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Clofarabine plus low‐dose cytarabine followed by clofarabine plus low‐dose cytarabine alternating with decitabine in acute myeloid leukemia frontline therapy for older patients
Author(s) -
Faderl Stefan,
Ravandi Farhad,
Huang Xuelin,
Wang Xuemei,
Jabbour Elias,
GarciaManero Guillermo,
Kadia Tapan,
Ferrajoli Alessandra,
Konopleva Marina,
Borthakur Gautam,
Burger Jan,
Feliu Jennie,
Kantarjian Hagop M.
Publication year - 2012
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.27429
Subject(s) - clofarabine , medicine , cytarabine , decitabine , myeloid leukemia , leukemia , gastroenterology , surgery , oncology , biochemistry , gene expression , chemistry , dna methylation , gene
BACKGROUND: Standard therapy for older patients with acute myeloid leukemia (AML) has a poor outcome. The authors have designed a combination of clofarabine plus low‐dose cytarabine followed by a prolonged consolidation alternating with decitabine. METHODS: Sixty patients with a median age of 70 years (range, 60‐81 years) with newly diagnosed AML were included. They received clofarabine 20 mg/m 2 intravenously daily for 5 days plus cytarabine 20 mg subcutaneously twice daily for 10 days. Responding patients continued for up to 17 courses of consolidation therapy including decitabine. RESULTS: Forty of 59 evaluable patients responded (66%). Complete remission rate was 58%. Median relapse‐free survival (RFS) was 14.1 (95% confidence interval [CI], 6.9 to not estimable), and median overall survival (OS) was 12.7 months (95% CI, 8.8 to not estimable). Median OS of responding patients (complete response [CR]/CR with platelet count <100 × 109/L) was 24.2 months (95% CI, 17 to not estimable). Compared with a historical group of patients who received clofarabine plus low‐dose cytarabine with a shorter consolidation, RFS was not statistically different. Induction mortality was low (7% at 8 weeks) and toxicities manageable. CONCLUSIONS: Clofarabine plus low‐dose cytarabine alternating with decitabine in consolidation is active in older patients with newly diagnosed AML. The benefits of a prolonged consolidation remain unproven. Cancer 2012. © 2012 American Cancer Society.