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Marrow transplantation for chronic myeloid leukemia: the influence of
plasma busulfan levels on the outcome of transplantation
JT Slattery, RA Clift, CD Buckner, J Radich, B Storer, WI Bensinger, E Soll, C Anasetti, R Bowden, E Bryant, T Chauncey, HJ Deeg, KC Doney, M Flowers, T Gooley, JA Hansen, PJ Martin, GB McDonald, R Nash, EW Petersdorf, JE Sanders, G Schoch, P Stewart, R Storb and FR Appelbaum
Fred Hutchinson Cancer Research Center, Seattle, WA 98104-2092, USA.
The influence of busulfan (BU) plasma concentration on outcome of
transplantation from HLA identical family members for the treatment of
chronic myelogenous leukemia (CML) was examined in 45 patients transplanted
in chronic phase (CP) (n = 39) or accelerated phase (AP) (n = 6). All
patients received the same regimen of BU, 16 mg/kg orally and
cyclophosphamide (CY), 120 mg/kg intravenously. Plasma concentrations of BU
at steady state (C(SS)BU) during the dosing interval were measured for each
patient. The mean C(SS)BU was 917 ng/mL (range, 642 to 1,749; median, 917;
standard deviation, 213). Of patients with C(SS)BU below the median, seven
(five of 18 in CP and two of four in AP) developed persistent cytogenetic
relapse and three of these patients died. There were no relapses in
patients with C(SS)BU above the median. The difference in the cumulative
incidence of relapse between the two groups was statistically significant
(P = .0003). C(SS)BU was the only statistically significant determinant of
relapse in univariable or multivariable analysis. The 3-year survival
estimates were 0.82 and 0.64 for patients with C(SS)BU above and below the
median (P = .33). There was no statistically significant association of
C(SS)BU with survival or nonrelapse mortality, although the power to detect
a difference in survival between 0.82 and 0.64 was only 0.24, similarly
C(SS)BU above the median was not associated with an increased risk of
severe regimen-related toxicity. We conclude that low BU plasma levels are
associated with an increased risk of relapse.
Volume 89,
Issue 8,
pp. 3055-3060,
04/15/1997
Copyright © 1997 by The American Society of Hematology
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