BIOSIMILARS OF FILGRASTIM ? ZARZIO
(Abstract release date: 05/19/16)
EHA Library. Tempescul A. 06/09/16; 134748; PB1848
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Dr. Adrian Tempescul
Contributions
Contributions
Abstract
Abstract: PB1848
Type: Publication Only
Background
he biosimilars of G-CSF are the object of debates on their efficiency and their harmlessness princeps medicine. Their use and efficiency for mobilization of the peripheral stem cells ( CSP) were less studied. Even less informations are available on the association of biosimilars and Plerixafor in view of the peripheral stem cells harvest in patients defined as hard to mobilize. .
Aims
We present our experience on the association of Zarzio ®-Plerixafor for mobilization of lymphoma patients, define as hard to mobilize, with the aim of obtaining of a sufficient graft for an autologous stem cell transplantation
Methods
Between January, 2012 and December, 2014, we identified 18 patients, 9 mens and 9 women with an average age of 53 years (22 - 69 years) which benefited from a harvest of the peripheral stem cells at University hospital Brest, France. The patients underwent stimulation by Zarzio ® 30MUI two injections a day, during 5 days (D-4 has D0) and Plerixafor 0.24mg / kg starting at day 0 J0. The stimulation was pursued until the obtaining of a sufficient graft (defined as more than 2.5 millions CD34 + / kg) or for a maximum of 3 consecutive days.
We collected for the patients the number of aphaeresis per patient and the number of the CD34 + cells harvested by aphaeresis and by patient
Results
All in all we have made 39 aphaeresis in 18 patients that underwent a double stimulation. The average number of aphaeresis per patient was of 2.16 sessions (1-3 / patient). Two patients benefited from a single session of aphaeresis, eleven patients benefited from two sessions of aphaeresis and five patients of three sessions of aphaeresis.
For twelve of eighteen patients (66.7 %) we achieved the target of a sufficient graft according to the local consensus (2.5 x10 6 CD34 + / kg). For 14 of 18 patients (77.8 %) there was a sufficient according to the recommendations EBMT (2 x 10 6 CD34 + cells / kg ) on the minimum necessity has the autograft.
The average number of CD34 + taken by aphaeresis was 1.58 x 10 6 cells / kg (0.22 - 6.31 x 10 6 CD34 + cells / kg). The total average number of the CD34 + cells harvested per patient was 3.41 x 10 6 / kg (1.5 - 6.77 x 10 6 CD34 + cells / kg).
Conclusion
We analyzed in a cohort of 18 lymphoma patients defined as hard to mobilize the results of the peripheral stem cell harvest obtained after stimulation by plerixafor associate to a biosimilar of filgrastim - Zarzio ®. We obtained a sufficient graft in 77% according to international recommendation with a limited number of aphaeresis procedure – 2.1 aphaeresis per patient.The results obtained by associating Zarzio® and Plerixafor for peripheral stem cell harvest in lymphoma patients defined as hard to mobilize are comparable with those obtained with products princeps and publish in the literature
Session topic: E-poster
Keyword(s): Stem cell collection
Type: Publication Only
Background
he biosimilars of G-CSF are the object of debates on their efficiency and their harmlessness princeps medicine. Their use and efficiency for mobilization of the peripheral stem cells ( CSP) were less studied. Even less informations are available on the association of biosimilars and Plerixafor in view of the peripheral stem cells harvest in patients defined as hard to mobilize. .
Aims
We present our experience on the association of Zarzio ®-Plerixafor for mobilization of lymphoma patients, define as hard to mobilize, with the aim of obtaining of a sufficient graft for an autologous stem cell transplantation
Methods
Between January, 2012 and December, 2014, we identified 18 patients, 9 mens and 9 women with an average age of 53 years (22 - 69 years) which benefited from a harvest of the peripheral stem cells at University hospital Brest, France. The patients underwent stimulation by Zarzio ® 30MUI two injections a day, during 5 days (D-4 has D0) and Plerixafor 0.24mg / kg starting at day 0 J0. The stimulation was pursued until the obtaining of a sufficient graft (defined as more than 2.5 millions CD34 + / kg) or for a maximum of 3 consecutive days.
We collected for the patients the number of aphaeresis per patient and the number of the CD34 + cells harvested by aphaeresis and by patient
Results
All in all we have made 39 aphaeresis in 18 patients that underwent a double stimulation. The average number of aphaeresis per patient was of 2.16 sessions (1-3 / patient). Two patients benefited from a single session of aphaeresis, eleven patients benefited from two sessions of aphaeresis and five patients of three sessions of aphaeresis.
For twelve of eighteen patients (66.7 %) we achieved the target of a sufficient graft according to the local consensus (2.5 x10 6 CD34 + / kg). For 14 of 18 patients (77.8 %) there was a sufficient according to the recommendations EBMT (2 x 10 6 CD34 + cells / kg ) on the minimum necessity has the autograft.
The average number of CD34 + taken by aphaeresis was 1.58 x 10 6 cells / kg (0.22 - 6.31 x 10 6 CD34 + cells / kg). The total average number of the CD34 + cells harvested per patient was 3.41 x 10 6 / kg (1.5 - 6.77 x 10 6 CD34 + cells / kg).
Conclusion
We analyzed in a cohort of 18 lymphoma patients defined as hard to mobilize the results of the peripheral stem cell harvest obtained after stimulation by plerixafor associate to a biosimilar of filgrastim - Zarzio ®. We obtained a sufficient graft in 77% according to international recommendation with a limited number of aphaeresis procedure – 2.1 aphaeresis per patient.The results obtained by associating Zarzio® and Plerixafor for peripheral stem cell harvest in lymphoma patients defined as hard to mobilize are comparable with those obtained with products princeps and publish in the literature
Session topic: E-poster
Keyword(s): Stem cell collection
Abstract: PB1848
Type: Publication Only
Background
he biosimilars of G-CSF are the object of debates on their efficiency and their harmlessness princeps medicine. Their use and efficiency for mobilization of the peripheral stem cells ( CSP) were less studied. Even less informations are available on the association of biosimilars and Plerixafor in view of the peripheral stem cells harvest in patients defined as hard to mobilize. .
Aims
We present our experience on the association of Zarzio ®-Plerixafor for mobilization of lymphoma patients, define as hard to mobilize, with the aim of obtaining of a sufficient graft for an autologous stem cell transplantation
Methods
Between January, 2012 and December, 2014, we identified 18 patients, 9 mens and 9 women with an average age of 53 years (22 - 69 years) which benefited from a harvest of the peripheral stem cells at University hospital Brest, France. The patients underwent stimulation by Zarzio ® 30MUI two injections a day, during 5 days (D-4 has D0) and Plerixafor 0.24mg / kg starting at day 0 J0. The stimulation was pursued until the obtaining of a sufficient graft (defined as more than 2.5 millions CD34 + / kg) or for a maximum of 3 consecutive days.
We collected for the patients the number of aphaeresis per patient and the number of the CD34 + cells harvested by aphaeresis and by patient
Results
All in all we have made 39 aphaeresis in 18 patients that underwent a double stimulation. The average number of aphaeresis per patient was of 2.16 sessions (1-3 / patient). Two patients benefited from a single session of aphaeresis, eleven patients benefited from two sessions of aphaeresis and five patients of three sessions of aphaeresis.
For twelve of eighteen patients (66.7 %) we achieved the target of a sufficient graft according to the local consensus (2.5 x10 6 CD34 + / kg). For 14 of 18 patients (77.8 %) there was a sufficient according to the recommendations EBMT (2 x 10 6 CD34 + cells / kg ) on the minimum necessity has the autograft.
The average number of CD34 + taken by aphaeresis was 1.58 x 10 6 cells / kg (0.22 - 6.31 x 10 6 CD34 + cells / kg). The total average number of the CD34 + cells harvested per patient was 3.41 x 10 6 / kg (1.5 - 6.77 x 10 6 CD34 + cells / kg).
Conclusion
We analyzed in a cohort of 18 lymphoma patients defined as hard to mobilize the results of the peripheral stem cell harvest obtained after stimulation by plerixafor associate to a biosimilar of filgrastim - Zarzio ®. We obtained a sufficient graft in 77% according to international recommendation with a limited number of aphaeresis procedure – 2.1 aphaeresis per patient.The results obtained by associating Zarzio® and Plerixafor for peripheral stem cell harvest in lymphoma patients defined as hard to mobilize are comparable with those obtained with products princeps and publish in the literature
Session topic: E-poster
Keyword(s): Stem cell collection
Type: Publication Only
Background
he biosimilars of G-CSF are the object of debates on their efficiency and their harmlessness princeps medicine. Their use and efficiency for mobilization of the peripheral stem cells ( CSP) were less studied. Even less informations are available on the association of biosimilars and Plerixafor in view of the peripheral stem cells harvest in patients defined as hard to mobilize. .
Aims
We present our experience on the association of Zarzio ®-Plerixafor for mobilization of lymphoma patients, define as hard to mobilize, with the aim of obtaining of a sufficient graft for an autologous stem cell transplantation
Methods
Between January, 2012 and December, 2014, we identified 18 patients, 9 mens and 9 women with an average age of 53 years (22 - 69 years) which benefited from a harvest of the peripheral stem cells at University hospital Brest, France. The patients underwent stimulation by Zarzio ® 30MUI two injections a day, during 5 days (D-4 has D0) and Plerixafor 0.24mg / kg starting at day 0 J0. The stimulation was pursued until the obtaining of a sufficient graft (defined as more than 2.5 millions CD34 + / kg) or for a maximum of 3 consecutive days.
We collected for the patients the number of aphaeresis per patient and the number of the CD34 + cells harvested by aphaeresis and by patient
Results
All in all we have made 39 aphaeresis in 18 patients that underwent a double stimulation. The average number of aphaeresis per patient was of 2.16 sessions (1-3 / patient). Two patients benefited from a single session of aphaeresis, eleven patients benefited from two sessions of aphaeresis and five patients of three sessions of aphaeresis.
For twelve of eighteen patients (66.7 %) we achieved the target of a sufficient graft according to the local consensus (2.5 x10 6 CD34 + / kg). For 14 of 18 patients (77.8 %) there was a sufficient according to the recommendations EBMT (2 x 10 6 CD34 + cells / kg ) on the minimum necessity has the autograft.
The average number of CD34 + taken by aphaeresis was 1.58 x 10 6 cells / kg (0.22 - 6.31 x 10 6 CD34 + cells / kg). The total average number of the CD34 + cells harvested per patient was 3.41 x 10 6 / kg (1.5 - 6.77 x 10 6 CD34 + cells / kg).
Conclusion
We analyzed in a cohort of 18 lymphoma patients defined as hard to mobilize the results of the peripheral stem cell harvest obtained after stimulation by plerixafor associate to a biosimilar of filgrastim - Zarzio ®. We obtained a sufficient graft in 77% according to international recommendation with a limited number of aphaeresis procedure – 2.1 aphaeresis per patient.The results obtained by associating Zarzio® and Plerixafor for peripheral stem cell harvest in lymphoma patients defined as hard to mobilize are comparable with those obtained with products princeps and publish in the literature
Session topic: E-poster
Keyword(s): Stem cell collection
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