Arsenic Trioxide and All-Trans Retinoic Acid Combination Therapy for the Treatment of High-Risk Acute Promyelocytic Leukemia: Results From the APOLLO Trial.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
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Platzbecker Uwe, Adès Lionel, Montesinos Pau, Ammatuna Emanuele, Fenaux Pierre, Baldus Claudia, Bernardi Massimo, Berthon Céline, Bocchia Monica, Bonmati Caroline, Borlenghi Erika, Bornhäuser Martin, Carp Diana, Chantepie Sylvain, Crea Enrico, Divona Mariadomenica, Döhner Hartmut, Ehninger Gerhard, Esteve Reyner Jordi, Frayfer Jamilé, Garrido Diaz Ana, Gil Cristina, Guarnera Luca, Hamm Anna Franziska, Heiblig Maël, Heidenreich Daniela, Krämer Alwin Johannes, Ledoux Marie-Pierre, Lunghi Monia, Mancini Valentina, Metzeler Klaus, Miggiano Maria Cristina, Müller-Tidow Carsten, Peterlin Pierre, Piciocchi Alfonso, Rieger Kathrin, Röllig Christoph, Rossi Giovanni, Sanz Miguel A, Serve Hubert, Söhne Maaike, Spiekermann Karsten, Tavernier-Tardy Emmanuelle, Thiede Christian, Vives Polo Susana, Vogel Wichard, Zappasodi Patrizia, Ziller-Walter Pauline, Voso Maria Teresa, SAL, AMCL-CG, AML-SG, OSHO, PETHEMA, HOVON and GIMEMA study groups
Аннотация
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.