GM-CSF Did Not Allow Doxorubicin Dose Escalation in the MAID Regimen: A Phase I Trial. A Southwest Oncology Group Study
作者:
HicksLee G.,
BalcerzakStanley P.,
ZalupskiMark,
期刊:
Cancer Investigation
(Taylor Available online 1996)
卷期:
Volume 14,
issue 6
页码: 507-512
ISSN:0735-7907
年代: 1996
DOI:10.3109/07357909609076895
出版商: Taylor&Francis
数据来源: Taylor
摘要:
Since dose intensity of doxorubicin is correlated with the clinical response of patients with sofl tissue sarcomas and since doxorubicin dose intensity niay be compromised in conibiiiation chemotherapy, we evaluated the use of recoinbinant granulocyte-macrophage colony-stiniulating factor (rGM-CSF) to ameliorate niyelosuppression and allow doxorubicin dose escalation in a phase I trial utilizing the MAID combination [Mesna 2.5 g/m2/day×4 days, Adrianiyciii (doxorubicin) 15 mg/m2/day×4 days, ifosfaniide 2.0 g/m2/day×3 days, dacarbazine 250 mg/m2/day×4 days; to be repeated every 21 days]. Thirteen patients were treated. The doxorubicin dose for the first 6 patients was at the standard dose of 15 mg/m2/day×4 days (level I), while the doxorubicin dose for the next 7 patients was escalated by 25% to 18.75 mg/m2/day×4 days (level 2). tGM-CSF was given at 5μg/kg/day, days 5-14. All patients experienced moderate to severe tiyelosuppression, with all patients at dose level 2 requiring doxorubicin dose reduction to dose level I or lower by their third course of treatment. rGM-CSF failed to allow sustained escalation of the doxorubicin dose in the MAID reginien.
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