title: Extended triple intrathecal therapy in children with T-cell acute lymphoblastic leukaemia: a report from the Israeli National ALL-Studies.
abstract: Owing to the increased central nervous system (CNS) relapse risk in T-cell acute lymphoblastic leukaemia (ALL), it is unclear whether preventive cranial radiation (pCRT) can be safely omitted. In this study, pCRT was replaced by extended triple intrathecal therapy (TIT) in prednisone good early responders - medium-risk (MR) group, accounting for 76% of T-ALL patients. From 1989 to 2003, 143 T-ALL patients aged 1-18 years were enrolled in the Israel National Studies (INS) 89 (n = 84) and INS 98 (n = 59) trials, based on ALL-Berlin-Frankfurt-Munster (BFM) 86/90 and ALL-BFM 95 protocols, respectively. Five-year event-free survival (EFS) of the MR group in the INS 89 (n = 60) was 70 +/- 5.9% and the INS 98 (n = 43), 83.7 +/- 5.6% (P = 0.12); the cumulative incidence (CI) of any CNS relapse was 5.0 +/- 2.8% and 2.3 +/- 2.3% (P = 0.50), respectively. There was no difference in outcome between MR patients with a white blood cell count (WBC) >or=100 x 10(9)/l treated with extended TIT (n = 17) or pCRT (n = 10). For all T-ALL patients, 5-year EFS was 61.9 +/- 5.3% in INS 89 and 72.9 +/- 5.8% in INS 98, (P = 0.21); the CI of any CNS relapse was 7.1 +/- 2.8% and 1.7 +/- 1.7% (P = 0.142), respectively. Outcome of T-ALL MR patients given extended TIT in the context of BFM-based protocols with long-term follow-up appeared to be comparable to studies in which a larger proportion of patients was irradiated, and was associated with low risk of CNS relapse, regardless of the WBC.
authors.affiliation: Centre of Paediatric Haematology/Oncology, Schneider Children's Medical Centre of Israel, Petah Tiqwa, Israel. bstark@clalit.org.il
authors.forename: Batia
authors.initials: B
authors.lastname: Stark
authors.forename: Galia
authors.initials: G
authors.lastname: Avrahami
authors.forename: Ronit
authors.initials: R
authors.lastname: Nirel
authors.forename: Aya
authors.initials: A
authors.lastname: Abramov
authors.forename: Dina
authors.initials: D
authors.lastname: Attias
authors.forename: Ami
authors.initials: A
authors.lastname: Ballin
authors.forename: Bella
authors.initials: B
authors.lastname: Bielorai
authors.forename: Yoav
authors.initials: Y
authors.lastname: Burstein
authors.forename: Hertzel
authors.initials: H
authors.lastname: Gavriel
authors.forename: Ronit
authors.initials: R
authors.lastname: Elhasid
authors.forename: Joseph
authors.initials: J
authors.lastname: Kapelushnik
authors.forename: Dalia
authors.initials: D
authors.lastname: Sthoeger
authors.forename: Amos
authors.initials: A
authors.lastname: Toren
authors.forename: Michael
authors.initials: M
authors.lastname: Wientraub
authors.forename: Isaac
authors.initials: I
authors.lastname: Yaniv
authors.forename: Shai
authors.initials: S
authors.lastname: Izraeli
mesh_terms: D000293:Adolescent; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000627:therapeutic use; D002490:Central Nervous System / Q000473:pathology*; D002648:Child; D002675:Child, Preschool; D016371:Cranial Irradiation; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D007278:Injections, Spinal; D017254:Leukemic Infiltration / Q000517:prevention & control*; D007958:Leukocyte Count; D054218:Precursor T-Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy* / Q000473:pathology; D011379:Prognosis; D016019:Survival Analysis; D016896:Treatment Outcome