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A randomized phase-III study of the efficacy of granulocyte colony-
stimulating factor in children with high-risk acute lymphoblastic leukemia.
Berlin-Frankfurt-Munster Study Group
K Welte, A Reiter, K Mempel, M Pfetsch, G Schwab, M Schrappe and H Riehm
Department of Pediatric Hematology and Oncology, Medical School Hannover,
Germany.
Overall chemotherapeutic treatment results in pediatric acute lymphoblastic
leukemia (ALL) are good, with event-free survival (EFS) rates over 70%.
However, for a subset of patients characterized by high- risk (HR) features
the outcome is less favorable, with EFS rates below 50%. Intensification of
chemotherapy may improve the outcome for those patients, but increased
toxicity, particularly myelosuppression, limits the escalation of dose
intensity. Recombinant methionyl human granulocyte colony-stimulating
factor (r-metHuG-CSF) is known to reduce myelosuppression after cancer
chemotherapy in adults. The objective of this study was to examine the
effect of r-metHuG-CSF on myelosuppression in HR pediatric ALL patients and
on the overall response rate to chemotherapy. Patients with HR pediatric
ALL were randomized to receive nine alternating cycles of chemotherapy
according to the German ALL-Berlin-Frankfurt-Munster 90 protocol either
alone or followed by r-metHuG-CSF administered prophylactically at a dose
of 5 microg/kg/d subcutaneously. In both groups, the planned interval
between chemotherapy courses was a minimum of 21 days. We report here
interim results of 34 patients. The incidence of febrile neutropenia
(absolute neutrophil count <0.5 x 10(9)/L and oral temperature > or =
38.5 degrees C) was 17% in children receiving r-metHuG-CSF, as compared
with 40% in the control group (P = .007). In addition, the median total
duration of febrile neutropenia was reduced from 20.3 to 6.2 days per
patient (P = .02). Culture-confirmed infections occurred less frequently in
the r-metHuG-CSF group (8% v 15%; P = .04), and the total duration of
intravenous antibiotic use was significantly reduced from 32.2 days to 18.2
days per patient (P = .02). A tighter adherence to the planned treatment
schedule was also facilitated by r-metHuG-CSF (P = .007). With a median
follow-up of 3.3 years, the estimated EFS of 4 years is 41% +/- 12%. In
conclusion, r-metHuG-CSF administered prophylactically in the interval
between chemotherapy courses significantly reduced febrile neutropenia,
culture-confirmed infections, and duration of intravenous antibiotic
administration and allowed for tighter adherence to the treatment schedule.
Volume 87,
Issue 8,
pp. 3143-3150,
04/15/1996
Copyright © 1996 by The American Society of Hematology
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