TY - JOUR
T1 - Long-term tolerability and efficacy after initial PegIFN-α addition to dasatinib in CML-CP
T2 - Five-year follow-up of the NordCML007 study
AU - Flygt, Hjalmar
AU - Söderlund, Stina
AU - Stentoft, Jesper
AU - Richter, Johan
AU - Koskenvesa, Perttu
AU - Mustjoki, Satu
AU - Majeed, Waleed
AU - Lübking, Anna
AU - Dreimane, Arta
AU - Markevärn, Berit
AU - Stenke, Leif
AU - Myhr Eriksson, Kristina
AU - Gjertsen, Bjørn Tore
AU - Gedde-Dahl, Tobias
AU - Dimitrijevic, Andreja
AU - Udby, Lene
AU - Olsson-Strömberg, Ulla
AU - Hjorth-Hansen, Henrik
PY - 2021
Y1 - 2021
N2 - 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.
AB - 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.
KW - BCR-ABL Positive
KW - chronic myelogenous leukemia
KW - clinical trial
KW - dasatinib
KW - interferon-alpha
U2 - 10.1111/ejh.13699
DO - 10.1111/ejh.13699
M3 - Article
C2 - 34418168
AN - SCOPUS:85113968962
SN - 0902-4441
VL - 107
SP - 617
EP - 623
JO - European Journal of Haematology
JF - European Journal of Haematology
IS - 6
ER -