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Arsenic trioxide and all-trans retinoic acid combination therapy for the treatment of high-risk acute promyelocytic leukemia: results from the APOLLO trial : hematologic malignancy

Purpose - The phase III APOLLO trial prospectively compared the efficacy of arsenic trioxide (ATO) in combination with all-trans retinoic acid (ATRA) regimen (ATRA and ATO [ATRA-ATO]) plus low-dose idarubicin versus standard ATRA plus anthracycline-based chemotherapy (ATRA-CHT) regimen (ie, ATRA and...

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Hauptverfasser: Platzbecker, Uwe (VerfasserIn) , Adès, Lionel (VerfasserIn) , Montesinos, Pau (VerfasserIn) , Ammatuna, Emanuele (VerfasserIn) , Fenaux, Pierre (VerfasserIn) , Baldus, Claudia (VerfasserIn) , Bernardi, Massimo (VerfasserIn) , Berthon, Céline (VerfasserIn) , Bocchia, Monica (VerfasserIn) , Bonmati, Caroline (VerfasserIn) , Borlenghi, Erika (VerfasserIn) , Bornhäuser, Martin (VerfasserIn) , Carp, Diana (VerfasserIn) , Chantepie, Sylvain (VerfasserIn) , Crea, Enrico (VerfasserIn) , Divona, Mariadomenica (VerfasserIn) , Döhner, Hartmut (VerfasserIn) , Ehninger, Gerhard (VerfasserIn) , Esteve Reyner, Jordi (VerfasserIn) , Frayfer, Jamilé (VerfasserIn) , Garrido Diaz, Ana (VerfasserIn) , Gil, Cristina (VerfasserIn) , Guarnera, Luca (VerfasserIn) , Hamm, Anna Franziska (VerfasserIn) , Heiblig, Maël (VerfasserIn) , Heidenreich, Daniela (VerfasserIn) , Krämer, Alwin (VerfasserIn) , Ledoux, Marie-Pierre (VerfasserIn) , Lunghi, Monia (VerfasserIn) , Mancini, Valentina (VerfasserIn) , Metzeler, Klaus (VerfasserIn) , Miggiano, Maria Cristina (VerfasserIn) , Müller-Tidow, Carsten (VerfasserIn) , Peterlin, Pierre (VerfasserIn) , Piciocchi, Alfonso (VerfasserIn) , Rieger, Kathrin (VerfasserIn) , Röllig, Christoph (VerfasserIn) , Rossi, Giovanni (VerfasserIn) , Sanz, Miguel A. (VerfasserIn) , Serve, Hubert (VerfasserIn) , Söhne, Maaike (VerfasserIn) , Spiekermann, Karsten (VerfasserIn) , Tavernier-Tardy, Emmanuelle (VerfasserIn) , Thiede, Christian (VerfasserIn) , Vives Polo, Susana (VerfasserIn) , Vogel, Wichard (VerfasserIn) , Zappasodi, Patrizia (VerfasserIn) , Ziller-Walter, Pauline (VerfasserIn) , Voso, Maria Teresa (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: August 18, 2025
In: Journal of clinical oncology
Year: 2025, Jahrgang: 43, Heft: 29, Pages: 3160-3169
ISSN:1527-7755
DOI:10.1200/JCO-25-00535
Online-Zugang:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1200/JCO-25-00535
Verlag, lizenzpflichtig, Volltext: https://ascopubs.org/doi/10.1200/JCO-25-00535
Volltext
Verfasserangaben:Uwe Platzbecker, MD, Lionel Adès, MD, PhD, Pau Montesinos, MD, Emanuele Ammatuna, MD, PhD, Pierre Fenaux, MD, PhD, Daniela Heidenreich, MD [und viele weitere], on behalf of the SAL, AMCL-CG, AML-SG, OSHO, PETHEMA, HOVON and GIMEMA study groups
Beschreibung
Zusammenfassung:Purpose - The phase III APOLLO trial prospectively compared the efficacy of arsenic trioxide (ATO) in combination with all-trans retinoic acid (ATRA) regimen (ATRA and ATO [ATRA-ATO]) plus low-dose idarubicin versus standard ATRA plus anthracycline-based chemotherapy (ATRA-CHT) regimen (ie, ATRA and idarubicin regimen) in patients with high-risk acute promyelocytic leukemia (APL; EudraCT 2015-01151-68; ClinicalTrials.gov identifier: NCT02688140). - Methods - Adult patients with newly diagnosed high-risk APL in the ATRA-ATO arm received ATO 0.15 mg/kg once daily and ATRA 45 mg/m2 twice daily until complete remission (CR), with two doses of idarubicin 12 mg/m2 on days 1 and 3, followed by consolidation therapy (four ATRA-ATO cycles). Patients in the ATRA-CHT arm received induction with ATRA 45 mg/m2 twice daily and idarubicin 12 mg/m2 once daily on days 1, 3, 5, and 7, followed by three cycles of chemotherapy-based consolidation and 2 years of maintenance therapy. The primary study end point was event-free survival (EFS) at 2 years. - Results - As of July 2022, 133 eligible patients had received either ATRA-ATO (n = 68) or ATRA-CHT (n = 65). The study was discontinued prematurely because of slow accrual during the COVID-19 pandemic. After a median follow-up of 37 months (range, 1.7-88.6 months), 2-year EFS was 88% in the ATRA-ATO arm and 71% in the ATRA-CHT arm (HR, 0.4 [95% CI, 0.17 to 0.92]; log-rank test P = .02). At a median of 7.8 and 12.1 months from achievement of CR, molecular relapse occurred in one (1.5%) ATRA-ATO patient versus eight (12.3%) ATRA-CHT patients (P = .014). Overall, 32% and 68% of patients receiving ATRA-ATO and ATRA-CHT, respectively, reported serious treatment-emergent adverse events (P < .01). - Conclusion - The results of the APOLLO trial support the use of ATO and ATRA for the treatment of newly diagnosed patients with high-risk APL.
Beschreibung:Mitglieder der SAL, AMCL-CG, AML-SG, OSHO, PETHEMA, HOVON, AND GIMEMA STUDY GROUPS: Fatiha Chermat (Groupe Francophone des My´elodysplasies (GFM), Hopital Saint Louis; Service d’Hematologie S´eniors, Paris, France); Livia Gorreo Renzulli, MSc(Fondazione GIMEMA Franco Mandelli Onlus, Roma, Italy); Madlen Jentzsch, MD (University Hospital Leipzig, Department for Hematology, Cellular Therapy and Hemostaseology, Leipzig, Germany); Dietger Niederwieser, MD (University Hospital Leipzig, Department for Hematology, Cellular Therapy and Hemostaseology, Leipzig, Germany); Michaela Weier (TUD Dresden University of Technology - Faculty of Medicine Carl Gustav Carus, Medical Clinic I, Dresden, Germany); Sven Zukunft, PhD (TUD Dresden University of Technology - Faculty of Medicine Carl Gustav Carus, Medical Clinic I, Dresden, Germany)
Gesehen am 08.01.2026
Beschreibung:Online Resource
ISSN:1527-7755
DOI:10.1200/JCO-25-00535

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