Characteristics and outcome of patients with low-/intermediate-risk acute promyelocytic leukemia treated with arsenic trioxide: an international collaborative study
Sabine Käyser, Richard F. Schlenk, Delphine Lebon, Martin Carré, Katharina S. Götze, Friedrich Stölzel, Ana Berceanu, Kerstin Schäfer‐Eckart, Pierre Péterlin, Yosr Hicheri, Ramy Rahmé, Emmanuel Raffoux, Fatiha Chermat, Stefan W. Krause, Walter E. Aulitzky, Sophie Rigaudeau, Richard Noppeney, Céline Berthon, Martin Görner, Edgar Jost, P. Carassou, Ulrich Keller, Corentin Orvain, Thorsten Braun, Colombe Saillard, Ali Arar, Volker Kunzmann, Mathieu Wémeau, Maike de Wit, Dirk Niemann, Caroline Bonmati, Carsten Schwänen, Julie Abraham, Ahmad Aljijakli, Stéphanie Haïat, 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
Abstract
The aim of this study was to characterize a large series of 154 patients with acute promyelocytic leukemia (median age, 53 years; range, 18-90 years) and evaluate real-life outcome after up-front treatment with arsenic trioxide and all-trans retinoic acid. All patients were included in the prospective NAPOLEON registry (NCT02192619) between 2013 and 2019. The acute promyelocytic leukemia was de novo in 91% (n=140) and therapy-related in 9% (n=14); 13% (n=20) of the patients 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 starting therapy. With a median follow-up of 1.99 years (95% confidence interval: 1.61-2.30 years) 1-year and 2-year overall survival rates were 97% (95% confidence interval: 94-100%) and 95% (95% confidence interval: 91-99%), respectively. Age above 70 years was associated with a significantly shorter overall survival (P<0.001) compared to that of younger patients. So far no relapses have been observed. Six patients (4%) died in complete remission at a median of 0.95 years after diagnosis (range, 0.18-2.38 years). Our data confirm the efficiency and durability of arsenic trioxide and all-trans retinoic acid therapy in the primary management of adults with low-/intermediate-risk acute promyelocytic leukemia in the real-life setting, irrespective of age.