Biomarker and Histopathology Evaluation of Patients with Recurrent Glioblastoma Treated with Galunisertib, Lomustine, or the Combination of Galunisertib and Lomustine
Identifieur interne : 001097 ( Main/Exploration ); précédent : 001096; suivant : 001098Biomarker and Histopathology Evaluation of Patients with Recurrent Glioblastoma Treated with Galunisertib, Lomustine, or the Combination of Galunisertib and Lomustine
Auteurs : David Capper [Allemagne] ; Andreas Von Deimling ; Alba A. Brandes ; Antoine F. Carpentier ; Santosh Kesari ; Juan M. Sepulveda-Sanchez ; Helen R. Wheeler ; Olivier Chinot ; Lawrence Cher ; Joachim P. Steinbach ; Pol Specenier ; Jordi Rodon ; Ann Cleverly ; Claire Smith ; Ivelina Gueorguieva ; Colin Miles ; Susan C. Guba ; Durisala Desaiah ; Shawn T. Estrem ; Michael M. Lahn ; Wolfgang WickSource :
- International Journal of Molecular Sciences [ 1422-0067 ] ; 2017.
Abstract
Galunisertib, a Transforming growth factor-βRI (TGF-βRI) kinase inhibitor, blocks TGF-β-mediated tumor growth in glioblastoma. In a three-arm study of galunisertib (300 mg/day) monotherapy (intermittent dosing; each cycle =14 days on/14 days off), lomustine monotherapy, and galunisertib plus lomustine therapy, baseline tumor tissue was evaluated to identify markers associated with tumor stage (e.g., histopathology, Ki67, glial fibrillary acidic protein) and TGF-β-related signaling (e.g., pSMAD2). Other pharmacodynamic assessments included chemokine, cytokine, and T cell subsets alterations. 158 patients were randomized to galunisertib plus lomustine (
Url:
DOI: 10.3390/ijms18050995
PubMed: 28481241
PubMed Central: 5454908
Affiliations:
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Biomarker and Histopathology Evaluation of Patients with Recurrent Glioblastoma Treated with Galunisertib, Lomustine, or the Combination of Galunisertib and Lomustine</title><author><name sortKey="Capper, David" sort="Capper, David" uniqKey="Capper D" first="David" last="Capper">David Capper</name><affiliation wicri:level="3"><nlm:aff id="af1-ijms-18-00995">Department of Neuropathology, Charité Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Neuropathology, Charité Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin</wicri:regionArea><placeName><region type="land" nuts="3">Berlin</region><settlement type="city">Berlin</settlement></placeName></affiliation></author><author><name sortKey="Von Deimling, Andreas" sort="Von Deimling, Andreas" uniqKey="Von Deimling A" first="Andreas" last="Von Deimling">Andreas Von Deimling</name><affiliation><nlm:aff id="af2-ijms-18-00995">Department of Neuropathology, University Hospital Heidelberg and Clinical Cooperation Unit Neuropathology, German Cancer Consortium (DKTK), German Cancer Research Center (DKFZ), 69120 Heidelberg, Germany;<email>andreas.vondeimling@med.uni-heidelberg.de</email></nlm:aff></affiliation></author><author><name sortKey="Brandes, Alba A" sort="Brandes, Alba A" uniqKey="Brandes A" first="Alba A." last="Brandes">Alba A. Brandes</name><affiliation><nlm:aff id="af3-ijms-18-00995">Medical Oncology Department, Bellaria-Maggiore Hospitals, Azienda USL—IRCCS Institute of Neurological Sciences, 40139 Bologna, Italy;<email>a.brandes@ausl.bo.it</email></nlm:aff></affiliation></author><author><name sortKey="Carpentier, Antoine F" sort="Carpentier, Antoine F" uniqKey="Carpentier A" first="Antoine F." last="Carpentier">Antoine F. Carpentier</name><affiliation><nlm:aff id="af4-ijms-18-00995">Assistance Publique-Hôpitaux de Paris (AP-HP) & Paris 13 University, Hôpital Avicenne, Service de Neurologie, 93009 Bobigny, France;<email>antoine.carpentier@avc.aphp.fr</email></nlm:aff></affiliation></author><author><name sortKey="Kesari, Santosh" sort="Kesari, Santosh" uniqKey="Kesari S" first="Santosh" last="Kesari">Santosh Kesari</name><affiliation><nlm:aff id="af5-ijms-18-00995">UC San Diego Health System, La Jolla, CA 92103, USA;<email>kesaris@jwci.org</email></nlm:aff></affiliation></author><author><name sortKey="Sepulveda Sanchez, Juan M" sort="Sepulveda Sanchez, Juan M" uniqKey="Sepulveda Sanchez J" first="Juan M." last="Sepulveda-Sanchez">Juan M. Sepulveda-Sanchez</name><affiliation><nlm:aff id="af6-ijms-18-00995">Hospital Universitario 12 de Octubre, 28041 Madrid, Spain;<email>jmsepulveda.hdoc@salud.madrid.org</email></nlm:aff></affiliation></author><author><name sortKey="Wheeler, Helen R" sort="Wheeler, Helen R" uniqKey="Wheeler H" first="Helen R." last="Wheeler">Helen R. Wheeler</name><affiliation><nlm:aff id="af7-ijms-18-00995">Department of Oncology, Royal North Shore Hospital, St. Leonards, NSW 2065, Australia;<email>hrwheeler@optusnet.com.au</email></nlm:aff></affiliation></author><author><name sortKey="Chinot, Olivier" sort="Chinot, Olivier" uniqKey="Chinot O" first="Olivier" last="Chinot">Olivier Chinot</name><affiliation><nlm:aff id="af8-ijms-18-00995">CHU Hôpital De La Timone, Rue Saint Pierre, 13385 Marseille, France;<email>olivier.chinot@ap-hm.fr</email></nlm:aff></affiliation></author><author><name sortKey="Cher, Lawrence" sort="Cher, Lawrence" uniqKey="Cher L" first="Lawrence" last="Cher">Lawrence Cher</name><affiliation><nlm:aff id="af9-ijms-18-00995">Austin Hospital, Heidelberg, VIC 3084, Australia;<email>lmcher@mac.com</email></nlm:aff></affiliation></author><author><name sortKey="Steinbach, Joachim P" sort="Steinbach, Joachim P" uniqKey="Steinbach J" first="Joachim P." last="Steinbach">Joachim P. Steinbach</name><affiliation><nlm:aff id="af10-ijms-18-00995">Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, 60590 Frankfurt, Germany;<email>Joachim.steinbach@med.uni-frankfurt.de</email></nlm:aff></affiliation></author><author><name sortKey="Specenier, Pol" sort="Specenier, Pol" uniqKey="Specenier P" first="Pol" last="Specenier">Pol Specenier</name><affiliation><nlm:aff id="af11-ijms-18-00995">Antwerp University Hospital, Wilrijkstraat 10, 2650 Edegem, Belgium;<email>pol.specenier@uza.be</email></nlm:aff></affiliation></author><author><name sortKey="Rodon, Jordi" sort="Rodon, Jordi" uniqKey="Rodon J" first="Jordi" last="Rodon">Jordi Rodon</name><affiliation><nlm:aff id="af12-ijms-18-00995">Medical Oncology, Vall d’Hebron University Hospital, Calle Natzaret, 115-117, 08035 Barcelona, Spain;<email>jrodon@vhebron.net</email></nlm:aff></affiliation></author><author><name sortKey="Cleverly, Ann" sort="Cleverly, Ann" uniqKey="Cleverly A" first="Ann" last="Cleverly">Ann Cleverly</name><affiliation><nlm:aff id="af13-ijms-18-00995">Eli Lilly and Company, Erl Wood Manor, Windlesham GU20 6PH, UK;<email>cleverly_ann_louise@lilly.com</email> (A.C.);<email>csmith@lilly.com</email> (C.S.);<email>gueorguieva_ivelina@lilly.com</email> (I.G.);<email>miles_colin_p@lilly.com</email> (C.M.)</nlm:aff></affiliation></author><author><name sortKey="Smith, Claire" sort="Smith, Claire" uniqKey="Smith C" first="Claire" last="Smith">Claire Smith</name><affiliation><nlm:aff id="af13-ijms-18-00995">Eli Lilly and Company, Erl Wood Manor, Windlesham GU20 6PH, UK;<email>cleverly_ann_louise@lilly.com</email> (A.C.);<email>csmith@lilly.com</email> (C.S.);<email>gueorguieva_ivelina@lilly.com</email> (I.G.);<email>miles_colin_p@lilly.com</email> (C.M.)</nlm:aff></affiliation></author><author><name sortKey="Gueorguieva, Ivelina" sort="Gueorguieva, Ivelina" uniqKey="Gueorguieva I" first="Ivelina" last="Gueorguieva">Ivelina Gueorguieva</name><affiliation><nlm:aff id="af13-ijms-18-00995">Eli Lilly and Company, Erl Wood Manor, Windlesham GU20 6PH, UK;<email>cleverly_ann_louise@lilly.com</email> (A.C.);<email>csmith@lilly.com</email> (C.S.);<email>gueorguieva_ivelina@lilly.com</email> (I.G.);<email>miles_colin_p@lilly.com</email> (C.M.)</nlm:aff></affiliation></author><author><name sortKey="Miles, Colin" sort="Miles, Colin" uniqKey="Miles C" first="Colin" last="Miles">Colin Miles</name><affiliation><nlm:aff id="af13-ijms-18-00995">Eli Lilly and Company, Erl Wood Manor, Windlesham GU20 6PH, UK;<email>cleverly_ann_louise@lilly.com</email> (A.C.);<email>csmith@lilly.com</email> (C.S.);<email>gueorguieva_ivelina@lilly.com</email> (I.G.);<email>miles_colin_p@lilly.com</email> (C.M.)</nlm:aff></affiliation></author><author><name sortKey="Guba, Susan C" sort="Guba, Susan C" uniqKey="Guba S" first="Susan C." last="Guba">Susan C. Guba</name><affiliation><nlm:aff id="af14-ijms-18-00995">Eli Lilly and Company, Indianapolis, IN 46285, USA;<email>guba_susan_c@lilly.com</email> (S.C.G.);<email>desaiah_durisala@lilly.com</email> (D.D.);<email>estrem_shawn_t@lilly.com</email> (S.T.E.);<email>michalahn@aol.com</email> (M.M.L.)</nlm:aff></affiliation></author><author><name sortKey="Desaiah, Durisala" sort="Desaiah, Durisala" uniqKey="Desaiah D" first="Durisala" last="Desaiah">Durisala Desaiah</name><affiliation><nlm:aff id="af14-ijms-18-00995">Eli Lilly and Company, Indianapolis, IN 46285, USA;<email>guba_susan_c@lilly.com</email> (S.C.G.);<email>desaiah_durisala@lilly.com</email> (D.D.);<email>estrem_shawn_t@lilly.com</email> (S.T.E.);<email>michalahn@aol.com</email> (M.M.L.)</nlm:aff></affiliation></author><author><name sortKey="Estrem, Shawn T" sort="Estrem, Shawn T" uniqKey="Estrem S" first="Shawn T." last="Estrem">Shawn T. Estrem</name><affiliation><nlm:aff id="af14-ijms-18-00995">Eli Lilly and Company, Indianapolis, IN 46285, USA;<email>guba_susan_c@lilly.com</email> (S.C.G.);<email>desaiah_durisala@lilly.com</email> (D.D.);<email>estrem_shawn_t@lilly.com</email> (S.T.E.);<email>michalahn@aol.com</email> (M.M.L.)</nlm:aff></affiliation></author><author><name sortKey="Lahn, Michael M" sort="Lahn, Michael M" uniqKey="Lahn M" first="Michael M." last="Lahn">Michael M. Lahn</name><affiliation><nlm:aff id="af14-ijms-18-00995">Eli Lilly and Company, Indianapolis, IN 46285, USA;<email>guba_susan_c@lilly.com</email> (S.C.G.);<email>desaiah_durisala@lilly.com</email> (D.D.);<email>estrem_shawn_t@lilly.com</email> (S.T.E.);<email>michalahn@aol.com</email> (M.M.L.)</nlm:aff></affiliation></author><author><name sortKey="Wick, Wolfgang" sort="Wick, Wolfgang" uniqKey="Wick W" first="Wolfgang" last="Wick">Wolfgang Wick</name><affiliation><nlm:aff id="af15-ijms-18-00995">Department of Neurology, University Hospital Heidelberg, 69120 Heidelberg, Germany;<email>wolfgang.wick@med.uni-heidelberg.de</email></nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">28481241</idno><idno type="pmc">5454908</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5454908</idno><idno type="RBID">PMC:5454908</idno><idno type="doi">10.3390/ijms18050995</idno><date when="2017">2017</date><idno type="wicri:Area/Pmc/Corpus">002604</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">002604</idno><idno type="wicri:Area/Pmc/Curation">002454</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">002454</idno><idno type="wicri:Area/Pmc/Checkpoint">000408</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">000408</idno><idno type="wicri:source">PubMed</idno><idno type="wicri:Area/PubMed/Corpus">000C07</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000C07</idno><idno type="wicri:Area/PubMed/Curation">000C04</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">000C04</idno><idno type="wicri:Area/PubMed/Checkpoint">000C04</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">000C04</idno><idno type="wicri:Area/Ncbi/Merge">004775</idno><idno type="wicri:Area/Ncbi/Curation">004775</idno><idno type="wicri:Area/Ncbi/Checkpoint">004775</idno><idno type="wicri:Area/Main/Merge">001092</idno><idno type="wicri:Area/Main/Curation">001097</idno><idno type="wicri:Area/Main/Exploration">001097</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Biomarker and Histopathology Evaluation of Patients with Recurrent Glioblastoma Treated with Galunisertib, Lomustine, or the Combination of Galunisertib and Lomustine</title><author><name sortKey="Capper, David" sort="Capper, David" uniqKey="Capper D" first="David" last="Capper">David Capper</name><affiliation wicri:level="3"><nlm:aff id="af1-ijms-18-00995">Department of Neuropathology, Charité Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Neuropathology, Charité Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin</wicri:regionArea><placeName><region type="land" nuts="3">Berlin</region><settlement type="city">Berlin</settlement></placeName></affiliation></author><author><name sortKey="Von Deimling, Andreas" sort="Von Deimling, Andreas" uniqKey="Von Deimling A" first="Andreas" last="Von Deimling">Andreas Von Deimling</name><affiliation><nlm:aff id="af2-ijms-18-00995">Department of Neuropathology, University Hospital Heidelberg and Clinical Cooperation Unit Neuropathology, German Cancer Consortium (DKTK), German Cancer Research Center (DKFZ), 69120 Heidelberg, Germany;<email>andreas.vondeimling@med.uni-heidelberg.de</email></nlm:aff></affiliation></author><author><name sortKey="Brandes, Alba A" sort="Brandes, Alba A" uniqKey="Brandes A" first="Alba A." last="Brandes">Alba A. Brandes</name><affiliation><nlm:aff id="af3-ijms-18-00995">Medical Oncology Department, Bellaria-Maggiore Hospitals, Azienda USL—IRCCS Institute of Neurological Sciences, 40139 Bologna, Italy;<email>a.brandes@ausl.bo.it</email></nlm:aff></affiliation></author><author><name sortKey="Carpentier, Antoine F" sort="Carpentier, Antoine F" uniqKey="Carpentier A" first="Antoine F." last="Carpentier">Antoine F. Carpentier</name><affiliation><nlm:aff id="af4-ijms-18-00995">Assistance Publique-Hôpitaux de Paris (AP-HP) & Paris 13 University, Hôpital Avicenne, Service de Neurologie, 93009 Bobigny, France;<email>antoine.carpentier@avc.aphp.fr</email></nlm:aff></affiliation></author><author><name sortKey="Kesari, Santosh" sort="Kesari, Santosh" uniqKey="Kesari S" first="Santosh" last="Kesari">Santosh Kesari</name><affiliation><nlm:aff id="af5-ijms-18-00995">UC San Diego Health System, La Jolla, CA 92103, USA;<email>kesaris@jwci.org</email></nlm:aff></affiliation></author><author><name sortKey="Sepulveda Sanchez, Juan M" sort="Sepulveda Sanchez, Juan M" uniqKey="Sepulveda Sanchez J" first="Juan M." last="Sepulveda-Sanchez">Juan M. Sepulveda-Sanchez</name><affiliation><nlm:aff id="af6-ijms-18-00995">Hospital Universitario 12 de Octubre, 28041 Madrid, Spain;<email>jmsepulveda.hdoc@salud.madrid.org</email></nlm:aff></affiliation></author><author><name sortKey="Wheeler, Helen R" sort="Wheeler, Helen R" uniqKey="Wheeler H" first="Helen R." last="Wheeler">Helen R. Wheeler</name><affiliation><nlm:aff id="af7-ijms-18-00995">Department of Oncology, Royal North Shore Hospital, St. Leonards, NSW 2065, Australia;<email>hrwheeler@optusnet.com.au</email></nlm:aff></affiliation></author><author><name sortKey="Chinot, Olivier" sort="Chinot, Olivier" uniqKey="Chinot O" first="Olivier" last="Chinot">Olivier Chinot</name><affiliation><nlm:aff id="af8-ijms-18-00995">CHU Hôpital De La Timone, Rue Saint Pierre, 13385 Marseille, France;<email>olivier.chinot@ap-hm.fr</email></nlm:aff></affiliation></author><author><name sortKey="Cher, Lawrence" sort="Cher, Lawrence" uniqKey="Cher L" first="Lawrence" last="Cher">Lawrence Cher</name><affiliation><nlm:aff id="af9-ijms-18-00995">Austin Hospital, Heidelberg, VIC 3084, Australia;<email>lmcher@mac.com</email></nlm:aff></affiliation></author><author><name sortKey="Steinbach, Joachim P" sort="Steinbach, Joachim P" uniqKey="Steinbach J" first="Joachim P." last="Steinbach">Joachim P. Steinbach</name><affiliation><nlm:aff id="af10-ijms-18-00995">Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, 60590 Frankfurt, Germany;<email>Joachim.steinbach@med.uni-frankfurt.de</email></nlm:aff></affiliation></author><author><name sortKey="Specenier, Pol" sort="Specenier, Pol" uniqKey="Specenier P" first="Pol" last="Specenier">Pol Specenier</name><affiliation><nlm:aff id="af11-ijms-18-00995">Antwerp University Hospital, Wilrijkstraat 10, 2650 Edegem, Belgium;<email>pol.specenier@uza.be</email></nlm:aff></affiliation></author><author><name sortKey="Rodon, Jordi" sort="Rodon, Jordi" uniqKey="Rodon J" first="Jordi" last="Rodon">Jordi Rodon</name><affiliation><nlm:aff id="af12-ijms-18-00995">Medical Oncology, Vall d’Hebron University Hospital, Calle Natzaret, 115-117, 08035 Barcelona, Spain;<email>jrodon@vhebron.net</email></nlm:aff></affiliation></author><author><name sortKey="Cleverly, Ann" sort="Cleverly, Ann" uniqKey="Cleverly A" first="Ann" last="Cleverly">Ann Cleverly</name><affiliation><nlm:aff id="af13-ijms-18-00995">Eli Lilly and Company, Erl Wood Manor, Windlesham GU20 6PH, UK;<email>cleverly_ann_louise@lilly.com</email> (A.C.);<email>csmith@lilly.com</email> (C.S.);<email>gueorguieva_ivelina@lilly.com</email> (I.G.);<email>miles_colin_p@lilly.com</email> (C.M.)</nlm:aff></affiliation></author><author><name sortKey="Smith, Claire" sort="Smith, Claire" uniqKey="Smith C" first="Claire" last="Smith">Claire Smith</name><affiliation><nlm:aff id="af13-ijms-18-00995">Eli Lilly and Company, Erl Wood Manor, Windlesham GU20 6PH, UK;<email>cleverly_ann_louise@lilly.com</email> (A.C.);<email>csmith@lilly.com</email> (C.S.);<email>gueorguieva_ivelina@lilly.com</email> (I.G.);<email>miles_colin_p@lilly.com</email> (C.M.)</nlm:aff></affiliation></author><author><name sortKey="Gueorguieva, Ivelina" sort="Gueorguieva, Ivelina" uniqKey="Gueorguieva I" first="Ivelina" last="Gueorguieva">Ivelina Gueorguieva</name><affiliation><nlm:aff id="af13-ijms-18-00995">Eli Lilly and Company, Erl Wood Manor, Windlesham GU20 6PH, UK;<email>cleverly_ann_louise@lilly.com</email> (A.C.);<email>csmith@lilly.com</email> (C.S.);<email>gueorguieva_ivelina@lilly.com</email> (I.G.);<email>miles_colin_p@lilly.com</email> (C.M.)</nlm:aff></affiliation></author><author><name sortKey="Miles, Colin" sort="Miles, Colin" uniqKey="Miles C" first="Colin" last="Miles">Colin Miles</name><affiliation><nlm:aff id="af13-ijms-18-00995">Eli Lilly and Company, Erl Wood Manor, Windlesham GU20 6PH, UK;<email>cleverly_ann_louise@lilly.com</email> (A.C.);<email>csmith@lilly.com</email> (C.S.);<email>gueorguieva_ivelina@lilly.com</email> (I.G.);<email>miles_colin_p@lilly.com</email> (C.M.)</nlm:aff></affiliation></author><author><name sortKey="Guba, Susan C" sort="Guba, Susan C" uniqKey="Guba S" first="Susan C." last="Guba">Susan C. Guba</name><affiliation><nlm:aff id="af14-ijms-18-00995">Eli Lilly and Company, Indianapolis, IN 46285, USA;<email>guba_susan_c@lilly.com</email> (S.C.G.);<email>desaiah_durisala@lilly.com</email> (D.D.);<email>estrem_shawn_t@lilly.com</email> (S.T.E.);<email>michalahn@aol.com</email> (M.M.L.)</nlm:aff></affiliation></author><author><name sortKey="Desaiah, Durisala" sort="Desaiah, Durisala" uniqKey="Desaiah D" first="Durisala" last="Desaiah">Durisala Desaiah</name><affiliation><nlm:aff id="af14-ijms-18-00995">Eli Lilly and Company, Indianapolis, IN 46285, USA;<email>guba_susan_c@lilly.com</email> (S.C.G.);<email>desaiah_durisala@lilly.com</email> (D.D.);<email>estrem_shawn_t@lilly.com</email> (S.T.E.);<email>michalahn@aol.com</email> (M.M.L.)</nlm:aff></affiliation></author><author><name sortKey="Estrem, Shawn T" sort="Estrem, Shawn T" uniqKey="Estrem S" first="Shawn T." last="Estrem">Shawn T. Estrem</name><affiliation><nlm:aff id="af14-ijms-18-00995">Eli Lilly and Company, Indianapolis, IN 46285, USA;<email>guba_susan_c@lilly.com</email> (S.C.G.);<email>desaiah_durisala@lilly.com</email> (D.D.);<email>estrem_shawn_t@lilly.com</email> (S.T.E.);<email>michalahn@aol.com</email> (M.M.L.)</nlm:aff></affiliation></author><author><name sortKey="Lahn, Michael M" sort="Lahn, Michael M" uniqKey="Lahn M" first="Michael M." last="Lahn">Michael M. Lahn</name><affiliation><nlm:aff id="af14-ijms-18-00995">Eli Lilly and Company, Indianapolis, IN 46285, USA;<email>guba_susan_c@lilly.com</email> (S.C.G.);<email>desaiah_durisala@lilly.com</email> (D.D.);<email>estrem_shawn_t@lilly.com</email> (S.T.E.);<email>michalahn@aol.com</email> (M.M.L.)</nlm:aff></affiliation></author><author><name sortKey="Wick, Wolfgang" sort="Wick, Wolfgang" uniqKey="Wick W" first="Wolfgang" last="Wick">Wolfgang Wick</name><affiliation><nlm:aff id="af15-ijms-18-00995">Department of Neurology, University Hospital Heidelberg, 69120 Heidelberg, Germany;<email>wolfgang.wick@med.uni-heidelberg.de</email></nlm:aff></affiliation></author></analytic><series><title level="j">International Journal of Molecular Sciences</title><idno type="eISSN">1422-0067</idno><imprint><date when="2017">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>Galunisertib, a Transforming growth factor-βRI (TGF-βRI) kinase inhibitor, blocks TGF-β-mediated tumor growth in glioblastoma. In a three-arm study of galunisertib (300 mg/day) monotherapy (intermittent dosing; each cycle =14 days on/14 days off), lomustine monotherapy, and galunisertib plus lomustine therapy, baseline tumor tissue was evaluated to identify markers associated with tumor stage (e.g., histopathology, Ki67, glial fibrillary acidic protein) and TGF-β-related signaling (e.g., pSMAD2). Other pharmacodynamic assessments included chemokine, cytokine, and T cell subsets alterations. 158 patients were randomized to galunisertib plus lomustine (<italic>n</italic> = 79), galunisertib (<italic>n</italic> = 39) and placebo+lomustine (<italic>n</italic> = 40). In 127 of these patients, tissue was adequate for central pathology review and biomarker work. Isocitrate dehydrogenase (<italic>IDH1</italic>) negative glioblastoma patients with baseline pSMAD2<sup>+</sup> in cytoplasm had median overall survival (OS) 9.5 months vs. 6.9 months for patients with no tumor pSMAD2 expression (<italic>p</italic> = 0.4574). Eight patients were IDH1 R132H<sup>+</sup> and had a median OS of 10.4 months compared to 6.9 months for patients with negative IDH1 R132H (<italic>p</italic> = 0.5452). IDH1 status was associated with numerically higher plasma macrophage-derived chemokine (MDC/CCL22), higher whole blood FOXP3, and reduced tumor CD3<sup>+</sup> T cell counts. Compared to the baseline, treatment with galunisertib monotherapy preserved CD4<sup>+</sup> T cell counts, eosinophils, lymphocytes, and the CD4/CD8 ratio. 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Wang</name></author><author><name sortKey="Downing, S R" uniqKey="Downing S">S.R. Downing</name></author><author><name sortKey="He, J" uniqKey="He J">J. He</name></author><author><name sortKey="Schnall Levin, M" uniqKey="Schnall Levin M">M. Schnall-Levin</name></author><author><name sortKey="White, J" uniqKey="White J">J. White</name></author><author><name sortKey="Sanford, E M" uniqKey="Sanford E">E.M. Sanford</name></author><author><name sortKey="An, P" uniqKey="An P">P. An</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Allemagne</li></country><region><li>Berlin</li></region><settlement><li>Berlin</li></settlement></list><tree><noCountry><name sortKey="Brandes, Alba A" sort="Brandes, Alba A" uniqKey="Brandes A" first="Alba A." last="Brandes">Alba A. Brandes</name><name sortKey="Carpentier, Antoine F" sort="Carpentier, Antoine F" uniqKey="Carpentier A" first="Antoine F." last="Carpentier">Antoine F. Carpentier</name><name sortKey="Cher, Lawrence" sort="Cher, Lawrence" uniqKey="Cher L" first="Lawrence" last="Cher">Lawrence Cher</name><name sortKey="Chinot, Olivier" sort="Chinot, Olivier" uniqKey="Chinot O" first="Olivier" last="Chinot">Olivier Chinot</name><name sortKey="Cleverly, Ann" sort="Cleverly, Ann" uniqKey="Cleverly A" first="Ann" last="Cleverly">Ann Cleverly</name><name sortKey="Desaiah, Durisala" sort="Desaiah, Durisala" uniqKey="Desaiah D" first="Durisala" last="Desaiah">Durisala Desaiah</name><name sortKey="Estrem, Shawn T" sort="Estrem, Shawn T" uniqKey="Estrem S" first="Shawn T." last="Estrem">Shawn T. Estrem</name><name sortKey="Guba, Susan C" sort="Guba, Susan C" uniqKey="Guba S" first="Susan C." last="Guba">Susan C. Guba</name><name sortKey="Gueorguieva, Ivelina" sort="Gueorguieva, Ivelina" uniqKey="Gueorguieva I" first="Ivelina" last="Gueorguieva">Ivelina Gueorguieva</name><name sortKey="Kesari, Santosh" sort="Kesari, Santosh" uniqKey="Kesari S" first="Santosh" last="Kesari">Santosh Kesari</name><name sortKey="Lahn, Michael M" sort="Lahn, Michael M" uniqKey="Lahn M" first="Michael M." last="Lahn">Michael M. Lahn</name><name sortKey="Miles, Colin" sort="Miles, Colin" uniqKey="Miles C" first="Colin" last="Miles">Colin Miles</name><name sortKey="Rodon, Jordi" sort="Rodon, Jordi" uniqKey="Rodon J" first="Jordi" last="Rodon">Jordi Rodon</name><name sortKey="Sepulveda Sanchez, Juan M" sort="Sepulveda Sanchez, Juan M" uniqKey="Sepulveda Sanchez J" first="Juan M." last="Sepulveda-Sanchez">Juan M. Sepulveda-Sanchez</name><name sortKey="Smith, Claire" sort="Smith, Claire" uniqKey="Smith C" first="Claire" last="Smith">Claire Smith</name><name sortKey="Specenier, Pol" sort="Specenier, Pol" uniqKey="Specenier P" first="Pol" last="Specenier">Pol Specenier</name><name sortKey="Steinbach, Joachim P" sort="Steinbach, Joachim P" uniqKey="Steinbach J" first="Joachim P." last="Steinbach">Joachim P. Steinbach</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="Wheeler, Helen R" sort="Wheeler, Helen R" uniqKey="Wheeler H" first="Helen R." last="Wheeler">Helen R. Wheeler</name><name sortKey="Wick, Wolfgang" sort="Wick, Wolfgang" uniqKey="Wick W" first="Wolfgang" last="Wick">Wolfgang Wick</name></noCountry><country name="Allemagne"><region name="Berlin"><name sortKey="Capper, David" sort="Capper, David" uniqKey="Capper D" first="David" last="Capper">David Capper</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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