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.
Subject(s)
Filgrastim/pharmacology , Hematopoietic Stem Cell Mobilization/economics , Hematopoietic Stem Cell Transplantation , Lymphoma, B-Cell/therapy , Lymphoma, T-Cell/therapy , Multiple Myeloma/therapy , Neoplasms, Plasma Cell/therapy , Adult , Aged , Antigens, CD34/immunology , Benzylamines , Blood Platelets/cytology , Blood Platelets/drug effects , Blood Platelets/immunology , Cost-Benefit Analysis , Cyclams , Female , Filgrastim/analogs & derivatives , Filgrastim/economics , Graft Survival , Hematopoietic Stem Cell Mobilization/methods , Heterocyclic Compounds/therapeutic use , Humans , Length of Stay/economics , Lymphoma, B-Cell/economics , Lymphoma, B-Cell/immunology , Lymphoma, B-Cell/pathology , Lymphoma, T-Cell/economics , Lymphoma, T-Cell/immunology , Lymphoma, T-Cell/pathology , Male , Middle Aged , Multiple Myeloma/economics , Multiple Myeloma/immunology , Multiple Myeloma/pathology , Neoplasms, Plasma Cell/economics , Neoplasms, Plasma Cell/immunology , Neoplasms, Plasma Cell/pathology , Neutrophils/cytology , Neutrophils/drug effects , Neutrophils/immunology , Retrospective Studies , Transplantation, AutologousABSTRACT
Sipuleucel-T is a therapeutic cancer vaccine approved for the treatment of castration- or hormone-refractory prostate cancer. Through a novel process, it activates the body's own antigen-presenting cells to induce an immune response to prostatic acid phosphatase, a protein found on prostate cancer cells. A treatment course consists of three total infusions spread 2 weeks apart. Throughout all phases of clinical trials, sipuleucel-T has been shown to be safe and well tolerated. Sipuleucel-T has demonstrated an ability to increase overall survival by approximately 4 months when compared with placebo. However, sipuleucel-T has not shown any improvement in affecting patients' time to disease progression.
