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Table 2 Modality and dose of GO therapy and treatment responses in 12 children with relapsed/refractory myeloid leukemia

From: Efficacy and tolerability of gemtuzumab ozogamicin (anti-CD33 monoclonal antibody, CMA-676, Mylotarg®) in children with relapsed/refractory myeloid leukemia

Nr Disease status Nb of GO courses GO dose/course BM before GO % * Diag/GO (days) Response GO toxicity (NCI-CTC) ¥ Further treatment Follow-up
#1 De novo refractory 1 1 × 9 mg/m2 (d1) 40 335 DP Anaphylaxis Transient grade IV hyperbili. Grade III transa. elevation None V from JMML
#2 Refractory relapse 1 1 × 9 mg/m2 (d1) 98 250 DP No None V from AML
#3 Post-SCT 2nd relapse 1 3 × 3 mg/m2 (d1,d4,d7) 49 555 DP Grade III febrile neutropenia Grade III transa. elevation None V from AML
#4 Refractory relapse 1 3 × 3 mg/m2 (d1,d4,d7) 43 177 DP Grade II vomiting Grade III febrile neutropenia Grade II stomatitis None V from AML
#5 De novo refractory 1 3 × 3 mg/m2 (d1,d4,d7) 45 667 CRp (d28) No MUD-SCT V from SCT
#6 Refractory relapse 1 3 × 3 mg/m2 (d1,d4,d7) 73 579 DP Grade II stomatitis None V from AML
#7 De novo refractory 1 1 × 9 mg/m2 (d1) 59 145 DP Septic shock Grade II vomiting Grade I fever None V from AML
#8 Refractory relapse 1 3 × 3 mg/m2 (d1,d4,d7) 96 298 DP Grade II vomiting Grade I fever None V from AML
#9 Refractory relapse 2 3 × 3 mg/m2 (d1,d4,d7) and 2 × 3 mg/m2 86 162 CR (d39) No MUD-SCT V from AML §
#10 Refractory relapse 1 2 × 9 mg/m2 (d1,d14) 25 357 DP Grade III febrile neutropenia Grade II transa elevation Grade II hyperbilirubinemia Grade III acute cholecystitis Grade IV hemorragic cystitis None V from AML
#11 Refractory relapse 1 2 × 7.5 mg/m2 (d1,d16) 20 513 CRp (d24) Grade II fever Grade II vomiting Haplo-SCT V from AML
#12 Refractory relapse 1 6 mg/m2 (d1)+9 mg/m2 (d16) 35 1367 DP Grade II pancreatitis Grade II fever Grade II vomiting Arsenic clofarabin. Alive in PR ♣
  1. BM: bone marrow; SCT, stem cell transplantation; MUD, matched unrelated donor; CR, complete remission; CRp, complete remission without total platelet recovery; PR, partial remission; DP, disease progression.
  2. *Bone marrow blast percentage. CD33 expression was greater than 20% before GO in all cases.
  3. ¥All patients experienced NCI-CTC grade III to IV hematological toxicity, which is not mentioned here.
  4. ‡This patient was treated with 3 × 3 mg/m2 of GO leading to a reduction in BM blasts from 86 to 20% at d28. Because of good tolerance, two more doses of 3 mg/m2 were administered and CR was obtained at d39.
  5. §This patient relapsed 69 days after MUD-SCT but a drastic reduction of BM blasts was obtained with 5 weekly doses of 3 mg/m2 GO without any significant adverse effects. He received GO maintenance therapy but died 12 months after MUD-SCT.
  6. V Death
  7. ♣ This patient was scheduled to receive MUD-SCT.