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Recombinant methionyl human stem cell factor and filgrastim for peripheral
blood progenitor cell mobilization and transplantation in non-Hodgkin's
lymphoma patients--results of a phase I/II trial
CH Moskowitz, P Stiff, MS Gordon, I McNiece, AD Ho, JJ Costa, ER Broun, RA Bayer, M Wyres, J Hill, K Jelaca-Maxwell, CR Nichols, SL Brown, SD Nimer and J Gabrilove
Lymphoma Service and the Hematology Service, Memorial Sloan Kettering
Cancer Center, New York, NY 10021, USA.
To examine the safety and efficacy of recombinant-methionyl human stem cell
factor (r-metHuSCF), 38 patients with intermediate-grade or immunoblastic
high-grade non-Hodgkin's lymphoma who were eligible for autologous
transplantation were randomized to receive r-metHuSCF (5, 10, 15, or 20
microg/kg/d) plus Filgrastim (10 microg/kg/d) or Filgrastim (10
microg/kg/d) alone to mobilize peripheral blood progenitor cells.
Subcutaneous administration of r-metHuSCF was well tolerated in conjunction
with a multi-agent pre-medication regimen; local injection site reactions
were the most commonly seen adverse event. The total mononuclear cell
count, CD34+ cell content, granulocyte-macrophage colony-forming cells
(GM-CFC), and burst-forming units-erythroid (BFU-E) per kilogram in the
apheresis product was similar when all patients were analyzed by treatment
cohort and mobilization regimen (Filgrastim or r-metHuSCF in combination
with Filgrastim); however, when prior chemotherapy was taken into account
in a supplementary analysis, clinically important differences were
observed. Extensive prior therapy was defined as the amount of exposure to
specific stem cell toxic chemotherapeutic agents that patients received.
These agents include procarbazine, nitrogen mustard, melphalan,
nitrosoureas (> or = 2 cycles of any of these drugs) or greater than 7.5
g of cytosine arabinoside. In these patients, there was an increased number
of CD34+ cells (1.76 v 0.28 x 10(6)/kg), GM-CFC (20.5 v 5.0 x 10(4)/kg),
and BFU-E (36.9 v 8.9 x 10(4)/kg) in patients receiving r-metHuSCF and
Filgrastim (N = 18) compared with Filgrastim alone (N = 5). These patients
also had a decreased time to an untransfused platelet count of 20 x 10(9)/L
that was 10.5 days shorter in the patients who received r-metHuSCF and
Filgrastim (12.5 v 23 days). These differences were not found to be
statistically significant, possibly because of small size, but are
clinically important.
Volume 89,
Issue 9,
pp. 3136-3147,
05/01/1997
Copyright © 1997 by The American Society of Hematology
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