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  • Long‐term tolerability and ...
    Flygt, Hjalmar; Söderlund, Stina; Stentoft, Jesper; Richter, Johan; Koskenvesa, Perttu; Mustjoki, Satu; Majeed, Waleed; Lübking, Anna; Dreimane, Arta; Markevärn, Berit; Stenke, Leif; Myhr Eriksson, Kristina; Gjertsen, Bjørn Tore; Gedde‐Dahl, Tobias; Dimitrijevic, Andreja; Udby, Lene; Olsson‐Strömberg, Ulla; Hjorth‐Hansen, Henrik

    European journal of haematology, December 2021, Letnik: 107, Številka: 6
    Journal Article

    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.