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Long-Term Results of the AIEOP-ALL-95 Trial for Childhood Acute Lymphoblastic Leukemia: Insight on the Prognostic Value of DNA Index in the Framework of Berlin-Frankfurt-Muenster–Based Chemotherapy

Maurizio Aricò, Maria Grazia Valsecchi, Carmelo Rizzari, Elena Barisone, Andrea Biondi, Fiorina Casale, Franco Locatelli, Luca Lo Nigro, Matteo Luciani, Chiara Messina, Concetta Micalizzi, Rosanna Parasole, Andrea Pession, Nicola Santoro, Anna Maria Testi, Daniela Silvestri, Giuseppe Basso, Giuseppe Masera, Valentino Conter

From the Pediatric Hematology Oncology, Ospedale dei Bambini G. Di Cristina, Palermo; Medical Statistics Unit and Department of Pediatrics, University of Milano-Bicocca, Milano; Ospedale San Gerardo, Monza; Pediatric Hematology Oncology, Torino; I Clinica Pediatrica, University of Napoli, Napoli; Pediatric Hematology Oncology, University of Pavia, Pavia; Pediatric Hematology Oncology, University of Catania, Catania; Pediatric Hematology, IRCCS Ospedale Bambino Gesù; Department of Hematology, University La Sapienza, Rome; Pediatric Hematology Oncology, University of Padua, Padua; Pediatric Hematology Oncology, Istituto di Ricovero e Cura a Carattere Scientifico, I.G. Gaslini, Genua, Genua; Pediatric Hematology Oncology, Ospedale Pausilipon, Naples; Pediatric Hematology Oncology, University of Bologna, Bologna; and Pediatric Hematology Oncology, University of Bari, Bari, Italy

Corresponding author: Giuseppe Basso, MD, Laboratorio di Oncoematologia Dipartimento di Pediatria, Università di Padova, Via Giustiniani, 3, 35128 Padova, Italy; e-mail: giuseppe.basso{at}unipd.it

Purpose Between May 1995 and August 2000 the Associazione Italiana di Ematologia Oncologia Pediatrica conducted the ALL-95 study for risk-directed, Berlin-Frankfurt-Muenster (BFM) –oriented therapy of childhood acute lymphoblastic leukemia, aimed at exploring treatment reduction in standard-risk patients (SR) and intensification during continuation therapy in intermediate-risk patients (IR) as randomized questions and treatment intensification in high-risk patients (HR). The prognostic value of DNA index was explored in this setting.

Patients and Methods A total of 1,744 patients were enrolled (115, SR; 1,385, IR; and 244, HR). SR patients (DNA index 1.16 and < 1.60; age, 1 to 5 years; and WBC < 20,000, non–T-immunophenotype, with no high-risk features) received a reduced induction therapy (no anthracyclines); IR patients were randomly assigned to receive or not receive vincristine and dexamethasone pulses during maintenance; HR therapy was based on a conventional BFM schedule intensified with three chemotherapy blocks followed by a double reinduction phase.

Results The event-free survival and overall survival probabilities at 10 years for the entire group were 72.5% (SE, 1.3) and 83.6% (SE, 0.9); 85.0% (SE, 3.4) and 95.5% (SE, 2.0) in SR, 75.1% (SE, 1.5) and 87.5% (SE, 0.9) in IR, and 51.0% (SE, 3.2) and 57.2% (SE, 3.3) in HR patients, respectively. Patients with a favorable DNA index had superior EFS in both IR (83.8% [2.7%] v 73.9% [1.7%]) and in HR (67.8% [9.4%] and 49.6% [3.5%]). Of the six patients with DNA index less than 0.8, only one remained in remission.

Conclusion Favorable DNA index was associated with a better prognosis in IR and HR patients defined by presenting clinical criteria and treatment with a BFM-oriented chemotherapy.

Supported by Associazione Italiana per la Ricerca sul Cancro, Ministero dell’Università e della Ricerca, Programmi di ricerca cofinanziati 2003 prot. 2003068942_001, Ric. Corr. Ospedale Bambino Gesù, Roma 2005-02P001576, Fondazione Tettamanti, Comitato M.L. Verga, and Fondazione Città della Speranza.

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

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