79: Pegfilgrastim (P) Appears to be Equivalent to Multiple Daily Doses of Filgrastim (F) to Treat Neutropenia Post-Autologous Peripheral Blood Stem Cell Transplant (PBSCT) in Patients with Non-Hodgkin's Lymphoma: Results of a Randomized Phase II Trial

Abstract

Filgrastim has previously 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.NHL patients over the age of 18 years who were deemed eligible for PBSCT were identified prior to the administration of high-dose chemotherapy, and following adequate harvest and cryopreservation of peripheral blood progenitor cells (ie, > 2.5 × 106 CD34+ cells/kg). Eligible patients with preserved end organ function received either standard BEAM or BEAC high-dose chemotherapy. Prior to high-dose therapy, 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.One-hundred one eligible patients were enrolled within US Oncology Transplant Network between July 2003 and April 2007. Three patients were deemed ineligible (CHF death, consent withdrawn, other). The analyses and results presented below outline the remaining 98. The demographic characteristics of both arms were well-balanced with regards to stage at diagnosis and treatment, ECOG Performance Status, histology, and lines of prior therapy. The comparison of P vs F is summarized in the table that follows.Transplant-related mortality and the incidence of Grade 3–4 adverse events were comparable in both arms.Tabled 1Comparison of Pegfilgrastim (P) versus Filgrastim (F)VariableArm A (Pegfilgrastim)Arm B (Filgrastim)No. of Patients Treated (n)5048Doses Received (mean ± SD)1.0 ± 012.7 ± 2.6ANC Recovery (days) (mean ± SD)8.3 ± 1.18.9 ± 1.5RBC Transfusions (mean ± SD)1.7 ± 0.91.9 ± 1.2Platelet Transfusions (mean ± SD)3.0 ± 1.92.8 ± 1.8Positive Blood Culture Rate (%)18.0%29.0%Febrile Neutropenia Rate (FN) (%)18.0%16.7%Duration of FN (days) (mean ± SD)5.1 ± 3.45.5 ± 4.9 Open table in a new tab Filgrastim has previously 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. NHL patients over the age of 18 years who were deemed eligible for PBSCT were identified prior to the administration of high-dose chemotherapy, and following adequate harvest and cryopreservation of peripheral blood progenitor cells (ie, > 2.5 × 106 CD34+ cells/kg). Eligible patients with preserved end organ function received either standard BEAM or BEAC high-dose chemotherapy. Prior to high-dose therapy, 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. One-hundred one eligible patients were enrolled within US Oncology Transplant Network between July 2003 and April 2007. Three patients were deemed ineligible (CHF death, consent withdrawn, other). The analyses and results presented below outline the remaining 98. The demographic characteristics of both arms were well-balanced with regards to stage at diagnosis and treatment, ECOG Performance Status, histology, and lines of prior therapy. The comparison of P vs F is summarized in the table that follows. Transplant-related mortality and the incidence of Grade 3–4 adverse events were comparable in both arms.