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Randomized Controlled Trial
. 2022 Sep;109(3):257-270.
doi: 10.1111/ejh.13805. Epub 2022 Jun 14.

Efficacy of conventional-dose cytarabine, idarubicin and thioguanine versus intermediate-dose cytarabine and idarubicin in the induction treatment of acute myeloid leukemia: Long-term results of the prospective randomized nationwide AML-2003 study by the Finnish Leukemia Group

Aarne Kolonen  1 , Marjatta Sinisalo  1 , Heini Huhtala  2 , Johanna Rimpiläinen  1 , Hannele Rintala  1 , Marja Sankelo  1 , Elli Koivunen  1 , Raija Silvennoinen  1 , Riikka Räty  3 , Tapani Ruutu  3 , Liisa Volin  3 , Kimmo Porkka  3 , Esa Jantunen  4 , Tapio Nousiainen  4 , Taru Kuittinen  4 , Karri Penttilä  4 , Marja Pyörälä  4 , Marjaana Säily  5 , Pirjo Koistinen  5 , Marjut Kauppila  6 , Maija Itälä-Remes  6 , Hanna Ollikainen  7 , Auvo Rauhala  8   9 , Veli Kairisto  10 , Tarja-Terttu Pelliniemi  11 , Erkki Elonen  3 ; Finnish Leukemia Group
Affiliations
Randomized Controlled Trial

Efficacy of conventional-dose cytarabine, idarubicin and thioguanine versus intermediate-dose cytarabine and idarubicin in the induction treatment of acute myeloid leukemia: Long-term results of the prospective randomized nationwide AML-2003 study by the Finnish Leukemia Group

Aarne Kolonen et al. Eur J Haematol. 2022 Sep.

Abstract

Objectives: AML-2003 study sought to compare the long-term efficacy and safety of IAT and IdAraC-Ida in induction chemotherapy of acute myeloid leukemia (AML) and introduce the results of an integrated genetic and clinical risk classification guided treatment strategy.

Methods: Patients were randomized to receive either IAT or IdAraC-Ida as the first induction treatment. Intensified postremission strategies were employed based on measurable residual disease (MRD) and risk classification. Structured questionnaire forms were used to gather data prospectively.

Results: A total of 356 AML patients with a median age of 53 years participated in the study. Long-term overall survival (OS) and relapse-free survival (RFS) were both 49% at 10 years. The median follow-up was 114 months. No significant difference in remission rate, OS or RFS was observed between the two induction treatments. Risk classification according to the protocol, MRD after the first and the last consolidation treatment affected the OS and RFS significantly (p < .001).

Conclusions: Intensified cytarabine dose in the first induction treatment was not better than IAT in patients with AML. Intensification of postremission treatment in patients with clinical risk factors or MRD seems reasonable, but randomized controlled studies are warranted in the future.

Keywords: AML; allogeneic stem cell transplant; induction chemotherapy; long-term follow-up; measurable residual disease; nationwide; randomized; survival.

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References

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