Results of a Randomized Phase II Trial of Pegfilgrastim Versus Filgrastim To Treat Neutropenia Post-Autologous Peripheral Blood Stem Cell Transplant (PBSCT) in Patients with Non-Hodgkin’s Lymphoma (NHL).

Granulocyte colony-stimulating factor has been shown to decrease the time to neutrophil recovery following autologous PBSCT. Therefore, it was hypothesized that a single injection of pegfilgrastim (P) would mimic the role of filgrastim (F), resulting in at least an equivalent shortening of post-PBSCT neutropenia. PBSCT eligible NHL patients over the age of 18 years with preserved end-organ function were identified prior to the administration of high-dose chemotherapy, and following adequate stem cell harvest and cryopreservation (ie, >2.5 x 10⁶ CD34+ cells/kg). All patients received either standard BEAM or BEAC high-dose chemotherapy (HDC). Prior to HDC, patients were randomly assigned to receive either P at a fixed-dose of 6 mg on Day +1(Arm A), or weight-based, dose-adjusted F rounded to the nearest prefilled syringe beginning on Day +1(Arm B) following transplantation. Between July 2003 and April 2007, 101 eligible patients were enrolled within our transplant network. Three patients were deemed ineligible (CHF death, patient withdrew consent, other). The analyses and results presented below outline the remaining 98 patients. The demographic characteristics of both arms were well-balanced with regards to stage at diagnosis, stage at treatment, ECOG Performance Status, histology, and prior therapy. The comparison of P vs F is summarized in the table below. Incidence of Grade 3–4 adverse events were comparable in both arms as was transplant-related mortality. In conclusion, administration of pegfilgrastim post-auto PBSCT appears to be equivalent to multiple daily dosing of filgrastim, and might be considered in lieu of filgrastim obviating the need for multiple injections.