Fixed-dose single administration of Pegfilgrastim vs daily Filgrastim in patients with haematological malignancies undergoing autologous peripheral blood stem cell transplantation

Abstract

Summary:Infectious complications are frequent events in patients undergoing high-dose cytotoxic chemotherapy with subsequent autologous peripheral blood stem cell transplantation (PBSCT). To evaluate whether a single subcutaneous injection of pegfilgrastim (6 mg) is as safe and effective as daily filgrastim (5 lg/kg/day), 60 consecutive autologous stem cell transplantations performed for various haematological malignancies have been analysed. In total, 24 patients undergoing 30 consecutive PBSCT received a single subcutaneous injection of 6 mg pegfilgrastim on day 5 after transplantation and were compared retrospectively with 30 patients receiving 5 lg/kg/day of filgrastim starting from day 7 post transplantation. The mean duration of grade 4 neutropenia in the pegfilgrastim and filgrastim groups was 8.3 and 9.5 days, respectively (P ¼ 0.047). The results of the two groups were not significantly different for incidence of febrile neutropenia and toxicity profile. However, duration of febrile neutropenia (1.6 vs 3.0 days) and total days of fever (1.73 vs 4.1) were different (P ¼ 0.017 and 0.003, respectively), favouring the pegfilgrastim arm. Consequently, a higher incidence of transplants with documented infectious complications associated with the filgrastim group could be observed (56 vs 26%) (P ¼ 0.02). A single injection of pegfilgrastim administered at day 5 post transplant shows comparable safety and efficacy profiles to daily injections of filgrastim. Bone Marrow Transplantation (2005) 35, 889-893.

Single-dose pegfilgrastim is comparable to daily filgrastim in mobilizing peripheral blood stem cells: a case-matched study in patients with lymphoproliferative malignancies

“…In patients with chemotherapy-induced neutropenia, however, a single PEGFIL dose of 6 mg once per cycle has been shown to be as effective as multiple daily doses of FIL 5 μg/kg [8,17]. Similarly, when used after high-dose chemotherapy and ASCT, a single 6-mg dose of PEGFIL given up to 5 days after autografting has been shown to be at least as effective as daily FIL for promoting engraftment [18,19].…”

Optimal use of G-CSF administration after hematopoietic SCT

“…[51][52][53][54] In each of the four studies, the time to neutrophil and plt engraftment, as well as the post-transplant length of stay, was not significantly different between the patients who received pegfilgrastim compared with those who received filgrastim (Table 4). Three of the studies compared the duration of febrile neutropenia.…”

“…Three of the studies compared the duration of febrile neutropenia. 51,53,54 In two of the three studies evaluating the duration of febrile neutropenia, there was no significant difference between pegfilgrastim compared with filgrastim. 51,54 One study, however, showed a significantly shorter duration of febrile neutropenia with pegfilgrastim (1.6 days) compared with filgrastim (3 days).…”

“…In addition, there was no significant difference between the pegfilgrastim and filgrastim groups in the duration of non-prophylactic i.v. antibiotic treatment 53,54 and the post-transplant hospital stay. 51,53,54 These studies show that the use of pegfilgrastim is equally efficacious to filgrastim in patients undergoing autologous PBSCT when various outcomes are considered.…”

“…antibiotic treatment 53,54 and the post-transplant hospital stay. 51,53,54 These studies show that the use of pegfilgrastim is equally efficacious to filgrastim in patients undergoing autologous PBSCT when various outcomes are considered. However, to make it a standard of practice, more RCTs need to be performed for evaluating the efficacy of pegfilgrastim over filgrastim in patients undergoing autologous PBSCT.…”