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

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Rolf A StahelA Nagler

Abstract

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). 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-microgram/kg/d subcutaneous (SC) bolus injection and 10-microgram/kg/d SC continuous infusion, starting on day 1 following ABMT. 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 10(9)/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. This study demonstrates that a dose of filgrastim 5 micrograms/kg/d administered as a daily SC bolus injection has a similar efficacy and saf...Continue Reading

Citations

Oct 14, 2000·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·H OzerUNKNOWN American Society of Clinical Oncology
Feb 24, 2001·Journal of Pediatric Hematology/oncology·M S Cairo
Jun 17, 2003·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·George A OmuraSusan G Arbuck

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