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Blood, 1 February 2005, Vol. 105, No. 3, pp. 948-958. Prepublished online as a Blood First Edition Paper on October 14, 2004; DOI 10.1182/blood-2004-03-0973. This Article Full Text (PDF) All Versions of this Article: 2004-03-0973v1 105/3/948    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Woessmann, W. Articles by Reiter, A. Search for Related Content PubMed PubMed Citation Articles by Woessmann, W. Articles by Reiter, A. Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted March 16, 2004 Accepted August 6, 2004 The impact of the methotrexate administration schedule and dose in the treatment of children and adolescents with B-cell neoplasms - a report of the BFM group study NHL-BFM95 Wilhelm Woessmann, Kathrin Seidemann, Georg Mann, Martin Zimmermann, Birgit Burkhardt, Ilske Oschlies, Wolf-Dieter Ludwig, Thomas Klingebiel, Norbert Graf, Bernd Gruhn, Heribert Juergens, Felix Niggli, Reza Parwaresch, Helmut Gadner, Hansjoerg Riehm, Martin Schrappe, and Alfred Reiter* Department of Pediatric Hematology and Oncology, Justus-Liebig-University, Giessen, Germany Department of Pediatric Hematology and Oncology, Medizinische Hochschule, Hannover, Germany St. Anna Kinderspital, Vienna, Austria Department of Pediatric Hematology and Oncology, Justus-Liebig-University, Giessen, Germany; Department of Pediatric Hematology and Oncology, Medizinische Hochschule, Hannover, Germany Institute of Hematopathology and Lymph Node Registry, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel, Germany Department of Hematology, Oncology and Tumor Immunology, HELIOS Clinic Berlin-Buch, Charite, Campus Berlin-Buch, Berlin, Germany Department of Pediatric Hematology and Oncology, Johann-Wolfgang-Goethe University, Frankfurt, Germany Department of Pediatric Hematology and Oncology, University of Saarland, Homburg, Germany Department of Pediatrics, Friedrich Schiller University, Jena, Germany Department of Pediatric Hematology and Oncology, Westfaelische Wilhelms-University, Muenster, Germany Department of Pediatrics, University of Zurich, Zurich, Switzerland * Corresponding author; email: alfred.reiter{at}paediat.med.uni-giessen.de. In study NHL-BFM95 we tested by randomization whether for patients with B-cell neoplasms methotrexate as IV infusion over 4 hours (MTX-4h) is non-inferior to, but less toxic than a 24 hours IV infusion (MTX-24h). Second, we investigated against the historical control of study NHL-BFM90 if for patients with moderate tumor mass MTX can be reduced from 5g/m2 to 1g/m2. Patients received two 5-day therapy courses in risk-group R1 (resected), 4 in R2 (LDH< 500U/L), 5 in R3 (LDH >500-< 1000U/L) and 6 in R4 (LDH >1000U/L or/and CNS-disease). Courses contained MTX 1g/m2 in R1+R2 and 5g/m2 in R3+R4. Of 505 patients (4/1996-3/2001) 364 were randomized to receive MTX-4h or MTX-24h. pFFS (1-year) for arm MTX-4h vs MTX-24h was 95%+5% (n=20) vs 100% (n=19) in R1, 94%+2% (n=88) vs 96%+2% (n=95) in R2, 77%+5% (n=62) vs 93%+3% (n=69) in R3+R4 (per-protocol analysis). Incidence of mucositis grade III/IV was significantly lower with MTX-4h in all risk-groups. For patients in R2 pEFS was 95%+2% (n=222) in NHL-BFM95 (MTX 1g/m2) and 97%+1% (n=154) in NHL-BFM90 (MTX 5g/m2). Conclusion: MTX-4h was less toxic than MTX-24h. MTX-4h was non-inferior to MTX-24h for limited stage B-NHL but not for advanced disease. For limited disease MTX 1g/m2 is non-inferior to 5g/m2. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: L. Brugieres, M.-C. Le Deley, A. Rosolen, D. Williams, K. Horibe, G. Wrobel, G. Mann, J. Zsiros, A. Uyttebroeck, I. Marky, et al. Impact of the Methotrexate Administration Dose on the Need for Intrathecal Treatment in Children and Adolescents With Anaplastic Large-Cell Lymphoma: Results of a Randomized Trial of the EICNHL Group J. Clin. Oncol., February 20, 2009; 27(6): 897 - 903. [Abstract] [Full Text] [PDF] W. Klapper, M. Szczepanowski, B. Burkhardt, H. Berger, M. Rosolowski, S. Bentink, C. Schwaenen, S. Wessendorf, R. Spang, P. Moller, et al. 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