Randomized trial showing equivalent efficacy of filgrastim 5 μg/kg/d and 10 μg/kg/d following high-dose chemotherapy and autologous bone marrow transplantation in high-risk lymphomas

R. A. Stahel*, L. M. Jost, H. Honegger, E. Betts, M. E.M. Goebel, A. Nagler

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

25 Scopus citations

Abstract

Purpose: To evaluate the effect of two filgrastim dosages after autologous bone marrow transplantation (ABMT) in patients with Hodgkin's disease (HD) and non-Hodgkin's lymphoma (NHL). Patients and Methods: Eighty- six patients were enrolled onto a multicenter, randomized, open-label study. The study compared the efficacy and safety of two different doses of filgrastim, 5-μg/kg/d subcutaneous (SC) bolus injection and 10-μg/kg/d SC continuous infusion, starting on day 1 following ABMT. Results: Both patient groups were well matched in terms of demography and disease. The results showed no statistical difference in the median time to reach an absolute neutrophil count (ANC) of 0.5 x 109/L (11 days; P = .685) and no difference in the median duration of neutropenia (10 v 11 days, respectively; P = .567) between either dose of filgrastim. The incidence and duration of fever and neutropenic fever were the same in both groups. The number and mean duration of clinically and documented infections, duration of intravenous (IV) antibiotics, time to discharge from hospital, and tumor response also were similar in both groups. Conclusion: This study demonstrates that a dose of filgrastim 5 μg/kg/d administered as a daily SC bolus injection has a similar efficacy and safety profile compared with the 10-μg/kg/d dose administered as a SC continuous infusion. The lower dose of filgrastim has potential cost-saving implications in terms of both the dose of drug administered and the ease of administration. Based on these findings, the recommended dose of filgrastim after ABMT should be 5 μg/kg/d.

Original languageEnglish
Pages (from-to)1730-1735
Number of pages6
JournalJournal of Clinical Oncology
Volume15
Issue number5
DOIs
StatePublished - May 1997
Externally publishedYes

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