EFFICACY AND SAFETY OF BIOSIMILAR FILGRASTIM (ZARZIO®) AFTER AUTOLOGOUS STEM CELL TRANSPLANT: UPDATE OF A COMPARATIVE STUDY WITH LENOGRASTIM AND PEG-FILGRASTIM
(Abstract release date: 05/19/16)
EHA Library. Marchesi F. 06/09/16; 133089; E1540
Dr. Francesco Marchesi
Contributions
Contributions
Abstract
Abstract: E1540
Type: Eposter Presentation
Background
Biosimilar Granulocyte Colony-Stimulating Factor (G-CSF) has been approved on the basis of comparable quality, safety and efficacy as the originator product. So far, biosimilar Filgrastim Zarzio® has been approved also for autologous peripheral stem cell mobilization and for prophylaxis of sever neutropenia duration following conditioning chemotherapy and stem cell infusion. However, there is still general skepticism about safety and efficacy of Zarzio® in these setting of patients, considering the lack of prospective studies with a long follow-up.
Aims
The aim of the study was to evaluate the efficacy and the safety of Zarzio® when used as hematologic recovery after autologous stem cell transplant (ASCT).
Methods
From March 2013 to November 2015, 114 consecutive adult patients with hematologic malignancies (Plasma cell disorders n=68; Non Hodgkin and Hodgkin's lymphomas n=42; others n=4) underwent ASCT in our Institution. Zarzio® was given at the dosage of 5 mcg/Kg beginning to day 3 from infusion of stem cells and continued until neutrophilis recovery. Hematologic recovery after ASCT was defined as an absolute neutrophilis count upper than 0.5 x 109/L and a platelets count upper than 20 x 109/L in three consecutive checks. This cohort of patients was compared with two historical cohorts of patients in our Institution: a) 99 consecutive adult patients treated with Lenograstim (Myelostim®) at dosage of 5 mcg/Kg daily given from day 3 after infusion from January 2009 to February 2013; b) 60 consecutive adult patients treated with peg-filgrastim (Neulasta®) at dosage of 6 mg single dose at day 3 after infusion from March 2006 to December 2008.
Results
The three patient cohorts were similar for all baseline features analyzed, without any significant differences in terms of sex, median age, diagnosis, median chemotherapy lines prior ASCT, disease status at ASCT, conditioning regimen and median infused CD34+ cells. We analyzed the time of hematologic recovery after stem cell infusion, the occurrence of fever of unknown origin (FUO) in neutropenia, documented infectious episodes and needing of intravenous antibiotics, number of red blood and platelet transfusions, the days of hospitalization and the transplant-related mortality (TRM). The results of the study show a significantly shorter time to neutrophilis and platelet recovery (P=0.001 and P=0.007, respectively) in the cohort of patients treated with Neulasta®, whereas no difference was observed among the other two groups. As for the other analyzed parameters, we didn't observe any significant difference among the three patient cohorts for all the other analyzed parameters. In particular, we did observe a similar incidence of FUO episodes (P=0.102), microbiologically documented infections (P=0.424) and needing of intravenous antibiotics (P=0.612). Moreover, we didn't find any significant differences as for transfusional needing (P=0.099), median hospitalization time (0.102) and TRM (P=0.709). No difference in terms of drug-related adverse events was observed in the three patient cohorts with no reported serious adverse events. Similar results were obtained performing two separate sub-analysis only for lymphoma or myeloma patients.
Conclusion
Despite the limitations due to the non-randomized nature of the study, from our data biosimilar Filgrastim (Zarzio®) seems to be substantially equivalent in terms of efficacy and safety to Lenograstim (Myelostim®) and Peg-Filgrastim (Neulasta®), when used for hematological recovery after ASCT in adult patients with hematologic malignancies.
Session topic: E-poster
Keyword(s): Autograft, Filgrastim, Stem cell transplant
Type: Eposter Presentation
Background
Biosimilar Granulocyte Colony-Stimulating Factor (G-CSF) has been approved on the basis of comparable quality, safety and efficacy as the originator product. So far, biosimilar Filgrastim Zarzio® has been approved also for autologous peripheral stem cell mobilization and for prophylaxis of sever neutropenia duration following conditioning chemotherapy and stem cell infusion. However, there is still general skepticism about safety and efficacy of Zarzio® in these setting of patients, considering the lack of prospective studies with a long follow-up.
Aims
The aim of the study was to evaluate the efficacy and the safety of Zarzio® when used as hematologic recovery after autologous stem cell transplant (ASCT).
Methods
From March 2013 to November 2015, 114 consecutive adult patients with hematologic malignancies (Plasma cell disorders n=68; Non Hodgkin and Hodgkin's lymphomas n=42; others n=4) underwent ASCT in our Institution. Zarzio® was given at the dosage of 5 mcg/Kg beginning to day 3 from infusion of stem cells and continued until neutrophilis recovery. Hematologic recovery after ASCT was defined as an absolute neutrophilis count upper than 0.5 x 109/L and a platelets count upper than 20 x 109/L in three consecutive checks. This cohort of patients was compared with two historical cohorts of patients in our Institution: a) 99 consecutive adult patients treated with Lenograstim (Myelostim®) at dosage of 5 mcg/Kg daily given from day 3 after infusion from January 2009 to February 2013; b) 60 consecutive adult patients treated with peg-filgrastim (Neulasta®) at dosage of 6 mg single dose at day 3 after infusion from March 2006 to December 2008.
Results
The three patient cohorts were similar for all baseline features analyzed, without any significant differences in terms of sex, median age, diagnosis, median chemotherapy lines prior ASCT, disease status at ASCT, conditioning regimen and median infused CD34+ cells. We analyzed the time of hematologic recovery after stem cell infusion, the occurrence of fever of unknown origin (FUO) in neutropenia, documented infectious episodes and needing of intravenous antibiotics, number of red blood and platelet transfusions, the days of hospitalization and the transplant-related mortality (TRM). The results of the study show a significantly shorter time to neutrophilis and platelet recovery (P=0.001 and P=0.007, respectively) in the cohort of patients treated with Neulasta®, whereas no difference was observed among the other two groups. As for the other analyzed parameters, we didn't observe any significant difference among the three patient cohorts for all the other analyzed parameters. In particular, we did observe a similar incidence of FUO episodes (P=0.102), microbiologically documented infections (P=0.424) and needing of intravenous antibiotics (P=0.612). Moreover, we didn't find any significant differences as for transfusional needing (P=0.099), median hospitalization time (0.102) and TRM (P=0.709). No difference in terms of drug-related adverse events was observed in the three patient cohorts with no reported serious adverse events. Similar results were obtained performing two separate sub-analysis only for lymphoma or myeloma patients.
Conclusion
Despite the limitations due to the non-randomized nature of the study, from our data biosimilar Filgrastim (Zarzio®) seems to be substantially equivalent in terms of efficacy and safety to Lenograstim (Myelostim®) and Peg-Filgrastim (Neulasta®), when used for hematological recovery after ASCT in adult patients with hematologic malignancies.
Session topic: E-poster
Keyword(s): Autograft, Filgrastim, Stem cell transplant
Abstract: E1540
Type: Eposter Presentation
Background
Biosimilar Granulocyte Colony-Stimulating Factor (G-CSF) has been approved on the basis of comparable quality, safety and efficacy as the originator product. So far, biosimilar Filgrastim Zarzio® has been approved also for autologous peripheral stem cell mobilization and for prophylaxis of sever neutropenia duration following conditioning chemotherapy and stem cell infusion. However, there is still general skepticism about safety and efficacy of Zarzio® in these setting of patients, considering the lack of prospective studies with a long follow-up.
Aims
The aim of the study was to evaluate the efficacy and the safety of Zarzio® when used as hematologic recovery after autologous stem cell transplant (ASCT).
Methods
From March 2013 to November 2015, 114 consecutive adult patients with hematologic malignancies (Plasma cell disorders n=68; Non Hodgkin and Hodgkin's lymphomas n=42; others n=4) underwent ASCT in our Institution. Zarzio® was given at the dosage of 5 mcg/Kg beginning to day 3 from infusion of stem cells and continued until neutrophilis recovery. Hematologic recovery after ASCT was defined as an absolute neutrophilis count upper than 0.5 x 109/L and a platelets count upper than 20 x 109/L in three consecutive checks. This cohort of patients was compared with two historical cohorts of patients in our Institution: a) 99 consecutive adult patients treated with Lenograstim (Myelostim®) at dosage of 5 mcg/Kg daily given from day 3 after infusion from January 2009 to February 2013; b) 60 consecutive adult patients treated with peg-filgrastim (Neulasta®) at dosage of 6 mg single dose at day 3 after infusion from March 2006 to December 2008.
Results
The three patient cohorts were similar for all baseline features analyzed, without any significant differences in terms of sex, median age, diagnosis, median chemotherapy lines prior ASCT, disease status at ASCT, conditioning regimen and median infused CD34+ cells. We analyzed the time of hematologic recovery after stem cell infusion, the occurrence of fever of unknown origin (FUO) in neutropenia, documented infectious episodes and needing of intravenous antibiotics, number of red blood and platelet transfusions, the days of hospitalization and the transplant-related mortality (TRM). The results of the study show a significantly shorter time to neutrophilis and platelet recovery (P=0.001 and P=0.007, respectively) in the cohort of patients treated with Neulasta®, whereas no difference was observed among the other two groups. As for the other analyzed parameters, we didn't observe any significant difference among the three patient cohorts for all the other analyzed parameters. In particular, we did observe a similar incidence of FUO episodes (P=0.102), microbiologically documented infections (P=0.424) and needing of intravenous antibiotics (P=0.612). Moreover, we didn't find any significant differences as for transfusional needing (P=0.099), median hospitalization time (0.102) and TRM (P=0.709). No difference in terms of drug-related adverse events was observed in the three patient cohorts with no reported serious adverse events. Similar results were obtained performing two separate sub-analysis only for lymphoma or myeloma patients.
Conclusion
Despite the limitations due to the non-randomized nature of the study, from our data biosimilar Filgrastim (Zarzio®) seems to be substantially equivalent in terms of efficacy and safety to Lenograstim (Myelostim®) and Peg-Filgrastim (Neulasta®), when used for hematological recovery after ASCT in adult patients with hematologic malignancies.
Session topic: E-poster
Keyword(s): Autograft, Filgrastim, Stem cell transplant
Type: Eposter Presentation
Background
Biosimilar Granulocyte Colony-Stimulating Factor (G-CSF) has been approved on the basis of comparable quality, safety and efficacy as the originator product. So far, biosimilar Filgrastim Zarzio® has been approved also for autologous peripheral stem cell mobilization and for prophylaxis of sever neutropenia duration following conditioning chemotherapy and stem cell infusion. However, there is still general skepticism about safety and efficacy of Zarzio® in these setting of patients, considering the lack of prospective studies with a long follow-up.
Aims
The aim of the study was to evaluate the efficacy and the safety of Zarzio® when used as hematologic recovery after autologous stem cell transplant (ASCT).
Methods
From March 2013 to November 2015, 114 consecutive adult patients with hematologic malignancies (Plasma cell disorders n=68; Non Hodgkin and Hodgkin's lymphomas n=42; others n=4) underwent ASCT in our Institution. Zarzio® was given at the dosage of 5 mcg/Kg beginning to day 3 from infusion of stem cells and continued until neutrophilis recovery. Hematologic recovery after ASCT was defined as an absolute neutrophilis count upper than 0.5 x 109/L and a platelets count upper than 20 x 109/L in three consecutive checks. This cohort of patients was compared with two historical cohorts of patients in our Institution: a) 99 consecutive adult patients treated with Lenograstim (Myelostim®) at dosage of 5 mcg/Kg daily given from day 3 after infusion from January 2009 to February 2013; b) 60 consecutive adult patients treated with peg-filgrastim (Neulasta®) at dosage of 6 mg single dose at day 3 after infusion from March 2006 to December 2008.
Results
The three patient cohorts were similar for all baseline features analyzed, without any significant differences in terms of sex, median age, diagnosis, median chemotherapy lines prior ASCT, disease status at ASCT, conditioning regimen and median infused CD34+ cells. We analyzed the time of hematologic recovery after stem cell infusion, the occurrence of fever of unknown origin (FUO) in neutropenia, documented infectious episodes and needing of intravenous antibiotics, number of red blood and platelet transfusions, the days of hospitalization and the transplant-related mortality (TRM). The results of the study show a significantly shorter time to neutrophilis and platelet recovery (P=0.001 and P=0.007, respectively) in the cohort of patients treated with Neulasta®, whereas no difference was observed among the other two groups. As for the other analyzed parameters, we didn't observe any significant difference among the three patient cohorts for all the other analyzed parameters. In particular, we did observe a similar incidence of FUO episodes (P=0.102), microbiologically documented infections (P=0.424) and needing of intravenous antibiotics (P=0.612). Moreover, we didn't find any significant differences as for transfusional needing (P=0.099), median hospitalization time (0.102) and TRM (P=0.709). No difference in terms of drug-related adverse events was observed in the three patient cohorts with no reported serious adverse events. Similar results were obtained performing two separate sub-analysis only for lymphoma or myeloma patients.
Conclusion
Despite the limitations due to the non-randomized nature of the study, from our data biosimilar Filgrastim (Zarzio®) seems to be substantially equivalent in terms of efficacy and safety to Lenograstim (Myelostim®) and Peg-Filgrastim (Neulasta®), when used for hematological recovery after ASCT in adult patients with hematologic malignancies.
Session topic: E-poster
Keyword(s): Autograft, Filgrastim, Stem cell transplant
{{ help_message }}
{{filter}}