Sequential azacitidine plus lenalidomide combination for elderly patients with untreated acute myeloid leukemia

Abstract

University Research Compliance Office and informed consent was obtained from all subjects involved in the study. The clinical research was conducted in accordance with the Declaration of Helsinki. The trial was registered at www.ClinicalTrials.gov as # NCT00890929.

Low-dose lenalidomide plus cytarabine induce complete remission that can be predicted by genetic profiling in elderly acute myeloid leukemia patients

“…1 High-dose lenalidomide is effective in AML, alone 2,3 or in combination with azacitidine. [4][5][6] Biomarkers that are able to predict response to lenalidomide would be extremely useful.…”

“…Bone marrow evaluation was performed after 1, 2, 4 and 6 cycles. Responding patients experiencing a non-hematological toxicity 42 WHO received reduced courses (lenalidomide (10 mg) once daily (days [1][2][3][4][5][6][7][8][9][10][11][12][13][14], and cytarabine (10 mg, subcutaneously) twice daily (days 1-10)). All patients were hospitalized for the first cycle.…”

“…CR rate was 28%, with 4 patients alive and disease-free after 88 weeks of median follow-up. 4,5 Ramsingh et al 6 reported on a prospective trial combining concomitant HDL and azacitidine (days 1-5 three-dose cohorts: 25, 50, 75 mg/m 2 ), followed by maintenance therapy with lenalidomide (10 mg) and azacitidine (75 mg/m 2 , up to 1 2 cycles). CR/CRi rate was 30.8%.…”

Comparable outcomes between autologous and allogeneic transplant for adult acute myeloid leukemia in first CR

“…The ORR was 41%, including a CR in 19% and CR with incomplete recovery of blood counts in 9%. 166 The median duration of response was 28 weeks and the median OS for responding patients was 69 weeks. Early death (death within 4 weeks from start of treatment) occurred in 17% of patients.…”

“…165 A recent trial evaluated this regimen with sequential 5-azacytidine and lenalidomide in older patients (age ≥60 years) with previously untreated AML not eligible for standard induction chemotherapy (n=45; n=42 evaluated). 166 Seven patients (17%) had a prior diagnosis of MDS, and five of these patients had received prior treatment with hypomethylating agents for MDS (5-azacytidine, n=5; decitabine, n=1). The ORR was 41%, including a CR in 19% and CR with incomplete recovery of blood counts in 9%.…”