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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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
August 18, 2025
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| 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 
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| 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 |
MARC
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| 245 | 1 | 0 | |a Arsenic trioxide and all-trans retinoic acid combination therapy for the treatment of high-risk acute promyelocytic leukemia |b results from the APOLLO trial : hematologic malignancy |c 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 |
| 264 | 1 | |c August 18, 2025 | |
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| 500 | |a 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) | ||
| 500 | |a Gesehen am 08.01.2026 | ||
| 520 | |a 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. | ||
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