BACKGROUND:Recombinant granulocyte colony-stimulating factor (G-CSF) is widely used to mobilize haematopoietic stem cells. We compared the efficacy and safety of a biosimilar G-CSF (Zarzio(®), Sandoz Biopharmaceuticals) with the originator G-CSF (Neupogen(®), Amgen) in patients with haematological malignancies. METHODS:A total of 108 patients were included in this study, 59 of whom were female (49 male), with an overall median age of 51 years (range 19-69). Patients had multiple myeloma (n=46), non-Hodgkin's lymphoma (n=28), Hodgkin's lymphoma (n=26), or other diagnosis (n=8). After administration of mobilizing regimens (primarily high-dose etoposide, high-dose cyclophosphamide, intermediate-dose Ara-C or ESHAP), patients were randomized to a standard daily 10 μg/kg dose of biosimilar G-CSF (n=54) or originator G-CSF (n=54). RESULTS:Median duration of G-CSF administration was 8 days with both biosimilar G-CSF (range 4-17) and originator G-CSF (range 4-14). Both groups had a median of one apheresis with a median time until first apheresis of 11 days. There were no statistically significant differences between groups in the mean ± SD number of mobilized CD34+ cells/μL in peripheral blood or the number of CD34+ cells/kg body weight. Five patients (9%) in the originator G-CSF group and six patients in the biosimilar G-CSF group (11%) did not mobilize sufficient CD34+ cells. The adverse event profile was similar between groups. CONCLUSIONS: A biosimilar G-CSF (Zarzio(®)) demonstrated similar efficacy and safety as the reference originator G-CSF (Neupogen(®)) in hematopoietic stem cell mobilization in patients with haematological malignancies.
RCT Entities:
BACKGROUND: Recombinant granulocyte colony-stimulating factor (G-CSF) is widely used to mobilize haematopoietic stem cells. We compared the efficacy and safety of a biosimilar G-CSF (Zarzio(®), Sandoz Biopharmaceuticals) with the originator G-CSF (Neupogen(®), Amgen) in patients with haematological malignancies. METHODS: A total of 108 patients were included in this study, 59 of whom were female (49 male), with an overall median age of 51 years (range 19-69). Patients had multiple myeloma (n=46), non-Hodgkin's lymphoma (n=28), Hodgkin's lymphoma (n=26), or other diagnosis (n=8). After administration of mobilizing regimens (primarily high-dose etoposide, high-dose cyclophosphamide, intermediate-dose Ara-C or ESHAP), patients were randomized to a standard daily 10 μg/kg dose of biosimilar G-CSF (n=54) or originator G-CSF (n=54). RESULTS: Median duration of G-CSF administration was 8 days with both biosimilar G-CSF (range 4-17) and originator G-CSF (range 4-14). Both groups had a median of one apheresis with a median time until first apheresis of 11 days. There were no statistically significant differences between groups in the mean ± SD number of mobilized CD34+ cells/μL in peripheral blood or the number of CD34+ cells/kg body weight. Five patients (9%) in the originator G-CSF group and six patients in the biosimilar G-CSF group (11%) did not mobilize sufficient CD34+ cells. The adverse event profile was similar between groups. CONCLUSIONS: A biosimilar G-CSF (Zarzio(®)) demonstrated similar efficacy and safety as the reference originator G-CSF (Neupogen(®)) in hematopoietic stem cell mobilization in patients with haematological malignancies.
Authors: Sadik Husian; Preethi Jeyaraman; S K Gupta; Reeta Rai; Sangeeta Pathak; Nitin Dayal; Rahul Naithani Journal: South Asian J Cancer Date: 2021-09-04