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Kayser, Sabine; Schlenk, Richard F.; Lebon, Delphine; Carre, Martin; Goetze, Katharina S.; Stoelzel, Friedrich; Berceanu, Ana; Schaefer-Eckart, Kerstin; Peterlin, Pierre; Hicheri, Yosr; Rahme, Ramy; Raffoux, Emmanuel; Chermat, Fatiha; Krause, Stefan W.; Aulitzky, Walter E.; Rigaudeau, Sophie; Noppeney, Richard; Berthon, Celine; Goerner, Martin; Jost, Edgar; Carassou, Philippe; Keller, Ulrich; Orvain, Corentin; Braun, Thorsten; Saillard, Colombe; Arar, Ali; Kunzmann, Volker; Wemeau, Mathieu; de Wit, Maike; Niemann, Dirk; Bonmati, Caroline; Schwaenen, Carsten; Abraham, Julie; Aljijakli, Ahmad; Haiat, Stephanie; Kraemer, Alwin; Reichle, Albrecht; Gnadler, Martina; Willekens, Christophe; Spiekermann, Karsten; Hiddemann, Wolfgang; Mueller-Tidow, Carsten; Thiede, Christian; Roellig, Christoph; Serve, Hubert; Bornhaeuser, Martin; Baldus, Claudia D.; Lengfelder, Eva; Fenaux, Pierre; Platzbecker, Uwe and Ades, Lionel (2021): Characteristics and outcome of patients with low-/intermediate-risk acute promyelocytic leukemia treated with arsenic trioxide: an international collaborative. In: Haematologica, Vol. 106, No. 12: pp. 3100-3106

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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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