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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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Main Authors: Platzbecker, Uwe (Author) , Adès, Lionel (Author) , Montesinos, Pau (Author) , Ammatuna, Emanuele (Author) , Fenaux, Pierre (Author) , Baldus, Claudia (Author) , Bernardi, Massimo (Author) , Berthon, Céline (Author) , Bocchia, Monica (Author) , Bonmati, Caroline (Author) , Borlenghi, Erika (Author) , Bornhäuser, Martin (Author) , Carp, Diana (Author) , Chantepie, Sylvain (Author) , Crea, Enrico (Author) , Divona, Mariadomenica (Author) , Döhner, Hartmut (Author) , Ehninger, Gerhard (Author) , Esteve Reyner, Jordi (Author) , Frayfer, Jamilé (Author) , Garrido Diaz, Ana (Author) , Gil, Cristina (Author) , Guarnera, Luca (Author) , Hamm, Anna Franziska (Author) , Heiblig, Maël (Author) , Heidenreich, Daniela (Author) , Krämer, Alwin (Author) , Ledoux, Marie-Pierre (Author) , Lunghi, Monia (Author) , Mancini, Valentina (Author) , Metzeler, Klaus (Author) , Miggiano, Maria Cristina (Author) , Müller-Tidow, Carsten (Author) , Peterlin, Pierre (Author) , Piciocchi, Alfonso (Author) , Rieger, Kathrin (Author) , Röllig, Christoph (Author) , Rossi, Giovanni (Author) , Sanz, Miguel A. (Author) , Serve, Hubert (Author) , Söhne, Maaike (Author) , Spiekermann, Karsten (Author) , Tavernier-Tardy, Emmanuelle (Author) , Thiede, Christian (Author) , Vives Polo, Susana (Author) , Vogel, Wichard (Author) , Zappasodi, Patrizia (Author) , Ziller-Walter, Pauline (Author) , Voso, Maria Teresa (Author)
Format: Article (Journal)
Language:English
Published: August 18, 2025
In: Journal of clinical oncology
Year: 2025, Volume: 43, Issue: 29, Pages: 3160-3169
ISSN:1527-7755
DOI:10.1200/JCO-25-00535
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1200/JCO-25-00535
Verlag, lizenzpflichtig, Volltext: https://ascopubs.org/doi/10.1200/JCO-25-00535
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Author Notes: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
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Summary: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.
Item Description: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
Physical Description:Online Resource
ISSN:1527-7755
DOI:10.1200/JCO-25-00535

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