Chemomodulation of sequential high-dose cytarabine by fludarabine in relapsed or refractory acute myeloid leukemia: a randomized trial of the AMLCG
| Autor: | Xaver Schiel, M. Unterhalt, Dietrich W. Beelen, Bernhard Wörmann, Th. Büchner, Karsten Spiekermann, Peter Staib, Hubert Serve, Achim Heinecke, Michael Fiegl, Wolfgang E. Berdel, Wolfgang Kern, Marcus Hentrich, Cristina Sauerland, D Schöndube, Andreas Grüneisen, Albrecht Reichle, C Rieger, Wolfgang Hiddemann, Jan Braess |
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| Rok vydání: | 2013 |
| Předmět: |
Adult
Male Oncology Cancer Research medicine.medical_specialty Adolescent Medizin law.invention Young Adult Randomized controlled trial Refractory High dose cytarabine Recurrence law hemic and lymphatic diseases Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Aged Aged 80 and over business.industry Cytarabine Myeloid leukemia Hematology Middle Aged Prognosis Survival Analysis Fludarabine Leukemia Myeloid Acute Female business Vidarabine medicine.drug |
| Zdroj: | Leukemia. 28:1001-1007 |
| ISSN: | 1476-5551 0887-6924 |
| DOI: | 10.1038/leu.2013.297 |
| Popis: | 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/m(2), 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, P0.05). 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%, P0.01). 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. |
| Databáze: | OpenAIRE |
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