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Blood, 1 February 2002, Vol. 99, No. 3, pp. 825-833
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Double-delayed intensification improves event-free survival
for children with intermediate-risk acute lymphoblastic
leukemia: a report from the Children's Cancer Group
Beverly J. Lange,
Bruce C. Bostrom,
Joel M. Cherlow,
Martha G. Sensel,
Mei K. L. La,
Wayne Rackoff,
Nyla A. Heerema,
Robert S. Wimmer,
Michael E. Trigg, and
Harland N. Sather
From the Division of Oncology, Children's Hospital of
Philadelphia, PA; Department of Pediatric Hematology-Oncology,
Children's Hospitals and Clinics, Minneapolis, MN; Department of
Radiation Oncology, Long Beach Memorial Medical Center, CA; Children's
Cancer Group Operations Office, Arcadia, CA; Ortho Biotech Oncology,
Weston, FL; Department of Genetics, Wayne Hughes Institute, St Paul,
MN; Department of Pediatrics, Albert Einstein Medical Center,
Philadelphia, PA; Division of Blood and Bone Marrow Transplantation,
Department of Pediatrics, DuPont Hospital for Children, Wilmington, DE;
and Department of Preventive Medicine, Keck School of Medicine,
University of Southern California, Los Angeles.
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.
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