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The prospects for children with acute lymphoblastic leukemia of being cured has increased in the Czech Republic in the 21st century to 90% – outcome of the ALL-IC BFM 2002 trial


Authors: Kateřina Zdráhalová 1;  Jaroslav Štěrba 2;  Jiří Domanský 2;  Bohumír Blažek 3;  Hana Ptoszková 3;  Vladimír Mihál 4;  Zbyněk Novák 4;  Jiří Hak 5;  Daniela Procházková 6;  Zdena Černá 7;  Pavel Timr 8;  Yahia Jabali 8;  Petr Sedláček 1;  Petr Smíšek 1;  Zuzana Zemanová 9;  Marie Jarošová 10;  Alena Houdková 11;  Ester Mejstříková 1;  Ondřej Hrušák 1;  Jan Zuna 1;  Iveta Janotová 1;  Jan Trka 1;  Jan Starý 1
Authors‘ workplace: Klinika dětské hematologie a onkologie 2. LF UK a FN Motol, Praha 1;  Klinika dětské onkologie FN, Brno 2;  Klinika dětského lékařství FN, Ostrava 3;  Dětská klinika LF UP a FN, Olomouc 4;  Dětská klinika FN, Hradec Králové 5;  Dětská klinika IPVZ, Masarykova nemocnice v Ústí nad Labem, Krajská zdravotní a. s. 6;  Dětská klinika FN, Plzeň 7;  Dětská klinika FN České Budějovice, a. s. 8;  Centrum nádorové cytogenetiky, Ústav klinické biochemie a diagnostiky 1. LF UK a VFN, Praha 9;  Hemato-onkologická klinika LF UP a FN, Olomouc 10;  Oddělení klinické hematologie FN Motol, Praha 11
Published in: Čas. Lék. čes. 2015; 154: 79-89
Category: Original Article

Overview

Background.
Acute lymphoblastic leukemia (ALL) is the most frequent childhood malignancy. Treatment has been unified in the middle of 1980 in the Czech Republic. In 2002–2007 children and adolescents with acute lymphoblastic leukemia were treated in an international randomized trial ALL-IC BFM 2002 in the Czech Republic. 291 patients aged 1–18 years were enrolled; infants below 1 year entered a separate trial.

Methods and results.
Patients were stratified into three risk groups according to their age, initial leukocyte count, prednisone response, presence of fusion genes BCR/ABL or MLL/AF4, bone marrow D+15 and remission status D+33. The whole therapy took 24 months. Randomized late intensification compared standard BFM therapy with extended, usually more intensive experimental treatment. The median follow-up was 8.7 years. Complete remission was achieved in 97.9% patients, 1% died in remission. 11% of children relapsed, 1.7% with CNS involvement. Six children (2.1%) developed secondary malignancy. Event free survival (EFS) 8 years from diagnosis was 83.5%, overall survival (OS) 91.4%. EFS and OS of the risk groups were: standard risk: 89.4%; 98.1%; intermediate risk: 82.6%; 89.6%; high risk: 68.8%; 78.1%. Male sex and age above 10 years were adverse prognostic factors.

Conclusions.
In comparison with the previous trial ALL-BFM 95, significant improvement was achieved.

Keywords:
acute lymphoblastic leukemia – children – chemotherapy – protocol ALL-IC BFM 2002


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