Skip to Content
MilliporeSigma
  • Fractionated gemtuzumab ozogamicin and standard dose cytarabine produced prolonged second remissions in patients over the age of 55 years with acute myeloid leukemia in late first relapse.

Fractionated gemtuzumab ozogamicin and standard dose cytarabine produced prolonged second remissions in patients over the age of 55 years with acute myeloid leukemia in late first relapse.

American journal of hematology (2014-01-01)
Sylvain Pilorge, Sophie Rigaudeau, Florence Rabian, Clémentine Sarkozy, Anne L Taksin, Hassan Farhat, Fathia Merabet, Stéphanie Ghez, Victoria Raggueneau, Christine Terré, Isabelle Garcia, Aline Renneville, Claude Preudhomme, Sylvie Castaigne, Philippe Rousselot
ABSTRACT

Gemtuzumab ozogamicin (fGO), a humanized anti-CD33 monoclonal antibody linked to calicheamicin in combination with intensive chemotherapy gives high response rates in adult acute myeloid leukemia (AML) patients in relapse. However, reduced intensity chemotherapy in combination with fractionated GO has not been tested in aged relapsing patients. Patients from our institution with CD33+ AML aged 55 years or more in first late relapse (≥ 6 months) were proposed participation in a GO compassionate use program. Induction therapy consisted in fractionated GO (fGO; 3 mg/m², days 1, 4, 7) with standard-dose cytarabine (200 mg/m² /day, 7 days). Patients were consolidated with two courses of GO and intermediate dose cytarabine. Twenty-four patients (median age 68 years) received fGO with cytarabine. Median follow-up was 42 months. The response rate was 75%, including complete remission (CR) in 16 patients and CR with incomplete platelet recovery (CRp) in two patients. Two-year overall survival (OS) was 51% (95% CI: 28-69) and 2 years relapse-free survival (RFS) was 51% (95%CI: 25-72). Duration of second CR (CR2) was longer than first CR (CR1) in 9 out of 18 patients. Minimal residual disease (MRD) was negative in evaluable patients in CR2, particularly in NPM1 mutated cases. Toxicity was in line with that of the same fractionated single agent GO schedule. Fractionated GO with low intensity chemotherapy produced high response rates and prolonged CR2 in aged AML patients in first late relapse.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
Cytosine β-D-arabinofuranoside, crystalline, ≥90% (HPLC)
Cytarabine, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
Cytosine β-D-arabinofuranoside hydrochloride, crystalline
Sigma-Aldrich
Daunorubicin hydrochloride, ≥90% (HPLC)
Sigma-Aldrich
Daunorubicin hydrochloride, meets USP testing specifications
Supelco
6α-Methylprednisolone, VETRANAL®, analytical standard
Sigma-Aldrich
6α-Methylprednisolone, ≥98%
USP
Methylprednisolone, United States Pharmacopeia (USP) Reference Standard
Filgrastim, European Pharmacopoeia (EP) Reference Standard
Methylprednisolone, European Pharmacopoeia (EP) Reference Standard
Daunorubicin hydrochloride, European Pharmacopoeia (EP) Reference Standard