Efficacy of fractionated gemtuzumab ozogamicin combined with cytarabine in advanced childhood myeloid leukaemia |
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Authors: | Brethon Benoit Yakouben Karima Oudot Caroline Boutard Patrick Bruno Bénédicte Jérome Cécile Nelken Brigitte de Lumley Lionel Bertrand Yves Dalle Jean-Hugues Chevret Sylvie Leblanc Thierry Baruchel André |
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Affiliation: | 1. Hématologie Pédiatrique, H?pital Saint‐Louis, APHP, Paris;2. Hématologie et Immunologie Pédiatrique, H?pital Robert Debré, APHP, Paris;3. Département de Pédiatrie Médicale, H?pital Universitaire Dupuytren, Limoges;4. Onco‐Hématologie Pédiatrique, Centre Hospitalier Régional, Caen;5. Hémato‐Oncologie Pédiatrique, H?pital Jeanne de Flandre, Lille;6. Unité de Pédiatrie, Institut de Cancérologie de la Loire, Saint‐Etienne;7. Hématologie Pédiatrique, H?pital Debrousse, Lyon;8. Département de Biostatistique et Informatique Médicale, H?pital Saint‐Louis, APHP, Paris, France |
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Abstract: | Gemtuzumab ozogamicin (GO) monotherapy is reported to yield a 20-30% response rate in advanced acute myeloid leukaemia (AML). This study examined the efficacy and tolerability of GO combined with cytarabine (GOCYT) in children with refractory/relapsed CD33(+) AML. Seventeen children received GO 3 mg/m(2) on days 1, 4 and 7 plus cytarabine 100 mg/m(2)/d for 7 d on a compassionate-use basis. Seven patients then received GO-based consolidation. At the outset of GOCYT, two patients were refractory; eight patients were in refractory first relapse; six patients had relapsed after stem cell transplantation (SCT); and one patient [del(5q) therapy-related AML (t-AML)] had not yet been treated. Mean follow-up was 17 months (8-33 months). Ten responses were obtained after GOCYT induction, including complete remission (CR) or CR without complete recovery of platelets (CRp) in six patients (35%). The responses improved in three children who received GOCYT consolidation, increasing the CR + CRp rate to 53%. SCT was subsequently performed in eight responders. Grade 3-4 adverse events consisted of haematological disorders (n = 17, 100%) and documented infections (n = 5, 29%). No cases of sinusoidal obstructive syndrome occurred. Three patients were alive at the cut-off date for this analysis, all of whom had responded to GOCYT. GOCYT combination therapy yielded a high response rate (53%) and showed acceptable toxicity in heavily pretreated children with refractory/relapsed AML. These results warrant a larger prospective study. |
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Keywords: | gemtuzumab ozogamicin mylotarg anti‐CD33 acute myeloid leukaemia children |
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