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; Marjatta Sinisalo; Heini Huhtala; Johanna Rimpiläinen; Hannele Rintala; Marja Sankelo; Elli Koivunen; Raija Silvennoinen; Riikka Räty; Tapani Ruutu; Liisa Volin; Kimmo Porkka; Esa Jantunen; Tapio Nousiainen; Taru Kuittinen; Karri Penttilä; Marja Pyörälä; Marjaana Säily; Pirjo Koistinen; Marjut Kauppila; Maija Itälä-Remes; Hanna Ollikainen; Auvo Rauhala; Veli Kairisto; Tarja-Terttu Pelliniemi; Erkki Elonen

doi:10.1111/ejh.13805

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

Översatt titel: Effekten av konventionella doser cytarabin, idarubicin och tioguanin (IAT) kontra mellandos cytarabin och idarubicin (IdAraC-Ida) vid induktionsbehandling av AML och effekterna av kvarvarande sjukdom: långsiktiga resultat av den potentiella randomiserade rikstäckande AML- 2003 studie av den finska leukemigruppen

Aarne Kolonen^*, Marjatta Sinisalo, Heini Huhtala, Johanna Rimpiläinen, Hannele Rintala, Marja Sankelo, Elli Koivunen, Raija Silvennoinen, Riikka Räty, Tapani Ruutu, Liisa Volin, Kimmo Porkka, Esa Jantunen, Tapio Nousiainen, Taru Kuittinen, Karri Penttilä, Marja Pyörälä, Marjaana Säily, Pirjo Koistinen, Marjut KauppilaMaija Itälä-Remes, Hanna Ollikainen, Auvo Rauhala, Veli Kairisto, Tarja-Terttu Pelliniemi, Erkki Elonen

^*Korresponderande författare för detta arbete

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Sammanfattning

Objectives
To compare the long-term efficacy and safety of two randomized induction treatments (IAT vs. IdAraC-Ida) in AML patients and introduce the results of a novel risk grouping and residual disease guided treatment strategy.
Methods
Structured questionnaire forms were used to gather data in each cycle of treatment and during follow-up. SPSS version 25 (SPSS Inc., Chicago, Illinois, USA) was used for statistical analysis.
Results
356 patients with AML participated in the study. Long term overall survival (OS) and relapse-free survival (RFS) observed in our study were 49 % and 49 % at 10 years, respectively. Median follow-up for the living patients was 114 months. No significant difference in remission induction rate, OS, RFS was observed between the two induction treatments. Risk classification according to protocol, measurable residual disease (MRD) status after first consolidation treatment (P < 0.001) and last consolidation treatment (P < 0.001) affected the overall survival and relapse-free survival.
Conclusions
Intensified cytarabine dose in first induction treatment is unlikely to yield favorable long-term results compared with IAT in patients with AML. Intensified post-remission treatment in patients with clinical risk factors or MRD seems reasonable, but randomized controlled studies are warranted in the future.

Översatt titel	Effekten av konventionella doser cytarabin, idarubicin och tioguanin (IAT) kontra mellandos cytarabin och idarubicin (IdAraC-Ida) vid induktionsbehandling av AML och effekterna av kvarvarande sjukdom: långsiktiga resultat av den potentiella randomiserade rikstäckande AML- 2003 studie av den finska leukemigruppen
Originalspråk	Engelska
Sidor (från-till)	257-270
Tidskrift	European Journal of Haematology
Volym	109
Nummer	3
DOI	https://doi.org/10.1111/ejh.13805
Status	Publicerad - 30 maj 2022
MoE-publikationstyp	A1 Tidskriftsartikel-refererad

Nyckelord

Randomized controlled trial
leukemia

Åtkomst av dokument

10.1111/ejh.13805

Kolonen_AML2003_revisionAccepterat manuskript från författare, 1,68 MBLicens: Publisher rights policy

https://urn.fi/URN:NBN:fi-fe2023060151025

Citera det här

Kolonen, A., Sinisalo, M., Huhtala, H., Rimpiläinen, J., Rintala, H., Sankelo, M., Koivunen, E., Silvennoinen, R., Räty, R., Ruutu, T., Volin, L., Porkka, K., Jantunen, E., Nousiainen, T., Kuittinen, T., Penttilä, K., Pyörälä, M., Säily, M., Koistinen, P., ... Elonen, E. (2022). 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. European Journal of Haematology, 109(3), 257-270. https://doi.org/10.1111/ejh.13805

Kolonen, Aarne ; Sinisalo, Marjatta ; Huhtala, Heini et al. / 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. I: European Journal of Haematology. 2022 ; Vol. 109, Nr. 3. s. 257-270.

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title = "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",

abstract = "ObjectivesTo compare the long-term efficacy and safety of two randomized induction treatments (IAT vs. IdAraC-Ida) in AML patients and introduce the results of a novel risk grouping and residual disease guided treatment strategy.MethodsStructured questionnaire forms were used to gather data in each cycle of treatment and during follow-up. SPSS version 25 (SPSS Inc., Chicago, Illinois, USA) was used for statistical analysis.Results356 patients with AML participated in the study. Long term overall survival (OS) and relapse-free survival (RFS) observed in our study were 49 % and 49 % at 10 years, respectively. Median follow-up for the living patients was 114 months. No significant difference in remission induction rate, OS, RFS was observed between the two induction treatments. Risk classification according to protocol, measurable residual disease (MRD) status after first consolidation treatment (P < 0.001) and last consolidation treatment (P < 0.001) affected the overall survival and relapse-free survival.ConclusionsIntensified cytarabine dose in first induction treatment is unlikely to yield favorable long-term results compared with IAT in patients with AML. Intensified post-remission treatment in patients with clinical risk factors or MRD seems reasonable, but randomized controlled studies are warranted in the future.",

keywords = "Randomized controlled trial, leukemia",

author = "Aarne Kolonen and Marjatta Sinisalo and Heini Huhtala and Johanna Rimpil{\"a}inen and Hannele Rintala and Marja Sankelo and Elli Koivunen and Raija Silvennoinen and Riikka R{\"a}ty and Tapani Ruutu and Liisa Volin and Kimmo Porkka and Esa Jantunen and Tapio Nousiainen and Taru Kuittinen and Karri Penttil{\"a} and Marja Py{\"o}r{\"a}l{\"a} and Marjaana S{\"a}ily and Pirjo Koistinen and Marjut Kauppila and Maija It{\"a}l{\"a}-Remes and Hanna Ollikainen and Auvo Rauhala and Veli Kairisto and Tarja-Terttu Pelliniemi and Erkki Elonen",

year = "2022",

month = may,

day = "30",

doi = "10.1111/ejh.13805",

language = "English",

volume = "109",

pages = "257--270",

journal = "European Journal of Haematology",

issn = "0902-4441",

publisher = "John Wiley and Sons",

number = "3",

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Kolonen, A, Sinisalo, M, Huhtala, H, Rimpiläinen, J, Rintala, H, Sankelo, M, Koivunen, E, Silvennoinen, R, Räty, R, Ruutu, T, Volin, L, Porkka, K, Jantunen, E, Nousiainen, T, Kuittinen, T, Penttilä, K, Pyörälä, M, Säily, M, Koistinen, P, Kauppila, M, Itälä-Remes, M, Ollikainen, H, Rauhala, A, Kairisto, V, Pelliniemi, T-T & Elonen, E 2022, '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', European Journal of Haematology, vol. 109, nr. 3, s. 257-270. https://doi.org/10.1111/ejh.13805

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. / Kolonen, Aarne; Sinisalo, Marjatta; Huhtala, Heini et al.
I: European Journal of Haematology, Vol. 109, Nr. 3, 30.05.2022, s. 257-270.

Forskningsoutput: Tidskriftsbidrag › Artikel › Vetenskaplig › Peer review

TY - JOUR

T1 - 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

AU - Kolonen, Aarne

AU - Sinisalo, Marjatta

AU - Huhtala, Heini

AU - Rimpiläinen, Johanna

AU - Rintala, Hannele

AU - Sankelo, Marja

AU - Koivunen, Elli

AU - Silvennoinen, Raija

AU - Räty, Riikka

AU - Ruutu, Tapani

AU - Volin, Liisa

AU - Porkka, Kimmo

AU - Jantunen, Esa

AU - Nousiainen, Tapio

AU - Kuittinen, Taru

AU - Penttilä, Karri

AU - Pyörälä, Marja

AU - Säily, Marjaana

AU - Koistinen, Pirjo

AU - Kauppila, Marjut

AU - Itälä-Remes, Maija

AU - Ollikainen, Hanna

AU - Rauhala, Auvo

AU - Kairisto, Veli

AU - Pelliniemi, Tarja-Terttu

AU - Elonen, Erkki

PY - 2022/5/30

Y1 - 2022/5/30

N2 - ObjectivesTo compare the long-term efficacy and safety of two randomized induction treatments (IAT vs. IdAraC-Ida) in AML patients and introduce the results of a novel risk grouping and residual disease guided treatment strategy.MethodsStructured questionnaire forms were used to gather data in each cycle of treatment and during follow-up. SPSS version 25 (SPSS Inc., Chicago, Illinois, USA) was used for statistical analysis.Results356 patients with AML participated in the study. Long term overall survival (OS) and relapse-free survival (RFS) observed in our study were 49 % and 49 % at 10 years, respectively. Median follow-up for the living patients was 114 months. No significant difference in remission induction rate, OS, RFS was observed between the two induction treatments. Risk classification according to protocol, measurable residual disease (MRD) status after first consolidation treatment (P < 0.001) and last consolidation treatment (P < 0.001) affected the overall survival and relapse-free survival.ConclusionsIntensified cytarabine dose in first induction treatment is unlikely to yield favorable long-term results compared with IAT in patients with AML. Intensified post-remission treatment in patients with clinical risk factors or MRD seems reasonable, but randomized controlled studies are warranted in the future.

AB - ObjectivesTo compare the long-term efficacy and safety of two randomized induction treatments (IAT vs. IdAraC-Ida) in AML patients and introduce the results of a novel risk grouping and residual disease guided treatment strategy.MethodsStructured questionnaire forms were used to gather data in each cycle of treatment and during follow-up. SPSS version 25 (SPSS Inc., Chicago, Illinois, USA) was used for statistical analysis.Results356 patients with AML participated in the study. Long term overall survival (OS) and relapse-free survival (RFS) observed in our study were 49 % and 49 % at 10 years, respectively. Median follow-up for the living patients was 114 months. No significant difference in remission induction rate, OS, RFS was observed between the two induction treatments. Risk classification according to protocol, measurable residual disease (MRD) status after first consolidation treatment (P < 0.001) and last consolidation treatment (P < 0.001) affected the overall survival and relapse-free survival.ConclusionsIntensified cytarabine dose in first induction treatment is unlikely to yield favorable long-term results compared with IAT in patients with AML. Intensified post-remission treatment in patients with clinical risk factors or MRD seems reasonable, but randomized controlled studies are warranted in the future.

KW - Randomized controlled trial

KW - leukemia

U2 - 10.1111/ejh.13805

DO - 10.1111/ejh.13805

M3 - Article

SN - 0902-4441

VL - 109

SP - 257

EP - 270

JO - European Journal of Haematology

JF - European Journal of Haematology

IS - 3

ER -

Kolonen A, Sinisalo M, Huhtala H, Rimpiläinen J, Rintala H, Sankelo M et al. 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. European Journal of Haematology. 2022 maj 30;109(3):257-270. doi: 10.1111/ejh.13805