Journal of Clinical Oncology, Vol 12, 1931-1938, Copyright © 1994 by American Society of Clinical Oncology
Randomized study of recombinant human granulocyte colony-stimulating factor after high-dose chemotherapy and autologous bone marrow transplantation for high-risk lymphoid malignancies
RA Stahel, LM Jost, T Cerny, G Pichert, H Honegger, A Tobler, E Jacky, M Fey and E Platzer
Department of Medicine, University Hospital, Zurich, Switzerland.
PURPOSE: The aim of this prospective randomized trial was to examine the
efficacy and safety of filgrastim after high-dose chemotherapy and
autologous bone marrow transplantation (ABMT). PATIENTS AND METHODS:
Patients with poor-risk non-Hodgkin's lymphoma or relapsed Hodgkin's
disease were treated in a randomized, open-label trial to study the use of
filgrastim as an adjunct to high-dose chemotherapy and ABMT. Of 43
assessable patients, 19 were randomized to receive filgrastim by continuous
subcutaneous infusion at a dose of 10 micrograms/kg/d, 10 to filgrastim 20
micrograms/kg/d, and 14 to a parallel control group that received no
filgrastim after ABMT. RESULTS: For all filgrastim-treated patients
analyzed together, the median time to neutrophil recovery > or = 0.5 x
10(9)/L after the day of ABMT was significantly accelerated to 10 days
compared with 18 days in control patients (P = .0001). The median number of
platelet transfusions was identical in both groups. Clinical parameters,
including the median number of days with fever (1 v 4, P = .0418) and
neutropenic fever (5 v 13.5, P = .0001) were significantly shorter in the
filgrastim than in the control group. The number of days on intravenous
antibiotics and duration of hospitalization were also shorter in the
treated groups; however, the differences did not reach statistical
significance. For patients treated with the two different dose levels of
filgrastim, the neutrophil recovery and clinical results were similar.
Filgrastim- associated toxicity appeared to be minimal, with five adverse
events considered at least possibly related to filgrastim: two in the
higher- dose group and three in the lower-dose group. All of these were
rated moderate, except one case of severe bone pain that did not preclude
continued filgrastim treatment at a lower dose. Survival and relapse- free
survival were similar for control and filgrastim-treated patients.
CONCLUSION: Taken together, the results of this first randomized study
support the role of filgrastim given as an adjunct to ABMT in accelerating
neutrophil recovery, as well as in reducing treatment- related morbidity
and overall duration of the treatment procedure.
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