title: Double-delayed intensification improves event-free survival for children with intermediate-risk acute lymphoblastic leukemia: a report from the Children's Cancer Group.
abstract: Addition of a delayed-intensification (DI) phase after standard induction/consolidation therapy was previously shown to improve outcome for patients younger than 10 years of age with intermediate-risk acute lymphoblastic leukemia (ALL). The current trial randomized 1204 patients to regimens containing a single DI phase (405 patients), 2 DI phases (DDI) (402 patients), or a single DI phase in conjunction with increased vincristine and prednisone pulses during maintenance (DIVPI) (397 patients). Estimates of event-free survival (EFS) and survival at 6 years are 79% +/- 1% and 89% +/- 1%, respectively. EFS was improved on DDI compared with either DI (log-rank P =.04; Kaplan-Meier [KM] P =.04; relative risk [RR] = 1.38) or DIVPI (log-rank P =.04; KM P =.01; RR = 1.39). There was no difference in EFS for the DI and DIVPI regimens (log-rank P =.96; KM P =.75). Survival estimates at 6 years were 87% (SD = 2%) for DI; 91% (SD = 2%) for DDI; and 90% (SD = 2%) for DIVPI (P =.17). Significant univariate risk factors for the overall cohort included poor day-7 marrow response, black race, and age of at least 5 years. These data demonstrate that DDI improves EFS of patients younger than 10 years of age with intermediate-risk ALL.
authors.affiliation: Division of Oncology, Children's Hospital of Philadelphia, PA, USA. lange@email.chop.edu
authors.forename: Beverly J
authors.initials: BJ
authors.lastname: Lange
authors.forename: Bruce C
authors.initials: BC
authors.lastname: Bostrom
authors.forename: Joel M
authors.initials: JM
authors.lastname: Cherlow
authors.forename: Martha G
authors.initials: MG
authors.lastname: Sensel
authors.forename: Mei K L
authors.initials: MK
authors.lastname: La
authors.forename: Wayne
authors.initials: W
authors.lastname: Rackoff
authors.forename: Nyla A
authors.initials: NA
authors.lastname: Heerema
authors.forename: Robert S
authors.initials: RS
authors.lastname: Wimmer
authors.forename: Michael E
authors.initials: ME
authors.lastname: Trigg
authors.forename: Harland N
authors.initials: HN
authors.lastname: Sather
mesh_terms: D000367:Age Factors; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000633:toxicity; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D018572:Disease-Free Survival; D005260:Female; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007223:Infant; D008297:Male; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy*; D044469:Racial Groups; D012307:Risk Factors; D013163:Splenomegaly; D016896:Treatment Outcome
chemical_list: D006454:Hemoglobins