Characteristics and outcome of patients with low-/intermediate-risk acute promyelocytic leukemia treated with arsenic trioxide - an international collaborative study.

The aim of this study was to characterize a large series of 154 patients with acute promyelocytic leukemia (APL; median age, 53 years; range, 18-90 years) and evaluate real-life outcome after up-front treatment with arsenic trioxide (ATO) and alltrans retinoic acid (ATRA). All patients were included in the prospective NAPOLEON registry (NCT02192619) between 2013 and 2019. APL was de novo in 91% (n=140) and therapy-related in 9% (n=14); 13% (n=20) were older than 70 years. At diagnosis bleeding/hemorrhage was present in 38% and thrombosis in 3%. Complete remission was achieved in 152 patients (99%), whereas two patients (1%) experienced induction death within 18 days after start of therapy. With a median follow-up of 1.99 years (95%-CI, 1.61-2.30 years) 1-year and 2-years overall survival (OS) rates were 97% (95%-CI, 94-100%) and 95% (95%-CI, 91-99%), respectively. Age above 70 years was associated with a significantly shorter OS (P<0.001) as compared to younger patients. So far no relapses were observed. Six patients (4%) died in CR after in median 0.95 years after diagnosis (range, 0.18-2.38 years). Our data confirm the efficiency and durability of ATO/ATRA in the primary management of adult low-/ intermediate-risk APL patients in the real life setting, irrespective of age.

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Authors: Sabine Kayser, Richard F Schlenk, Delphine Lebon, Martin Carre, Katharina S Götze, Friedrich Stölzel, Ana Berceanu, Kerstin Schäfer-Eckart, Pierre Peterlin, Yosr Hicheri, Ramy Rahme, Emmanuel Raffoux, Fatiha Chermat, Stefan W Krause, Walter E Aulitzky, Sophie Rigaudeau, Richard Noppeney, Celine Berthon, Martin Görner, Edgar Jost, Philippe Carassou, Ulrich Keller, Corentin Orvain, Thorsten Braun, Colombe Saillard, Ali Arar, Volker Kunzmann, Mathieu Wemeau, Maike De Wit, Dirk Niemann, Caroline Bonmati, Carsten Schwänen, Julie Abraham, Ahmad Aljijakli, Stephanie Haiat, Alwin Krämer, Albrecht Reichle, Martina Gnadler, Christophe Willekens, Karsten Spiekermann, Wolfgang Hiddemann, Carsten Müller-Tidow, Christian Thiede, Christoph Röllig, Hubert Serve, Martin Bornhäuser, Claudia D Baldus, Eva Lengfelder, Pierre Fenaux, Uwe Platzbecker, Lionel Adès