Results of the prospective EORTC Children Leukemia Group study 58081 in precursor B‐ and T‐cell acute lymphoblastic leukemia
Year: 2024
Type: article
Study design: Clinical Trial
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 BCR::ABL1 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/m2/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/m2/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 (p = 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.
Source: HemaSphere
DOI: 10.1002/hem3.70025
Authors: Carine Domenech, Michal Kicinski, Barbara De Moerloose, Caroline Piette, Wadih A. Chahla, Laure Kornreich, Marlène Pasquet, Anne Uyttebroeck, Alexandre Theron, Marilyne Poirée, Chloé Arfeuille, Marleen Bakkus, Nathalie Grardel, Catherine Paillard, Claire Freycon, Frédéric Millot, Pauline Simon, Pierre Philippet, Claire Pluchart, Stefan Suciu, Pierre Rohrlich, Alina Ferster, Yves Bertrand, Hélène Cavé
Institutions: Institut d’Hématologie et d’Oncologie Pédiatrique, Hospices Civils de Lyon, European Organisation for Research and Treatment of Cancer, Ghent University Hospital, University of Liège, Centre Hospitalier Universitaire de Liège, Centre Hospitalier Universitaire de Lille, Université Libre de Bruxelles, Queen Fabiola Children's University Hospital, Hôpital des Enfants, Universitair Ziekenhuis Leuven, Centre Hospitalier Universitaire de Montpellier, Centre Hospitalier Universitaire de Nice, Inserm, Université Paris Cité, Assistance Publique – Hôpitaux de Paris, Hôpital Robert-Debré, Hématopoïèse normale et pathologique : Emergence, environnement et recherche translationnelle, Universitair Ziekenhuis Brussel, Hôpital d'Hautepierre, Centre Hospitalier Universitaire de Grenoble, Centre Hospitalier Universitaire de Poitiers, Centre Hospitalier Universitaire de Besançon, Centre Hospitalier Chrétien, Centre Hospitalier Universitaire de Reims
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,250
OpenAlex ID: W4404327562