Postremission Treatment with Chemotherapy or Allogeneic Stem Cell Transplantation (Allo-SCT) in Adults with Acute Myeloid Leukemia (AML) -JALSG AML-97 Trial-.

Abstract

The aim of this study was to investigate the efficacy of allo-SCT as a postremission treatment in patients (pts) with intermediate/poor risk AML in first CR. Previously untreated pts aged15–64 years were eligible. Pts received standard induction therapy consisting of cytarabine (100 mg/m2 d1–7) and idarubicin (12 mg/m2 d1- 3). If the pts did not achieve remission after the first induction therapy, the same induction therapy was given once more. The pts who achieved CR were randomized into an intensified short-course postremission regimen group (arm A) and conventional JALSG postremission regimen group (arm B). Pts were also categorized into good, intermediate or poor risk groups by risk factors based on previous JALSG AML trials using univariate and multivariate analyses. The intermediate or poor risk pts <=50 years old with an HLA-matched sibling were assigned to the allo-SCT group. The overall survival rate (OS) and the disease-free survival rate (DFS) of the pts of this group were compared with those of intermediate or poor risk pts <=50 years old without an HLA-matched donor (non-transplant group), to adhere to the intention-to-treat principle.Result: 809 pts were registered between December 1997 and July 2001. 789 pts were evaluable (median age: 45 years). 621 pts achieved CR (78.7%) after one or two courses of induction therapy. Os of 789 evaluable pts at five years and DFS of CR pts at five years were 40.8% and 35.5%, respectively. Of the 75 pts who were assigned to the allo-SCT group, 56 pts underwent allo-SCT (38 during CR1 and 18 after relapse). For the allo-SCT group, OS and DFS at 5 years were 51.8% and 43.1%, respectively. For the non-transplant group (n=95), OS and DSF at 5 years were 32.2% and 18.3%, respectively. DFS was significantly better in the allo-SCT group compared to the non-transplant group (p=0.005). OS was marginally better in the allo-SCT group (p=0.06).In conclusion, our study showed that allo-SCT for pts with intermediate or poor risk is effective as a postremission treatment in adult AML.