Fiegl, M. and Unterhalt, M. and Kern, W. and Braess, J. and Spiekermann, K. and Staib, P. and Grueneisen, A. and Woermann, B. and Schoendube, D. and Serve, H. and Reichle, A. and Hentrich, M. and Schiel, X. and Sauerland, C. and Heinecke, A. and Rieger, C. and Beelen, D. and Berdel, W. E. and Buechner, T. and Hiddemann, W. (2014) Chemomodulation of sequential high-dose cytarabine by fludarabine in relapsed or refractory acute myeloid leukemia: a randomized trial of the AMLCG. LEUKEMIA, 28 (5). pp. 1001-1007. ISSN 0887-6924, 1476-5551
Full text not available from this repository. (Request a copy)Abstract
Chemomodulation of cytarabine by fludarabine has been attributed with a higher antileukemic efficacy, but randomized trials to address this question are rare. We therefore conducted a multicenter, randomized phase III study to evaluate the antileukemic efficacy of adding fludarabine to sequential high-dose cytarabine_idarubicin (SHAI) re-induction chemotherapy in relapsed or refractory acute myeloid leukemia (AML). Patients (n = 326, of which 281 were evaluable) were randomly assigned to SHAI (cytarabine, 1 g/m(2) bid, days 1-2 and 8-9 (3 g/m(2) for patients <= 60 years with refractory AML or >= 2nd relapse); idarubicin 10 mg/m(2) daily, days 3-4 and 10-11) or F-SHAI (SHAI with fludarabine, 15 mg/m2, 4 h before cytarabine). Although complete remission (CR) rates (35% SHAI and 44% F-SHAI) and overall survival did not differ between both regimens, fludarabine prolonged time to treatment failure from 2.04 to 3.38 months (median, P<0.05). Twenty-seven percent of patients proceeded to allogeneic stem cell transplantation, with a significantly higher number of patients in CR or incomplete remission in the F-SHAI group (22 vs 10%, P<0.01). In conclusion, fludarabine has a beneficial, although moderate, impact on the antileukemic efficacy of high-dose cytarabine-based salvage therapy for relapsed and refractory AML.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | ACUTE MYELOGENOUS LEUKEMIA; STEM-CELL TRANSPLANTATION; CYTOSINE-ARABINOSIDE; FLAG-IDA; G-CSF; PHASE-III; ARA-C; IDARUBICIN; CHEMOTHERAPY; THERAPY; acute myeloid leukemia; relapse; chemotherapy; cytarabine; fludarabine |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin II |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 11 Nov 2019 10:13 |
| Last Modified: | 11 Nov 2019 10:13 |
| URI: | https://pred.uni-regensburg.de/id/eprint/10223 |
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