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Long-term tolerability and efficacy after initial PegIFN-α addition to dasatinib in CML-CP : Five-year follow-up of the NordCML007 study

Flygt, Hjalmar ; Söderlund, Stina ; Stentoft, Jesper ; Richter, Johan LU ; Koskenvesa, Perttu ; Mustjoki, Satu ; Majeed, Waleed ; Lübking, Anna LU ; Dreimane, Arta and Markevärn, Berit , et al. (2021) In European Journal of Haematology 107(6). p.617-623
Abstract

Objectives: Treatment-free remission (TFR) has emerged as a treatment goal in chronic myeloid leukemia in the chronic phase (CML-CP). Attempts to increase proportion of patients achieving TFR include combination of tyrosine kinase inhibitors (TKI) and other drugs. Interferon-α in addition to TKI has shown promising efficacy but with dose-dependent toxicity and discontinuations. NordCML007 was initiated to study the efficacy and safety of low dose pegylated IFN-α (PegIFN-α) in combination with dasatinib (DAS) in CML-CP. Methods: Forty patients with newly diagnosed CML-CP were given DAS upfront. After month 3 (M3) 15 μg/wk of PegIFN-α was added and increased to 25 μg/wk from M7 until M15. DAS treatment was continued and adverse events and... (More)

Objectives: Treatment-free remission (TFR) has emerged as a treatment goal in chronic myeloid leukemia in the chronic phase (CML-CP). Attempts to increase proportion of patients achieving TFR include combination of tyrosine kinase inhibitors (TKI) and other drugs. Interferon-α in addition to TKI has shown promising efficacy but with dose-dependent toxicity and discontinuations. NordCML007 was initiated to study the efficacy and safety of low dose pegylated IFN-α (PegIFN-α) in combination with dasatinib (DAS) in CML-CP. Methods: Forty patients with newly diagnosed CML-CP were given DAS upfront. After month 3 (M3) 15 μg/wk of PegIFN-α was added and increased to 25 μg/wk from M7 until M15. DAS treatment was continued and adverse events and BCR-ABL1 qRT-PCR values were reported yearly after M24. Results from M1 to M18 have previously been published, and here we present long-term data. Results: After 5 years of follow-up, there were no suspected unexpected serious adverse reactions, no increase in serosal effusions, no disease progressions and no CML-related deaths. Rates of MR3.0 (MMR), MR4.0 and MR4.5 were 84.6%, 64.1% and 51.3% respectively at M60, and 95% of patients reached MMR at some point during the study. Conclusion: Initial addition of PegIFN-α to DAS shows good long-term efficacy without increased toxicity.

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publishing date
type
Contribution to journal
publication status
published
subject
keywords
BCR-ABL Positive, chronic myelogenous leukemia, clinical trial, dasatinib, interferon-alpha
in
European Journal of Haematology
volume
107
issue
6
pages
617 - 623
publisher
Wiley-Blackwell
external identifiers
  • scopus:85113968962
  • pmid:34418168
ISSN
0902-4441
DOI
10.1111/ejh.13699
language
English
LU publication?
no
id
679c01be-e10c-42ef-b447-3027d7e97e0c
date added to LUP
2021-09-21 16:01:19
date last changed
2024-06-15 16:42:42
@article{679c01be-e10c-42ef-b447-3027d7e97e0c,
  abstract     = {{<p>Objectives: Treatment-free remission (TFR) has emerged as a treatment goal in chronic myeloid leukemia in the chronic phase (CML-CP). Attempts to increase proportion of patients achieving TFR include combination of tyrosine kinase inhibitors (TKI) and other drugs. Interferon-α in addition to TKI has shown promising efficacy but with dose-dependent toxicity and discontinuations. NordCML007 was initiated to study the efficacy and safety of low dose pegylated IFN-α (PegIFN-α) in combination with dasatinib (DAS) in CML-CP. Methods: Forty patients with newly diagnosed CML-CP were given DAS upfront. After month 3 (M3) 15 μg/wk of PegIFN-α was added and increased to 25 μg/wk from M7 until M15. DAS treatment was continued and adverse events and BCR-ABL1 qRT-PCR values were reported yearly after M24. Results from M1 to M18 have previously been published, and here we present long-term data. Results: After 5 years of follow-up, there were no suspected unexpected serious adverse reactions, no increase in serosal effusions, no disease progressions and no CML-related deaths. Rates of MR<sup>3.0</sup> (MMR), MR<sup>4.0</sup> and MR<sup>4.5</sup> were 84.6%, 64.1% and 51.3% respectively at M60, and 95% of patients reached MMR at some point during the study. Conclusion: Initial addition of PegIFN-α to DAS shows good long-term efficacy without increased toxicity.</p>}},
  author       = {{Flygt, Hjalmar and Söderlund, Stina and Stentoft, Jesper and Richter, Johan and Koskenvesa, Perttu and Mustjoki, Satu and Majeed, Waleed and Lübking, Anna and Dreimane, Arta and Markevärn, Berit and Stenke, Leif and Myhr Eriksson, Kristina and Gjertsen, Bjørn Tore and Gedde-Dahl, Tobias and Dimitrijevic, Andreja and Udby, Lene and Olsson-Strömberg, Ulla and Hjorth-Hansen, Henrik}},
  issn         = {{0902-4441}},
  keywords     = {{BCR-ABL Positive; chronic myelogenous leukemia; clinical trial; dasatinib; interferon-alpha}},
  language     = {{eng}},
  number       = {{6}},
  pages        = {{617--623}},
  publisher    = {{Wiley-Blackwell}},
  series       = {{European Journal of Haematology}},
  title        = {{Long-term tolerability and efficacy after initial PegIFN-α addition to dasatinib in CML-CP : Five-year follow-up of the NordCML007 study}},
  url          = {{http://dx.doi.org/10.1111/ejh.13699}},
  doi          = {{10.1111/ejh.13699}},
  volume       = {{107}},
  year         = {{2021}},
}