Management of advanced acute lymphoblastic leukemia in children and adults: Results of the ALL R-87 protocol

Fifty-seven patients aged < 55 years with acute lymphoblastic leukemia (ALL ) in second or third bone marrow (BM) relapse or refractory to first-line t herapy 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. C omplete remission (CR) was achieved in 41/57 patients (72 %). The CR rate w as significantly higher in patients aged < 15 years at diagnosis and at tim e of treatment compared to those aged greater than or equal to 15 (84 % vs 50 %, p=0.01 and 85 % vs 54 %, p = 0.02, respectively). Nineteen of 41 resp onders (46.3 %) underwent bone marrow transplant (BMT) (10 autologous and 9 allogeneic). The estimated probabilities of event free survival (EFS +/- S E) and survival +/- SE at 6 years were 0.13 +/- 0.05 and 0.20 +/- 0.06, res pectively, for all enrolled patients. Univariate analysis showed that child ren had a better EFS rate compared to adults (0.16 +/- 0.07 vs 0.08 +/- 0.0 7, 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 DFS 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 r elapse, a first CR length greater than or equal to 48 months favorably infl uenced both DFS (p = 0.014) and EFS (p = 0.018). Our results show the efficacy of the intermediate dose ARA-C plus IDA sched ule for high risk adult and childhood ALL patients. No differences in disea se outcome were observed between allogeneic and autologous BMT.