Long‐term tolerability and efficacy after initial PegIFN‐α addition to dasatinib in CML‐CP: Five‐year follow‐up of the NordCML007 study
H Flygt, S Söderlund, J Stentoft… - European journal of …, 2021 - Wiley Online Library
H Flygt, S Söderlund, J Stentoft, J Richter, P Koskenvesa, S Mustjoki, W Majeed, A Lübking…
European journal of haematology, 2021•Wiley Online LibraryObjectives 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 …
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 …
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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