BIOSIMILARS OF FILGRASTIM HAVE AN EQUIVALENT EFFICACY WHEN USED AFTER PERIPHERAL BLOOD STEM CELL TRANSPLANTATION
(Abstract release date: 05/19/16)
EHA Library. Tempescul A. 06/09/16; 135054; PB2154
Dr. Adrian Tempescul
Contributions
Contributions
Abstract
Abstract: PB2154
Type: Publication Only
Background
The biosimilars of G-CSF are sometimes the object of discussions about their efficiency and their harmlessness compared to historical products. Their use and efficiency for mobilization of the peripheral stem cells ( PBSCH) or the regeneration post-reinjection of these CSP were little studied.
Aims
We wished to compare the efficacy of two products, biosimilars of filgrastim, Ratiograstim® and Zarzio®, compared to the original products in post-autograft stimulation.
Methods
Between February, 2008 and November, 2014, we identified all the patients who underwent autologous stem cell transplantation (ABSCT), in our Sector of Intensive Care, for of a lymphoma or of a multiple myeloma. The patients with lymphoma had a conditioning regimen by standard BEAM chemotherapy meanwhile the patients with myeloma had a high dose Melphalan (HDM) conditioning regimen. The reinjection of the PBSC was made 24 hours after the end of conditioning chemotherapy. All of the patients were stimulated by daily injection of G-SCF from J5 post-transplant until reach 1 giga / L of PNN. We collected the information concerning the times of hospitalization, the results of blood counts, transfusion needs, clinical data and infectious complications. The results) are expressed in median.
Results
We supported 187 patients (114 men and 73 women) for autologous stem cell transplantation (lymphoma/myeloma = 99/88). We treated 51 consecutive patients Neupogen®-Amgen Inc (26 lymphoma and 25 myeloma, respectively), 74 patients Ratiograstim®-Ratiopharm AG (44 lymphoma and 30 myeloma ) and 62 patients Zarzio® Sandoz AG (29 lymphoma and 33 myeloma).Within the patients with lymphoma, length of hospital stay was 22 days (16-64 days) . The median use of filgrastim was for a period of 7.5 days (4-13 days). Cytopenias were deep in CSP post-reinjection with at least 10 days to less than 1 giga / L leukocytes and 13 days to less than 50 giga / L of plates. There was no difference for the results ragardinf the different types of filgrastim. The percent of patients transfused in red cells was 85%, and platelets 99%, without differences between the products. Three patients had bone pain (all under Ratiograstim®). Ten patients transferred into intensive care unit (ICU) because of infectious complications (5 under Zarzio® and 4 under Ratiograstim®). Four patients died within 100 days, two of them were under Neupogen®.Within the patients with myeloma, length of hospital stay was 16 days (13-42 days) and the administration of filgrastim was for period of 7.5 days (1-16 days). Cytopenias lasts for 6 days, under 1 giga / L leukocytes (the minimum of 6 days under Zarzio®, p = 0.03), 0 days under 9 g / dL of hemoglobin (non-significant) and 6 days under 50 giga / L platelets s (more than 7 days within Neupogen®, p = 0.04). The percent of patients transfused in red cells was 26% and in platelet 91%, without differences between the products. Eighteen patients had bone pain (9 under Ratiograstim® and 6 under Neupogen®). Four patients transferred into ICU (2 in Neupogen®). No patients died within 100 days post-autograft.
Conclusion
We compared the efficacy and safety in post-autologous of three G-CSF products, two biosimilars and one originator product. This retrospective analysis shows that for most of the parameters studied, the tree products have similar efficacy and side effects. By analyzing these results we concluded that biosimilars as well as princeps products may be use for stimulation after peripheral blood stem cell transplantation.
Session topic: E-poster
Keyword(s): Autologous bone marrow transplant, Filgrastim
Type: Publication Only
Background
The biosimilars of G-CSF are sometimes the object of discussions about their efficiency and their harmlessness compared to historical products. Their use and efficiency for mobilization of the peripheral stem cells ( PBSCH) or the regeneration post-reinjection of these CSP were little studied.
Aims
We wished to compare the efficacy of two products, biosimilars of filgrastim, Ratiograstim® and Zarzio®, compared to the original products in post-autograft stimulation.
Methods
Between February, 2008 and November, 2014, we identified all the patients who underwent autologous stem cell transplantation (ABSCT), in our Sector of Intensive Care, for of a lymphoma or of a multiple myeloma. The patients with lymphoma had a conditioning regimen by standard BEAM chemotherapy meanwhile the patients with myeloma had a high dose Melphalan (HDM) conditioning regimen. The reinjection of the PBSC was made 24 hours after the end of conditioning chemotherapy. All of the patients were stimulated by daily injection of G-SCF from J5 post-transplant until reach 1 giga / L of PNN. We collected the information concerning the times of hospitalization, the results of blood counts, transfusion needs, clinical data and infectious complications. The results) are expressed in median.
Results
We supported 187 patients (114 men and 73 women) for autologous stem cell transplantation (lymphoma/myeloma = 99/88). We treated 51 consecutive patients Neupogen®-Amgen Inc (26 lymphoma and 25 myeloma, respectively), 74 patients Ratiograstim®-Ratiopharm AG (44 lymphoma and 30 myeloma ) and 62 patients Zarzio® Sandoz AG (29 lymphoma and 33 myeloma).Within the patients with lymphoma, length of hospital stay was 22 days (16-64 days) . The median use of filgrastim was for a period of 7.5 days (4-13 days). Cytopenias were deep in CSP post-reinjection with at least 10 days to less than 1 giga / L leukocytes and 13 days to less than 50 giga / L of plates. There was no difference for the results ragardinf the different types of filgrastim. The percent of patients transfused in red cells was 85%, and platelets 99%, without differences between the products. Three patients had bone pain (all under Ratiograstim®). Ten patients transferred into intensive care unit (ICU) because of infectious complications (5 under Zarzio® and 4 under Ratiograstim®). Four patients died within 100 days, two of them were under Neupogen®.Within the patients with myeloma, length of hospital stay was 16 days (13-42 days) and the administration of filgrastim was for period of 7.5 days (1-16 days). Cytopenias lasts for 6 days, under 1 giga / L leukocytes (the minimum of 6 days under Zarzio®, p = 0.03), 0 days under 9 g / dL of hemoglobin (non-significant) and 6 days under 50 giga / L platelets s (more than 7 days within Neupogen®, p = 0.04). The percent of patients transfused in red cells was 26% and in platelet 91%, without differences between the products. Eighteen patients had bone pain (9 under Ratiograstim® and 6 under Neupogen®). Four patients transferred into ICU (2 in Neupogen®). No patients died within 100 days post-autograft.
Conclusion
We compared the efficacy and safety in post-autologous of three G-CSF products, two biosimilars and one originator product. This retrospective analysis shows that for most of the parameters studied, the tree products have similar efficacy and side effects. By analyzing these results we concluded that biosimilars as well as princeps products may be use for stimulation after peripheral blood stem cell transplantation.
Session topic: E-poster
Keyword(s): Autologous bone marrow transplant, Filgrastim
Abstract: PB2154
Type: Publication Only
Background
The biosimilars of G-CSF are sometimes the object of discussions about their efficiency and their harmlessness compared to historical products. Their use and efficiency for mobilization of the peripheral stem cells ( PBSCH) or the regeneration post-reinjection of these CSP were little studied.
Aims
We wished to compare the efficacy of two products, biosimilars of filgrastim, Ratiograstim® and Zarzio®, compared to the original products in post-autograft stimulation.
Methods
Between February, 2008 and November, 2014, we identified all the patients who underwent autologous stem cell transplantation (ABSCT), in our Sector of Intensive Care, for of a lymphoma or of a multiple myeloma. The patients with lymphoma had a conditioning regimen by standard BEAM chemotherapy meanwhile the patients with myeloma had a high dose Melphalan (HDM) conditioning regimen. The reinjection of the PBSC was made 24 hours after the end of conditioning chemotherapy. All of the patients were stimulated by daily injection of G-SCF from J5 post-transplant until reach 1 giga / L of PNN. We collected the information concerning the times of hospitalization, the results of blood counts, transfusion needs, clinical data and infectious complications. The results) are expressed in median.
Results
We supported 187 patients (114 men and 73 women) for autologous stem cell transplantation (lymphoma/myeloma = 99/88). We treated 51 consecutive patients Neupogen®-Amgen Inc (26 lymphoma and 25 myeloma, respectively), 74 patients Ratiograstim®-Ratiopharm AG (44 lymphoma and 30 myeloma ) and 62 patients Zarzio® Sandoz AG (29 lymphoma and 33 myeloma).Within the patients with lymphoma, length of hospital stay was 22 days (16-64 days) . The median use of filgrastim was for a period of 7.5 days (4-13 days). Cytopenias were deep in CSP post-reinjection with at least 10 days to less than 1 giga / L leukocytes and 13 days to less than 50 giga / L of plates. There was no difference for the results ragardinf the different types of filgrastim. The percent of patients transfused in red cells was 85%, and platelets 99%, without differences between the products. Three patients had bone pain (all under Ratiograstim®). Ten patients transferred into intensive care unit (ICU) because of infectious complications (5 under Zarzio® and 4 under Ratiograstim®). Four patients died within 100 days, two of them were under Neupogen®.Within the patients with myeloma, length of hospital stay was 16 days (13-42 days) and the administration of filgrastim was for period of 7.5 days (1-16 days). Cytopenias lasts for 6 days, under 1 giga / L leukocytes (the minimum of 6 days under Zarzio®, p = 0.03), 0 days under 9 g / dL of hemoglobin (non-significant) and 6 days under 50 giga / L platelets s (more than 7 days within Neupogen®, p = 0.04). The percent of patients transfused in red cells was 26% and in platelet 91%, without differences between the products. Eighteen patients had bone pain (9 under Ratiograstim® and 6 under Neupogen®). Four patients transferred into ICU (2 in Neupogen®). No patients died within 100 days post-autograft.
Conclusion
We compared the efficacy and safety in post-autologous of three G-CSF products, two biosimilars and one originator product. This retrospective analysis shows that for most of the parameters studied, the tree products have similar efficacy and side effects. By analyzing these results we concluded that biosimilars as well as princeps products may be use for stimulation after peripheral blood stem cell transplantation.
Session topic: E-poster
Keyword(s): Autologous bone marrow transplant, Filgrastim
Type: Publication Only
Background
The biosimilars of G-CSF are sometimes the object of discussions about their efficiency and their harmlessness compared to historical products. Their use and efficiency for mobilization of the peripheral stem cells ( PBSCH) or the regeneration post-reinjection of these CSP were little studied.
Aims
We wished to compare the efficacy of two products, biosimilars of filgrastim, Ratiograstim® and Zarzio®, compared to the original products in post-autograft stimulation.
Methods
Between February, 2008 and November, 2014, we identified all the patients who underwent autologous stem cell transplantation (ABSCT), in our Sector of Intensive Care, for of a lymphoma or of a multiple myeloma. The patients with lymphoma had a conditioning regimen by standard BEAM chemotherapy meanwhile the patients with myeloma had a high dose Melphalan (HDM) conditioning regimen. The reinjection of the PBSC was made 24 hours after the end of conditioning chemotherapy. All of the patients were stimulated by daily injection of G-SCF from J5 post-transplant until reach 1 giga / L of PNN. We collected the information concerning the times of hospitalization, the results of blood counts, transfusion needs, clinical data and infectious complications. The results) are expressed in median.
Results
We supported 187 patients (114 men and 73 women) for autologous stem cell transplantation (lymphoma/myeloma = 99/88). We treated 51 consecutive patients Neupogen®-Amgen Inc (26 lymphoma and 25 myeloma, respectively), 74 patients Ratiograstim®-Ratiopharm AG (44 lymphoma and 30 myeloma ) and 62 patients Zarzio® Sandoz AG (29 lymphoma and 33 myeloma).Within the patients with lymphoma, length of hospital stay was 22 days (16-64 days) . The median use of filgrastim was for a period of 7.5 days (4-13 days). Cytopenias were deep in CSP post-reinjection with at least 10 days to less than 1 giga / L leukocytes and 13 days to less than 50 giga / L of plates. There was no difference for the results ragardinf the different types of filgrastim. The percent of patients transfused in red cells was 85%, and platelets 99%, without differences between the products. Three patients had bone pain (all under Ratiograstim®). Ten patients transferred into intensive care unit (ICU) because of infectious complications (5 under Zarzio® and 4 under Ratiograstim®). Four patients died within 100 days, two of them were under Neupogen®.Within the patients with myeloma, length of hospital stay was 16 days (13-42 days) and the administration of filgrastim was for period of 7.5 days (1-16 days). Cytopenias lasts for 6 days, under 1 giga / L leukocytes (the minimum of 6 days under Zarzio®, p = 0.03), 0 days under 9 g / dL of hemoglobin (non-significant) and 6 days under 50 giga / L platelets s (more than 7 days within Neupogen®, p = 0.04). The percent of patients transfused in red cells was 26% and in platelet 91%, without differences between the products. Eighteen patients had bone pain (9 under Ratiograstim® and 6 under Neupogen®). Four patients transferred into ICU (2 in Neupogen®). No patients died within 100 days post-autograft.
Conclusion
We compared the efficacy and safety in post-autologous of three G-CSF products, two biosimilars and one originator product. This retrospective analysis shows that for most of the parameters studied, the tree products have similar efficacy and side effects. By analyzing these results we concluded that biosimilars as well as princeps products may be use for stimulation after peripheral blood stem cell transplantation.
Session topic: E-poster
Keyword(s): Autologous bone marrow transplant, Filgrastim
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