Results of the prospective EORTC Children Leukemia Group study 58081 in precursor B‐ and T‐cell acute lymphoblastic leukemia

Here, we report the results of the prospective cohort study EORTC-CLG 58081 and compare them to the control arm of the randomized phase 3 trial EORTC-CLG 58951, on which treatment recommendations were built. In both studies, patients aged 1-18 years with <i>BCR::ABL1</i> negative acute lymphoblastic leukemia of the B-lineage (B-ALL) or T-lineage (T-ALL) were treated using a BFM backbone without cranial irradiation. Similarly to the control arm of 58951, prednisolone (PRED) 60 mg/m<sup>2</sup>/day was used for induction therapy, but a few modifications were made. Dexamethasone (DXM) was used in average-risk 2 (AR2) T-ALL and B-ALL during induction, 10 and 6 mg/m<sup>2</sup>/day, respectively. Leucovorin rescue was delayed to 42 h instead of 36 h after initiation of high-dose methotrexate, and a postconsolidation MRD time point was added to stratify patients. Between 2011 and 2017, 835 patients were prospectively enrolled in the 58081 study. Overall, the 5-year event-free survival (EFS) was 84.8% versus 83.6% (hazard ratio [HR], 0.96 [95% confidence interval [CI]: 0.76-1.21]) for 58081 versus 58951 considered as a control group, respectively, 84.3% versus 84.9% (HR, 1.06 [99% CI: 0.75-1.49]) in B-ALL but 87.3% versus 76.6% (HR, 0.59 [99% CI: 0.28-1.24]) in T-ALL. The comparison between the two studies regarding EFS differed by risk group (<i>p</i> = 0.012). The HR was 2.15 (99% CI: 0.67-6.85) for very low-risk but 0.34 (99% CI: 0.13-0.89) for AR2. The particularly favorable results observed in the T-ALLs and AR2 subgroups suggest the benefit of using DXM in specific patient groups and highlight the importance of risk stratification.

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Publication Details

Journal
HemaSphere
Published
2024-11-01
DOI
https://doi.org/10.1002/hem3.70025
Citations
2
Primary Topic
Acute Lymphoblastic Leukemia research
Type
article
Field-Weighted Citation Impact
1.09

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article

Results of the prospective EORTC Children Leukemia Group study 58081 in precursor B‐ and T‐cell acute lymphoblastic leukemia

Alexandre Théron, Catherine Paillard, Hélène Cavé, Laure Kornreich et al.
2 citations
HemaSphere
Acute Lymphoblastic Leukemia research
1.09
article

Results of the prospective EORTC Children Leukemia Group study 58081 in precursor B‐ and T‐cell acute lymphoblastic leukemia

Alexandre Théron, Catherine Paillard, Hélène Cavé, Laure Kornreich, Alina Ferster, Claire Pluchart, Marilyne Poirée, Marlène Pasquet, Michal Kiciński, Nathalie Grardel, Chloé Arfeuille, Pierre‐Simon Rohrlich, Wadih Abou Chahla, Anne Uyttebroeck, Barbara De Moerloose, Carine Domenech, Claire Freyçon, Stefan Suciu, Pauline Simon, Caroline Piette, Marleen Bâkkus, Yves Bertrand, Frédéric Millot, Pierre Philippet
article en
2 citations

Abstract

Here, we report the results of the prospective cohort study EORTC-CLG 58081 and compare them to the control arm of the randomized phase 3 trial EORTC-CLG 58951, on which treatment recommendations were built. In both studies, patients aged 1-18 years with <i>BCR::ABL1</i> negative acute lymphoblastic leukemia of the B-lineage (B-ALL) or T-lineage (T-ALL) were treated using a BFM backbone without cranial irradiation. Similarly to the control arm of 58951, prednisolone (PRED) 60 mg/m<sup>2</sup>/day was used for induction therapy, but a few modifications were made. Dexamethasone (DXM) was used in average-risk 2 (AR2) T-ALL and B-ALL during induction, 10 and 6 mg/m<sup>2</sup>/day, respectively. Leucovorin rescue was delayed to 42 h instead of 36 h after initiation of high-dose methotrexate, and a postconsolidation MRD time point was added to stratify patients. Between 2011 and 2017, 835 patients were prospectively enrolled in the 58081 study. Overall, the 5-year event-free survival (EFS) was 84.8% versus 83.6% (hazard ratio [HR], 0.96 [95% confidence interval [CI]: 0.76-1.21]) for 58081 versus 58951 considered as a control group, respectively, 84.3% versus 84.9% (HR, 1.06 [99% CI: 0.75-1.49]) in B-ALL but 87.3% versus 76.6% (HR, 0.59 [99% CI: 0.28-1.24]) in T-ALL. The comparison between the two studies regarding EFS differed by risk group (<i>p</i> = 0.012). The HR was 2.15 (99% CI: 0.67-6.85) for very low-risk but 0.34 (99% CI: 0.13-0.89) for AR2. The particularly favorable results observed in the T-ALLs and AR2 subgroups suggest the benefit of using DXM in specific patient groups and highlight the importance of risk stratification.

HemaSphereVol. 8(11)
Université Claude Bernard Lyon 1 (FR), Hôpital américain de paris (FR), Inserm (FR), University of Liège (BE), Université Paris Cité (FR), Universitair Ziekenhuis Leuven (BE), Centre Hospitalier Universitaire de Grenoble (FR), Ghent University Hospital (BE), Centre Hospitalier Universitaire de Lille (FR), Centre Hospitalier Universitaire de Nice (FR), Centre Hospitalier Chrétien (BE), Centre Hospitalier Universitaire de Besançon (FR), Institut d’Hématologie et d’Oncologie Pédiatrique (FR), Lille’s Cardiology Hospital (FR), Sorbonne Paris Cité (FR), Centre Hospitalier Universitaire de Montpellier (FR), Hospices Civils de Lyon (FR), Queen Fabiola Children's University Hospital (BE), Centre Hospitalier Universitaire de Poitiers (FR), European Organisation for Research and Treatment of Cancer (BE), Hôpital Robert-Debré (FR), Universitair Ziekenhuis Brussel (BE)
Société Française de lutte contre les Cancers et les leucémies de l'Enfant et de l'Adolescent, European Commission, Fondation ARC pour la Recherche sur le Cancer
Good health and well-being
Openalex Percentile: Top 19%
Acute Lymphoblastic Leukemia research
1.09
DOIOpen Access PDFOpenAlex
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