Abstract
The purine nucleoside analogues clofarabine and fludarabine are active in acute myeloid leukemia (AML). We conducted a phase I/II randomized study of idarubicin and cytarabine with either clofarabine (CIA) or fludarabine (FIA) for relapsed or refractory AML. Clofarabine 15 mg/m2 was identified as the recommended phase II dose. Eighty-one patients were assigned using adaptive randomization to CIA (n=48) or FIA (n=33). The complete response (CR)/CR without platelet recovery rate did not differ between CIA and FIA (38% versus 30%, respectively; p=.50). In both arms, more than half of patients who had received only one prior line of therapy achieved remission. The median event-free survival for CIA and FIA was 2.0 and 1.9 months (p=.48), and the median overall survival was 6.3 and 4.7 months, respectively (p=.28). No significant differences in adverse events or early mortality rates were observed. Overall, CIA and FIA resulted in similar response rates and survival in patients with relapsed/refractory AML.
Original language | English (US) |
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Pages (from-to) | 813-820 |
Number of pages | 8 |
Journal | Leukemia and Lymphoma |
Volume | 59 |
Issue number | 4 |
DOIs | |
State | Published - Jul 19 2018 |
Externally published | Yes |
Keywords
- Acute myeloid leukemia
- Clofarabine
- Fludarabine
- Purine nucleoside analogues
- Refractory
- Relapsed
ASJC Scopus subject areas
- Hematology
- Oncology
- Cancer Research