HGG-16. Final analysis of the HIT-HGG-2007 trial (ISRCTN19852453): Significant survival benefit for pontine and non-pontine pediatric high-grade gliomas in comparison to previous HIT-GBM-C/-D trials
The aim of the HIT-HGG-2007 trial (ISRCTN19852453) was to demonstrate therapeutic non-inferiority of temozolomide radiochemotherapy for pediatric patients (3-18 years) with high-grade gliomas (pedHGG) in comparison to the cisplatinum-based radiochemotherapy of the two previous clinical trials HIT-GB...
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| creator | von Bueren, Andrè O Kwiecien, Robert Gielen, Gerrit H Benesch, Martin Perwein, Thomas Nussbaumer, Gunther Sturm, Dominik Jones, David T W Pfister, Stefan M Eyrich, Matthias Rutkowski, Stefan Fleischhack, Gudrun von Buiren, Miriam Karremann, Michael Kortmann, Rolf-Dieter Hagel, Christian Calaminus, Gabriele Faldum, Andreas Bison, Brigitte Pietsch, Torsten Hoffmann, Marion Kramm, Christof M |
| description | The aim of the HIT-HGG-2007 trial (ISRCTN19852453) was to demonstrate therapeutic non-inferiority of temozolomide radiochemotherapy for pediatric patients (3-18 years) with high-grade gliomas (pedHGG) in comparison to the cisplatinum-based radiochemotherapy of the two previous clinical trials HIT-GBM-C/-D. Between 06/2009 and 12/2016, 456 patients were enrolled at 79 centers in Germany, Austria, and Switzerland (n=18 dropouts, remaining patients for confirmatory analysis: n=438). 438 patients from HIT-GBM-C/-D served as historical control. All pedHGG diagnoses had been confirmed by central neuroradiological and neuropathological review. Primary objective was achieved since non-inferiority of HIT-HGG-2007 in comparison to HIT-GBM-C/-D as indicated by 6 months event-free survival (EFS) was statistically confirmed (p=0.0125). Statistical survival analyses even revealed a better overall survival (OS) and EFS for HIT-HGG-2007 patients in comparison to their HIT-GBM-C/-D counterparts (EFS: p |
| doi_str_mv | 10.1093/neuonc/noac079.231 |
| format | Article |
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Final analysis of the HIT-HGG-2007 trial (ISRCTN19852453): Significant survival benefit for pontine and non-pontine pediatric high-grade gliomas in comparison to previous HIT-GBM-C/-D trials</title><source>Oxford University Press Journals All Titles (1996-Current)</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>PubMed Central</source><creator>von Bueren, Andrè O ; Kwiecien, Robert ; Gielen, Gerrit H ; Benesch, Martin ; Perwein, Thomas ; Nussbaumer, Gunther ; Sturm, Dominik ; Jones, David T W ; Pfister, Stefan M ; Eyrich, Matthias ; Rutkowski, Stefan ; Fleischhack, Gudrun ; von Buiren, Miriam ; Karremann, Michael ; Kortmann, Rolf-Dieter ; Hagel, Christian ; Calaminus, Gabriele ; Faldum, Andreas ; Bison, Brigitte ; Pietsch, Torsten ; Hoffmann, Marion ; Kramm, Christof M</creator><creatorcontrib>von Bueren, Andrè O ; Kwiecien, Robert ; Gielen, Gerrit H ; Benesch, Martin ; Perwein, Thomas ; Nussbaumer, Gunther ; Sturm, Dominik ; Jones, David T W ; Pfister, Stefan M ; Eyrich, Matthias ; Rutkowski, Stefan ; Fleischhack, Gudrun ; von Buiren, Miriam ; Karremann, Michael ; Kortmann, Rolf-Dieter ; Hagel, Christian ; Calaminus, Gabriele ; Faldum, Andreas ; Bison, Brigitte ; Pietsch, Torsten ; Hoffmann, Marion ; Kramm, Christof M</creatorcontrib><description>The aim of the HIT-HGG-2007 trial (ISRCTN19852453) was to demonstrate therapeutic non-inferiority of temozolomide radiochemotherapy for pediatric patients (3-18 years) with high-grade gliomas (pedHGG) in comparison to the cisplatinum-based radiochemotherapy of the two previous clinical trials HIT-GBM-C/-D. Between 06/2009 and 12/2016, 456 patients were enrolled at 79 centers in Germany, Austria, and Switzerland (n=18 dropouts, remaining patients for confirmatory analysis: n=438). 438 patients from HIT-GBM-C/-D served as historical control. All pedHGG diagnoses had been confirmed by central neuroradiological and neuropathological review. Primary objective was achieved since non-inferiority of HIT-HGG-2007 in comparison to HIT-GBM-C/-D as indicated by 6 months event-free survival (EFS) was statistically confirmed (p=0.0125). Statistical survival analyses even revealed a better overall survival (OS) and EFS for HIT-HGG-2007 patients in comparison to their HIT-GBM-C/-D counterparts (EFS: p<0.0001; OS: p=0.0328). While EFS subgroup analyses for pontine and non-pontine pedHGG also showed a better survival of HIT-HGG-2007 patients (median EFS pontine pedHGG: 8.2 (n=152; confidence interval (CI): 7.6-9.4) versus 6.2 (n=170; CI: 5.5-6.9) months, p=0.0079; median EFS non-pontine pedHGG: 10.7 (n=276; CI: 9.6-12.4) versus 7.4 (n=267; CI: 6.4-9.2) months, p<0.0001), OS was only improved in HIT-HGG-2007 patients with non-pontine pedHGG (median OS non-pontine pedHGG: 19.3 (CI: 16.8-23.3) versus 16.2 (CI: 14.2-19.1) months; p=0.0181) but not with pontine pedHGG (median OS pontine pedHGG: 11.4 months versus 11.3 months, p=0.4021) Toxicity profile of HIT-HGG-2007 seemed very favorable with most CTCAE (common toxicity criteria adverse event) ≥ grade 3 as hematological toxicity, hepatotoxicity, and neurotoxicity. Less toxicity was observed during concomitant radiochemotherapy in comparison to HIT-GBM-C/-D. Further subgroup survival analyses as well as the assessment of the impact of MGMT promoter methylation are ongoing. In conclusion, our data show non-inferiority of the HIT-HGG-2007 trial with increased survival and less toxicity when compared with previous trials HIT-GBM-C/-D.</description><identifier>ISSN: 1522-8517</identifier><identifier>EISSN: 1523-5866</identifier><identifier>DOI: 10.1093/neuonc/noac079.231</identifier><language>eng</language><publisher>US: Oxford University Press</publisher><subject>High Grade Glioma</subject><ispartof>Neuro-oncology (Charlottesville, Va.), 2022-06, Vol.24 (Supplement_1), p.i63-i64</ispartof><rights>The Author(s) 2022. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. 2022</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c1911-aa706c45e4bf4c592a92aa824f7f5d9f18e76b365e350d76ab2fd8a4b488a3d63</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9164809/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9164809/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,881,27901,27902,53766,53768</link.rule.ids></links><search><creatorcontrib>von Bueren, Andrè O</creatorcontrib><creatorcontrib>Kwiecien, Robert</creatorcontrib><creatorcontrib>Gielen, Gerrit H</creatorcontrib><creatorcontrib>Benesch, Martin</creatorcontrib><creatorcontrib>Perwein, Thomas</creatorcontrib><creatorcontrib>Nussbaumer, Gunther</creatorcontrib><creatorcontrib>Sturm, Dominik</creatorcontrib><creatorcontrib>Jones, David T W</creatorcontrib><creatorcontrib>Pfister, Stefan M</creatorcontrib><creatorcontrib>Eyrich, Matthias</creatorcontrib><creatorcontrib>Rutkowski, Stefan</creatorcontrib><creatorcontrib>Fleischhack, Gudrun</creatorcontrib><creatorcontrib>von Buiren, Miriam</creatorcontrib><creatorcontrib>Karremann, Michael</creatorcontrib><creatorcontrib>Kortmann, Rolf-Dieter</creatorcontrib><creatorcontrib>Hagel, Christian</creatorcontrib><creatorcontrib>Calaminus, Gabriele</creatorcontrib><creatorcontrib>Faldum, Andreas</creatorcontrib><creatorcontrib>Bison, Brigitte</creatorcontrib><creatorcontrib>Pietsch, Torsten</creatorcontrib><creatorcontrib>Hoffmann, Marion</creatorcontrib><creatorcontrib>Kramm, Christof M</creatorcontrib><title>HGG-16. Final analysis of the HIT-HGG-2007 trial (ISRCTN19852453): Significant survival benefit for pontine and non-pontine pediatric high-grade gliomas in comparison to previous HIT-GBM-C/-D trials</title><title>Neuro-oncology (Charlottesville, Va.)</title><description>The aim of the HIT-HGG-2007 trial (ISRCTN19852453) was to demonstrate therapeutic non-inferiority of temozolomide radiochemotherapy for pediatric patients (3-18 years) with high-grade gliomas (pedHGG) in comparison to the cisplatinum-based radiochemotherapy of the two previous clinical trials HIT-GBM-C/-D. Between 06/2009 and 12/2016, 456 patients were enrolled at 79 centers in Germany, Austria, and Switzerland (n=18 dropouts, remaining patients for confirmatory analysis: n=438). 438 patients from HIT-GBM-C/-D served as historical control. All pedHGG diagnoses had been confirmed by central neuroradiological and neuropathological review. Primary objective was achieved since non-inferiority of HIT-HGG-2007 in comparison to HIT-GBM-C/-D as indicated by 6 months event-free survival (EFS) was statistically confirmed (p=0.0125). Statistical survival analyses even revealed a better overall survival (OS) and EFS for HIT-HGG-2007 patients in comparison to their HIT-GBM-C/-D counterparts (EFS: p<0.0001; OS: p=0.0328). While EFS subgroup analyses for pontine and non-pontine pedHGG also showed a better survival of HIT-HGG-2007 patients (median EFS pontine pedHGG: 8.2 (n=152; confidence interval (CI): 7.6-9.4) versus 6.2 (n=170; CI: 5.5-6.9) months, p=0.0079; median EFS non-pontine pedHGG: 10.7 (n=276; CI: 9.6-12.4) versus 7.4 (n=267; CI: 6.4-9.2) months, p<0.0001), OS was only improved in HIT-HGG-2007 patients with non-pontine pedHGG (median OS non-pontine pedHGG: 19.3 (CI: 16.8-23.3) versus 16.2 (CI: 14.2-19.1) months; p=0.0181) but not with pontine pedHGG (median OS pontine pedHGG: 11.4 months versus 11.3 months, p=0.4021) Toxicity profile of HIT-HGG-2007 seemed very favorable with most CTCAE (common toxicity criteria adverse event) ≥ grade 3 as hematological toxicity, hepatotoxicity, and neurotoxicity. Less toxicity was observed during concomitant radiochemotherapy in comparison to HIT-GBM-C/-D. Further subgroup survival analyses as well as the assessment of the impact of MGMT promoter methylation are ongoing. In conclusion, our data show non-inferiority of the HIT-HGG-2007 trial with increased survival and less toxicity when compared with previous trials HIT-GBM-C/-D.</description><subject>High Grade Glioma</subject><issn>1522-8517</issn><issn>1523-5866</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><recordid>eNpVkdtqGzEQhpfQQlK3L5ArXbYXsnVYabW9KLROYxvSFhrnWmi10nqKLS3S2pAX7HNVidNCYZgD88_PwFdV15TMKWn5IrhjDHYRorGkaeeM04vqigrGsVBSvnruGVaCNpfVm5x_EcKokPSq-r1erTCVc3QLweyRKekxQ0bRo2nn0HqzxU8KRkiDpgRF8n5z_3O5_U5bJVgt-IeP6B6GAB6sCRPKx3SCU5F1LjgPE_IxoTGGCYIr7j0KMeC_8-h6MMXVoh0MOzwk0zs07CEeTEYQkI2H0STIMaApojG5E8Rjfn5q9eUbXi7wzfmp_LZ67Utx717qrHq4_bpdrvHdj9Vm-fkOW9pSio1piLS1cHXnaytaZkoYxWrfeNG3nirXyI5L4bggfSNNx3yvTN3VShneSz6rPp19x2N3cL11YUpmr8cEB5MedTSg_98E2OkhnnRLZa0KqVnFzgY2xZyT8_9uKdFPKPUZpX5BqQtK_gdUXZYH</recordid><startdate>20220603</startdate><enddate>20220603</enddate><creator>von Bueren, Andrè O</creator><creator>Kwiecien, Robert</creator><creator>Gielen, Gerrit H</creator><creator>Benesch, Martin</creator><creator>Perwein, Thomas</creator><creator>Nussbaumer, Gunther</creator><creator>Sturm, Dominik</creator><creator>Jones, David T W</creator><creator>Pfister, Stefan M</creator><creator>Eyrich, Matthias</creator><creator>Rutkowski, Stefan</creator><creator>Fleischhack, Gudrun</creator><creator>von Buiren, Miriam</creator><creator>Karremann, Michael</creator><creator>Kortmann, Rolf-Dieter</creator><creator>Hagel, Christian</creator><creator>Calaminus, Gabriele</creator><creator>Faldum, Andreas</creator><creator>Bison, Brigitte</creator><creator>Pietsch, Torsten</creator><creator>Hoffmann, Marion</creator><creator>Kramm, Christof M</creator><general>Oxford University Press</general><scope>AAYXX</scope><scope>CITATION</scope><scope>5PM</scope></search><sort><creationdate>20220603</creationdate><title>HGG-16. Final analysis of the HIT-HGG-2007 trial (ISRCTN19852453): Significant survival benefit for pontine and non-pontine pediatric high-grade gliomas in comparison to previous HIT-GBM-C/-D trials</title><author>von Bueren, Andrè O ; Kwiecien, Robert ; Gielen, Gerrit H ; Benesch, Martin ; Perwein, Thomas ; Nussbaumer, Gunther ; Sturm, Dominik ; Jones, David T W ; Pfister, Stefan M ; Eyrich, Matthias ; Rutkowski, Stefan ; Fleischhack, Gudrun ; von Buiren, Miriam ; Karremann, Michael ; Kortmann, Rolf-Dieter ; Hagel, Christian ; Calaminus, Gabriele ; Faldum, Andreas ; Bison, Brigitte ; Pietsch, Torsten ; Hoffmann, Marion ; Kramm, Christof M</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c1911-aa706c45e4bf4c592a92aa824f7f5d9f18e76b365e350d76ab2fd8a4b488a3d63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>High Grade Glioma</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>von Bueren, Andrè O</creatorcontrib><creatorcontrib>Kwiecien, Robert</creatorcontrib><creatorcontrib>Gielen, Gerrit H</creatorcontrib><creatorcontrib>Benesch, Martin</creatorcontrib><creatorcontrib>Perwein, Thomas</creatorcontrib><creatorcontrib>Nussbaumer, Gunther</creatorcontrib><creatorcontrib>Sturm, Dominik</creatorcontrib><creatorcontrib>Jones, David T W</creatorcontrib><creatorcontrib>Pfister, Stefan M</creatorcontrib><creatorcontrib>Eyrich, Matthias</creatorcontrib><creatorcontrib>Rutkowski, Stefan</creatorcontrib><creatorcontrib>Fleischhack, Gudrun</creatorcontrib><creatorcontrib>von Buiren, Miriam</creatorcontrib><creatorcontrib>Karremann, Michael</creatorcontrib><creatorcontrib>Kortmann, Rolf-Dieter</creatorcontrib><creatorcontrib>Hagel, Christian</creatorcontrib><creatorcontrib>Calaminus, Gabriele</creatorcontrib><creatorcontrib>Faldum, Andreas</creatorcontrib><creatorcontrib>Bison, Brigitte</creatorcontrib><creatorcontrib>Pietsch, Torsten</creatorcontrib><creatorcontrib>Hoffmann, Marion</creatorcontrib><creatorcontrib>Kramm, Christof M</creatorcontrib><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Neuro-oncology (Charlottesville, Va.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>von Bueren, Andrè O</au><au>Kwiecien, Robert</au><au>Gielen, Gerrit H</au><au>Benesch, Martin</au><au>Perwein, Thomas</au><au>Nussbaumer, Gunther</au><au>Sturm, Dominik</au><au>Jones, David T W</au><au>Pfister, Stefan M</au><au>Eyrich, Matthias</au><au>Rutkowski, Stefan</au><au>Fleischhack, Gudrun</au><au>von Buiren, Miriam</au><au>Karremann, Michael</au><au>Kortmann, Rolf-Dieter</au><au>Hagel, Christian</au><au>Calaminus, Gabriele</au><au>Faldum, Andreas</au><au>Bison, Brigitte</au><au>Pietsch, Torsten</au><au>Hoffmann, Marion</au><au>Kramm, Christof M</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>HGG-16. Final analysis of the HIT-HGG-2007 trial (ISRCTN19852453): Significant survival benefit for pontine and non-pontine pediatric high-grade gliomas in comparison to previous HIT-GBM-C/-D trials</atitle><jtitle>Neuro-oncology (Charlottesville, Va.)</jtitle><date>2022-06-03</date><risdate>2022</risdate><volume>24</volume><issue>Supplement_1</issue><spage>i63</spage><epage>i64</epage><pages>i63-i64</pages><issn>1522-8517</issn><eissn>1523-5866</eissn><abstract>The aim of the HIT-HGG-2007 trial (ISRCTN19852453) was to demonstrate therapeutic non-inferiority of temozolomide radiochemotherapy for pediatric patients (3-18 years) with high-grade gliomas (pedHGG) in comparison to the cisplatinum-based radiochemotherapy of the two previous clinical trials HIT-GBM-C/-D. Between 06/2009 and 12/2016, 456 patients were enrolled at 79 centers in Germany, Austria, and Switzerland (n=18 dropouts, remaining patients for confirmatory analysis: n=438). 438 patients from HIT-GBM-C/-D served as historical control. All pedHGG diagnoses had been confirmed by central neuroradiological and neuropathological review. Primary objective was achieved since non-inferiority of HIT-HGG-2007 in comparison to HIT-GBM-C/-D as indicated by 6 months event-free survival (EFS) was statistically confirmed (p=0.0125). Statistical survival analyses even revealed a better overall survival (OS) and EFS for HIT-HGG-2007 patients in comparison to their HIT-GBM-C/-D counterparts (EFS: p<0.0001; OS: p=0.0328). While EFS subgroup analyses for pontine and non-pontine pedHGG also showed a better survival of HIT-HGG-2007 patients (median EFS pontine pedHGG: 8.2 (n=152; confidence interval (CI): 7.6-9.4) versus 6.2 (n=170; CI: 5.5-6.9) months, p=0.0079; median EFS non-pontine pedHGG: 10.7 (n=276; CI: 9.6-12.4) versus 7.4 (n=267; CI: 6.4-9.2) months, p<0.0001), OS was only improved in HIT-HGG-2007 patients with non-pontine pedHGG (median OS non-pontine pedHGG: 19.3 (CI: 16.8-23.3) versus 16.2 (CI: 14.2-19.1) months; p=0.0181) but not with pontine pedHGG (median OS pontine pedHGG: 11.4 months versus 11.3 months, p=0.4021) Toxicity profile of HIT-HGG-2007 seemed very favorable with most CTCAE (common toxicity criteria adverse event) ≥ grade 3 as hematological toxicity, hepatotoxicity, and neurotoxicity. Less toxicity was observed during concomitant radiochemotherapy in comparison to HIT-GBM-C/-D. Further subgroup survival analyses as well as the assessment of the impact of MGMT promoter methylation are ongoing. In conclusion, our data show non-inferiority of the HIT-HGG-2007 trial with increased survival and less toxicity when compared with previous trials HIT-GBM-C/-D.</abstract><cop>US</cop><pub>Oxford University Press</pub><doi>10.1093/neuonc/noac079.231</doi><oa>free_for_read</oa></addata></record> |
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| source | Oxford University Press Journals All Titles (1996-Current); Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central |
| subjects | High Grade Glioma |
| title | HGG-16. Final analysis of the HIT-HGG-2007 trial (ISRCTN19852453): Significant survival benefit for pontine and non-pontine pediatric high-grade gliomas in comparison to previous HIT-GBM-C/-D trials |
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