Journal of Clinical Oncology, Vol 14, 220-226, Copyright © 1996 by American Society of Clinical Oncology
Allogeneic marrow transplantation for myelodysplastic syndrome with advanced disease morphology: a phase II study of busulfan, cyclophosphamide, and total-body irradiation and analysis of prognostic factors
JE Anderson, FR Appelbaum, G Schoch, T Gooley, C Anasetti, WI Bensinger, E Bryant, CD Buckner, T Chauncey and RA Clift
Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98104, USA.
PURPOSE: To determine if an intensive preparative regimen of busulfan (BU),
cyclophosphamide (CY), and total-body irradiation (TBI) could improve
outcome after marrow transplantation for advanced morphology myelodysplasia
(refractory anemia with excess blasts [RAEB], RAEB in transformation
[RAEB-T], and chronic myelomonocytic leukemia [CMML]) compared with that
obtained with conventional CY/TBI and to analyze prognostic factors for
transplantation for myelodysplasia. PATIENTS AND METHODS: A phase II study
was conducted of 31 patients (median age, 41 years) treated with BU (7
mg/kg), CY (50 mg/kg), TBI (12 Gy), and human leukocyte antigen
(HLA)-matched (n = 23) or -mismatched (n = 2) related or unrelated donor (n
= 6) marrow transplantation. Results were compared with 44 historical
control patients treated with CY (120 mg/kg) and TBI. RESULTS: The 3-year
actuarial disease-free survival (DFS) rate was similar for the BU/CY/TBI
group and the CY/TBI group (23% v 30%, P = .6), but there were trends
toward lower relapse rates (28% v 54%, P = .27) and higher nonrelapse
mortality rates (68% v 36%, P = .12) among the current patients compared
with historical controls. Multivariate analysis showed that a normal
karyotype pretransplant and the use of methotrexate as part of
posttransplant immunosuppression were associated with improved survival and
reduced nonrelapse mortality. Univariate analysis showed significant
differences in relapse rates based on marrow source (57% for HLA
genotypically matched marrow v 18% for all others, P = .04) and on disease
morphology (66% for RAEB-T v 38% for RAEB and CMML, P = .05). CONCLUSION:
Patients with advanced morphology myelodysplasia tolerated the intensified
BU/CY/TBI preparative regimen and reduced posttransplant immunosuppression
poorly. Novel transplant procedures are needed to reduce relapse rates
without increasing nonrelapse mortality rates. In addition, transplantation
before progression to RAEB-T, if possible, may reduce the risk of relapse.
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