Publication Date:
2004-11-16
Description:
DFCI Consortium Protocol 95–01 was designed to minimize therapy-related morbidity for children with newly diagnosed ALL without compromising efficacy. Patients were considered high risk (HR) if they met any of the following criteria: 1) white blood cell count (WBC) ≥ 50,000/microliter, 2) age between 〈 1.00 years or ≥ 10.00 years, 3) presence of leukemia blasts at diagnosis in a cytocentrifuged cerebrospinal fluid specimen, 4) presence of a mediastinal mass, 5) T-cell immunophenotype, or 6) presence of the Philadelphia chromosome. All other patients were considered standard risk (SR). The protocol included three randomizations designed to evaluate whether acute and late toxicities could be reduced, including comparisons of 1) Erwinia and E.coli asparaginase given weekly for 20 weeks during post-remission consolidation (SR and HR patients), 2) intrathecal chemotherapy given with or without 18 Gy cranial radiation as central nervous system (CNS)-directed treatment (SR patients only), and 3) doxorubicin given with or without dexrazoxane, a potential cardioprotectant agent, during remission induction and post-remission consolidation (HR patients only). Between 1996 and 2000, 491 eligible patients (ages 0-18 years) were enrolled, 272 of whom were classified as SR and 219 HR. With 4.6 years median follow-up, the estimated 5-year event-free survival (EFS) was 81 ± 2% for all patients. The 5-year EFS according to risk group was 86 ± 2% for SR and 76 ± 3% for HR patients (p
Print ISSN:
0006-4971
Electronic ISSN:
1528-0020
Topics:
Biology
,
Medicine
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