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


Journal

Haematologica
ISSN: 1592-8721
Titre abrégé: Haematologica
Pays: Italy
ID NLM: 0417435

Informations de publication

Date de publication:
01 12 2021
Historique:
received: 06 03 2021
pubmed: 29 5 2021
medline: 1 4 2022
entrez: 28 5 2021
Statut: epublish

Résumé

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.

Identifiants

pubmed: 34047178
doi: 10.3324/haematol.2021.278722
pmc: PMC8634174
doi:

Substances chimiques

Tretinoin 5688UTC01R
Arsenic Trioxide S7V92P67HO

Banques de données

ClinicalTrials.gov
['NCT02192619']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

3100-3106

Commentaires et corrections

Type : CommentIn

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Auteurs

Sabine Kayser (S)

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. sabine.kayser@medizin.uni-leipzig.de.

Richard F Schlenk (RF)

NCT Trial Center, National Center of Tumor Diseases, German Cancer Research Center (DKFZ), Heidelberg; Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg.

Delphine Lebon (D)

Service des Maladies du Sang GH Sud, Amiens.

Martin Carre (M)

5HCE Grenoble, Service d'Oncologie et Hématologie Pédiatrique, Grenoble.

Katharina S Götze (KS)

Department of Medicine III, Technical University of Munich.

Friedrich Stölzel (F)

Department of Medicine I, University Hospital Carl-Gustav-Carus, Dresden, TU Dresden.

Ana Berceanu (A)

Service d'Hématologie du Pr. Cahn Hopital Jean Minjoz, Besancon.

Kerstin Schäfer-Eckart (K)

Hospital Nord, Nurnberg.

Pierre Peterlin (P)

Service d'Hématologie, Hotel Dieu Nantes.

Yosr Hicheri (Y)

Département d'Hématologie Clinique du Chu Saint Eloi Montpellier.

Ramy Rahme (R)

Hôpital Saint Louis, Université Paris Diderot, Paris.

Emmanuel Raffoux (E)

Hôpital Saint Louis, Université Paris Diderot, Paris.

Fatiha Chermat (F)

Hôpital Saint Louis, Université Paris Diderot, Paris.

Stefan W Krause (SW)

Department of Internal Medicine 5 - Hematology/Oncology, University Hospital of Erlangen.

Walter E Aulitzky (WE)

Robert-Bosch-Hospital, Stuttgart.

Sophie Rigaudeau (S)

Service d'Hémato-Oncologie du Pr. Castaigne Hopital Andre Mignot le Chesnay.

Richard Noppeney (R)

University Hospital Essen.

Celine Berthon (C)

Service des Maladies du Sang Chru, Hopital Claude Huriez, Lille.

Martin Görner (M)

Klinik für Hämatologie, Onkologie und Palliativmedizin, Klinikum Bielefeld Mitte.

Edgar Jost (E)

University Hospital Aachen.

Philippe Carassou (P)

Service de Médecine interne, Hématologie du Pr. Christian Chr Metz Thionville, Hopital de Marcy, Metz.

Ulrich Keller (U)

Department of Hematology, Oncology and Tumor Immunology, Charité-University Medical Center, Campus Benjamin Franklin, Berlin.

Corentin Orvain (C)

Angers University Hospital, Maladies du Sang, Angers; Fédération Hospitalo-Universitaire Grand-Ouest Acute Leukemia, FHU-GOAL, France; Université d'Angers, Inserm, CRCINA, Angers.

Thorsten Braun (T)

Hôpital Avicenne, Assistance Publique - Hôpitaux de Paris, Université Paris.

Colombe Saillard (C)

Hematology Department, Institut Paoli Calmettes, Marseille.

Ali Arar (A)

Service d' Oncologie Médicale Hopital de la Source, Orleans.

Volker Kunzmann (V)

University Hospital of Würzburg.

Mathieu Wemeau (M)

Service d'Hématologie, Hopital v.Provo, Roubaix.

Maike De Wit (M)

Vivantes Klinikum Neukölln, Berlin.

Dirk Niemann (D)

Gemeinschaftsklinikum Mittelrhein gGmbH, Koblenz.

Caroline Bonmati (C)

Division of Hematology, Hôpital de Brabois, Centre Hospitalier Universitaire de Nancy, Nancy.

Carsten Schwänen (C)

Klinikum Offenburg.

Julie Abraham (J)

Service d' Hématologie, Thérapie Cellulaire du Pr. Bordessoule, Hopital Universitaire Dupuytren, Limoges.

Ahmad Aljijakli (A)

Service d'Hématologie du Dr. Sutton Centre Hospitalier v. Dupouy, Argenteuil.

Stephanie Haiat (S)

Service d'Hematologie Clinique, CH Sud Francilien, Corbeil Essonnes.

Alwin Krämer (A)

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.

Albrecht Reichle (A)

Department of Medicine III - Hematology and Internal Oncology, University Hospital Regensburg, Regensburg.

Martina Gnadler (M)

St. Vincentius Kliniken, Abteilung für Hämatologie, Onkologie, Immunologie und Palliativmedizin, Karlsruhe.

Christophe Willekens (C)

Département d'Hématologie, Gustave Roussy, Université Paris-Saclay, Villejuif; INSERM Unit 1170, Gustave Roussy Cancer Campus, Paris-Saclay University, Villejuif.

Karsten Spiekermann (K)

Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich.

Wolfgang Hiddemann (W)

Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich.

Carsten Müller-Tidow (C)

Department of Internal Medicine V, University Hospital of Heidelberg, Heidelberg.

Christian Thiede (C)

Department of Medicine I, University Hospital Carl-Gustav-Carus, Dresden, TU Dresden.

Christoph Röllig (C)

Department of Medicine I, University Hospital Carl-Gustav-Carus, Dresden, TU Dresden.

Hubert Serve (H)

Department of Internal Medicine II, University Hospital of Frankfurt Main.

Martin Bornhäuser (M)

Department of Medicine I, University Hospital Carl-Gustav-Carus, Dresden, TU Dresden.

Claudia D Baldus (CD)

Department of Internal Medicine II, University Hospital of Kiel.

Eva Lengfelder (E)

Department of Hematology and Oncology, University Hospital Mannheim, Mannheim.

Pierre Fenaux (P)

Hôpital Saint Louis, Université Paris Diderot, Paris.

Uwe Platzbecker (U)

Medical Clinic and Policlinic I, Hematology and Cellular Therapy, University Hospital Leipzig, Leipzig.

Lionel Adès (L)

Hôpital Saint Louis, Université Paris Diderot, Paris.

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