https://m2.mtmt.hu/ hun 2026-09-22 15:50 JournalArticle 33041717 VALIDATED true Institute of Biostatistics and Clinical Research, University of Muenster, Muenster, Germany Department of Medical Oncology, Leiden University Medical Center, Leiden, Netherlands Department of Solid Tumors, Princess Máxima Center for Pediatric Oncology, Utrecht, Netherlands Department of Pediatric Haematology and Oncology, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels, Belgium Department of Pediatric Hematology and Oncology, University Children's Hospital Muenster, Muenster, Germany Charles University, Motol Children's Hospital, Prague, Czech Republic Department of Pediatrics/Oncology, Emma Children's Hospital, University of Amsterdam, Amsterdam, Netherlands Pediatric Hematology and Oncology, University Hospital Eppendorf, Hamburg, Germany Department of Oncology and Surgical Oncology for Children and Youth, Mother and Child Institute, Warsaw, Poland Childhood Cancer Center, Queen Silvia Children's Hospital, Gothenburg, Sweden Bone Tumor Reference Center at the Institute of Medical Genetics and Pathology, University Hospital Basel and University of Basel, Basel, Switzerland Department of Internal Medicine, Heidelberg University Hospital, Heidelberg, Germany Department of Radiation Oncology, University Hospital Muenster, Muenster, Germany Pediatric Hematology and Oncology, University Hospital Leuven Gasthuisberg, Leuven, Belgium Head of the Pediatric Oncology and Transplantation Unit, Velkey László Child's Health Center, Borsod-Abaúj-Zemplén County University Teaching Hospital, Miskolc, Hungary Department of Pediatrics, Semmelweis University, Budapest, Hungary Department of Pediatrics and Children's Cancer Research Center (CCRC), Technische Universität München, Munich, Germany British Columbia Cancer Research Centre, Vancouver, BC, Canada Department of Pathology, Leiden University Medical Center, Leiden, Netherlands Douglass Hanly Moir Pathology, Macquarie Park, Australia Department of Oncology and Palliative Care, Helios Klinikum Berlin-Buch, Berlin, Germany Clinic of Orthopedics, University Hospital Essen, West German Cancer Centre, Essen, Germany Department of Oncology and Hematology, University Children's Hospital Basel, Basel, Switzerland Department of Medicine, Oncology and Pneumology, University Hospital Muenster, Muenster, Germany Department of Thoracic Surgery, Ruhrlandklinik, University Hospital Essen, Essen, Germany Department of Pediatrics, St Anna Children's Hospital and Children's Cancer Research Institute, Medical University of Vienna, Vienna, Austria Centre for Clinical Trials (ZKS) Muenster, University of Muenster, Muenster, Germany Department of Pediatric Hematology, Oncology and Hematopoietic Stem Cell Transplantation, Princess Elisabeth Children's Hospital, Ghent, Belgium Department of Medical Oncology, Sarcoma Center, University of Duisburg-Essen, Essen, Germany West German Cancer Centre (WTZ) Network, Essen and Muenster, Hufelandstr. 55, Essen, 45147, Germany Department of Orthopaedics, Semmelweis University, Budapest, Hungary General Pediatrics, Oncology and Hematology, Vestische Kinder und Jugendklinik Datteln, Witten/Herdecke University, Datteln, Germany Chris o'Brien Lifehouse, Camperdown, Australia Sydney Medical School, University of Sydney, Sydney, Australia Paediatrics III, University Hospital Essen, Essen, Germany German Consortium for Translational Cancer Research (DKTK), German Cancer Research Centre, Essen, Germany Department of Particle Therapy, University Hospital Essen, West German Proton Therapy Centre Essen (WPE), Essen, Germany Center for Pediatric Oncology and Hematology, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania Institute of Clinical Medicine, Vilnius University, Vilnius, Lithuania Department of Clinical Radiology, Klinikum Ibbenbüren, Ibbenbüren, Germany Hematology and Stem Cell Transplantation, New Children's Hospital, HUS Helsinki University Hospital, Helsinki, Finland Department of Pediatrics, University Hospital Erlangen, Erlangen, Germany Division of Translational Pathology, Gerhard-Domagk-Institute of Pathology, University Hospital Muenster, Muenster, Germany Department of Clinical Sciences, Skåne University Hospital, Lund, Sweden Department of Medical Oncology, Chris o'Brien Lifehouse, Sydney, Australia Faculty of Medicine and Health, University of Sydney, Sydney, Australia Cited By :15 Export Date: 8 July 2023 CODEN: JCOND Correspondence Address: Dirksen, U.; West German Cancer Centre (WTZ) Network, Hufelandstr. 55, Germany; email: uta.dirksen@uk-essen.de 0 false 2026-06-14T00:12:45.160+0000 2022-08-08T07:57:16.457+0000 2022-08-08T07:47:53.473+0000 true 10080205 Szalóky-Siki Ágnes /api/admin/10080205 Admin true 2024-10-29T11:40:50.462+0000 2022-08-08T07:57:16.467+0000 true 10080205 Szalóky-Siki Ágnes /api/admin/10080205 Admin true true false true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle true 10000359 Study Group true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle /api/subtype/10000359 Sokszerzős vagy csoportos szerzőségű szakcikk SubType 104 true 10000359 true 1 /api/category/1 Category true 1 Koch, Raphael High-Dose Treosulfan and Melphalan as Consolidation Therapy Versus Standard Therapy for High-Risk (Metastatic) Ewing Sarcoma true true /api/journal/2374 REVIEWED true false 2374 false 2374 true 0732-183X 1527-7755 Journal FOREIGN 40 21 2307 2321 2307 15 2022 PURPOSE Ewing 2008R3 was conducted in 12 countries and evaluated the effect of treosulfan and melphalan high-dose chemotherapy (TreoMel-HDT) followed by reinfusion of autologous hematopoietic stem cells on event-free survival (EFS) and overall survival in high-risk Ewing sarcoma (EWS). METHODS Phase III, open-label, prospective, multicenter, randomized controlled clinical trial. Eligible patients had disseminated EWS with metastases to bone and/or other sites, excluding patients with only pulmonary metastases. Patients received six cycles of vincristine, ifosfamide, doxorubicin, and etoposide induction and eight cycles of vincristine, actinomycin D, and cyclophosphamide consolidation therapy. Patients were randomly assigned to receive additional TreoMel-HDT or no further treatment (control). The random assignment was stratified by number of bone metastases (1, 2-5, and > 5). The one-sided adaptive-inverse-normal-4-stage-design was changed after the first interim analysis via Muller-Schafer method. RESULTS Between 2009 and 2018, 109 patients were randomly assigned, and 55 received TreoMel-HDT. With a median follow-up of 3.3 years, there was no significant difference in EFS between TreoMel-HDT and control in the adaptive design (hazard ratio [HR] 0.85; 95% CI, 0.55 to 1.32, intention-to-treat). Three-year EFS was 20.9% (95% CI, 11.5 to 37.9) in TreoMel-HDT and 19.2% (95% CI, 10.8 to 34.4) in control patients. The results were similar in the per-protocol collective. Males treated with TreoMel-HDT had better EFS compared with controls: median 1.0 years (95% CI, 0.8 to 2.2) versus 0.6 years (95% CI, 0.5 to 0.9); P = .035; HR 0.52 (0.28 to 0.97). Patients age < 14 years benefited from TreoMel-HDT with a 3-years EFS of 39.3% (95% CI, 20.4 to 75.8%) versus 9% (95% CI, 2.4 to 34); P = .016; HR 0.40 (0.19 to 0.87). These effects were similar in the per-protocol collective. This observation is supported by comparable results from the nonrandomized trial EE99R3. CONCLUSION In patients with very high-risk EWS, additional TreoMel-HDT was of no benefit for the entire cohort of patients. TreoMel-HDT may be of benefit for children age < 14 years. 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title="Idézőközlemény" style="float: left" src="/frontend/resources/grid/publication-citation-icon.png"> <div class="autype autype0"> <span class="author-name" >Koch Raphael </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10012832"><a href="/gui2/?type=authors&mode=browse&sel=10012832" target="_blank">Hauser Peter (<span class="authorship-author-name">Hauser Péter</span> <span class="authorAux-mtmt"> Gyermekkori központi idegrendszeri daganatok</span>) </a> </span> <span class="author-affil"><span title="Semmelweis Egyetem">SE</span>/<span title="Általános Orvostudományi Kar">AOK</span>/<span title="Klinikum">K</span>/II. Sz. Gyermekgyógyászati Klinika</span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10025789"><a href="/gui2/?type=authors&mode=browse&sel=10025789" target="_blank">Kiss Janos (<span class="authorship-author-name">Kiss János</span> <span class="authorAux-mtmt"> Ortopédia</span>) </a> </span> <span class="author-affil"><span title="Semmelweis Egyetem">SE</span>/<span title="Általános Orvostudományi Kar">AOK</span>/<span title="Klinikum">K</span>/Ortopédiai Klinika</span> ;&nbsp;&nbsp;&nbsp; et al. (42) </div> <div><a target="_blank" href="/api/publication/33041717?labelLang=hun">Összes szerző</a></div> </div> <div class="title"><a href="/gui2/?mode=browse&params=publication;33041717" target="_blank">High-Dose Treosulfan and Melphalan as Consolidation Therapy Versus Standard Therapy for High-Risk (Metastatic) Ewing Sarcoma</a></div> <div> <span class="journal-title">JOURNAL OF CLINICAL ONCOLOGY</span> <span class="journal-issn">(<a target="_blank" href="https://portal.issn.org/resource/ISSN/0732-183X">0732-183X</a> <a target="_blank" href="https://portal.issn.org/resource/ISSN/1527-7755">1527-7755</a>)</span>: <span class="journal-volume">40</span> <span class="journal-issue">21</span> <span class="page"> pp 2307-2321 </span> <span class="year">(2022)</span> </div> <div class="pub-footer"> <span class="language" xmlns="http://www.w3.org/1999/html">Nyelv: Angol | </span> <span class="identifiers"> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="10.1200/JCO.21.01942" target="_blank" href="https://doi.org/10.1200/JCO.21.01942"> DOI </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="000827762800005" target="_blank" href="https://www.webofscience.com/wos/woscc/full-record/000827762800005"> WoS </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="85130126587" target="_blank" href="http://www.scopus.com/record/display.url?origin=inward&eid=2-s2.0-85130126587"> Scopus </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="35427190" target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=35427190&dopt=Abstract"> PubMed </a> </span> </span> <OnlyViewableByAuthor><div class="ratings"> <div class="journal-subject">Folyóirat szakterülete: Scopus - Cancer Research&nbsp;&nbsp;&nbsp;SJR indikátor:&nbsp;D1</div> <div class="journal-subject">Folyóirat szakterülete: Scopus - Medicine (miscellaneous)&nbsp;&nbsp;&nbsp;SJR indikátor:&nbsp;D1</div> <div class="journal-subject">Folyóirat szakterülete: Scopus - Oncology&nbsp;&nbsp;&nbsp;SJR indikátor:&nbsp;D1</div> </div></OnlyViewableByAuthor> <div class="publication-citation" style="margin-left: 0.5cm;"> <span title="Nyilvános idézőközlemények összesen, említések nélkül" class="citingPub-count">Nyilvános idéző összesen: 42</span> | Független: 26 | Függő: 16 | Nem jelölt: 0 | WoS jelölt: 40 | Scopus jelölt:&nbsp;35 | WoS/Scopus jelölt:&nbsp;42 | DOI jelölt:&nbsp;42 </div> <div class="publication-citation"> <a target="_blank" href="/api/publication?cond=citations.related;eq;33041717&sort=publishedYear,desc&sort=title"> Idézett közlemények száma: 2 </a> </div> <div class="mtid"><span class="long-pub-mtid">Közlemény: 33041717</span> | <span class="status-data status-VALIDATED"> Egyeztetett </span> Forrás Idéző | <span class="type-subtype">Folyóiratcikk ( Sokszerzős vagy csoportos szerzőségű szakcikk ) </span> | <span class="pub-category">Tudományos</span> | <span class="publication-sourceOfData">WOS TAGGED</span> </div> <div class="lastModified">Utolsó módosítás: 2022.08.08. 09:57 Szalóky-Siki Ágnes (SE_KK_Admin5_SZSA, admin) </div> <pre class="comment" style="margin-top: 0; margin-bottom: 0;"><u>Megjegyzés</u>: Institute of Biostatistics and Clinical Research, University of Muenster, Muenster, Germany Department of Medical Oncology, Leiden University Medical Center, Leiden, Netherlands Department of Solid Tumors, Princess Máxima Center for Pediatric Oncology, Utrecht, Netherlands Department of Pediatric Haematology and Oncology, C...</pre> </div></div>