Acute toxicity and first clinical results of intensive postinduction
therapy using a modified busulfan and cyclophosphamide regimen with
autologous bone marrow rescue in first remission of acute myeloid leukemia
[see comments]
DW Beelen, K Quabeck, U Graeven, HG Sayer, HK Mahmoud and UW Schaefer
Department of Bone Marrow Transplantation, University Hospital Essen,
Federal Republic of Germany.
The combination of high-dose busulfan (16 mg/kg) and 200 mg/kg
cyclophosphamide is gaining increasing significance as a preparative
regimen prior to autologous, syngeneic, or allogeneic marrow
transplantation. A new regimen of high-dose busulfan in conjunction with a
reduced dose of 120 mg/kg cyclophosphamide has recently been described as a
preparative regimen prior to allogeneic transplantation. To determine the
drug-related nonhematologic toxic effects of this new regimen without
confounding factors associated with allogeneic transplantation, we
conducted a pilot study using this new regimen in 20 patients with acute
myeloid leukemia (AML) in first remission prior to autologous unpurged
marrow transplantation. All patients experienced transient
non-life-threatening acute drug-related toxicity with skin reactions in 20
(100%), nausea and vomiting in 20 (100%), oral mucositis in 18 (90%),
hepatic functional impairment in 17 (85%), hemorrhagic cystitis in three
(15%), and generalized seizures in two (10%) of these patients,
respectively. Two procedural, fatal complications resulted from infectious
causes that were not directly related to the speed of hematopoietic
reconstitution or the toxicity of the preparative regimen. The 3-year
event-free survival estimate (55% +/- 11%) and probability of leukemic
recurrence (38% +/- 11%) attained with this new regimen in recipients of
autografts in first remission of AML are promising and challenge
comparisons with preparative regimens employing combinations of cytotoxic
agents or total body irradiation (TBI).
Volume 74,
Issue 5,
pp. 1507-1516,
10/01/1989
Copyright © 1989 by The American Society of Hematology