Haematologica (May 2021)

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

DOI
https://doi.org/10.3324/haematol.2021.278722
Journal volume & issue
Vol. 106, no. 12

Abstract

Read online

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.