Biosimilar granulocyte colony-stimulating factor is effective in reducing the duration of neutropenia after autologous peripheral blood stem cell transplantation.
BACKGROUND
Autologous peripheral blood stem cell transplantation (APBSCT) is the standard of therapy for patients with multiple myeloma and refractory Hodgkin's and non-Hodgkin's lymphomas. Granulocyte colony-stimulating factor (G-CSF) is widely used to accelerate hematopoietic recovery after transplantation and to reduce the morbidity and mortality associated with prolonged neutropenia. Biosimilar G-CSF is approved for the same indications as the originator G-CSF. This is one of the first reported uses of a biosimilar G-CSF for neutrophil recovery after APBSCT.


METHODS
A total of 23 consecutive patients with hematological malignancy (multiple myeloma, Hodgkin's and non-Hodgkin's lymphomas, and acute myelogenous leukemia) were recruited at the Department of Haematooncology and Bone Marrow Transplantation at the Medical University of Lublin. Patients (12 men and 11 women; median age, 47 ± 13 years) received biosimilar G-CSF (Zarzio, Sandoz Biopharmaceuticals) after myeloablative chemotherapy (primarily BiCnU, etoposide, cytarabine, and melphalan or melphalan 140/200 mg/m(2)) followed by PBSCT. The median number of transplanted CD34+ cells was 4.2 ± 0.8 × 10(6)/kg body wt. G-CSF therapy was started when absolute neutrophil count (ANC) was <0.5 × 10(9)/L and was continued until ANC reached >1.5 × 10(9)/L for 3 consecutive days. Hematopoietic recovery parameters were compared with those in the control group, which consisted of 23 consecutive patients transplanted in the period before the biosimilar G-CSF group and receiving originator G-CSF (Neupogen, Amgen).


RESULTS
The mean duration of treatment with biosimilar and originator G-CSF was 14.4 ± 5.1 and 18.6 ± 11.5 days, respectively (P = .43). The adverse event profile was comparable between the biosimilar G-CSF and originator G-CSF groups, with similar occurrence of neutropenic fever (5 versus 6 patients) and bone pain (7 patients in each group). One patient in the biosimilar group had neutropenic enterocolitis and sepsis. There was no case of death in either group. Granulocyte recovery in the study group was as follows: mean days to ANC >0.5 × 10(9)/L was 13.0 ± 4.0 days; to ANC >1.5 × 10(9)/L, 13.6 ± 4.5 days; and to ANC >1.5 × 10(9)/L, 14.0 ± 4.7 days. Mean duration until platelet recovery >20 × 10(9)/L was 16.1 ± 4.4 days. There were no statistically significant differences between the biosimilar and originator G-CSF groups in hematopoietic recovery parameters.


CONCLUSIONS
Biosimilar G-CSF is safe and effective in reducing the duration of neutropenia in patients undergoing myeloablative therapy followed by APBSCT and probably in cost savings in transplantation budgets.
Department of Haematooncology and Bone Marrow Transplantation, Medical University in Lublin, Lublin, Poland. Electronic address: hematologia_lublin@wp.pl.
M
M
Cioch
Department of Haematooncology and Bone Marrow Transplantation, Medical University in Lublin, Lublin, Poland.
D
D
Jawniak
Department of Haematooncology and Bone Marrow Transplantation, Medical University in Lublin, Lublin, Poland.
K
K
Kotwica
Department of Haematooncology and Bone Marrow Transplantation, Medical University in Lublin, Lublin, Poland.
M
M
Wach
Department of Haematooncology and Bone Marrow Transplantation, Medical University in Lublin, Lublin, Poland.
J
J
Mańko
Department of Haematooncology and Bone Marrow Transplantation, Medical University in Lublin, Lublin, Poland.
A
A
Gorący
Department of Haematooncology and Bone Marrow Transplantation, Medical University in Lublin, Lublin, Poland.
P
P
Klimek
Department of Haematooncology and Bone Marrow Transplantation, Medical University in Lublin, Lublin, Poland.
E
E
Mazurkiewicz
Department of Haematooncology and Bone Marrow Transplantation, Medical University in Lublin, Lublin, Poland.
P
P
Jarosz
Department of Haematooncology and Bone Marrow Transplantation, Medical University in Lublin, Lublin, Poland.
M
M
Hus
D000328:Adult; D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D002330:Carmustine / Q000627:therapeutic use; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D019337:Hematologic Neoplasms / Q000188:drug therapy* / Q000601:surgery*; D006689:Hodgkin Disease / Q000188:drug therapy / Q000601:surgery; D006801:Humans; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy / Q000601:surgery / Q000628:therapy; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy / Q000601:surgery; D009503:Neutropenia / Q000188:drug therapy / Q000517:prevention & control; D036102:Peripheral Blood Stem Cell Transplantation; D011994:Recombinant Proteins; D014182:Transplantation, Autologous
D059451:Biosimilar Pharmaceuticals; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim; D002330:Carmustine