Journal of Clinical Oncology, Vol 16, 522-526, Copyright © 1998 by American Society of Clinical Oncology
Randomized trial of r-metHu granulocyte colony-stimulating factor in an intensive treatment for T-cell leukemia and advanced-stage lymphoblastic lymphoma of childhood: a Pediatric Oncology Group pilot study
J Laver, M Amylon, S Desai, M Link, M Schwenn, H Mahmoud and J Shuster
Division of Pediatric Hematology Oncology, Medical University of South Carolina, Charleston, USA. laverjh@musc.edu
PURPOSE: Contemporary chemotherapy has significantly improved the event-
free survival (EFS) among patients with T-cell disease. However,
myelosuppression has been a significant adverse effect of this approach. In
this study, we assessed the impact of r-metHu granulocyte
colony-stimulating factor (G-CSF) on the period of neutropenia, number of
days of hospitalization, and delays in subsequent administration of
chemotherapy in a cohort of patients with T-cell leukemia (T-ALL) or
advanced stage lymphoblastic lymphoma (ASLL). PATIENTS AND METHODS: This
open-label, randomized trial incorporated r-metHuG-CSF into the induction
and two consecutive continuation-therapy cycles of our intensive program
for T-cell malignancies. In the induction phase, r- metHuG-CSF was given
after two different combinations of chemotherapy, one of which included
vincristine, prednisone, cyclophosphamide, and adriamycin and the other a
continuous infusion of high-dose ara-C and L- asparaginase. In the two
continuation-therapy cycles, r-metHuG-CSF was given following the
combination of vincristine, adriamycin, prednisone, and 6-mercaptopurine
(MP) and after continuous infusion of high-dose cytarabine (ara-C).
RESULTS: Fifty-six patients with T-ALL and 33 with ASLL were enrolled onto
study from April 1994 to December 1995. Our data show no significant
difference in number of days of absolute neutrophil count (ANC) less than
500/microL, hospitalizations, or delays in therapy in the induction phase.
However, in the continuation- therapy phase the number of days of ANC less
than 500/microL was significantly shorter (P = .017) on the G-CSF-arm
without significantly affecting the number of days of hospitalizations or
delays in therapy. CONCLUSION: r-metHuG-CSF did not significantly affect
the period of neutropenia, hospitalization, or delays in therapy in the
induction phase, whereas in the two cycles of continuation therapy, it
significantly shortened the period of neutropenia.
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