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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 (author)
Uppsala universitet,Hematologi
Söderlund, Stina (author)
Uppsala universitet,Hematologi
Stentoft, Jesper (author)
Aarhus Univ Hosp, Dept Hematol, Aarhus, Denmark.
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Richter, Johan (author)
Skane Univ Hosp, Dept Hematol Oncol & Radiat Phys, Lund, Sweden.
Koskenvesa, Perttu (author)
Univ Helsinki, Helsinki Univ Hosp, Comprehens Canc Ctr, Hematol Res Unit Helsinki, Helsinki, Finland.;Univ Helsinki, Helsinki Univ Hosp, Comprehens Canc Ctr, Dept Hematol, Helsinki, Finland.
Mustjoki, Satu (author)
Univ Helsinki, Helsinki Univ Hosp, Comprehens Canc Ctr, Hematol Res Unit Helsinki, Helsinki, Finland.;Univ Helsinki, Helsinki Univ Hosp, Comprehens Canc Ctr, Dept Hematol, Helsinki, Finland.;Univ Helsinki, Translat Immunol Res Program, Helsinki, Finland.;Univ Helsinki, Dept Clin Chem & Hematol, Helsinki, Finland.
Majeed, Waleed (author)
Stavanger Univ Hosp, Dept Hematooncol, Stavanger, Norway.
Lübking, Anna (author)
Skane Univ Hosp, Dept Hematol Oncol & Radiat Phys, Lund, Sweden.
Dreimane, Arta (author)
Linköping Univ Hosp, Dept Hematol, Linköping, Sweden.
Markevärn, Berit (author)
Umeå Univ Hosp, Dept Hematol, Umeå, Sweden.
Stenke, Leif (author)
Karolinska Institutet
Myhr Eriksson, Kristina (author)
Sunderby Hosp, Dept Internal Med & Hematol, Luleå, Sweden.
Gjertsen, Bjørn Tore (author)
Haukeland Hosp, Hematol Sect, Dept Internal Med, Bergen, Norway.
Gedde-Dahl, Tobias (author)
Natl Hosp Norway, Oslo Univ Hosp, Dept Hematol, Oslo, Norway.
Dimitrijevic, Andreja (author)
Odense Univ Hosp, Dept Hematol, Odense, Denmark.
Udby, Lene (author)
Zealand Univ Hosp, Dept Hematol, Roskilde, Denmark.
Olsson-Strömberg, Ulla (author)
Uppsala universitet,Hematologi
Hjorth-Hansen, Henrik (author)
St Olavs Hosp Trondheim, Dept Hematol, Trondheim, Norway.;Norwegian Univ Sci & Technol, Dept Clin & Mol Med, Trondheim, Norway.
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 (creator_code:org_t)
2021-08-31
2021
English.
In: European Journal of Haematology. - : John Wiley & Sons. - 0902-4441 .- 1600-0609. ; 107:6, s. 617-623
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  • Journal article (peer-reviewed)
Abstract Subject headings
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  • ObjectivesTreatment-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.MethodsForty 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.ResultsAfter 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.ConclusionInitial addition of PegIFN-α to DAS shows good long-term efficacy without increased toxicity.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Hematologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Hematology (hsv//eng)

Keyword

BCR-ABL Positive
chronic myelogenous leukemia
clinical trial
dasatinib
interferon-alpha

Publication and Content Type

ref (subject category)
art (subject category)

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