Comparison of Long-Acting G-CSF (PD-Lasta) with Short-Acting G-CSF (PD-Grastim) in Neutrophil Recovery Following Consolidation Chemotherapy with High-Dose Cytarabine in Acute Myeloid Leukemia: A Randomized Clinical Trial

Mohsen Esfandbod; Fatemeh  Agha Bararzadeh; Mona Faraz; Fariba Zarrabi; Gholamreza Toogeh

doi:10.18502/ijhoscr.v15i2.6040

Mohsen Esfandbod Thrombosis Hemostasis Research Center, Tehran University of Medical Sciences, Tehran, Iran
Fatemeh Agha Bararzadeh Thrombosis Hemostasis Research Center, Tehran University of Medical Sciences, Tehran, Iran
Mona Faraz Thrombosis Hemostasis Research Center, Tehran University of Medical Sciences, Tehran, Iran
Fariba Zarrabi Thrombosis Hemostasis Research Center, Tehran University of Medical Sciences, Tehran, Iran
Gholamreza Toogeh Thrombosis Hemostasis Research Center, Tehran University of Medical Sciences, Tehran, Iran

DOI: https://doi.org/10.18502/ijhoscr.v15i2.6040

Keywords: Neutropenia; Acute Myeloid Leukemia; Granulocyte colony-stimulating factor (G-CSF)

Abstract

Background: Acute myeloid leukemia (AML) patients are often neutropenic as a result of their disease alone or following their chemotherapy. In this randomized clinical trial the efficacy of Iranian short-acting (PD-Grastim) and long-acting G-CSF (PD-Lasta) were compared in term of time to recovery from neutropenia in de novo AML patients following the consolidation chemotherapy.

Materials and Methods: Patients (n = 51) received one or two courses of Cytarabine and Daunorubicin as an induction. If complete remission was achieved, the treatment was followed by high-dose Cytarabine as consolidation chemotherapy. Twenty- four hours after the consolidation chemotherapy, patient were randomized to receive either daily short-acting G-CSF (PD-Grastim) (300 µg/kg) or single-dose long-acting G-CSF (PDLasta) (6 mg).

Results: The median time to recovery of neutrophils was 11.00 and 13.00 days for short-acting G-CSF (PDGrastim) (n=22) and long-acting G-CSF (PD-Lasta) (n=29) groups, respectively (U=186.5, P>0.05 two-tailed). Incidence of adverse effects was similar in both short-acting G-CSF (PD-Grastim) and long-acting G-CSF (PDLasta) groups.

Conclusion: Overall, data show that Iranian long-acting G-CSF (PD-Lasta) was not significantly different with Iranian short-acting G-CSF (PD-Grastim).