Pilot study of Mylotarg, idarubicin and cytarabine combination regimen in patients with primary resistant or relapsed acute myeloid leukemia

Yesid Alvarado, Apostolia Tsimberidou, Hagop Kantarjian, Jorge Cortes, Guillermo Garcia-Manero, Stefan Faderl, Deborah Thomas, Elihu Estey, Francis J. Giles

Research output: Contribution to journalArticle

Abstract

Purpose: Mylotarg has moderate activity as a single agent in patients with CD33-positive refractory or relapsed acute myelogenous leukemia (AML). A combination of an anthracycline and cytarabine (ara-C) is the core of most AML induction regimens. We conducted a pilot study of Mylotarg combined with idarubicin and ara-C in patients with refractory or relapsed AML. Methods: Mylotarg was administered at 6 mg/m2 intravenously on days 1 and 15, idarubicin 12 mg/m2 daily on days 2 through 4, and ara-C at 1.5 g/m2 daily on days 2 through 5 (MIA). Results: Of 14 patients were treated, 4 (29%) had primary resistant AML, and 10 (71%) relapsed AML. The median age of the patients was 61 years (range 34-74 years). MIA induced complete remission (CR) in three patients (21%) and CR with incomplete platelet recovery (CRp) in three patients (21%). The median survival was 8 weeks (range 2-64 weeks), and the median failure-free survival of CR patients was 27 weeks (range 11-64 weeks). All patients developed grade 3/4 myelosuppression - severe sepsis occurred in ten patients (71%). Other grade 3/4 nonhematologic toxicities included hepatic transaminitis, oral mucositis, and diarrhea. Two patients (14%) developed hepatic venoocclusive disease (VOD). Conclusions: The addition of Mylotarg to idarubicin and ara-C is feasible. MIA has significant activity in patients with refractory AML. Hepatotoxicity and VOD are significant toxicities of Mylotarg-based combinations.

Original languageEnglish (US)
Pages (from-to)87-90
Number of pages4
JournalCancer Chemotherapy and Pharmacology
Volume51
Issue number1
DOIs
StatePublished - Jan 16 2003
Externally publishedYes

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Idarubicin
Cytarabine
Acute Myeloid Leukemia
Anthracyclines
Refractory materials
Toxicity
Platelets
gemtuzumab
Recovery
Stomatitis
Survival
Liver
Proxy
Diarrhea
Sepsis
Blood Platelets

Keywords

  • Acute myeloid leukemia
  • Cytarabine
  • Idarubicin
  • Mylotarg
  • Venoocclusive disease

ASJC Scopus subject areas

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)

Cite this

Pilot study of Mylotarg, idarubicin and cytarabine combination regimen in patients with primary resistant or relapsed acute myeloid leukemia. / Alvarado, Yesid; Tsimberidou, Apostolia; Kantarjian, Hagop; Cortes, Jorge; Garcia-Manero, Guillermo; Faderl, Stefan; Thomas, Deborah; Estey, Elihu; Giles, Francis J.

In: Cancer Chemotherapy and Pharmacology, Vol. 51, No. 1, 16.01.2003, p. 87-90.

Research output: Contribution to journalArticle

Alvarado, Yesid ; Tsimberidou, Apostolia ; Kantarjian, Hagop ; Cortes, Jorge ; Garcia-Manero, Guillermo ; Faderl, Stefan ; Thomas, Deborah ; Estey, Elihu ; Giles, Francis J. / Pilot study of Mylotarg, idarubicin and cytarabine combination regimen in patients with primary resistant or relapsed acute myeloid leukemia. In: Cancer Chemotherapy and Pharmacology. 2003 ; Vol. 51, No. 1. pp. 87-90.
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abstract = "Purpose: Mylotarg has moderate activity as a single agent in patients with CD33-positive refractory or relapsed acute myelogenous leukemia (AML). A combination of an anthracycline and cytarabine (ara-C) is the core of most AML induction regimens. We conducted a pilot study of Mylotarg combined with idarubicin and ara-C in patients with refractory or relapsed AML. Methods: Mylotarg was administered at 6 mg/m2 intravenously on days 1 and 15, idarubicin 12 mg/m2 daily on days 2 through 4, and ara-C at 1.5 g/m2 daily on days 2 through 5 (MIA). Results: Of 14 patients were treated, 4 (29{\%}) had primary resistant AML, and 10 (71{\%}) relapsed AML. The median age of the patients was 61 years (range 34-74 years). MIA induced complete remission (CR) in three patients (21{\%}) and CR with incomplete platelet recovery (CRp) in three patients (21{\%}). The median survival was 8 weeks (range 2-64 weeks), and the median failure-free survival of CR patients was 27 weeks (range 11-64 weeks). All patients developed grade 3/4 myelosuppression - severe sepsis occurred in ten patients (71{\%}). Other grade 3/4 nonhematologic toxicities included hepatic transaminitis, oral mucositis, and diarrhea. Two patients (14{\%}) developed hepatic venoocclusive disease (VOD). Conclusions: The addition of Mylotarg to idarubicin and ara-C is feasible. MIA has significant activity in patients with refractory AML. Hepatotoxicity and VOD are significant toxicities of Mylotarg-based combinations.",
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T1 - Pilot study of Mylotarg, idarubicin and cytarabine combination regimen in patients with primary resistant or relapsed acute myeloid leukemia

AU - Alvarado, Yesid

AU - Tsimberidou, Apostolia

AU - Kantarjian, Hagop

AU - Cortes, Jorge

AU - Garcia-Manero, Guillermo

AU - Faderl, Stefan

AU - Thomas, Deborah

AU - Estey, Elihu

AU - Giles, Francis J.

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Y1 - 2003/1/16

N2 - Purpose: Mylotarg has moderate activity as a single agent in patients with CD33-positive refractory or relapsed acute myelogenous leukemia (AML). A combination of an anthracycline and cytarabine (ara-C) is the core of most AML induction regimens. We conducted a pilot study of Mylotarg combined with idarubicin and ara-C in patients with refractory or relapsed AML. Methods: Mylotarg was administered at 6 mg/m2 intravenously on days 1 and 15, idarubicin 12 mg/m2 daily on days 2 through 4, and ara-C at 1.5 g/m2 daily on days 2 through 5 (MIA). Results: Of 14 patients were treated, 4 (29%) had primary resistant AML, and 10 (71%) relapsed AML. The median age of the patients was 61 years (range 34-74 years). MIA induced complete remission (CR) in three patients (21%) and CR with incomplete platelet recovery (CRp) in three patients (21%). The median survival was 8 weeks (range 2-64 weeks), and the median failure-free survival of CR patients was 27 weeks (range 11-64 weeks). All patients developed grade 3/4 myelosuppression - severe sepsis occurred in ten patients (71%). Other grade 3/4 nonhematologic toxicities included hepatic transaminitis, oral mucositis, and diarrhea. Two patients (14%) developed hepatic venoocclusive disease (VOD). Conclusions: The addition of Mylotarg to idarubicin and ara-C is feasible. MIA has significant activity in patients with refractory AML. Hepatotoxicity and VOD are significant toxicities of Mylotarg-based combinations.

AB - Purpose: Mylotarg has moderate activity as a single agent in patients with CD33-positive refractory or relapsed acute myelogenous leukemia (AML). A combination of an anthracycline and cytarabine (ara-C) is the core of most AML induction regimens. We conducted a pilot study of Mylotarg combined with idarubicin and ara-C in patients with refractory or relapsed AML. Methods: Mylotarg was administered at 6 mg/m2 intravenously on days 1 and 15, idarubicin 12 mg/m2 daily on days 2 through 4, and ara-C at 1.5 g/m2 daily on days 2 through 5 (MIA). Results: Of 14 patients were treated, 4 (29%) had primary resistant AML, and 10 (71%) relapsed AML. The median age of the patients was 61 years (range 34-74 years). MIA induced complete remission (CR) in three patients (21%) and CR with incomplete platelet recovery (CRp) in three patients (21%). The median survival was 8 weeks (range 2-64 weeks), and the median failure-free survival of CR patients was 27 weeks (range 11-64 weeks). All patients developed grade 3/4 myelosuppression - severe sepsis occurred in ten patients (71%). Other grade 3/4 nonhematologic toxicities included hepatic transaminitis, oral mucositis, and diarrhea. Two patients (14%) developed hepatic venoocclusive disease (VOD). Conclusions: The addition of Mylotarg to idarubicin and ara-C is feasible. MIA has significant activity in patients with refractory AML. Hepatotoxicity and VOD are significant toxicities of Mylotarg-based combinations.

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KW - Cytarabine

KW - Idarubicin

KW - Mylotarg

KW - Venoocclusive disease

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