7101 Background: Filgrastim (FIL), granulocyte-colony stimulating factor(G-CSF) reduces time to neutrophil engraftment, hospital stay and antibiotic therapy but requires uncomfortable and inconvenient daily subcutaneous (SC) injections.Pegfilgrastim (PFIL), while more expensive, requires a single SC injection.Before changing our practice and for internal validation, we initiated phase II nonrandomized trial using PFIL instead of FIL for hematopoietic recovery after autologous peripheral stem cell transplantation(autoPBSCT).An interim analysis of this study was presented (Poster No: - 417) at 2006 BMT Tandem Meetings.Here we present a complete analysis of our study. Method: A Phase II nonrandomized trial compares a single injection PFIL 6mg SC on Day +1 to historical controls using FIL 5mcg/kg SC daily starting Day+7 and continued until ANC=500/mm3 for three consecutive days.Twenty-two patients prospectively(05/2005–06/2006) accrued (MM=2; NHL=13; HD=7, MM=Multiple Myeloma, NHL= Nonhodgkin's lymphoma, HD= Hodgkin's lymphoma).Sixty-six consecutive patients retrospectively (MM=21; NHL=25; HD=20) were analyzed as historical controls(04/1999–04/2005).This study has been completed and closed. The primary endpoint of this study was to determine the days needed to engraft neutrophils & platelet following PFIL administration after autoPBSCT. Wilcoxon Rank Sums test performed for all comparisons except gender comparison was done by chi-square test. Results: Use of a single convenient injection of PFIL resulted in earlier neutrophilic recovery, less packed red blood cell(PRBC) transfusion & shorter hospital stay. No PFIL patients required additional G-CSF. One patient had prolonged fever probably PFIL- related. Conclusion: Our phase II study indicates the equivalency of PFIL and FIL related to hematopoietic recovery after autoPBSCT. No significant financial relationships to disclose. [Table: see text]
Long-term sequelae of autologous bone marrow or peripheral stem cell transplantation for lymphoid malignancies
