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Prognostic Role of Minimal Residual Disease in Mature B-Cell Acute Lymphoblastic Leukemia of Childhood

Lara Mussolin, Marta Pillon, Valentino Conter, Matilde Piglione, Luca Lo Nigro, Paolo Pierani, Concetta Micalizzi, Salvatore Buffardi, Giuseppe Basso, Luigi Zanesco, Angelo Rosolen

From the Clinica di Oncoematologia Pediatrica, Azienda Ospedaliera-Università di Padova, Padova; Clinica Pediatrica, Ospedale S. Gerardo, Monza; Clinica Pediatrica, Ospedale Regina Margherita, Torino; Centro di Riferimento Regionale di Ematologia ed Oncologia Pediatrica, Università di Catania, Catania; Oncoematologia Pediatrica, Politecnico delle Marche, Ancona; Ematologia Pediatrica, Istituto Gaslini, Genova; Ospedale Pausilipon, Napoli; and the Comitato Strategico di Studio Linfoma Non-Hodgkin Associazione Italiana Emato-Oncologia Pediatrica, Italy

Address reprint requests to Angelo Rosolen, MD, Clinica di Oncoematologia Pediatrica, Azienda Ospedaliera-Università di Padova, Via Giustiniani 3, 35128 Padova, Italy; e-mail: angelo.rosolen{at}unipd.it

Purpose To study the prevalence of t(8;14) at diagnosis and the response kinetics to treatment of minimal residual disease (MRD) in B-cell acute lymphoblastic leukemia (B-ALL) patients and determine its impact on prognosis.

Patients and Methods A total of 68 children affected by de novo B-ALL enrolled onto the Berlin-Frankfurt-Muenster–based Italian Association of Pediatric Hematology and Oncology LNH-97 clinical protocol were studied. Bone marrow aspirate from each patient was analyzed for the presence of t(8;14)(q24;q32) by long-distance polymerase chain reaction at diagnosis, after the first chemotherapy cycle, and after subsequent cycles until negative for MRD. Morphologic and immunophenotypic analyses were reviewed centrally.

Results A total of 47 patients (69%) were positive for t(8;14)(q24;q32). MRD response kinetics was determined in 39 patients. All of them reached clinical complete remission and most (31 of 39) became MRD negative after the first chemotherapy cycle. The 3-year relapse-free survival (RFS) was 38% (SE = 17%) in patients MRD positive after the first chemotherapy cycle compared with 84% (SE = 7%) in MRD-negative patients (P = .0005), whereas there was no difference in RFS for children who reached a clinical complete remission after the first chemotherapy cycle versus those who did not (RFS = 72% and SE = 9%; RFS = 79% and SE = 11%, respectively; P = .8). In multivariate analysis, MRD was shown to be predictive of higher risk of failure.

Conclusion Our study demonstrated that MRD carries a negative prognostic impact in B-ALL patients and suggests that a better risk-adapted therapy, possibly including the use of anti-CD20 monoclonal antibody, should be considered in selected patients.

Supported by Fondazione Città della Speranza, Associazione Italiana contro le Leucemie and by Camera di Commercio di Venezia.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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