Journal
BLOOD
Volume 115, Issue 16, Pages 3206-3214Publisher
AMER SOC HEMATOLOGY
DOI: 10.1182/blood-2009-10-248146
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Funding
- Comitato M. L. Verga and Fondazione Tettamanti
- Fondazione Citta della Speranza
- Fondazione Cariparo and Grant Ric. Corrente OBG [2006/02/R/001822]
- Associazione Italiana per la Ricerca sul Cancro (AIRC)
- Fondazione Cariplo
- Ministero dell'Istruzione, Universita e Ricerca (MIUR)
- Deutsche Krebshilfe [50-2698 Schr1, 50-2410 Ba7]
- Competence Network Pediatric Hematology and Oncology (KPOH)
- Federal Ministry of Research (BMBF)
- Oncosuisse/Krebsforschung Schweiz [OCS 1230-02-2002]
- St Anna Kinderkrebsforschung Austria
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The Associazione Italiana di Ematologia Oncologia Pediatrica and the Berlin-Frankfurt-Munster Acute Lymphoblastic Leukemia (AIEOP-BFM ALL 2000) study has for the first time introduced standardized quantitative assessment of minimal residual disease (MRD) based on immunoglobulin and T-cell receptor gene rearrangements as polymerase chain reaction targets (PCR-MRD), at 2 time points (TPs), to stratify patients in a large prospective study. Patients with precursor B (pB) ALL (n = 3184) were considered MRD standard risk (MRD-SR) if MRD was already negative at day 33 (analyzed by 2 markers, with a sensitivity of at least 10(-4)); MRD high risk (MRD-HR) if 10(-3) or more at day 78 and MRD intermediate risk (MRD-IR): others. MRD-SR patients were 42% (1348): 5-year event-free survival (EFS, standard error) is 92.3% (0.9). Fifty-two percent (1647) were MRD-IR: EFS 77.6% (1.3). Six percent of patients (189) were MRD-HR: EFS 50.1% (4.1; P < .001). PCR-MRD discriminated prognosis even on top of white blood cell count, age, early response to prednisone, and genotype. MRD response detected by sensitive quantitative PCR at 2 predefined TPs is highly predictive for relapse in childhood pB-ALL. The study is registered at http://clinicaltrials.gov: NCT00430118 for BFM and NCT00613457 for AIEOP. (Blood. 2010; 115(16): 3206-3214)
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