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Blood. 2018 Jul 26;132(4):405-412. doi: 10.1182/blood-2018-03-836528. Epub 2018 May 22.

Risk-adapted treatment of acute promyelocytic leukemia: results from the International Consortium for Childhood APL.

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Department of Cellular Biotechnologies and Hematology, Sapienza University of Rome, Rome, Italy.
Department of Pediatrics, Sant'Orsola Hospital, University of Bologna, Bologna, Italy.
Division of Genetics and Molecular Medicine, King's College, London, United Kingdom.
Department of Paediatric Haematology, Royal Hospital for Children, Glasgow, United Kingdom.
Hematology/Oncology Department, Boldrini's Children Center, Campinas, Sao Paulo, Brazil.
Grupo Argentino de Tratamiento de la Leucemia Aguda, Buenos Aires, Argentina.
Assistance Publique-Hôpitaux de Paris, Hospital Armand Trousseau, Sorbonne Universitè, Paris, France.
Pediatric Hematology-Oncology, Schneider Children's Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Department of Pediatrics, Aarhus University Hospital, Aarhus, Denmark.
Department of Pediatrics, Universitair Ziekenhuis Brussel, Brussels, Belgium.
Department of Paediatric Hematology/Oncology, Our Lady's Children's Hospital, Dublin, Ireland.
Cineca Interuniversity Consortium, Bologna, Italy.
Gruppo Italiano Malattie Ematologiche dell'Adulto Foundation, Rome, Italy.
Department of Biomedicine and Prevention, Tor Vergata University of Rome, Rome, Italy.
Department of Pediatric Hematology/Oncology, IRCCS Bambino Gesù Children's Hospital, Rome, Italy.
Department of Pediatric Sciences, University of Pavia, Pavia, Italy.
Pediatric Oncology, VU University Medical Center, Amsterdam, The Netherlands.
Princess Maxima Center for Pediatric Oncology, Utrecht, The Netherlands; and.
Dutch Childhood Oncology Group, The Hague, The Netherlands.


Pediatric acute promyelocytic leukemia (APL) can be cured with all-trans retinoic acid (ATRA) and anthracycline. However, most published trials have employed high cumulative doses of anthracyclines. Here, we report the outcome of newly diagnosed APL patients enrolled in the International Consortium for Childhood APL (ICC-APL-01) trial, which reduced anthracycline exposure but extended that of ATRA. The study recruited 258 children/adolescents with molecularly/cytogenetically proven APL. Patients were stratified into standard-risk (SR) and high-risk (HR) groups according to baseline white blood cell counts (<10 × 109/L or ≥10 × 109/L); both groups received identical induction treatment with ATRA and 3 doses of idarubicin. Two or 3 blocks of consolidation therapy were administered to SR and HR patients, respectively, while maintenance therapy with low-dose chemotherapy and ATRA cycles was given to all patients for 2 years. The cumulative dose of daunorubicin equivalent anthracyclines in SR and HR patients was lower than that of previous studies (355 mg/m2 and 405 mg/m2, respectively). Hematologic remission was obtained in 97% of patients; 8 children died of intracranial hemorrhage in the first 2 weeks following diagnosis. Five-year overall and event-free survival for the whole cohort were 94.6% and 79.9%, respectively; they were 98.4% and 89.4% in SR patients and 84.3% and 74.2% in HR patients (P = .002 and P = .043, respectively). These data demonstrate that extended use of ATRA coupled to a risk-adapted consolidation can achieve high cure rates in childhood APL and limit anthracycline exposure. The trial was registered at as EudractCT 2008-002311-40.

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