Peripheral blood stem cell mobilization with pegfilgrastim compared to filgrastim in children and young adults with malignancies

Abstract

Group 2 data show that stem cell mobilization with Pegfilgrastim in children when performed during primary or without previous long lasting chemotherapy seems to produce earlier CD34+ peaks and better CD34+ yields than in Group 1. CD34+ cell mobilization with Pegfilgrastim in Group 3-patients with previous long lasting chemotherapy was possible.

A Phase II study on the safety and efficacy of a single dose of pegfilgrastim for mobilization and transplantation of autologous hematopoietic stem cells in pediatric oncohematology patients

“…The potential mobilizing capacity of higher doses of pegfilgrastim remains an open question: on the one hand, the proof of this concept was demonstrated for filgrastim in two prospective studies in which higher doses, that is, 10 µg/kg versus 5 µg/kg and 16 µg/kg versus 8 µg/kg, resulted in improved CD34+ yields; on the other hand, a randomized prospective study in patients affected by non‐Hodgkin's lymphoma did not find any significant difference in using a dose of 6 or 12 mg of pegfilgrastim compared to 5 µg/kg filgrastim 25‐27 . A recent study by Fritsch and colleagues, 21 on a limited number of pediatric patients with newly diagnosed malignancies, reported that the use of 200 µg/kg pegfilgrastim produces an earlier CD34+ peak, a higher CD34+ yield, and fewer days of leukapheresis to achieve the target CD34+ dose than 10 µg/kg filgrastim, while no adverse effects were observed except for leukocytosis. Merlin and coworkers 20 assessed a dose of 300 µg/kg pegfilgrastim as the sole mobilizing agent in hematologic steady state in 26 pediatric patients affected by solid tumors.…”

“…Pegfilgrastim is not licensed for pediatric use, but several retrospective and prospective Phase II to III, single‐center studies have recently shown that its efficacy and safety in reducing severe neutropenia after chemotherapy is comparable to filgrastim 12‐18 . Limited data are available on the use of pegfilgrastim in pediatric patients as a mobilizing agent in association with chemotherapy, the studies being mainly single‐center experience and differing in the dose and mobilization schemes used 19‐21 . We report the results of a prospective, multicenter, Phase II study that evaluated the safety and efficacy of a single‐dose of 100 µg/kg pegfilgrastim in mobilizing PBSCs in pediatric patients who were candidates for autologous PBSC transplantation.…”

A Randomized, Non-Inferiority Study Comparing Efficacy and Safety of a Single Dose of Pegfilgrastim versus Daily Filgrastim in Pediatric Patients after Autologous Peripheral Blood Stem Cell Transplant

“…Interestingly, the analysis of costs in 2 randomized trials, one single-centre, double-blind, placebo-controlled, and one multicenter, open-label, showed that the use of pegfilgrastim was less expensive than filgrastim [22],[23]. Pegfilgrastim is still off-label for pediatric patients despite several authors having documented its efficacy and safety for prophylaxis of febrile neutropenia post-chemotherapy and as the mobilizing agent for peripheral blood stem cell collection [6]–[10],[12]–[15],[34]. No data have been published so far on the role of pegfilgrastim as a supportive agent after pediatric autologous HSCT.…”

“…Both drugs were administered beginning from day +3 after PBSC infusion. The doses of pegfilgrastim and filgrastim, and timing of their administration, were chosen on the basis of previous pediatric studies regarding the off-label use of pegfilgrastim for stem cell mobilization or prophylaxis of severe neutropenia after chemotherapy and the use of filgrastim after autologous stem cell transplantation [6]–[9],[10]–[15]. The secondary endpoints were the time to platelet engraftment, the incidence and severity of mucositis according to World Health Organization (WHO) score, the incidence of febrile neutropenia and proven infection, the duration of parenteral nutrition and intravenous antibiotic therapy, the duration of hospitalization, and overall survival.…”

Peripheral Blood Progenitor Cell Mobilization for Autologous and Allogeneic Hematopoietic Cell Transplantation: Guidelines from the American Society for Blood and Marrow Transplantation

“…For chemotherapy plus growth factor mobilization, both filgrastim and pegfilgrastim have been studied. Although reports indicate similar efficacy and side effect profiles for both, filgrastim is generally used [61][62][63].…”