RESUMEN
Autologous stem cell transplantation (ASCT), supported by high-dose chemotherapy, is the prevalent option for multiple myeloma (MM) treatment in candidates suitable for transplantation. Although granulocyte colony-stimulating factor (G-CSF) supported cyclophosphamide (CY) is used as the pre-ASCT mobilization regimen, there is no consensus on the optimal dosage of CY. Thus, in this study, we examined the results of 47 MM patients, who underwent ASCT after mobilization with intermediate (ID) or low-dose (LD) CY treatment supported with G-CSF. As the mobilization regimen, we used ID (2.4 g/m2) of CY in 22 patients, and LD (1 g/m2) of CY in 25 patients. Adequate doses of CD34+ cells were collected in both groups. At the same time, febrile neutropenia was observed to be less common in patients in the LD-CY group. Additionaly 96% of patients in LD-CY group did not need to be hospitalized during the mobilization. In conclusion, we think that mobilization with LD-CY and G-CSF is advantageous since it results in a sufficient amount of stem cells in addition to being advantageous in terms of patient safety and cost.
Asunto(s)
Ciclofosfamida/uso terapéutico , Factor Estimulante de Colonias de Granulocitos/uso terapéutico , Movilización de Célula Madre Hematopoyética/métodos , Mieloma Múltiple/tratamiento farmacológico , Anciano , Ciclofosfamida/farmacología , Femenino , Factor Estimulante de Colonias de Granulocitos/farmacología , Humanos , Masculino , Persona de Mediana Edad , Mieloma Múltiple/patologíaRESUMEN
OBJECTIVES AND AIM: In this study, we aimed to compare the potency of different G-CSF agents including original filgrastim (Neupogen®), biosimilar filgrastim (Leucostim®) and Lenograstim (Granocyte®) on CD34(+) cell mobilization in patients that underwent allogeneic hematopoietic stem cell transplantation (alloHSCT). PATIENTS AND METHODS: The data of 243 donors for alloHSCT recipients diagnosed with mostly acute leukemia and myelodsyplastic syndromes (MDS) were analyzed, retrospectively. Data for stem cell mobilization have been recorded from patients' files. Donors who received Filgrastim (Neupogen®, Group I), biosimilar Filgrastim (Leucostim®, Group II) and Lenograstim (Granocyte®, Group III) were analyzed for total CD34(+) cell count at the end of mobilization procedures. RESULTS: A total of 243 donors and patients for alloHSCT were analyzed retrospectively. The diagnosis of the patients were; acute myeloid leukemia (AML) (110 patients, 45.2%), acute lymphoid leukemia (ALL) (61 patients, 25.1%), aplastic anemia (AA) (38 patients, 15.6%), lymphomas (14 patients, 5.7%) and others (20 patients, 8.4%). The median number of total collected PB CD34(+) cells (×10(6)/kg) was 7.12 (min-max: 5.38-7.90) in the Neupogen® group, 7.27 (min-max: 6.79-7.55) in the Leucostim® group and 7.15 (min-max: 5.34-7.58) in the Granocyte® group. There was no statistically significant difference among groups in terms of total collected PB CD34(+) cells (p = 0.919). The median doses of G-CSF agents (µg/kg/day) in PBSC collection in Neupogen® group was; 11.00 (10.00-12.00) in Leucostim® group10.35 (min-max: 10.00-11.10) and in Granocyte® group11.00 (min-max: 10.00-11.00). There was no statistical significance among groups (p = 0.215). CONCLUSION: Biosimilar filgrastim (Leucostim®) was found comparable to original Filgrastim (Neupogen®) and Lenograstim (Granocyte®) for PBSC mobilization in donors of the patients that underwent alloHSCT.
Asunto(s)
Biosimilares Farmacéuticos/administración & dosificación , Filgrastim/administración & dosificación , Factor Estimulante de Colonias de Granulocitos/administración & dosificación , Neoplasias Hematológicas/terapia , Movilización de Célula Madre Hematopoyética/métodos , Trasplante de Células Madre de Sangre Periférica , Donante no Emparentado , Adulto , Aloinjertos , Biosimilares Farmacéuticos/efectos adversos , Femenino , Filgrastim/efectos adversos , Factor Estimulante de Colonias de Granulocitos/efectos adversos , Movilización de Célula Madre Hematopoyética/efectos adversos , Humanos , Lenograstim , Masculino , Proteínas Recombinantes/administración & dosificación , Proteínas Recombinantes/efectos adversosRESUMEN
OBJECTIVES AND AIM: Patients affected by hematological malignancies can often benefit from high dose chemotherapy followed by peripheral blood stem cells (PBSCs) transplantation. Different strategies have been used to mobilize an adequate number of PBSC, including granulocyte colony-stimulating factor (G-CSF) alone or chemotherapy plus G-CSF. In this study, we aimed to compare the efficacy profile of different G-CSF agents including filgrastim (Neupogen®), biosimilar filgrastim (Leucostim®) and Lenograstim (Granocyte®) on CD34(+) mobilization in patients who underwent autologous hematopoietic stem cell transplantation (autoHSCT). MATERIALS AND METHODS: We retrospectively analysed data of patients who underwent autoHSCT diagnosed with multiple myeloma (MM), Hodgkin Lymphoma (HL), non-Hodgkin Lymphoma (NHL) and others. Data for stem cell mobilization has been obtained from patients' files. Patients who received Filgrastim (Neupogen®), biosimilar Filgrastim (Leucostim®, Group) and Lenograstim (Granocyte®) were evaluated mainly for total CD34(+) cell count at the end of mobilization procedure. RESULTS: A total of 96 patients who underwent autoHSCT were retrospectively analyzed. 27 (28.2%) of the patients were female, and 69 (71.8%) were male. The diagnosis of the patients were; multiple myeloma (39 patients, 40.6%), Hodgkin Lyphoma (23 patients, 23.9%), non-Hodgkin lymphoma (16 patients, 16.6%), and others (18 patients, 18.9%). The median number of leukapheresis cycle necessary to harvest a minimal count of 3×10(6) CD34(+)/kg was 2 in Neupogen® (min-max: 1-4) and Granocyte® (min-max: 1-3) groups and 1 (min-max: 1-2) in Leucostim® group. The median doses of G-CSF agents (µg/kg/day) in PBSC collection procedure were; 10.00 (min-max: 7.00-12.00) in the Neupogen® group, 8.00 (min-max: 7.25-9.00) in the Leucostim® group and 8.50 (6.00-9.50) in the Granocyte® group. There was no statistical significance among groups (p=0.067). The number of total collected PB CD34(+) cells (×10(6)/kg) was 7.64 (min-max: 4.09-13.86) in the Neupogen® group, 13.43 (min-max: 8.15-23.38) in the Leucostim® group and 5.45 (min-max: 4.28-9.40) in the Granocyte® group. The data showed that patients in the leucostim group had significantly higher PB CD34(+) cells compared to patients in the Granocyte® group (p=0.013). CONCLUSION: Leucostim® was comparable to Neupogen® for PBSC mobilization in patients who underwent autoHSCT.