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

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, 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

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.

Figures

Figure 1.
Figure 1.
Kaplan Meier plot of overall survival. Green and red curves indicate upper and lower 95% confidence intervals, respectively.
Figure 2.
Figure 2.
Kaplan Meier plot of overall survival according to age. Red curve indicates age >70 years, black curve indicates age ≤70 years.
Figure 3.
Figure 3.
Cumulative incidence of death according to age.

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