PURPOSE: Older patients with acute myeloid leukemia (AML) have limited treatment options because of the lack of effectiveness and the toxicity of available therapies. We investigated the efficacy and toxicity of the hypomethylating agent decitabine as initial therapy in older patients with AML. PATIENTS AND METHODS: In this multicenter, phase II study, patients older than 60 years who had AML (ie, > 20% bone marrow blasts) and no prior therapy for AML were treated with decitabine 20 mg/m(2) intravenously for 5 consecutive days of a 4-week cycle. Response was assessed by weekly CBC and bone marrow biopsy after cycle 2 and after each subsequent cycle. Patients continued to receive decitabine until disease progression or an unacceptable adverse event occurred. RESULTS: Fifty-five patients (mean age, 74 years) were enrolled and were treated with a median of three cycles (range, one to 25 cycles) of decitabine. The expert-reviewed overall response rate was 25% (complete response rate, 24%). The response rate was consistent across subgroups, including in patients with poor-risk cytogenetics and in those with a history of myelodysplastic syndrome. The overall median survival was 7.7 months, and the 30-day mortality rate was 7%. The most common toxicities were myelosuppression, febrile neutropenia, and fatigue. CONCLUSION: Decitabine given in a low-dose, 5-day regimen has activity as upfront therapy in older patients with AML, and it has acceptable toxicity and 30-day mortality.
PURPOSE: Older patients with acute myeloid leukemia (AML) have limited treatment options because of the lack of effectiveness and the toxicity of available therapies. We investigated the efficacy and toxicity of the hypomethylating agent decitabine as initial therapy in older patients with AML. PATIENTS AND METHODS: In this multicenter, phase II study, patients older than 60 years who had AML (ie, > 20% bone marrow blasts) and no prior therapy for AML were treated with decitabine 20 mg/m(2) intravenously for 5 consecutive days of a 4-week cycle. Response was assessed by weekly CBC and bone marrow biopsy after cycle 2 and after each subsequent cycle. Patients continued to receive decitabine until disease progression or an unacceptable adverse event occurred. RESULTS: Fifty-five patients (mean age, 74 years) were enrolled and were treated with a median of three cycles (range, one to 25 cycles) of decitabine. The expert-reviewed overall response rate was 25% (complete response rate, 24%). The response rate was consistent across subgroups, including in patients with poor-risk cytogenetics and in those with a history of myelodysplastic syndrome. The overall median survival was 7.7 months, and the 30-day mortality rate was 7%. The most common toxicities were myelosuppression, febrile neutropenia, and fatigue. CONCLUSION:Decitabine given in a low-dose, 5-day regimen has activity as upfront therapy in older patients with AML, and it has acceptable toxicity and 30-day mortality.
Authors: Y Boumber; H Kantarjian; J Jorgensen; S Wen; S Faderl; R Castoro; J Autry; G Garcia-Manero; G Borthakur; E Jabbour; Z Estrov; J Cortes; J-P Issa; F Ravandi Journal: Leukemia Date: 2012-06-05 Impact factor: 11.528
Authors: Judith E Karp; Tatiana I Vener; Mitch Raponi; Ellen K Ritchie; B Douglas Smith; Steven D Gore; Lawrence E Morris; Eric J Feldman; Jacqueline M Greer; Sami Malek; Hetty E Carraway; Valerie Ironside; Steven Galkin; Mark J Levis; Michael A McDevitt; Gail R Roboz; Christopher D Gocke; Carlo Derecho; John Palma; Yixin Wang; Scott H Kaufmann; John J Wright; Elizabeth Garret-Mayer Journal: Blood Date: 2011-10-14 Impact factor: 22.113
Authors: Chana L Glasser; Alice Lee; Don Eslin; Lianna Marks; Shakeel Modak; Julia L Glade Bender Journal: J Pediatr Hematol Oncol Date: 2017-10 Impact factor: 1.289