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Clinical Trial
. 2010 Feb;24(2):371-82.
doi: 10.1038/leu.2009.252. Epub 2009 Dec 10.

Long-term results of St Jude Total Therapy Studies 11, 12, 13A, 13B, and 14 for childhood acute lymphoblastic leukemia

C H Pui  1 , D Pei, J T Sandlund, R C Ribeiro, J E Rubnitz, S C Raimondi, M Onciu, D Campana, L E Kun, S Jeha, C Cheng, S C Howard, M L Metzger, D Bhojwani, J R Downing, W E Evans, M V Relling
Affiliations
Clinical Trial

Long-term results of St Jude Total Therapy Studies 11, 12, 13A, 13B, and 14 for childhood acute lymphoblastic leukemia

C H Pui et al. Leukemia. 2010 Feb.

Abstract

We analyzed the long-term outcome of 1011 patients treated in five successive clinical trials (Total Therapy Studies 11, 12, 13A, 13B, and 14) between 1984 and 1999. The event-free survival improved significantly (P=0.003) from the first two trials conducted in the 1980s to the three more recent trials conducted in the 1990s. Approximately 75% of patients treated in the 1980s and 80% in the 1990s were cured. Early intensive triple intrathecal therapy, together with more effective systemic therapy, including consolidation and reinduction treatment (Studies 13A and 13B) as well as dexamethasone (Study 13B), resulted in a very low rate of isolated central nervous system (CNS) relapse rate (<2%), despite the reduced use of cranial irradiation. Factors consistently associated with treatment outcome were age, leukocyte count, immunophenotype, DNA index, and minimal residual disease level after remission induction treatment. Owing to concerns about therapy-related secondary myeloid leukemia and brain tumors, in our current trials we reserve the use of etoposide for patients with refractory or relapsed leukemia undergoing hematopoietic stem cell transplantation, and cranial irradiation for those with CNS relapse. The next main challenge is to further increase cure rates while improving quality of life for all patients.

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Figures

Fig. 1
Fig. 1
Event-free survival (EFS), survival and cumulative incidence of isolated or any CNS relapse in Total Therapy Study 11.
Fig. 2
Fig. 2
Duration of continuous complete remission according to postremission therapy in patients with low-risk or higher-risk ALL in Total Therapy Study 11.
Fig. 3
Fig. 3
Event-free survival (EFS), survival and cumulative incidence of isolated or any CNS relapse in Total Therapy Study 12.
Fig. 4
Fig. 4
Duration of continuous complete remission according to postremission therapy for B-lineage and T-lineage cases, respectively.
Fig. 5
Fig. 5
Event-free survival (EFS), survival and cumulative incidence of isolated or any CNS relapse in Total Therapy Study 13A.
Fig. 6
Fig. 6
Event-free survival (EFS), survival and cumulative incidence of isolated or any CNS relapse in Total Therapy Study 13B.
Fig. 7
Fig. 7
Event-free survival (EFS), survival and cumulative incidence of isolated or any CNS relapse in Total Therapy Study 14.
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