Links to Exploration step
Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Phase III Study of Enzastaurin Compared With Lomustine in the Treatment of Recurrent Intracranial Glioblastoma</title><author><name sortKey="Wick, Wolfgang" sort="Wick, Wolfgang" uniqKey="Wick W" first="Wolfgang" last="Wick">Wolfgang Wick</name><affiliation><nlm:aff id="aff1">From the University of Heidelberg, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; H. Lee Moffitt Cancer Center, Tampa, FL; Erasmus Medisch Centrum, Rotterdam, the Netherlands; Hopital Pitie Salpetriere, Paris, France; Austin Health, Victoria, Australia; Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Eli Lilly and Company, Indianapolis, IN; and Neuro-Oncology Branch, National Cancer Institute, Bethesda, MD.</nlm:aff></affiliation></author><author><name sortKey="Puduvalli, Vinay K" sort="Puduvalli, Vinay K" uniqKey="Puduvalli V" first="Vinay K." last="Puduvalli">Vinay K. Puduvalli</name><affiliation><nlm:aff id="aff1">From the University of Heidelberg, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; H. Lee Moffitt Cancer Center, Tampa, FL; Erasmus Medisch Centrum, Rotterdam, the Netherlands; Hopital Pitie Salpetriere, Paris, France; Austin Health, Victoria, Australia; Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Eli Lilly and Company, Indianapolis, IN; and Neuro-Oncology Branch, National Cancer Institute, Bethesda, MD.</nlm:aff></affiliation></author><author><name sortKey="Chamberlain, Marc C" sort="Chamberlain, Marc C" uniqKey="Chamberlain M" first="Marc C." last="Chamberlain">Marc C. Chamberlain</name><affiliation><nlm:aff id="aff1">From the University of Heidelberg, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; H. Lee Moffitt Cancer Center, Tampa, FL; Erasmus Medisch Centrum, Rotterdam, the Netherlands; Hopital Pitie Salpetriere, Paris, France; Austin Health, Victoria, Australia; Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Eli Lilly and Company, Indianapolis, IN; and Neuro-Oncology Branch, National Cancer Institute, Bethesda, MD.</nlm:aff></affiliation></author><author><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><affiliation><nlm:aff id="aff1">From the University of Heidelberg, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; H. Lee Moffitt Cancer Center, Tampa, FL; Erasmus Medisch Centrum, Rotterdam, the Netherlands; Hopital Pitie Salpetriere, Paris, France; Austin Health, Victoria, Australia; Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Eli Lilly and Company, Indianapolis, IN; and Neuro-Oncology Branch, National Cancer Institute, Bethesda, MD.</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="aff1">From the University of Heidelberg, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; H. Lee Moffitt Cancer Center, Tampa, FL; Erasmus Medisch Centrum, Rotterdam, the Netherlands; Hopital Pitie Salpetriere, Paris, France; Austin Health, Victoria, Australia; Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Eli Lilly and Company, Indianapolis, IN; and Neuro-Oncology Branch, National Cancer Institute, Bethesda, MD.</nlm:aff></affiliation></author><author><name sortKey="Cher, Lawrence M" sort="Cher, Lawrence M" uniqKey="Cher L" first="Lawrence M." last="Cher">Lawrence M. Cher</name><affiliation><nlm:aff id="aff1">From the University of Heidelberg, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; H. Lee Moffitt Cancer Center, Tampa, FL; Erasmus Medisch Centrum, Rotterdam, the Netherlands; Hopital Pitie Salpetriere, Paris, France; Austin Health, Victoria, Australia; Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Eli Lilly and Company, Indianapolis, IN; and Neuro-Oncology Branch, National Cancer Institute, Bethesda, MD.</nlm:aff></affiliation></author><author><name sortKey="Mason, Warren" sort="Mason, Warren" uniqKey="Mason W" first="Warren" last="Mason">Warren Mason</name><affiliation><nlm:aff id="aff1">From the University of Heidelberg, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; H. Lee Moffitt Cancer Center, Tampa, FL; Erasmus Medisch Centrum, Rotterdam, the Netherlands; Hopital Pitie Salpetriere, Paris, France; Austin Health, Victoria, Australia; Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Eli Lilly and Company, Indianapolis, IN; and Neuro-Oncology Branch, National Cancer Institute, Bethesda, MD.</nlm:aff></affiliation></author><author><name sortKey="Weller, Michael" sort="Weller, Michael" uniqKey="Weller M" first="Michael" last="Weller">Michael Weller</name><affiliation><nlm:aff id="aff1">From the University of Heidelberg, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; H. Lee Moffitt Cancer Center, Tampa, FL; Erasmus Medisch Centrum, Rotterdam, the Netherlands; Hopital Pitie Salpetriere, Paris, France; Austin Health, Victoria, Australia; Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Eli Lilly and Company, Indianapolis, IN; and Neuro-Oncology Branch, National Cancer Institute, Bethesda, MD.</nlm:aff></affiliation></author><author><name sortKey="Hong, Shengyan" sort="Hong, Shengyan" uniqKey="Hong S" first="Shengyan" last="Hong">Shengyan Hong</name><affiliation><nlm:aff id="aff1">From the University of Heidelberg, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; H. Lee Moffitt Cancer Center, Tampa, FL; Erasmus Medisch Centrum, Rotterdam, the Netherlands; Hopital Pitie Salpetriere, Paris, France; Austin Health, Victoria, Australia; Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Eli Lilly and Company, Indianapolis, IN; and Neuro-Oncology Branch, National Cancer Institute, Bethesda, MD.</nlm:aff></affiliation></author><author><name sortKey="Musib, Luna" sort="Musib, Luna" uniqKey="Musib L" first="Luna" last="Musib">Luna Musib</name><affiliation><nlm:aff id="aff1">From the University of Heidelberg, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; H. Lee Moffitt Cancer Center, Tampa, FL; Erasmus Medisch Centrum, Rotterdam, the Netherlands; Hopital Pitie Salpetriere, Paris, France; Austin Health, Victoria, Australia; Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Eli Lilly and Company, Indianapolis, IN; and Neuro-Oncology Branch, National Cancer Institute, Bethesda, MD.</nlm:aff></affiliation></author><author><name sortKey="Liepa, Astra M" sort="Liepa, Astra M" uniqKey="Liepa A" first="Astra M." last="Liepa">Astra M. Liepa</name><affiliation><nlm:aff id="aff1">From the University of Heidelberg, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; H. Lee Moffitt Cancer Center, Tampa, FL; Erasmus Medisch Centrum, Rotterdam, the Netherlands; Hopital Pitie Salpetriere, Paris, France; Austin Health, Victoria, Australia; Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Eli Lilly and Company, Indianapolis, IN; and Neuro-Oncology Branch, National Cancer Institute, Bethesda, MD.</nlm:aff></affiliation></author><author><name sortKey="Thornton, Donald E" sort="Thornton, Donald E" uniqKey="Thornton D" first="Donald E." last="Thornton">Donald E. Thornton</name><affiliation><nlm:aff id="aff1">From the University of Heidelberg, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; H. Lee Moffitt Cancer Center, Tampa, FL; Erasmus Medisch Centrum, Rotterdam, the Netherlands; Hopital Pitie Salpetriere, Paris, France; Austin Health, Victoria, Australia; Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Eli Lilly and Company, Indianapolis, IN; and Neuro-Oncology Branch, National Cancer Institute, Bethesda, MD.</nlm:aff></affiliation></author><author><name sortKey="Fine, Howard A" sort="Fine, Howard A" uniqKey="Fine H" first="Howard A." last="Fine">Howard A. Fine</name><affiliation><nlm:aff id="aff1">From the University of Heidelberg, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; H. Lee Moffitt Cancer Center, Tampa, FL; Erasmus Medisch Centrum, Rotterdam, the Netherlands; Hopital Pitie Salpetriere, Paris, France; Austin Health, Victoria, Australia; Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Eli Lilly and Company, Indianapolis, IN; and Neuro-Oncology Branch, National Cancer Institute, Bethesda, MD.</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">20124186</idno><idno type="pmc">2834468</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2834468</idno><idno type="RBID">PMC:2834468</idno><idno type="doi">10.1200/JCO.2009.23.2595</idno><date when="2010">2010</date><idno type="wicri:Area/Pmc/Corpus">001937</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">001937</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Phase III Study of Enzastaurin Compared With Lomustine in the Treatment of Recurrent Intracranial Glioblastoma</title><author><name sortKey="Wick, Wolfgang" sort="Wick, Wolfgang" uniqKey="Wick W" first="Wolfgang" last="Wick">Wolfgang Wick</name><affiliation><nlm:aff id="aff1">From the University of Heidelberg, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; H. Lee Moffitt Cancer Center, Tampa, FL; Erasmus Medisch Centrum, Rotterdam, the Netherlands; Hopital Pitie Salpetriere, Paris, France; Austin Health, Victoria, Australia; Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Eli Lilly and Company, Indianapolis, IN; and Neuro-Oncology Branch, National Cancer Institute, Bethesda, MD.</nlm:aff></affiliation></author><author><name sortKey="Puduvalli, Vinay K" sort="Puduvalli, Vinay K" uniqKey="Puduvalli V" first="Vinay K." last="Puduvalli">Vinay K. Puduvalli</name><affiliation><nlm:aff id="aff1">From the University of Heidelberg, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; H. Lee Moffitt Cancer Center, Tampa, FL; Erasmus Medisch Centrum, Rotterdam, the Netherlands; Hopital Pitie Salpetriere, Paris, France; Austin Health, Victoria, Australia; Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Eli Lilly and Company, Indianapolis, IN; and Neuro-Oncology Branch, National Cancer Institute, Bethesda, MD.</nlm:aff></affiliation></author><author><name sortKey="Chamberlain, Marc C" sort="Chamberlain, Marc C" uniqKey="Chamberlain M" first="Marc C." last="Chamberlain">Marc C. Chamberlain</name><affiliation><nlm:aff id="aff1">From the University of Heidelberg, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; H. Lee Moffitt Cancer Center, Tampa, FL; Erasmus Medisch Centrum, Rotterdam, the Netherlands; Hopital Pitie Salpetriere, Paris, France; Austin Health, Victoria, Australia; Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Eli Lilly and Company, Indianapolis, IN; and Neuro-Oncology Branch, National Cancer Institute, Bethesda, MD.</nlm:aff></affiliation></author><author><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><affiliation><nlm:aff id="aff1">From the University of Heidelberg, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; H. Lee Moffitt Cancer Center, Tampa, FL; Erasmus Medisch Centrum, Rotterdam, the Netherlands; Hopital Pitie Salpetriere, Paris, France; Austin Health, Victoria, Australia; Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Eli Lilly and Company, Indianapolis, IN; and Neuro-Oncology Branch, National Cancer Institute, Bethesda, MD.</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="aff1">From the University of Heidelberg, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; H. Lee Moffitt Cancer Center, Tampa, FL; Erasmus Medisch Centrum, Rotterdam, the Netherlands; Hopital Pitie Salpetriere, Paris, France; Austin Health, Victoria, Australia; Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Eli Lilly and Company, Indianapolis, IN; and Neuro-Oncology Branch, National Cancer Institute, Bethesda, MD.</nlm:aff></affiliation></author><author><name sortKey="Cher, Lawrence M" sort="Cher, Lawrence M" uniqKey="Cher L" first="Lawrence M." last="Cher">Lawrence M. Cher</name><affiliation><nlm:aff id="aff1">From the University of Heidelberg, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; H. Lee Moffitt Cancer Center, Tampa, FL; Erasmus Medisch Centrum, Rotterdam, the Netherlands; Hopital Pitie Salpetriere, Paris, France; Austin Health, Victoria, Australia; Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Eli Lilly and Company, Indianapolis, IN; and Neuro-Oncology Branch, National Cancer Institute, Bethesda, MD.</nlm:aff></affiliation></author><author><name sortKey="Mason, Warren" sort="Mason, Warren" uniqKey="Mason W" first="Warren" last="Mason">Warren Mason</name><affiliation><nlm:aff id="aff1">From the University of Heidelberg, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; H. Lee Moffitt Cancer Center, Tampa, FL; Erasmus Medisch Centrum, Rotterdam, the Netherlands; Hopital Pitie Salpetriere, Paris, France; Austin Health, Victoria, Australia; Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Eli Lilly and Company, Indianapolis, IN; and Neuro-Oncology Branch, National Cancer Institute, Bethesda, MD.</nlm:aff></affiliation></author><author><name sortKey="Weller, Michael" sort="Weller, Michael" uniqKey="Weller M" first="Michael" last="Weller">Michael Weller</name><affiliation><nlm:aff id="aff1">From the University of Heidelberg, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; H. Lee Moffitt Cancer Center, Tampa, FL; Erasmus Medisch Centrum, Rotterdam, the Netherlands; Hopital Pitie Salpetriere, Paris, France; Austin Health, Victoria, Australia; Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Eli Lilly and Company, Indianapolis, IN; and Neuro-Oncology Branch, National Cancer Institute, Bethesda, MD.</nlm:aff></affiliation></author><author><name sortKey="Hong, Shengyan" sort="Hong, Shengyan" uniqKey="Hong S" first="Shengyan" last="Hong">Shengyan Hong</name><affiliation><nlm:aff id="aff1">From the University of Heidelberg, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; H. Lee Moffitt Cancer Center, Tampa, FL; Erasmus Medisch Centrum, Rotterdam, the Netherlands; Hopital Pitie Salpetriere, Paris, France; Austin Health, Victoria, Australia; Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Eli Lilly and Company, Indianapolis, IN; and Neuro-Oncology Branch, National Cancer Institute, Bethesda, MD.</nlm:aff></affiliation></author><author><name sortKey="Musib, Luna" sort="Musib, Luna" uniqKey="Musib L" first="Luna" last="Musib">Luna Musib</name><affiliation><nlm:aff id="aff1">From the University of Heidelberg, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; H. Lee Moffitt Cancer Center, Tampa, FL; Erasmus Medisch Centrum, Rotterdam, the Netherlands; Hopital Pitie Salpetriere, Paris, France; Austin Health, Victoria, Australia; Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Eli Lilly and Company, Indianapolis, IN; and Neuro-Oncology Branch, National Cancer Institute, Bethesda, MD.</nlm:aff></affiliation></author><author><name sortKey="Liepa, Astra M" sort="Liepa, Astra M" uniqKey="Liepa A" first="Astra M." last="Liepa">Astra M. Liepa</name><affiliation><nlm:aff id="aff1">From the University of Heidelberg, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; H. Lee Moffitt Cancer Center, Tampa, FL; Erasmus Medisch Centrum, Rotterdam, the Netherlands; Hopital Pitie Salpetriere, Paris, France; Austin Health, Victoria, Australia; Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Eli Lilly and Company, Indianapolis, IN; and Neuro-Oncology Branch, National Cancer Institute, Bethesda, MD.</nlm:aff></affiliation></author><author><name sortKey="Thornton, Donald E" sort="Thornton, Donald E" uniqKey="Thornton D" first="Donald E." last="Thornton">Donald E. Thornton</name><affiliation><nlm:aff id="aff1">From the University of Heidelberg, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; H. Lee Moffitt Cancer Center, Tampa, FL; Erasmus Medisch Centrum, Rotterdam, the Netherlands; Hopital Pitie Salpetriere, Paris, France; Austin Health, Victoria, Australia; Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Eli Lilly and Company, Indianapolis, IN; and Neuro-Oncology Branch, National Cancer Institute, Bethesda, MD.</nlm:aff></affiliation></author><author><name sortKey="Fine, Howard A" sort="Fine, Howard A" uniqKey="Fine H" first="Howard A." last="Fine">Howard A. Fine</name><affiliation><nlm:aff id="aff1">From the University of Heidelberg, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; H. Lee Moffitt Cancer Center, Tampa, FL; Erasmus Medisch Centrum, Rotterdam, the Netherlands; Hopital Pitie Salpetriere, Paris, France; Austin Health, Victoria, Australia; Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Eli Lilly and Company, Indianapolis, IN; and Neuro-Oncology Branch, National Cancer Institute, Bethesda, MD.</nlm:aff></affiliation></author></analytic><series><title level="j">Journal of Clinical Oncology</title><idno type="ISSN">0732-183X</idno><idno type="eISSN">1527-7755</idno><imprint><date when="2010">2010</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Purpose</title><p>This phase III open-label study compared the efficacy and safety of enzastaurin versus lomustine in patients with recurrent glioblastoma (WHO grade 4).</p></sec><sec><title>Patients and Methods</title><p>Patients were randomly assigned 2:1 to receive 6-week cycles of enzastaurin 500 mg/d (1,125-mg loading dose, day 1) or lomustine (100 to 130 mg/m<sup>2</sup>, day 1). Assuming a 45% improvement in progression-free survival (PFS), 397 patients were required to provide 80% power to achieve statistical significance at a one-sided level of .025.</p></sec><sec><title>Results</title><p>Enrollment was terminated at 266 patients (enzastaurin, n = 174; lomustine, n = 92) after a planned interim analysis for futility. Patient characteristics were balanced between arms. Median PFS (1.5 <italic>v</italic> 1.6 months; hazard ratio [HR] = 1.28; 95% CI, 0.97 to 1.70), overall survival (6.6 <italic>v</italic> 7.1 months; HR = 1.20; 95% CI, 0.88 to 1.65), and 6-month PFS rate (<italic>P</italic> = .13) did not differ significantly between enzastaurin and lomustine, respectively. Stable disease occurred in 38.5% and 35.9% of patients and objective response occurred in 2.9% and 4.3% of patients, respectively. Time to deterioration of physical and functional well-being and symptoms did not differ between arms (HR = 1.12; <italic>P</italic> = .54). Four patients discontinued enzastaurin because of drug-related serious adverse events (AEs). Eleven patients treated with enzastaurin died on study (four because of AEs; one was drug-related). All four deaths that occurred in patients receiving lomustine were disease-related. Grade 3 to 4 hematologic toxicities were significantly higher with lomustine (46 events) than with enzastaurin (one event; <italic>P</italic> ≤ .001).</p></sec><sec><title>Conclusion</title><p>Enzastaurin was well tolerated and had a better hematologic toxicity profile but did not have superior efficacy compared with lomustine in patients with recurrent glioblastoma.</p></sec></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">J Clin Oncol</journal-id><journal-id journal-id-type="hwp">jco</journal-id><journal-id journal-id-type="pmc">jco</journal-id><journal-id journal-id-type="publisher-id">JCO</journal-id><journal-title-group><journal-title>Journal of Clinical Oncology</journal-title></journal-title-group><issn pub-type="ppub">0732-183X</issn><issn pub-type="epub">1527-7755</issn><publisher><publisher-name>American Society of Clinical Oncology</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">20124186</article-id><article-id pub-id-type="pmc">2834468</article-id><article-id pub-id-type="publisher-id">32595</article-id><article-id pub-id-type="doi">10.1200/JCO.2009.23.2595</article-id><article-categories><subj-group subj-group-type="collcodes"><subject>Neur1</subject><subject>Neur6</subject></subj-group><subj-group subj-group-type="heading"><subject>Original Reports</subject><subj-group><subject>Neurooncology</subject></subj-group></subj-group></article-categories><title-group><article-title>Phase III Study of Enzastaurin Compared With Lomustine in the Treatment of Recurrent Intracranial Glioblastoma</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Wick</surname><given-names>Wolfgang</given-names></name><xref ref-type="aff" rid="aff1"></xref><xref ref-type="corresp" rid="cor1"></xref></contrib><contrib contrib-type="author"><name><surname>Puduvalli</surname><given-names>Vinay K.</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Chamberlain</surname><given-names>Marc C.</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>van den Bent</surname><given-names>Martin J.</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Carpentier</surname><given-names>Antoine F.</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Cher</surname><given-names>Lawrence M.</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Mason</surname><given-names>Warren</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Weller</surname><given-names>Michael</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Hong</surname><given-names>Shengyan</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Musib</surname><given-names>Luna</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Liepa</surname><given-names>Astra M.</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Thornton</surname><given-names>Donald E.</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Fine</surname><given-names>Howard A.</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><aff id="aff1">From the University of Heidelberg, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; H. Lee Moffitt Cancer Center, Tampa, FL; Erasmus Medisch Centrum, Rotterdam, the Netherlands; Hopital Pitie Salpetriere, Paris, France; Austin Health, Victoria, Australia; Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Eli Lilly and Company, Indianapolis, IN; and Neuro-Oncology Branch, National Cancer Institute, Bethesda, MD.</aff></contrib-group><author-notes><corresp id="cor1">Corresponding author: Wolfgang Wick, MD, Department of Neurooncology, University of Heidelberg, Im Neuenheimer Feld, 400 D-69120 Heidelberg; e-mail: <email>wolfgang.wick@med.uni-heidelberg.de</email>.</corresp></author-notes><pub-date pub-type="ppub"><day>1</day><month>3</month><year>2010</year></pub-date><pub-date pub-type="epub"><day>1</day><month>2</month><year>2010</year></pub-date><pub-date pub-type="pmc-release"><day>1</day><month>3</month><year>2011</year></pub-date><pmc-comment> PMC Release delay is 12 months and 0 days and was based on the
<volume>28</volume><issue>7</issue><fpage>1168</fpage><lpage>1174</lpage><history><date date-type="received"><day>27</day><month>3</month><year>2009</year></date><date date-type="accepted"><day>19</day><month>10</month><year>2009</year></date></history><permissions><copyright-statement>© 2010 by American Society of Clinical Oncology</copyright-statement></permissions><self-uri xlink:title="pdf" xlink:type="simple" xlink:href="zlj00710001168.pdf"></self-uri><abstract><sec><title>Purpose</title><p>This phase III open-label study compared the efficacy and safety of enzastaurin versus lomustine in patients with recurrent glioblastoma (WHO grade 4).</p></sec><sec><title>Patients and Methods</title><p>Patients were randomly assigned 2:1 to receive 6-week cycles of enzastaurin 500 mg/d (1,125-mg loading dose, day 1) or lomustine (100 to 130 mg/m<sup>2</sup>, day 1). Assuming a 45% improvement in progression-free survival (PFS), 397 patients were required to provide 80% power to achieve statistical significance at a one-sided level of .025.</p></sec><sec><title>Results</title><p>Enrollment was terminated at 266 patients (enzastaurin, n = 174; lomustine, n = 92) after a planned interim analysis for futility. Patient characteristics were balanced between arms. Median PFS (1.5 <italic>v</italic> 1.6 months; hazard ratio [HR] = 1.28; 95% CI, 0.97 to 1.70), overall survival (6.6 <italic>v</italic> 7.1 months; HR = 1.20; 95% CI, 0.88 to 1.65), and 6-month PFS rate (<italic>P</italic> = .13) did not differ significantly between enzastaurin and lomustine, respectively. Stable disease occurred in 38.5% and 35.9% of patients and objective response occurred in 2.9% and 4.3% of patients, respectively. Time to deterioration of physical and functional well-being and symptoms did not differ between arms (HR = 1.12; <italic>P</italic> = .54). Four patients discontinued enzastaurin because of drug-related serious adverse events (AEs). Eleven patients treated with enzastaurin died on study (four because of AEs; one was drug-related). All four deaths that occurred in patients receiving lomustine were disease-related. Grade 3 to 4 hematologic toxicities were significantly higher with lomustine (46 events) than with enzastaurin (one event; <italic>P</italic> ≤ .001).</p></sec><sec><title>Conclusion</title><p>Enzastaurin was well tolerated and had a better hematologic toxicity profile but did not have superior efficacy compared with lomustine in patients with recurrent glioblastoma.</p></sec></abstract></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Asie/explor/AustralieFrV1/Data/Pmc/Corpus
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 001937 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Pmc/Corpus/biblio.hfd -nk 001937 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Asie
|area= AustralieFrV1
|flux= Pmc
|étape= Corpus
|type= RBID
|clé=
|texte=
}}
| This area was generated with Dilib version V0.6.33. |  |