2002
CTOS Annual Meeting Posters
— Pediatric Oncology
RANDOMIZED
TRIAL OF AMIFOSTINE WITH HIGH DOSE ALKYLATOR THERAPY IN EWING SARCOMA:
A POG/CCG INTERGROUP STUDY
[Abstract
ID: 15]
Category:
Pediatric Oncology
Authors:
Mark L. Bernstein1, Meenakshi Devidas1
Author Institutions:
1Childrens Oncology Group, United States
Presenter:
Mark L. Bernstein
bernstm@magellan.umontreal.ca
Correspondent: Mark L. Bernstein
bernstm@magellan.umontreal.ca
Montreal Quebec Canada H3T 1C5
Ph: 514-345-4969
Fax: 514-345-4792
Objectives: To
determine if amifostine given twice with each dose of ifosfamide
or cyclophosphamide could provide protection bfrom the myelotoxic
effects of high dosage alkylator
therapy, and prevent delay in the adminstration of chemotherapy.
Methods: Patients less than 30 years of age with Ewing sarcoma
metastatic at diagnosis and normal organ function were enrolled
on P9457, a study of maximally intensified alkylator therapy administered
without stem cell support. Cycles included alternating courses of
ifosfamide, etoposide and vincristine, doxorubicin and cyclophosphamide.
Amifostine was given to a randomized one-half of ___patients entered
in the last half of the study. The dosage administered was 825 mg/m2
15 minutes prior to, and 3 hours after the beginning of each dose
of ifosfamide or cyclophosphamide, with premedications and precautions
as previously described. Days ANC <500/ul, platelets >50,000/ul
and between cycles were analyzed at weeks 6, 12 and 18 of therapy.
Results: There
was no significant difference seen in the arithmetic mean number
of days with platelet count < 50,000/ul: 31 with amifostine,
30 without amifostine (Wilcoxon rank sum
test, p-value: 0.38), the arithmetic mean number of days with absolute
neutrophil count < 500/ul: with amifostine, 31 days, without
amifostine, 30 days (WRS, p = 0.14), or the number of days until
the next chemotherapy cycle: with amifostine: 30 days, without amifostine,
29 days (p= 0.45)
Conclusions: In the dose and schedule used, amifostine did
not provide myeloprotection from the toxicity of high dose alkylator
therapy, and did not shorten the interval until the administration
of the next chemotherapy cycle.
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