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Blood, 1 July 2006, Vol. 108, No. 1, pp. 97-102. Prepublished online as a Blood First Edition Paper on March 14, 2006; DOI 10.1182/blood-2006-01-0066.
CLINICAL TRIALS AND OBSERVATIONS A simplified flow cytometric assay identifies children with acute lymphoblastic leukemia who have a superior clinical outcomeFrom the Departments of Hematology-Oncology, Biostatistics, and Pathology, and International Outreach Program, St Jude Children's Research Hospital, Memphis, TN; the Department of Pediatrics, University of Tennessee, Memphis, TN; and Centro de Hematologia e Oncologia de Pernambuco e Instituto Materno-Infantil de Pernambuco, Recife, Brazil.
Bone marrow normal lymphoid progenitors (CD19+, CD10+, and/or CD34+) are exquisitely sensitive to corticosteroids and other antileukemic drugs. We hypothesized that, in patients with B-lineage acute lymphoblastic leukemia (ALL), cells with this phenotype detected early in treatment should be leukemic rather than normal. We therefore developed a simple and inexpensive flow cytometric assay for such cells and prospectively applied it to bone marrow samples collected on day 19 from 380 children with B-lineage ALL. In 211 patients (55.5%), these cells represented 0.01% or more of the mononuclear cells; results correlated remarkably well with those of more complex flow cytometric and molecular minimal residual disease (MRD) evaluations. Among 84 uniformly treated children, the 10-year incidence of relapse or remission failure was 28.8% ± 7.1% (SE) for the 42 patients with 0.01% or more leukemic cells on day 19 detected by the simplified assay versus 4.8% ± 3.3% for the 42 patients with lower levels (P = .003). These assay results were the strongest predictor of outcome, even after adjustment for competing clinicobiologic variables. Thus, this new assay would enable most treatment centers to identify a high proportion of children with ALL who have an excellent early treatment response and a high likelihood of cure. (Blood. 2006;108:97-102)
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