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. 2021 Dec 1;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

Sabine Kayser  1 , Richard F Schlenk  2 , Delphine Lebon  3 , Martin Carre  4 , Katharina S Götze  5 , Friedrich Stölzel  6 , Ana Berceanu  7 , Kerstin Schäfer-Eckart  8 , Pierre Peterlin  9 , Yosr Hicheri  10 , Ramy Rahme  11 , Emmanuel Raffoux  11 , Fatiha Chermat  11 , Stefan W Krause  12 , Walter E Aulitzky  13 , Sophie Rigaudeau  14 , Richard Noppeney  15 , Celine Berthon  16 , Martin Görner  17 , Edgar Jost  18 , Philippe Carassou  19 , Ulrich Keller  20 , Corentin Orvain  21 , Thorsten Braun  22 , Colombe Saillard  23 , Ali Arar  24 , Volker Kunzmann  25 , Mathieu Wemeau  26 , Maike De Wit  27 , Dirk Niemann  28 , Caroline Bonmati  29 , Carsten Schwänen  30 , Julie Abraham  31 , Ahmad Aljijakli  32 , Stephanie Haiat  33 , Alwin Krämer  34 , Albrecht Reichle  35 , Martina Gnadler  36 , Christophe Willekens  37 , Karsten Spiekermann  38 , Wolfgang Hiddemann  38 , Carsten Müller-Tidow  39 , Christian Thiede  6 , Christoph Röllig  6 , Hubert Serve  40 , Martin Bornhäuser  6 , Claudia D Baldus  41 , Eva Lengfelder  42 , Pierre Fenaux  11 , Uwe Platzbecker  43 , Lionel Adès  11
Affiliations

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

Sabine Kayser et al. Haematologica. .

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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Figures

Figure 1.
Figure 1.
Kaplan Meier plot of overall survival. Green and red curves indicate upper and lower 95% confidence intervals, respectively.
Figure 2.
Figure 2.
Kaplan Meier plot of overall survival according to age. Red curve indicates age >70 years, black curve indicates age ≤70 years.
Figure 3.
Figure 3.
Cumulative incidence of death according to age.
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References

    1. Swerdlow SH, Campo E, Harris NL, et al. WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues. Revised 4th edition. WHO Press, Geneva, Switzerland, 2017.
    1. Lo-Coco F, Avvisati G, Vignetti M, et al. Retinoic acid and arsenic trioxide for acute promyelocytic leukemia. N Engl J Med. 2013;369(2):111-121. - PubMed
    1. Platzbecker U, Avvisati G, Cicconi L, et al. Improved outcomes with retinoic acid and arsenic trioxide compared with retinoic acid and chemotherapy in non-high-risk acute promyelocytic leukemia: final results of the randomized Italian-German APL0406 trial. J Clin Oncol. 2016;35(6):605-612. - PubMed
    1. Burnett AK, Russell NH, Hills RK, et al. Arsenic trioxide and all-trans retinoic acid treatment for acute promyelocytic leukaemia in all risk groups (AML17): results of a randomised, controlled, phase 3 trial. Lancet Oncol. 2015;16(13):1295-1305. - PubMed
    1. Paulson K, Serebrin A, Lambert P, et al. Acute promyelocytic leukaemia is characterized by stable incidence and improved survival that is restricted to patients managed in leukaemia referral centres: a pan-Canadian epidemiological study. Br J Haematol. 2014;166(5):660-666. - PubMed

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