title: Tbo-Filgrastim versus Filgrastim during Mobilization and Neutrophil Engraftment for Autologous Stem Cell Transplantation.
abstract: There are limited data available supporting the use of the recombinant granulocyte colony-stimulating factor (G-CSF), tbo-filgrastim, rather than traditionally used filgrastim to mobilize peripheral blood stem cells (PBSC) or to accelerate engraftment after autologous stem cell transplantation (ASCT). We sought to compare the efficacy and cost of tbo-filgrastim to filgrastim in these settings. Patients diagnosed with lymphoma or plasma cell disorders undergoing G-CSF mobilization, with or without plerixafor, were included in this retrospective analysis. The primary outcome was total collected CD34(+) cells/kg. Secondary mobilization endpoints included peripheral CD34(+) cells/μL on days 4 and 5 of mobilization, adjunctive use of plerixafor, CD34(+) cells/kg collected on day 5, number of collection days and volumes processed, number of collections reaching 5 million CD34(+) cells/kg, and percent reaching target collection goal in 1 day. Secondary engraftment endpoints included time to neutrophil and platelet engraftment, number of blood product transfusions required before engraftment, events of febrile neutropenia, and length of stay. A total of 185 patients were included in the final analysis. Patients receiving filgrastim (n = 86) collected a median of 5.56 × 10(6) CD34(+) cells/kg, compared with a median of 5.85 × 10(6) CD34(+) cells/kg in the tbo-filgrastim group (n = 99; P = .58). There were no statistically significant differences in all secondary endpoints with the exception of apheresis volumes processed (tbo-filgrastim, 17.0 liters versus filgrastim, 19.7 liters; P < .01) and mean platelet transfusions (tbo-filgrastim, 1.7 units versus filgrastim, 1.4 units; P = .04). In conclusion, tbo-filgrastim demonstrated similar CD34(+) yield compared with filgrastim in mobilization and post-transplantation settings, with no clinically meaningful differences in secondary efficacy and safety endpoints. Furthermore, tbo-filgrastim utilization was associated with cost savings of approximately $1406 per patient utilizing average wholesale price.
authors.affiliation: Adult Blood and Marrow Transplant, Texas Transplant Institute, San Antonio, Texas. Electronic address: mohammed.elayan@mhshealth.com.
authors.forename: Mohammed M
authors.initials: MM
authors.lastname: Elayan
authors.affiliation: Adult Blood and Marrow Transplant, Texas Transplant Institute, San Antonio, Texas; University of Texas College of Pharmacy, Austin, Texas.
authors.forename: Justin G
authors.initials: JG
authors.lastname: Horowitz
authors.affiliation: Adult Blood and Marrow Transplant, Texas Transplant Institute, San Antonio, Texas.
authors.forename: Jose M
authors.initials: JM
authors.lastname: Magraner
authors.affiliation: Adult Blood and Marrow Transplant, Texas Transplant Institute, San Antonio, Texas; Sarah Cannon Blood Cancer Network, Nashville, Tennessee.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Shaughnessy
authors.affiliation: Adult Blood and Marrow Transplant, Texas Transplant Institute, San Antonio, Texas; Sarah Cannon Blood Cancer Network, Nashville, Tennessee.
authors.forename: Carlos
authors.initials: C
authors.lastname: Bachier
mesh_terms: D000328:Adult; D000368:Aged; D018952:Antigens, CD34 / Q000276:immunology; D001596:Benzylamines; D001792:Blood Platelets / Q000166:cytology / Q000187:drug effects / Q000276:immunology; D003362:Cost-Benefit Analysis; D000080027:Cyclams; D005260:Female; D000069585:Filgrastim / Q000031:analogs & derivatives / Q000191:economics / Q000494:pharmacology*; D006085:Graft Survival; D019650:Hematopoietic Stem Cell Mobilization / Q000191:economics* / Q000379:methods; D018380:Hematopoietic Stem Cell Transplantation; D006571:Heterocyclic Compounds / Q000627:therapeutic use; D006801:Humans; D007902:Length of Stay / Q000191:economics; D016393:Lymphoma, B-Cell / Q000191:economics / Q000276:immunology / Q000473:pathology / Q000628:therapy*; D016399:Lymphoma, T-Cell / Q000191:economics / Q000276:immunology / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000191:economics / Q000276:immunology / Q000473:pathology / Q000628:therapy*; D054219:Neoplasms, Plasma Cell / Q000191:economics / Q000276:immunology / Q000473:pathology / Q000628:therapy*; D009504:Neutrophils / Q000166:cytology / Q000187:drug effects / Q000276:immunology; D012189:Retrospective Studies; D014182:Transplantation, Autologous
chemical_list: D018952:Antigens, CD34; D001596:Benzylamines; D000080027:Cyclams; D006571:Heterocyclic Compounds; D000069585:Filgrastim; C088327:plerixafor
keywords: Biosimilar; Engraftment; Granulocyte colony–stimulating factor; Mobilization; Tbo-filgrastim