Pegfilgrastim Shows Safety and Efficacy Similar to Filgrastim in Patients Undergoing Autologous Stem Cell Transplantation for Hematological Malignancies.

Abstract

Infectious complications are frequent events in patients undergoing high dose cytotoxic chemotherapy with subsequent autologous hematopoietic stem cell transplantation. In order to determine whether a single subcutaneous injection of pegfilgrastim (6mg) is as safe and effective as daily filgrastim (5mcg/kg/d) for reducing duration of grade 4 neutropenia and infectious complications, 60 consecutive autologous stem cell transplantations (ASCT) performed for various hematological malignancies have been analyzed retrospectively at our institution. 24 patients undergoing 30 consecutive ASCT received a single subcutaneous injection of 6 mg pegfilgrastim on day 5 after transplantation and were compared retrospectively to 30 patients receiving 5mcg/kg/d of filgrastim starting from day 7 post-transplantation. Both patient cohorts were comparable with respect to baseline patient and transplant characteristics. Duration of grade 4 neutropenia, infectious complications including incidence of febrile neutropenia, microbiological surveillance data and safety parameters were assessed. The mean duration of grade 4 neutropenia in the pegfilgrastim and filgrastim groups was 8.3 and 9.5 days, respectively (p=0,058). The results of the two groups were also not significantly different for febrile neutropenia, time to neutrophil recovery and toxicity profile, including bone pain episodes. However, a higher incidence of infectious complications associated with the filgrastim vs the pegfilgrastim group could be observed (50% vs 20%) (p=0,011). Pegfilgrastim was safe and well tolerated in this patient population. A single injection of pegfilgrastim administered at day 5 post-transplant shows comparable safety and efficacy profiles to that provided by daily injections of filgrastim. A fixed-dose pegfilgrastim facilitates the management of aplasia following autologous stem cell transplantation and may offer significant benefits for patients and health care providers. Consequently, it may serve as an attractive alternative to a repetitive single G-CSF administration modus. However, prospective randomized studies are warranted to corroborate the results obtained by this retrospective analysis.