SEARCH:   Advanced

Prepublished online as a Blood First Edition Paper on January 23, 2003; DOI 10.1182/blood-2002-07-1947. This Article Full Text (PDF) All Versions of this Article: 2002-07-1947v1 101/10/3868    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 Zwaan, C. M Articles by Kaspers, G. J L Search for Related Content PubMed PubMed Citation Articles by Zwaan, C. M Articles by Kaspers, G. J L Social Bookmarking                   What's this? Submitted July 2, 2002 Accepted January 13, 2003 Gemtuzumab ozogamicin: first clinical experiences in children with relapsed/refractory acute myeloid leukemia treated on compassionate use basis Christian M Zwaan*, Dirk Reinhardt, Selim Corbacioglu, Elisabeth R van Wering, Jos P M Bokkerink, Wim J E Tissing, Ulf Samuelsson, Jay Feingold, Ursula Creutzig, and Gertjan J L Kaspers Department of Pediatric Hematology and Oncology, VU University Medical Center, Amsterdam, The Netherlands AML-BFM Study Group, Muenster, Germany Department of Pediatrics, University of Ulm, Ulm, Germany Dutch Childhood Oncology Group, Den Haag, The Netherlands Department of Pediatric Oncology, University Medical Center St. Radboud, Nijmegen, The Netherlands Department of Pediatric Oncology, Sophia Children's Hospital/Erasmus University Medical Center, Rotterdam, The Netherlands Division of Pediatrics, Linkoping University, Linkoping, Sweden Wyeth Pharmaceuticals, St. Davids, PA, USA * Corresponding author; email: cm.zwaan{at}vumc.nl. Gemtuzumab ozogamicin (GO) was developed to treat CD33 positive acute myeloid leukemia (AML). To date, only studies in adults and preliminary data from a phase I study in children have been reported. We report on 15 children with relapsed/refractory CD33 positive AML who were treated with GO monotherapy on compassionate use basis (4 to 9 mg/m2 up to 3 courses). Eight children showed a reduction in bone marrow blasts to 5%, including 5 in complete remission without full platelet recovery (CRp). Three of the 5 children with CRp were transplanted almost directly following their last GO course, without awaiting further platelet regeneration. Hence in these children no clear discrimination between CR and CRp could be made. In 6 out of 8 responding patients further treatment was given consisting of a stem cell transplantation (SCT). Two patients are still alive, currently 6 and 9 months after SCT. Hematological toxicity was difficult to assess due to subsequent stem cell transplantation or leukemia. Side effects were: veno-occlusive disease (n=1), transient grade 3 hyperbilirubinemia (n=1), transient grade 3 transaminase elevation (n=1) and grade 3 hypotension during GO administration (n=1). No infections or mucositis occurred. This report demonstrates clinical efficacy of GO in a subset of relapsed/refractory pediatric CD33 positive AML patients, and suggests that intensive post-remission therapy after remission induction by GO may result in durable responses in some patients, although follow up is still short. Further studies are needed to determine the efficacy and safety of GO in children with AML. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: R. Aplenc, T. A. Alonzo, R. B. Gerbing, B. J. Lange, C. A. Hurwitz, R. J. Wells, I. Bernstein, P. Buckley, K. Krimmel, F. O. Smith, et al. Safety and Efficacy of Gemtuzumab Ozogamicin in Combination With Chemotherapy for Pediatric Acute Myeloid Leukemia: A Report From The Children's Oncology Group J. Clin. Oncol., May 10, 2008; 26(14): 2390 - 2395. [Abstract] [Full Text] [PDF] L. Fianchi, L. Pagano, F. Leoni, S. Storti, M. T. Voso, C. G. Valentini, S. Rutella, A. Scardocci, M. Caira, G. Gianfaldoni, et al. Gemtuzumab ozogamicin, citosine arabinoside, G-CSF combination (G-AraMy) in the treatment of elderly patients with poor-prognosis acute myeloid leukemia Ann. Onc., January 1, 2008; 19(1): 128 - 134. [Abstract] [Full Text] [PDF] G. J.L. Kaspers and C. M. Zwaan Pediatric acute myeloid leukemia: towards high-quality cure of all patients Haematologica, November 1, 2007; 92(11): 1519 - 1532. [Abstract] [Full Text] [PDF] E. Roman, E. Cooney, L. Harrison, O. Militano, K. Wolownik, R. Hawks, S. Foley, P. Satwani, E. Unal, M. Bhatia, et al. Preliminary Results of the Safety of Immunotherapy with Gemtuzumab Ozogamicin following Reduced Intensity Allogeneic Stem Cell Transplant in Children with CD33+ Acute Myeloid Leukemia Clin. Cancer Res., October 1, 2005; 11(19): 7164s - 7170s. [Abstract] [Full Text] [PDF] R. J. Arceci, J. Sande, B. Lange, K. Shannon, J. Franklin, R. Hutchinson, T. A. Vik, D. Flowers, R. Aplenc, M. S. Berger, et al. Safety and efficacy of gemtuzumab ozogamicin in pediatric patients with advanced CD33+ acute myeloid leukemia Blood, August 15, 2005; 106(4): 1183 - 1188. [Abstract] [Full Text] [PDF] S. Modak and N.-K. V. Cheung Antibody-Based Targeted Radiation to Pediatric Tumors J. Nucl. Med., January 1, 2005; 46(1_suppl): 157S - 163S. [Abstract] [Full Text] [PDF] M. Buckwalter, J. A. Dowell, J. Korth-Bradley, B. Gorovits, and P. R. Mayer Pharmacokinetics of Gemtuzumab Ozogamicin as a Single-Agent Treatment of Pediatric Patients With Refractory or Relapsed Acute Myeloid Leukemia J. Clin. Pharmacol., August 1, 2004; 44(8): 873 - 880. [Abstract] [Full Text] [PDF]

	Copyright © 2003 by American Society of Hematology         Online ISSN: 1528-0020