Treatment results in childhood acute lymphoblastic leukemia with a modified ALL-BFM'90 protocol: lack of improvement in high-risk group

We report results achieved in our institution with an acute lymphoblastic l eukaemia risk-oriented treatment trial opened in January 1990 and dosed on December 1995. The study was similar to the German ALL-BFM'90, except for u sing Protocol III for the standard-risk group, 2 g/m(2) of methotrexate in protocol M, and preventive cranial irradiation for the high-risk group only . The high-risk group included mostly patients with prednisone poor initial response and/or adverse cytogenetic features. This analysis included 374 p atients, whose mean age was 6 years (range: 1 month-17 years). The overall complete remission rate was 94.4% (353/374) and the 5-year event-free survi val (standard error) probability is 64(5)%. The 5-year event-free survival estimates for each risk group were: (1) high-risk group 37(5)%; (2) interme diate-risk group 66(1)%; and (3) standard-risk group 74(4)% (P = 0.0001). T here are significantly higher-rates of isolated bone marrow and testicular relapses in the high-risk subset of patients. Our dismal results and the pu blished experience, lead us to conclude that the optimal treatment for thes e high-risk acute lymphoblastic leukaemia patients is not currently known. (C) 1999 Elsevier Science Ltd. All rights reserved.