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


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.

SUBMITTER: Kayser S 

PROVIDER: S-EPMC8634174 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature

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

Kayser Sabine S   Schlenk Richard F RF   Lebon Delphine D   Carre Martin M   Götze Katharina S KS   Stölzel Friedrich F   Berceanu Ana A   Schäfer-Eckart Kerstin K   Peterlin Pierre P   Hicheri Yosr Y   Rahme Ramy R   Raffoux Emmanuel E   Chermat Fatiha F   Krause Stefan W SW   Aulitzky Walter E WE   Rigaudeau Sophie S   Noppeney Richard R   Berthon Celine C   Görner Martin M   Jost Edgar E   Carassou Philippe P   Keller Ulrich U   Orvain Corentin C   Braun Thorsten T   Saillard Colombe C   Arar Ali A   Kunzmann Volker V   Wemeau Mathieu M   De Wit Maike M   Niemann Dirk D   Bonmati Caroline C   Schwänen Carsten C   Abraham Julie J   Aljijakli Ahmad A   Haiat Stephanie S   Krämer Alwin A   Reichle Albrecht A   Gnadler Martina M   Willekens Christophe C   Spiekermann Karsten K   Hiddemann Wolfgang W   Müller-Tidow Carsten C   Thiede Christian C   Röllig Christoph C   Serve Hubert H   Bornhäuser Martin M   Baldus Claudia D CD   Lengfelder Eva E   Fenaux Pierre P   Platzbecker Uwe U   Adès Lionel L  

Haematologica 20211201 12


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 ye  ...[more]

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