstract

Background

Outcome of low-grade glioma (LGG, WHO grade II) is highly variable reflecting molecular heterogeneity of the disease. We compared two different single modality treatment strategies: standard radiotherapy (RT) versus primary temozolomide (TMZ) chemotherapy with the aim of tailoring treatment and identifying predictive molecular factors.

Methods

477 patients (2005 – 2012, median FU 48 months) with a low-grade glioma (astrocytoma, oligoastrocytoma, oligodendroglioma, WHO grade II) with at least one high-risk feature (age > 40 years, progressive disease, tumor > 5 cm or crossing the midline, neurological symptoms (e.g. focal or mental deficits, increased intracranial pressure or intractable seizures)) were, after stratification by chromosome 1p-status, randomized to either conformal RT (50.4 Gy/28 fractions) or dose-dense TMZ (75 mg/m2 daily × 21 days, q28 days, max. 12 cycles). Random treatment allocation was performed online using a minimization technique. A planned analysis was performed after 246 progression events. All analyses are intent to treat. Primary clinical endpoint was progression-free survival (PFS), correlative analyses included molecular markers (1p/19q co-deletion, MGMT methylation status, IDH1+2 mutations). The trial has been registered at the European Trials Registry (EudraCT 2004-002714-11) and at ClinicalTrials.gov (NCT00182819).

Findings

Four hundred seventy-seven patients were randomized. Severe hematological toxicity occurred in 14% of TMZ-treated patients, infections in 3% of TMZ-treated patients, and 1% of RT-treated patients. Moderate to severe fatigue was recorded in 3% of patients in the RT group and 7% in the TMZ group.

At a median follow-up of 48 months (IQR:31–56), median PFS was 39 months (IQR:16–46) in the TMZ arm and 46 months (IQR:19–48) in the RT group (hazard ratio 1.16, 95% CI, 0.9–1.5; p=0.22). Median OS has not been reached. Exploratory analyses identified treatment-dependent variation in outcome of molecular LGG subgroups (n=318).

Interpretation

There was no significant difference in outcome of the overall patient population treated with either radiotherapy alone or TMZ chemotherapy alone. Further data maturation is needed for overall survival analyses and evaluation of the full predictive impact of the molecular subtypes for individualized treatment choices.

Funding

Merck & Co, Swiss-Bridge Award 2011, Swiss Cancer League.


Url:
DOI: 10.1016/S1470-2045(16)30313-8
PubMed: 27686946
PubMed Central: 5124485


Affiliations:

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Le document en format XML

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<name sortKey="Capper, David" sort="Capper, David" uniqKey="Capper D" first="David" last="Capper">David Capper</name>
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<name sortKey="Reni, Michele" sort="Reni, Michele" uniqKey="Reni M" first="Michele" last="Reni">Michele Reni</name>
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<name sortKey="Thiessen, Brian" sort="Thiessen, Brian" uniqKey="Thiessen B" first="Brian" last="Thiessen">Brian Thiessen</name>
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<name sortKey="Dhermain, Frederic" sort="Dhermain, Frederic" uniqKey="Dhermain F" first="Frederic" last="Dhermain">Frederic Dhermain</name>
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<nlm:aff id="A17">Institut Gustave Roussy, Villejuif, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Institut Gustave Roussy, Villejuif</wicri:regionArea>
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<name sortKey="Bromberg, Jacoline E" sort="Bromberg, Jacoline E" uniqKey="Bromberg J" first="Jacoline E." last="Bromberg">Jacoline E. Bromberg</name>
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<nlm:aff id="A3">Erasmus MC Cancer Institute University Medical Center Rotterdam, Netherlands</nlm:aff>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Erasmus MC Cancer Institute University Medical Center Rotterdam</wicri:regionArea>
</affiliation>
</author>
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<name sortKey="Feuvret, Loic" sort="Feuvret, Loic" uniqKey="Feuvret L" first="Loic" last="Feuvret">Loic Feuvret</name>
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<nlm:aff id="A6">APHP, Pitie-Salpetriere Hospital and UPMC, Sorbonne Universités, Paris, France</nlm:aff>
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<name sortKey="Reijneveld, Jaap C" sort="Reijneveld, Jaap C" uniqKey="Reijneveld J" first="Jaap C." last="Reijneveld">Jaap C. Reijneveld</name>
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<nlm:aff id="A18">VU University Medical Center and Academic Medical Center, Amsterdam, Netherlands</nlm:aff>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>VU University Medical Center and Academic Medical Center, Amsterdam</wicri:regionArea>
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<settlement type="city">Amsterdam</settlement>
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<name sortKey="Chinot, Olivier" sort="Chinot, Olivier" uniqKey="Chinot O" first="Olivier" last="Chinot">Olivier Chinot</name>
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<nlm:aff id="A19">Aix Marseille, Université, APHM, Hôpital de la Timone, Marseille, France</nlm:aff>
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<region type="region">Provence-Alpes-Côte d'Azur</region>
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</affiliation>
</author>
<author>
<name sortKey="Gijtenbeek, Johanna M M" sort="Gijtenbeek, Johanna M M" uniqKey="Gijtenbeek J" first="Johanna M. M." last="Gijtenbeek">Johanna M. M. Gijtenbeek</name>
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<nlm:aff id="A20">Radboud University Medical Center, Nijmegen, Netherlands</nlm:aff>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Radboud University Medical Center, Nijmegen</wicri:regionArea>
<placeName>
<settlement type="city">Nimègue</settlement>
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<author>
<name sortKey="Rossiter, John P" sort="Rossiter, John P" uniqKey="Rossiter J" first="John P." last="Rossiter">John P. Rossiter</name>
<affiliation wicri:level="1">
<nlm:aff id="A21">Queen’s University, Kingston, Ontario, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Queen’s University, Kingston, Ontario</wicri:regionArea>
<wicri:noRegion>Ontario</wicri:noRegion>
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<author>
<name sortKey="Dif, Nicolas" sort="Dif, Nicolas" uniqKey="Dif N" first="Nicolas" last="Dif">Nicolas Dif</name>
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<country xml:lang="fr">Belgique</country>
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<settlement type="city">Bruxelles</settlement>
<region nuts="2">Région de Bruxelles-Capitale</region>
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<name sortKey="Balana, Carmen" sort="Balana, Carmen" uniqKey="Balana C" first="Carmen" last="Balana">Carmen Balana</name>
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<nlm:aff id="A23">ICO Badalona – Hospital Germans Trias I Pujol, Barcelona, Spain</nlm:aff>
<country xml:lang="fr">Espagne</country>
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<settlement type="city">Barcelone</settlement>
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</affiliation>
</author>
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<name sortKey="Bravo Marques, Jose" sort="Bravo Marques, Jose" uniqKey="Bravo Marques J" first="Jose" last="Bravo-Marques">Jose Bravo-Marques</name>
<affiliation wicri:level="1">
<nlm:aff id="A24">Instituto Portugues de Oncologia de Lisboa, Lisbon, Portugal</nlm:aff>
<country xml:lang="fr">Portugal</country>
<wicri:regionArea>Instituto Portugues de Oncologia de Lisboa, Lisbon</wicri:regionArea>
<wicri:noRegion>Lisbon</wicri:noRegion>
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<author>
<name sortKey="Clement, Paul M" sort="Clement, Paul M" uniqKey="Clement P" first="Paul M." last="Clement">Paul M. Clement</name>
<affiliation wicri:level="1">
<nlm:aff id="A25">KU Leuven, Leuven, Belgium</nlm:aff>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>KU Leuven, Leuven</wicri:regionArea>
<wicri:noRegion>Leuven</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Marosi, Christine" sort="Marosi, Christine" uniqKey="Marosi C" first="Christine" last="Marosi">Christine Marosi</name>
<affiliation wicri:level="1">
<nlm:aff id="A26">Medical University of Vienna, Austria</nlm:aff>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea>Medical University of Vienna</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Tzuk Shina, Tzahala" sort="Tzuk Shina, Tzahala" uniqKey="Tzuk Shina T" first="Tzahala" last="Tzuk-Shina">Tzahala Tzuk-Shina</name>
<affiliation wicri:level="1">
<nlm:aff id="A27">Rambam Health Care Campus, Oncology Institute, Haifa, Israel</nlm:aff>
<country xml:lang="fr">Israël</country>
<wicri:regionArea>Rambam Health Care Campus, Oncology Institute, Haifa</wicri:regionArea>
<wicri:noRegion>Haifa</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Nordal, Robert A" sort="Nordal, Robert A" uniqKey="Nordal R" first="Robert A." last="Nordal">Robert A. Nordal</name>
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<title xml:lang="en" level="a" type="main">Temozolomide chemotherapy
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radiotherapy in high-risk low-grade glioma</title>
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<name sortKey="Hoang Xuan, Khe" sort="Hoang Xuan, Khe" uniqKey="Hoang Xuan K" first="Khê" last="Hoang-Xuan">Khê Hoang-Xuan</name>
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<nlm:aff id="A6">APHP, Pitie-Salpetriere Hospital and UPMC, Sorbonne Universités, Paris, France</nlm:aff>
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<name sortKey="Brandes, Alba A" sort="Brandes, Alba A" uniqKey="Brandes A" first="Alba A." last="Brandes">Alba A. Brandes</name>
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<nlm:aff id="A7">AUSL-IRCCS Scienze Neurologische, Bologna, Italy</nlm:aff>
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<nlm:aff id="A8">Institut Bergonié, Comprehensive Cancer Center and University Bordeaux Segalen, Bordeaux, France</nlm:aff>
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<wicri:regionArea>Institut Bergonié, Comprehensive Cancer Center and University Bordeaux Segalen, Bordeaux</wicri:regionArea>
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<nlm:aff id="A9">Medical Center Haaglanden, The Hague, The Netherlands, Leiden University Center, Leiden</nlm:aff>
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<settlement type="city">Leyde</settlement>
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<nlm:aff id="A10">Centre Eugène Marquis, Rennes, France</nlm:aff>
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<wicri:regionArea>Centre Eugène Marquis, Rennes</wicri:regionArea>
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<region type="region">Région Bretagne</region>
<region type="old region">Région Bretagne</region>
<settlement type="city">Rennes</settlement>
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<name sortKey="Hartmann, Christian" sort="Hartmann, Christian" uniqKey="Hartmann C" first="Christian" last="Hartmann">Christian Hartmann</name>
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<nlm:aff id="A4">University of Heidelberg and CCU Neuropathology German Cancer Research Center, Heidelberg, Germany</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>University of Heidelberg and CCU Neuropathology German Cancer Research Center, Heidelberg</wicri:regionArea>
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<region type="land" nuts="1">Bade-Wurtemberg</region>
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<country xml:lang="fr">Allemagne</country>
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<nlm:aff id="A12">Peter MacCallum Cancer Center, Melbourne, Victoria, Australia</nlm:aff>
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<wicri:regionArea>Peter MacCallum Cancer Center, Melbourne, Victoria</wicri:regionArea>
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<nlm:aff id="A4">University of Heidelberg and CCU Neuropathology German Cancer Research Center, Heidelberg, Germany</nlm:aff>
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<name sortKey="Kros, Johan M" sort="Kros, Johan M" uniqKey="Kros J" first="Johan M." last="Kros">Johan M. Kros</name>
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<nlm:aff id="A3">Erasmus MC Cancer Institute University Medical Center Rotterdam, Netherlands</nlm:aff>
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<wicri:regionArea>Erasmus MC Cancer Institute University Medical Center Rotterdam</wicri:regionArea>
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<name sortKey="Kurscheid, Sebastian" sort="Kurscheid, Sebastian" uniqKey="Kurscheid S" first="Sebastian" last="Kurscheid">Sebastian Kurscheid</name>
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<nlm:aff id="A2">Lausanne University Hospital, Lausanne, Switzerland</nlm:aff>
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<settlement type="city">Lausanne</settlement>
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</affiliation>
<affiliation wicri:level="1">
<nlm:aff id="A13">The John Curtin School of Medical Research, The Australian National University, Canberra, Australia</nlm:aff>
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<name sortKey="Wick, Wolfgang" sort="Wick, Wolfgang" uniqKey="Wick W" first="Wolfgang" last="Wick">Wolfgang Wick</name>
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<nlm:aff id="A4">University of Heidelberg and CCU Neuropathology German Cancer Research Center, Heidelberg, Germany</nlm:aff>
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<wicri:regionArea>University of Heidelberg and CCU Neuropathology German Cancer Research Center, Heidelberg</wicri:regionArea>
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<name sortKey="Enting, Roelien" sort="Enting, Roelien" uniqKey="Enting R" first="Roelien" last="Enting">Roelien Enting</name>
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<nlm:aff id="A14">University of Groningen, Groningen, Netherlands</nlm:aff>
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<wicri:regionArea>University of Groningen, Groningen</wicri:regionArea>
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<name sortKey="Reni, Michele" sort="Reni, Michele" uniqKey="Reni M" first="Michele" last="Reni">Michele Reni</name>
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<nlm:aff id="A15">IRCCS San Raffaele Scientific Institute, Milano, Italy</nlm:aff>
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<name sortKey="Thiessen, Brian" sort="Thiessen, Brian" uniqKey="Thiessen B" first="Brian" last="Thiessen">Brian Thiessen</name>
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<name sortKey="Dhermain, Frederic" sort="Dhermain, Frederic" uniqKey="Dhermain F" first="Frederic" last="Dhermain">Frederic Dhermain</name>
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<nlm:aff id="A17">Institut Gustave Roussy, Villejuif, France</nlm:aff>
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</author>
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<name sortKey="Bromberg, Jacoline E" sort="Bromberg, Jacoline E" uniqKey="Bromberg J" first="Jacoline E." last="Bromberg">Jacoline E. Bromberg</name>
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<nlm:aff id="A3">Erasmus MC Cancer Institute University Medical Center Rotterdam, Netherlands</nlm:aff>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Erasmus MC Cancer Institute University Medical Center Rotterdam</wicri:regionArea>
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</author>
<author>
<name sortKey="Feuvret, Loic" sort="Feuvret, Loic" uniqKey="Feuvret L" first="Loic" last="Feuvret">Loic Feuvret</name>
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<nlm:aff id="A6">APHP, Pitie-Salpetriere Hospital and UPMC, Sorbonne Universités, Paris, France</nlm:aff>
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<wicri:regionArea>APHP, Pitie-Salpetriere Hospital and UPMC, Sorbonne Universités, Paris</wicri:regionArea>
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<region type="region">Île-de-France</region>
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</affiliation>
</author>
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<name sortKey="Reijneveld, Jaap C" sort="Reijneveld, Jaap C" uniqKey="Reijneveld J" first="Jaap C." last="Reijneveld">Jaap C. Reijneveld</name>
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<nlm:aff id="A18">VU University Medical Center and Academic Medical Center, Amsterdam, Netherlands</nlm:aff>
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<wicri:regionArea>VU University Medical Center and Academic Medical Center, Amsterdam</wicri:regionArea>
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</affiliation>
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<name sortKey="Chinot, Olivier" sort="Chinot, Olivier" uniqKey="Chinot O" first="Olivier" last="Chinot">Olivier Chinot</name>
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<name sortKey="Gijtenbeek, Johanna M M" sort="Gijtenbeek, Johanna M M" uniqKey="Gijtenbeek J" first="Johanna M. M." last="Gijtenbeek">Johanna M. M. Gijtenbeek</name>
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<name sortKey="Rossiter, John P" sort="Rossiter, John P" uniqKey="Rossiter J" first="John P." last="Rossiter">John P. Rossiter</name>
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<nlm:aff id="A21">Queen’s University, Kingston, Ontario, Canada</nlm:aff>
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<name sortKey="Dif, Nicolas" sort="Dif, Nicolas" uniqKey="Dif N" first="Nicolas" last="Dif">Nicolas Dif</name>
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<name sortKey="Balana, Carmen" sort="Balana, Carmen" uniqKey="Balana C" first="Carmen" last="Balana">Carmen Balana</name>
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<name sortKey="Bravo Marques, Jose" sort="Bravo Marques, Jose" uniqKey="Bravo Marques J" first="Jose" last="Bravo-Marques">Jose Bravo-Marques</name>
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<nlm:aff id="A24">Instituto Portugues de Oncologia de Lisboa, Lisbon, Portugal</nlm:aff>
<country xml:lang="fr">Portugal</country>
<wicri:regionArea>Instituto Portugues de Oncologia de Lisboa, Lisbon</wicri:regionArea>
<wicri:noRegion>Lisbon</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Clement, Paul M" sort="Clement, Paul M" uniqKey="Clement P" first="Paul M." last="Clement">Paul M. Clement</name>
<affiliation wicri:level="1">
<nlm:aff id="A25">KU Leuven, Leuven, Belgium</nlm:aff>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>KU Leuven, Leuven</wicri:regionArea>
<wicri:noRegion>Leuven</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Marosi, Christine" sort="Marosi, Christine" uniqKey="Marosi C" first="Christine" last="Marosi">Christine Marosi</name>
<affiliation wicri:level="1">
<nlm:aff id="A26">Medical University of Vienna, Austria</nlm:aff>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea>Medical University of Vienna</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Tzuk Shina, Tzahala" sort="Tzuk Shina, Tzahala" uniqKey="Tzuk Shina T" first="Tzahala" last="Tzuk-Shina">Tzahala Tzuk-Shina</name>
<affiliation wicri:level="1">
<nlm:aff id="A27">Rambam Health Care Campus, Oncology Institute, Haifa, Israel</nlm:aff>
<country xml:lang="fr">Israël</country>
<wicri:regionArea>Rambam Health Care Campus, Oncology Institute, Haifa</wicri:regionArea>
<wicri:noRegion>Haifa</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Nordal, Robert A" sort="Nordal, Robert A" uniqKey="Nordal R" first="Robert A." last="Nordal">Robert A. Nordal</name>
<affiliation wicri:level="4">
<nlm:aff id="A28">Tom Baker Cancer Center, University of Calgary, Calgary, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Tom Baker Cancer Center, University of Calgary, Calgary</wicri:regionArea>
<orgName type="university">Université de Calgary</orgName>
<placeName>
<settlement type="city">Calgary</settlement>
<region type="state">Alberta</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Rees, Jeremy" sort="Rees, Jeremy" uniqKey="Rees J" first="Jeremy" last="Rees">Jeremy Rees</name>
<affiliation wicri:level="3">
<nlm:aff id="A29">National Hospital for Neurology and Neurosurgery, London, United Kingdom</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>National Hospital for Neurology and Neurosurgery, London</wicri:regionArea>
<placeName>
<settlement type="city">Londres</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Grand Londres</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Lacombe, Denis" sort="Lacombe, Denis" uniqKey="Lacombe D" first="Denis" last="Lacombe">Denis Lacombe</name>
<affiliation wicri:level="3">
<nlm:aff id="A22">European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium</nlm:aff>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>European Organisation for Research and Treatment of Cancer Headquarters, Brussels</wicri:regionArea>
<placeName>
<settlement type="city">Bruxelles</settlement>
<region nuts="2">Région de Bruxelles-Capitale</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Mason, Warren P" sort="Mason, Warren P" uniqKey="Mason W" first="Warren P." last="Mason">Warren P. Mason</name>
<affiliation wicri:level="4">
<nlm:aff id="A30">Princess Margaret Hospital, University of Toronto, Toronto, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Princess Margaret Hospital, University of Toronto, Toronto</wicri:regionArea>
<orgName type="university">Université de Toronto</orgName>
<placeName>
<settlement type="city">Toronto</settlement>
<region type="state">Ontario</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Stupp, Roger" sort="Stupp, Roger" uniqKey="Stupp R" first="Roger" last="Stupp">Roger Stupp</name>
<affiliation wicri:level="3">
<nlm:aff id="A2">Lausanne University Hospital, Lausanne, Switzerland</nlm:aff>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Lausanne University Hospital, Lausanne</wicri:regionArea>
<placeName>
<settlement type="city">Lausanne</settlement>
<region nuts="3" type="region">Canton de Vaud</region>
</placeName>
</affiliation>
<affiliation wicri:level="1">
<nlm:aff id="A31">University Hospital Zurich, Zurich, Switzerland</nlm:aff>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>University Hospital Zurich, Zurich</wicri:regionArea>
<wicri:noRegion>Zurich</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series>
<title level="j">The Lancet. Oncology</title>
<idno type="ISSN">1470-2045</idno>
<idno type="eISSN">1474-5488</idno>
<imprint>
<date when="2016">2016</date>
</imprint>
</series>
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<keywords scheme="KwdEn" xml:lang="en">
<term>Adult</term>
<term>Antineoplastic Agents, Alkylating (therapeutic use)</term>
<term>Brain Neoplasms (mortality)</term>
<term>Brain Neoplasms (therapy)</term>
<term>Dacarbazine (analogs & derivatives)</term>
<term>Dacarbazine (therapeutic use)</term>
<term>Glioma (mortality)</term>
<term>Glioma (therapy)</term>
<term>Humans</term>
<term>Isocitrate Dehydrogenase (genetics)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Radiotherapy, Conformal</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr">
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Antinéoplasiques alcoylants (usage thérapeutique)</term>
<term>Dacarbazine (analogues et dérivés)</term>
<term>Dacarbazine (usage thérapeutique)</term>
<term>Gliome ()</term>
<term>Gliome (mortalité)</term>
<term>Humains</term>
<term>Isocitrate dehydrogenases (génétique)</term>
<term>Mâle</term>
<term>Radiothérapie conformationnelle</term>
<term>Tumeurs du cerveau ()</term>
<term>Tumeurs du cerveau (mortalité)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="analogs & derivatives" xml:lang="en">
<term>Dacarbazine</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="genetics" xml:lang="en">
<term>Isocitrate Dehydrogenase</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en">
<term>Antineoplastic Agents, Alkylating</term>
<term>Dacarbazine</term>
</keywords>
<keywords scheme="MESH" qualifier="analogues et dérivés" xml:lang="fr">
<term>Dacarbazine</term>
</keywords>
<keywords scheme="MESH" qualifier="génétique" xml:lang="fr">
<term>Isocitrate dehydrogenases</term>
</keywords>
<keywords scheme="MESH" qualifier="mortality" xml:lang="en">
<term>Brain Neoplasms</term>
<term>Glioma</term>
</keywords>
<keywords scheme="MESH" qualifier="mortalité" xml:lang="fr">
<term>Gliome</term>
<term>Tumeurs du cerveau</term>
</keywords>
<keywords scheme="MESH" qualifier="therapy" xml:lang="en">
<term>Brain Neoplasms</term>
<term>Glioma</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr">
<term>Antinéoplasiques alcoylants</term>
<term>Dacarbazine</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Adult</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Radiotherapy, Conformal</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr">
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Gliome</term>
<term>Humains</term>
<term>Mâle</term>
<term>Radiothérapie conformationnelle</term>
<term>Tumeurs du cerveau</term>
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<front>
<div type="abstract" xml:lang="en">
<sec id="S1">
<title>Background</title>
<p id="P2">Outcome of low-grade glioma (LGG, WHO grade II) is highly variable reflecting molecular heterogeneity of the disease. We compared two different single modality treatment strategies: standard radiotherapy (RT) versus primary temozolomide (TMZ) chemotherapy with the aim of tailoring treatment and identifying predictive molecular factors.</p>
</sec>
<sec id="S2">
<title>Methods</title>
<p id="P3">477 patients (2005 – 2012, median FU 48 months) with a low-grade glioma (astrocytoma, oligoastrocytoma, oligodendroglioma, WHO grade II) with at least one high-risk feature (age > 40 years, progressive disease, tumor > 5 cm or crossing the midline,
<italic>neurological symptoms (e.g. focal or mental deficits, increased intracranial pressure or intractable seizures)</italic>
) were, after stratification by chromosome 1p-status, randomized to either conformal RT (50.4 Gy/28 fractions) or dose-dense TMZ (75 mg/m
<sup>2</sup>
daily × 21 days, q28 days, max. 12 cycles). Random treatment allocation was performed online using a minimization technique. A planned analysis was performed after 246 progression events. All analyses are intent to treat. Primary clinical endpoint was progression-free survival (PFS), correlative analyses included molecular markers (1p/19q co-deletion,
<italic>MGMT</italic>
methylation status,
<italic>IDH1+2</italic>
mutations). The trial has been registered at the European Trials Registry (EudraCT 2004-002714-11) and at
<ext-link ext-link-type="uri" xlink:href="http://ClinicalTrials.gov">ClinicalTrials.gov</ext-link>
(NCT00182819).</p>
</sec>
<sec id="S3">
<title>Findings</title>
<p id="P4">Four hundred seventy-seven patients were randomized. Severe hematological toxicity occurred in 14% of TMZ-treated patients, infections in 3% of TMZ-treated patients, and 1% of RT-treated patients. Moderate to severe fatigue was recorded in 3% of patients in the RT group and 7% in the TMZ group.</p>
<p id="P5">At a median follow-up of 48 months (IQR:31–56), median PFS was 39 months (IQR:16–46) in the TMZ arm and 46 months (IQR:19–48) in the RT group (hazard ratio 1.16, 95% CI, 0.9–1.5; p=0.22). Median OS has not been reached. Exploratory analyses identified treatment-dependent variation in outcome of molecular LGG subgroups (n=318).</p>
</sec>
<sec id="S4">
<title>Interpretation</title>
<p id="P6">There was no significant difference in outcome of the overall patient population treated with either radiotherapy alone or TMZ chemotherapy alone. Further data maturation is needed for overall survival analyses and evaluation of the full predictive impact of the molecular subtypes for individualized treatment choices.</p>
</sec>
<sec id="S5">
<title>Funding</title>
<p id="P7">Merck & Co, Swiss-Bridge Award 2011, Swiss Cancer League.</p>
</sec>
</div>
</front>
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<name sortKey="Hentschel, B" uniqKey="Hentschel B">B Hentschel</name>
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<author>
<name sortKey="Douw, L" uniqKey="Douw L">L Douw</name>
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<author>
<name sortKey="Klein, M" uniqKey="Klein M">M Klein</name>
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<author>
<name sortKey="Fagel, Ss" uniqKey="Fagel S">SS Fagel</name>
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</analytic>
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<author>
<name sortKey="Douw, L" uniqKey="Douw L">L Douw</name>
</author>
<author>
<name sortKey="Reijneveld, Jc" uniqKey="Reijneveld J">JC Reijneveld</name>
</author>
</analytic>
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<author>
<name sortKey="Correa, Dd" uniqKey="Correa D">DD Correa</name>
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<author>
<name sortKey="Deangelis, Lm" uniqKey="Deangelis L">LM DeAngelis</name>
</author>
<author>
<name sortKey="Shi, W" uniqKey="Shi W">W Shi</name>
</author>
<author>
<name sortKey="Thaler, Ht" uniqKey="Thaler H">HT Thaler</name>
</author>
<author>
<name sortKey="Lin, M" uniqKey="Lin M">M Lin</name>
</author>
<author>
<name sortKey="Abrey, Le" uniqKey="Abrey L">LE Abrey</name>
</author>
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<analytic>
<author>
<name sortKey="Reijneveld, Jc" uniqKey="Reijneveld J">JC Reijneveld</name>
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<author>
<name sortKey="Martin, J" uniqKey="Martin J">J Martin</name>
</author>
<author>
<name sortKey="Taphoorn, Mj" uniqKey="Taphoorn M">MJ Taphoorn</name>
</author>
<author>
<name sortKey="Coens, C" uniqKey="Coens C">C Coens</name>
</author>
</analytic>
</biblStruct>
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<analytic>
<author>
<name sortKey="Wick, W" uniqKey="Wick W">W Wick</name>
</author>
<author>
<name sortKey="Hartmann, C" uniqKey="Hartmann C">C Hartmann</name>
</author>
<author>
<name sortKey="Engel, C" uniqKey="Engel C">C Engel</name>
</author>
</analytic>
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<analytic>
<author>
<name sortKey="Van Den Bent, Mj" uniqKey="Van Den Bent M">MJ van den Bent</name>
</author>
<author>
<name sortKey="Brandes, Aa" uniqKey="Brandes A">AA Brandes</name>
</author>
<author>
<name sortKey="Taphoorn, Mj" uniqKey="Taphoorn M">MJ Taphoorn</name>
</author>
</analytic>
</biblStruct>
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<analytic>
<author>
<name sortKey="Cairncross, G" uniqKey="Cairncross G">G Cairncross</name>
</author>
<author>
<name sortKey="Wang, M" uniqKey="Wang M">M Wang</name>
</author>
<author>
<name sortKey="Shaw, E" uniqKey="Shaw E">E Shaw</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Pallud, J" uniqKey="Pallud J">J Pallud</name>
</author>
<author>
<name sortKey="Llitjos, Jf" uniqKey="Llitjos J">JF Llitjos</name>
</author>
<author>
<name sortKey="Dhermain, F" uniqKey="Dhermain F">F Dhermain</name>
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<analytic>
<author>
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<author>
<name sortKey="Ohgaki, H" uniqKey="Ohgaki H">H Ohgaki</name>
</author>
<author>
<name sortKey="Wiestler, Od" uniqKey="Wiestler O">OD Wiestler</name>
</author>
<author>
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</author>
</analytic>
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<analytic>
<author>
<name sortKey="Cairncross, Jg" uniqKey="Cairncross J">JG Cairncross</name>
</author>
<author>
<name sortKey="Wang, M" uniqKey="Wang M">M Wang</name>
</author>
<author>
<name sortKey="Jenkins, Rb" uniqKey="Jenkins R">RB Jenkins</name>
</author>
</analytic>
</biblStruct>
</listBibl>
</div1>
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</TEI>
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<list>
<country>
<li>Allemagne</li>
<li>Australie</li>
<li>Autriche</li>
<li>Belgique</li>
<li>Canada</li>
<li>Espagne</li>
<li>France</li>
<li>Israël</li>
<li>Italie</li>
<li>Pays-Bas</li>
<li>Portugal</li>
<li>Royaume-Uni</li>
<li>Suisse</li>
</country>
<region>
<li>Alberta</li>
<li>Angleterre</li>
<li>Aquitaine</li>
<li>Bade-Wurtemberg</li>
<li>Canton de Vaud</li>
<li>Catalogne</li>
<li>District de Cologne</li>
<li>District de Karlsruhe</li>
<li>Grand Londres</li>
<li>Groningue (province)</li>
<li>Gueldre</li>
<li>Hollande-Méridionale</li>
<li>Hollande-Septentrionale</li>
<li>Nouvelle-Aquitaine</li>
<li>Ontario</li>
<li>Provence-Alpes-Côte d'Azur</li>
<li>Rhénanie-du-Nord-Westphalie</li>
<li>Région Bretagne</li>
<li>Région de Bruxelles-Capitale</li>
<li>Île-de-France</li>
</region>
<settlement>
<li>Amsterdam</li>
<li>Barcelone</li>
<li>Bonn</li>
<li>Bordeaux</li>
<li>Bruxelles</li>
<li>Calgary</li>
<li>Groningue</li>
<li>Groningue (ville)</li>
<li>Heidelberg</li>
<li>Lausanne</li>
<li>Leyde</li>
<li>Londres</li>
<li>Marseille</li>
<li>Nimègue</li>
<li>Paris</li>
<li>Rennes</li>
<li>Toronto</li>
</settlement>
<orgName>
<li>Université de Calgary</li>
<li>Université de Groningue</li>
<li>Université de Toronto</li>
</orgName>
</list>
<tree>
<country name="Allemagne">
<region name="Rhénanie-du-Nord-Westphalie">
<name sortKey="Baumert, Brigitta G" sort="Baumert, Brigitta G" uniqKey="Baumert B" first="Brigitta G." last="Baumert">Brigitta G. Baumert</name>
</region>
<name sortKey="Capper, David" sort="Capper, David" uniqKey="Capper D" first="David" last="Capper">David Capper</name>
<name sortKey="Hartmann, Christian" sort="Hartmann, Christian" uniqKey="Hartmann C" first="Christian" last="Hartmann">Christian Hartmann</name>
<name sortKey="Hartmann, Christian" sort="Hartmann, Christian" uniqKey="Hartmann C" first="Christian" last="Hartmann">Christian Hartmann</name>
<name sortKey="Von Deimling, Andreas" sort="Von Deimling, Andreas" uniqKey="Von Deimling A" first="Andreas" last="Von Deimling">Andreas Von Deimling</name>
<name sortKey="Wick, Wolfgang" sort="Wick, Wolfgang" uniqKey="Wick W" first="Wolfgang" last="Wick">Wolfgang Wick</name>
</country>
<country name="Suisse">
<region name="Canton de Vaud">
<name sortKey="Hegi, Monika E" sort="Hegi, Monika E" uniqKey="Hegi M" first="Monika E." last="Hegi">Monika E. Hegi</name>
</region>
<name sortKey="Kurscheid, Sebastian" sort="Kurscheid, Sebastian" uniqKey="Kurscheid S" first="Sebastian" last="Kurscheid">Sebastian Kurscheid</name>
<name sortKey="Stupp, Roger" sort="Stupp, Roger" uniqKey="Stupp R" first="Roger" last="Stupp">Roger Stupp</name>
<name sortKey="Stupp, Roger" sort="Stupp, Roger" uniqKey="Stupp R" first="Roger" last="Stupp">Roger Stupp</name>
</country>
<country name="Pays-Bas">
<noRegion>
<name sortKey="Van Den Bent, Martin J" sort="Van Den Bent, Martin J" uniqKey="Van Den Bent M" first="Martin J." last="Van Den Bent">Martin J. Van Den Bent</name>
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<name sortKey="Bromberg, Jacoline E" sort="Bromberg, Jacoline E" uniqKey="Bromberg J" first="Jacoline E." last="Bromberg">Jacoline E. Bromberg</name>
<name sortKey="Enting, Roelien" sort="Enting, Roelien" uniqKey="Enting R" first="Roelien" last="Enting">Roelien Enting</name>
<name sortKey="Gijtenbeek, Johanna M M" sort="Gijtenbeek, Johanna M M" uniqKey="Gijtenbeek J" first="Johanna M. M." last="Gijtenbeek">Johanna M. M. Gijtenbeek</name>
<name sortKey="Kros, Johan M" sort="Kros, Johan M" uniqKey="Kros J" first="Johan M." last="Kros">Johan M. Kros</name>
<name sortKey="Reijneveld, Jaap C" sort="Reijneveld, Jaap C" uniqKey="Reijneveld J" first="Jaap C." last="Reijneveld">Jaap C. Reijneveld</name>
<name sortKey="Taphoorn, Martin J B" sort="Taphoorn, Martin J B" uniqKey="Taphoorn M" first="Martin J. B." last="Taphoorn">Martin J. B. Taphoorn</name>
</country>
<country name="Belgique">
<region name="Région de Bruxelles-Capitale">
<name sortKey="Gorlia, Thierry" sort="Gorlia, Thierry" uniqKey="Gorlia T" first="Thierry" last="Gorlia">Thierry Gorlia</name>
</region>
<name sortKey="Clement, Paul M" sort="Clement, Paul M" uniqKey="Clement P" first="Paul M." last="Clement">Paul M. Clement</name>
<name sortKey="Dif, Nicolas" sort="Dif, Nicolas" uniqKey="Dif N" first="Nicolas" last="Dif">Nicolas Dif</name>
<name sortKey="Lacombe, Denis" sort="Lacombe, Denis" uniqKey="Lacombe D" first="Denis" last="Lacombe">Denis Lacombe</name>
</country>
<country name="France">
<region name="Île-de-France">
<name sortKey="Hoang Xuan, Khe" sort="Hoang Xuan, Khe" uniqKey="Hoang Xuan K" first="Khê" last="Hoang-Xuan">Khê Hoang-Xuan</name>
</region>
<name sortKey="Chinot, Olivier" sort="Chinot, Olivier" uniqKey="Chinot O" first="Olivier" last="Chinot">Olivier Chinot</name>
<name sortKey="Dhermain, Frederic" sort="Dhermain, Frederic" uniqKey="Dhermain F" first="Frederic" last="Dhermain">Frederic Dhermain</name>
<name sortKey="Feuvret, Loic" sort="Feuvret, Loic" uniqKey="Feuvret L" first="Loic" last="Feuvret">Loic Feuvret</name>
<name sortKey="Hassel, Mohamed Ben" sort="Hassel, Mohamed Ben" uniqKey="Hassel M" first="Mohamed Ben" last="Hassel">Mohamed Ben Hassel</name>
<name sortKey="Kantor, Guy" sort="Kantor, Guy" uniqKey="Kantor G" first="Guy" last="Kantor">Guy Kantor</name>
</country>
<country name="Italie">
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<name sortKey="Brandes, Alba A" sort="Brandes, Alba A" uniqKey="Brandes A" first="Alba A." last="Brandes">Alba A. Brandes</name>
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<name sortKey="Reni, Michele" sort="Reni, Michele" uniqKey="Reni M" first="Michele" last="Reni">Michele Reni</name>
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<country name="Australie">
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<name sortKey="Ryan, Gail" sort="Ryan, Gail" uniqKey="Ryan G" first="Gail" last="Ryan">Gail Ryan</name>
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<name sortKey="Kurscheid, Sebastian" sort="Kurscheid, Sebastian" uniqKey="Kurscheid S" first="Sebastian" last="Kurscheid">Sebastian Kurscheid</name>
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<country name="Canada">
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<name sortKey="Thiessen, Brian" sort="Thiessen, Brian" uniqKey="Thiessen B" first="Brian" last="Thiessen">Brian Thiessen</name>
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<name sortKey="Mason, Warren P" sort="Mason, Warren P" uniqKey="Mason W" first="Warren P." last="Mason">Warren P. Mason</name>
<name sortKey="Nordal, Robert A" sort="Nordal, Robert A" uniqKey="Nordal R" first="Robert A." last="Nordal">Robert A. Nordal</name>
<name sortKey="Rossiter, John P" sort="Rossiter, John P" uniqKey="Rossiter J" first="John P." last="Rossiter">John P. Rossiter</name>
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<country name="Espagne">
<region name="Catalogne">
<name sortKey="Balana, Carmen" sort="Balana, Carmen" uniqKey="Balana C" first="Carmen" last="Balana">Carmen Balana</name>
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</country>
<country name="Portugal">
<noRegion>
<name sortKey="Bravo Marques, Jose" sort="Bravo Marques, Jose" uniqKey="Bravo Marques J" first="Jose" last="Bravo-Marques">Jose Bravo-Marques</name>
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</country>
<country name="Autriche">
<noRegion>
<name sortKey="Marosi, Christine" sort="Marosi, Christine" uniqKey="Marosi C" first="Christine" last="Marosi">Christine Marosi</name>
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</country>
<country name="Israël">
<noRegion>
<name sortKey="Tzuk Shina, Tzahala" sort="Tzuk Shina, Tzahala" uniqKey="Tzuk Shina T" first="Tzahala" last="Tzuk-Shina">Tzahala Tzuk-Shina</name>
</noRegion>
</country>
<country name="Royaume-Uni">
<region name="Angleterre">
<name sortKey="Rees, Jeremy" sort="Rees, Jeremy" uniqKey="Rees J" first="Jeremy" last="Rees">Jeremy Rees</name>
</region>
</country>
</tree>
</affiliations>
</record>

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