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Randomized, double-blind, placebo-controlled, phase III study of
recombinant human granulocyte-macrophage colony-stimulating factor as
adjunct to induction treatment of high-grade malignant non-Hodgkin's
lymphomas [see comments]
HH Gerhartz, M Engelhard, P Meusers, G Brittinger, W Wilmanns, G Schlimok, P Mueller, D Huhn, R Musch and W Siegert
Medical Department III, Klinikum GroBhadem, Munich University, Germany.
We evaluated recombinant human granulocyte-macrophage colony- stimulating
factor (rhGM-CSF; Sandoz Pharma [Basel, Switzerland]/Schering-Plough
[Kenilworth, NJ]) as an adjunct to a modified (mainly cyclophosphamide and
doxorubicin increased 1.5-fold) COP-BLAM regimen in the primary treatment
of high-grade malignant non- Hodgkin's lymphomas (NHL). Patients (n = 182;
stage II-IV; age, 15 to 73 years) were randomized to rhGM-CSF (400
micrograms) or placebo for 7 days subcutaneously after chemotherapy.
Efficacy was analyzed for patients receiving at least 70% of study
medication (n = 125). The frequency of clinically relevant infection was
reduced by rhGM-CSF (28 v 69 infections, 16 v 30 patients, P = .02) with a
cumulative probability of remaining infection free in 70% versus 48% (P =
.05 log rank test at 190 days). Periods of neutropenia (P = .01 in 5 of 6
courses), days with fever (2.1 v 4.0, P = .04) and days of hospitalization
for infection (3.5 v 8.0 days, P = .01) were significantly reduced.
Complete response (CR) rates, assessed by prognostic risk, were 15 of 19
(79%) in treated versus 20 of 21 (95%) in controls in the low-risk group (P
= .12). In the high-risk group, 31 of 45 (69%) treated patients achieved CR
versus 25 of 52 (48%) of controls (P = .04). No difference in survival has
been seen after 1 year. Only injection site reactions (45% treated v 7%
controls) and rash (26% v 2%) occurred more frequently in treated patients
(n = 176). These data show that rhGM-CSF is well tolerated in most patients
with NHL, significantly reduces infection, and improves response.
Volume 82,
Issue 8,
pp. 2329-2339,
10/15/1993
Copyright © 1993 by The American Society of Hematology
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