Pegfilgrastim to accelerate neutrophil engraftment following peripheral blood stem cell transplant and reduce the duration of neutropenia, hospitalization, and use of intravenous antibiotics: a phase II study in multiple myeloma and lymphoma and comparison with filgrastim-treated matched controls.

Abstract

This trial was aimed to explore the efficacy of pegfilgrastim to accelerate neutrophil engraftment after stem cell autotransplant. Twenty patients with multiple myeloma and 20 with lymphoma received pegfilgrastim 6 mg on day +1. Forty cases treated with daily filgrastim starting at median day +7 (5-7), matched by age, sex, diagnosis, high-dose chemotherapy schedule, CD34 +  cell-dose, and prior therapy lines, were used for comparison. Median time to neutrophil engraftment was 9.5 vs. 11 days for pegfilgrastim and filgrastim, respectively (p < 0.0001). Likewise, duration of neutropenia, intravenous antibiotic use, and hospitalization favored pegfilgrastim, while platelet engraftment, transfusion requirement, and fever duration were equivalent in both groups. No grade  ≥ 3 toxicities were observed. Patients with lymphoma performed similarly to the entire cohort, while patients with myeloma showed faster neutrophil engraftment and shorter neutropenia but not shorter hospitalization and antibiotic use. The possibility of different outcomes for lymphoma and myeloma suggests that stratification by diagnosis may be useful in future phase III studies.

• Authors: Luciano Wannesson, François Luthi, Emanuele Zucca, Anne Rosselet-Christ, Mauro Baglioni, Lucia Marelli, Michele Ghielmini, Nicolas Ketterer
• Journal: Leukemia & lymphoma (Leuk Lymphoma) Vol. 52 Issue 3 Pg. 436-43 (Mar 2011) ISSN: 1029-2403 [Electronic] United States
• PMID: 21323524 (Publication Type: Clinical Trial, Phase II, Comparative Study, Controlled Clinical Trial, Journal Article)

Chemical References

• Anti-Bacterial Agents
• Recombinant Proteins
• Granulocyte Colony-Stimulating Factor
• pegfilgrastim
• Polyethylene Glycols
• Filgrastim

Topics

• Adult
• Aged
• Anti-Bacterial Agents (administration & dosage)
• Antibiotic Prophylaxis (statistics & numerical data)
• Drug Administration Schedule
• Female
• Filgrastim
• Granulocyte Colony-Stimulating Factor (administration & dosage, pharmacology, therapeutic use)
• Hospitalization (statistics & numerical data)
• Humans
• Injections, Intravenous
• Length of Stay
• Lymphoma (drug therapy, therapy)
• Male
• Matched-Pair Analysis
• Middle Aged
• Multiple Myeloma (drug therapy, therapy)
• Neutropenia (prevention & control)
• Neutrophils (drug effects, transplantation)
• Peripheral Blood Stem Cell Transplantation (adverse effects, methods)
• Polyethylene Glycols
• Recombinant Proteins
• Time Factors
• Young Adult