Randomized comparison of fixed-schedule versus response-oriented individualized induction therapy and use of ubenimex during and after consolidation therapy for elderly patients with acute myeloid leukemia: the JALSG GML200 Study

Abstract

We conducted a multicenter prospective randomized study to compare a fixed-scheduled induction therapy with a response-oriented individualized induction therapy for elderly patients with acute myeloid leukemia (AML). Newly diagnosed AML patients, aged between 65 and 80, were randomly assigned to receive fixed or individualized induction. Both groups received daunorubicin (DNR) 40 mg/m(2) for 3 days and behenoyl cytarabine (BHAC) 200 mg/m(2) for 8 days. In the individualized group, bone marrow biopsy was done on days 8 and 10, and according to the cellularity and blast ratio, the patients received additional DNR and BHAC for two to four more days. All patients achieving complete remission (CR) were randomized a second time to determine whether they would receive ubenimex. CR was obtained in 60.1 % of the fixed group and 63.6 % of the individualized group. Predicted 4-year relapse-free survival (RFS) was 9 % for the fixed group and 18 % for the individualized group. There were no statistically significant differences in CR and RFS between the fixed and individualized groups. In the ubenimex group, prolonged RFS was observed. Notably, gender was a prognostic factor in this study, as 102 female patients had a significantly higher CR rate (72.5 vs. 54.3 %, p = 0.0048) and better OS (24 vs. 14 % at 4 years, p = 0.018), compared with 140 male patients.

Clonal evolution detected with conventional cytogenetic analysis is a potent prognostic factor in adult patients with relapsed AML

“…All 144 patients included in this study were treated according to the Japan Adult Leukemia Study Group (JALSG) treatment protocols (JALSG AML92, AML95, AML97, GML200, or AML201). All protocols consisted of single induction therapy with anthracycline (daunorubicin or idarubicin) plus standard‐dose Ara‐C and were followed by 3 or 4 courses of consolidation therapy.…”

Recombinant human thrombomodulin in the treatment of acute myeloid leukemia patients complicated by disseminated intravascular coagulation: retrospective analysis of outcomes between patients treated with heparin and recombinant human thrombomodulin therapy

“…Patients younger than 65 years of age were treated with idarubicin (12 mg/m 2 per day) for 3 days (days 1-3) and cytarabine (100 mg/m 2 per day) by continuous infusion for 7 days (days 1-7) [20]. Patients 65 years of age or older were treated with daunorubicin (40 mg/m 2 per day) for 3 days (days 1-3) and 200 mg/m 2 per day of behenoyl cytarabine for 8 days (days 1-8) [21]. The continuous infusion of dalteparin sodium (low-molecular-weight heparin, LMWH) (75 IU/kg per day) or recombinant human thrombomodulin (rTM) (380 U/kg per day, Asahi Kasei Pharmacy, Tokyo, Japan) was used to treat DIC.…”

Inhibition of p38 MAPK Phosphorylation Is Critical for Bestatin to Enhance ATRA-Induced Cell Differentiation in Acute Promyelocytic Leukemia NB4 Cells

“…Bestatin has been clinically used in the treatment of non-small cell lung carcinoma and myeloid leukemia in Japan for many years. 23,24 As an active anti-angiogenic agent, Bestatin has attracted extensive attention. Downregulation of expression of vascular endothelial growth factor (VEGF) might contribute to the anti-angiogenesis effect of Bestatin.…”