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Haematologica. 2021 Dec 01;106(12):3100-3106. doi: 10.3324/haematol.2021.278722.

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

Haematologica

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

Affiliations

  1. Medical Clinic and Policlinic I, Hematology and Cellular Therapy, University Hospital Leipzig, Leipzig, Germany; NCT Trial Center, National Center of Tumor Diseases, German Cancer Research Center (DKFZ), Heidelberg. [email protected].
  2. NCT Trial Center, National Center of Tumor Diseases, German Cancer Research Center (DKFZ), Heidelberg; Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg.
  3. Service des Maladies du Sang GH Sud, Amiens.
  4. 5HCE Grenoble, Service d'Oncologie et Hématologie Pédiatrique, Grenoble.
  5. Department of Medicine III, Technical University of Munich.
  6. Department of Medicine I, University Hospital Carl-Gustav-Carus, Dresden, TU Dresden.
  7. Service d'Hématologie du Pr. Cahn Hopital Jean Minjoz, Besancon.
  8. Hospital Nord, Nurnberg.
  9. Service d'Hématologie, Hotel Dieu Nantes.
  10. Département d'Hématologie Clinique du Chu Saint Eloi Montpellier.
  11. Hôpital Saint Louis, Université Paris Diderot, Paris.
  12. Department of Internal Medicine 5 - Hematology/Oncology, University Hospital of Erlangen.
  13. Robert-Bosch-Hospital, Stuttgart.
  14. Service d'Hémato-Oncologie du Pr. Castaigne Hopital Andre Mignot le Chesnay.
  15. University Hospital Essen.
  16. Service des Maladies du Sang Chru, Hopital Claude Huriez, Lille.
  17. Klinik für Hämatologie, Onkologie und Palliativmedizin, Klinikum Bielefeld Mitte.
  18. University Hospital Aachen.
  19. Service de Médecine interne, Hématologie du Pr. Christian Chr Metz Thionville, Hopital de Marcy, Metz.
  20. Department of Hematology, Oncology and Tumor Immunology, Charité-University Medical Center, Campus Benjamin Franklin, Berlin.
  21. Angers University Hospital, Maladies du Sang, Angers; Fédération Hospitalo-Universitaire Grand-Ouest Acute Leukemia, FHU-GOAL, France; Université d'Angers, Inserm, CRCINA, Angers.
  22. Hôpital Avicenne, Assistance Publique - Hôpitaux de Paris, Université Paris.
  23. Hematology Department, Institut Paoli Calmettes, Marseille.
  24. Service d' Oncologie Médicale Hopital de la Source, Orleans.
  25. University Hospital of Würzburg.
  26. Service d'Hématologie, Hopital v.Provo, Roubaix.
  27. Vivantes Klinikum Neukölln, Berlin.
  28. Gemeinschaftsklinikum Mittelrhein gGmbH, Koblenz.
  29. Division of Hematology, Hôpital de Brabois, Centre Hospitalier Universitaire de Nancy, Nancy.
  30. Klinikum Offenburg.
  31. Service d' Hématologie, Thérapie Cellulaire du Pr. Bordessoule, Hopital Universitaire Dupuytren, Limoges.
  32. Service d'Hématologie du Dr. Sutton Centre Hospitalier v. Dupouy, Argenteuil.
  33. Service d'Hematologie Clinique, CH Sud Francilien, Corbeil Essonnes.
  34. Department of Internal Medicine V, University Hospital of Heidelberg, Heidelberg; German Cancer Research Center (DKFZ) and Department of Internal Medicine V, University of Heidelberg, Heidelberg.
  35. Department of Medicine III - Hematology and Internal Oncology, University Hospital Regensburg, Regensburg.
  36. St. Vincentius Kliniken, Abteilung für Hämatologie, Onkologie, Immunologie und Palliativmedizin, Karlsruhe.
  37. Département d'Hématologie, Gustave Roussy, Université Paris-Saclay, Villejuif; INSERM Unit 1170, Gustave Roussy Cancer Campus, Paris-Saclay University, Villejuif.
  38. Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich.
  39. Department of Internal Medicine V, University Hospital of Heidelberg, Heidelberg.
  40. Department of Internal Medicine II, University Hospital of Frankfurt Main.
  41. Department of Internal Medicine II, University Hospital of Kiel.
  42. Department of Hematology and Oncology, University Hospital Mannheim, Mannheim.
  43. Medical Clinic and Policlinic I, Hematology and Cellular Therapy, University Hospital Leipzig, Leipzig.

PMID: 34047178 DOI: 10.3324/haematol.2021.278722

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.

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