Management of Advanced Acute Lymphoblastic Leukemia in Children and Adults: Results of the ALL R-87 Protocol

Abstract

Fifty-seven patients aged > 55 years with acute lymphoblastic leukemia (ALL) in second or third bone marrow (BM) relapse or refractory to first-line therapy were enrolled in an Italian cooperative study. The ALL R-87 protocol included idarubicin (IDA) plus intermediate dose cytarabine (IDARA-C) and Prednisone (PDN) as induction, followed by a consolidation phase and BMT. Complete remission (CR) was achieved in 41/57 patients (72 %). The CR rate was significantly higher in patients aged ≥ 15 years at diagnosis and at time of treatment compared to those aged ≥ 15 (84 % vs 50 %, p=0.01 and 85 % vs 54 %, p = 0.02, respectively). Nineteen of 41 responders (46.3 %) underwent bone marrow transplant (BMT) (10 autologous and 9 allogeneic). The estimated probabilities of event free survival (EFS + SE) and survival± SE at 6 years were 0.13± 0.05 and 0.20± 0.06, respectively, for all enrolled patients. Univariate analysis showed that children had a better EFS rate compared to adults (0.16± 0.07 vs 0.08± 0.07, p = 0.014). The estimated probability of disease free survival (DFS + SE) at 6 years was 0.18± 0.07 for all responders. No differences in DPS were observed between patients submitted to allogeneic or autologous BMT (0.33 + 0.16 vs 0.25 + 0.15). Among patients treated in second or third relapse, a first CR length ≥ 48 months favorably influenced both DFS (p = 0.014) and EFS (p = 0.018).