Results in pediatric T‐ALL patients treated in trial AIEOP‐BFM ALL 2009: Prognostic factors in the context of modern risk‐adapted therapy

To improve the outcome of pediatric T-cell acute lymphoblastic leukemia (T-ALL) patients, the AIEOP-BFM ALL 2009 trial modified T-ALL stratification and treatment based on AIEOP-BFM ALL 2000 and other pediatric ALL groups' results. This report aims to describe the outcome of T-ALL patients in trial AIEOP-BFM ALL 2009 and evaluate prognostic features defined within the end of induction (EOI) therapy, for future protocols stratification and interventions. From 06/2010 to 02/2017, 872 T-ALL patients, aged 1-17, were enrolled. High risk (HR) criteria were prednisone poor response (PPR), Day 15 flow cytometry minimal residual disease (MRD) ≥ 10%, no complete remission at EOI, or polymerase chain reaction (PCR)-MRD ≥ 5 × 10<sup>-4</sup> at end of consolidation (EOC). Three Cox regression models on event-free survival (EFS) evaluated prognostic factors. Overall, 5-year EFS and survival were 79.9% ± 1.4% and 84.9% ± 1.2% with cumulative incidence of relapse (CIR) and death of 13.0% ± 1.2% and 5.9% ± 0.8%. Five-year EFS and CIR were 86.8% ± 1.6% and 8.7% ± 1.3% in non-HR patients (<i>n</i> = 470); 71.9% ± 2.3% and 18.0% ± 1.9% in HR patients (<i>n</i> = 402). High PCR-MRD levels at EOI and EOC were prognostic in all models, with EOC-MRD ≥ 5 × 10<sup>-3</sup> related to a hazard ratio of 6.22 (P < 0.001). When a model considered factors identified at EOI only, central nervous system (CNS)3 (hazard ratio = 2.3, P < 0.001), PPR (hazard ratio = 1.74, P = 0.02), and high EOI-MRD (hazard ratio 4.71 for ≥5 × 10<sup>-2</sup> vs. negative, P < 0.001) significantly impacted EFS. Results of T-ALL patients in AIEOP-BFM ALL 2009 were favorable. While EOC-MRD remained the strongest prognostic predictor, PPR, CNS3 disease, and EOI-MRD showed relevant prognostic value, with CNS3 and EOI-MRD ≥ 5 × 10<sup>-2</sup> being candidate criteria for early stratification and intervention modifications.

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Journal
HemaSphere
Published
2025-09-01
DOI
https://doi.org/10.1002/hem3.70206
Citations
1
Primary Topic
Acute Lymphoblastic Leukemia research
Type
article
Field-Weighted Citation Impact
1.88

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article

Results in pediatric T‐ALL patients treated in trial AIEOP‐BFM ALL 2009: Prognostic factors in the context of modern risk‐adapted therapy

Valentino Conter, Martin Stanulla, Annika Rademacher, Draga Barbaric et al.
1 citations
HemaSphere
Acute Lymphoblastic Leukemia research
1.88
article

Results in pediatric T‐ALL patients treated in trial AIEOP‐BFM ALL 2009: Prognostic factors in the context of modern risk‐adapted therapy

Valentino Conter, Martin Stanulla, Annika Rademacher, Draga Barbaric, Martin Schrappe, Franco Locatelli, Shai Izraeli, Luciano Dalla‐Pozza, Ondřej Hrušák, Martin Zimmermann, Jan Starý, Daniela Silvestri, Gunnar Cario, Michaela Vossen‐Gajcy, Barbara Buldini, Andrea Biondi, Jean‐Pierre Bourquin, Carmelo Rizzari, Michael Dworzak, Nicole Bodmer, Anja Möricke, Lennart Lenk, Franca Fagioli, Maria Grazia Valsecchi, Giacomo Gotti, Sarah Elitzur, Andishe Attarbaschi, A. E. Kulozik
article en
1 citations

Abstract

To improve the outcome of pediatric T-cell acute lymphoblastic leukemia (T-ALL) patients, the AIEOP-BFM ALL 2009 trial modified T-ALL stratification and treatment based on AIEOP-BFM ALL 2000 and other pediatric ALL groups' results. This report aims to describe the outcome of T-ALL patients in trial AIEOP-BFM ALL 2009 and evaluate prognostic features defined within the end of induction (EOI) therapy, for future protocols stratification and interventions. From 06/2010 to 02/2017, 872 T-ALL patients, aged 1-17, were enrolled. High risk (HR) criteria were prednisone poor response (PPR), Day 15 flow cytometry minimal residual disease (MRD) ≥ 10%, no complete remission at EOI, or polymerase chain reaction (PCR)-MRD ≥ 5 × 10<sup>-4</sup> at end of consolidation (EOC). Three Cox regression models on event-free survival (EFS) evaluated prognostic factors. Overall, 5-year EFS and survival were 79.9% ± 1.4% and 84.9% ± 1.2% with cumulative incidence of relapse (CIR) and death of 13.0% ± 1.2% and 5.9% ± 0.8%. Five-year EFS and CIR were 86.8% ± 1.6% and 8.7% ± 1.3% in non-HR patients (<i>n</i> = 470); 71.9% ± 2.3% and 18.0% ± 1.9% in HR patients (<i>n</i> = 402). High PCR-MRD levels at EOI and EOC were prognostic in all models, with EOC-MRD ≥ 5 × 10<sup>-3</sup> related to a hazard ratio of 6.22 (P < 0.001). When a model considered factors identified at EOI only, central nervous system (CNS)3 (hazard ratio = 2.3, P < 0.001), PPR (hazard ratio = 1.74, P = 0.02), and high EOI-MRD (hazard ratio 4.71 for ≥5 × 10<sup>-2</sup> vs. negative, P < 0.001) significantly impacted EFS. Results of T-ALL patients in AIEOP-BFM ALL 2009 were favorable. While EOC-MRD remained the strongest prognostic predictor, PPR, CNS3 disease, and EOI-MRD showed relevant prognostic value, with CNS3 and EOI-MRD ≥ 5 × 10<sup>-2</sup> being candidate criteria for early stratification and intervention modifications.

HemaSphereVol. 9(9)
Università Cattolica del Sacro Cuore (IT), University of Padua (IT), Tel Aviv University (IL), Charles University (CZ), Heidelberg University (DE), University Hospital Heidelberg (DE), Children's Hospital at Westmead (AU), UNSW Sydney (AU), Medizinische Hochschule Hannover (DE), University Hospital in Motol (CZ), Schneider Children's Medical Center (IL), Azienda Ospedaliera San Gerardo (IT), University Hospital Schleswig-Holstein (DE), Children's & Women's Health Centre of British Columbia (CA), Bambino Gesù Children's Hospital (IT), St Anna Children's Hospital (AT), Sydney Children's Hospital (AU), University Children's Hospital Zurich (CH), Ospedale Regina Margherita (IT), Istituti di Ricovero e Cura a Carattere Scientifico (IT), Grammar School (SK), St. Anna Children's Cancer Research Institute, University of Milano-Bicocca (IT), Medical University of Vienna (AT), University of Lübeck (DE)
Ministero della Salute
Openalex Percentile: Top 12%
Acute Lymphoblastic Leukemia research
1.88
DOIOpen Access PDFOpenAlex
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