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Prepublished online as a Blood First Edition Paper on January 23, 2003; DOI 10.1182/blood-2002-07-1947.
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Blood, 15 May 2003, Vol. 101, No. 10, pp. 3868-3871
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
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. Bökkerink,
Wim J. E. Tissing,
Ulf Samuelsson,
Jay Feingold,
Ursula Creutzig, and
Gertjan J. L. Kaspers
From the Department of Pediatric
Hematology/Oncology, Vrije Universiteit University Medical Center,
Amsterdam, the Netherlands; AML-BFM Study Group,
University Children's Hospital Münster, Germany;
Department of Pediatrics, University of Ulm, Germany;
Dutch Childhood Oncology Group, Den Haag, the Netherlands;
Department of Pediatric Hemato-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, Department of Health and Environment, Linköping
University, Sweden; and Wyeth Pharmaceuticals, St
Davids, PA.
Gemtuzumab ozogamicin (GO; Mylotarg) was developed to
treat CD33+ acute myeloid leukemia (AML). To date, only
studies in adults and preliminary data from a phase 1 study in children
have been reported. We report data on 15 children with
relapsed/refractory CD33+ AML who were treated with GO
monotherapy on compassionate use basis (4-9 mg/m2 up to 3 courses). Eight children showed a reduction in bone marrow blasts to
5% or less, including 5 in complete remission without full platelet
recovery (CRp). Three of the 5 children with CRp received transplants
almost directly following the last GO course, without awaiting further
platelet regeneration. Hence in these children no clear discrimination
between complete remission (CR) and CRp could be made. In 6 of 8 responding patients further treatment was given consisting of stem cell
transplantation (SCT). Two patients are still alive, currently 6 and 9 months after SCT. Hematologic toxicity was difficult to assess due to
subsequent SCT or leukemia. Side effects, in one patient each included
veno-occlusive disease, transient grade 3 hyperbilirubinemia, transient
grade 3 transaminase elevation, and grade 3 hypotension during GO
administration. No infections or mucositis occurred. This report
demonstrates clinical efficacy of GO in a subset of relapsed/refractory
pediatric CD33+ AML patients and suggests that intensive
postremission 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.
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