TY - JOUR
T1 - Treatment-free remission after a second TKI discontinuation attempt in patients with Chronic Myeloid Leukemia re-treated with dasatinib – interim results from the DAstop2 trial
AU - Flygt, Hjalmar
AU - Söderlund, Stina
AU - Richter, Johan
AU - Saussele, Susanne
AU - Koskenvesa, Perttu
AU - Stenke, Leif
AU - Mustjoki, Satu
AU - Dimitrijevic, Andreja
AU - Stentoft, Jesper
AU - Majeed, Waleed
AU - Roy, Lydia
AU - Wolf, Dominik
AU - Dreimane, Arta
AU - Gjertsen, Bjørn Tore
AU - Gedde-Dahl, Tobias
AU - Ahlstrand, Erik
AU - Markevärn, Berit
AU - Hjorth-Hansen, Henrik
AU - Janssen, Jeroen
AU - Olsson-Strömberg, Ulla
N1 - Publisher Copyright: © The Author(s) 2024. corrected publication 2024.
PY - 2024/4
Y1 - 2024/4
N2 - Tyrosine kinase inhibitor (TKI) discontinuation in chronic myeloid leukemia (CML) has become part of routine care for patients with a sustained deep molecular response (DMR). Approximately 50% experience a molecular relapse upon TKI cessation. Most of them quickly regain DMR upon TKI resumption. Whether these patients can achieve a second treatment-free remission (TFR) remains unclear. DAstop2 (ClinicalTrials.gov ID: NCT03573596) is a prospective study including patients with a failed first TFR attempt re-treated with any TKI for ≥ one year. Upon entering the study, patients received the TKI dasatinib for additional two years. Patients with sustained DMR for ≥1 year qualified for a second TKI stop. Ninety-four patients were included between Oct 2017-Dec 2021. At the time of data analysis, 62 patients had attempted a 2nd stop. After a median follow-up of 27 months from 2nd stop, TFR rates were 61, 56 and 46% at 6, 12 and 24 months respectively. No progression to advanced stage disease was seen and 87% had re-achieved MR4 within a median of 3 months from TKI re-initiation. In summary, we show that a 2nd TFR attempt after dasatinib treatment is safe, feasible and TFR rates seem in the range of those reported in trials of a first TKI stop.
AB - Tyrosine kinase inhibitor (TKI) discontinuation in chronic myeloid leukemia (CML) has become part of routine care for patients with a sustained deep molecular response (DMR). Approximately 50% experience a molecular relapse upon TKI cessation. Most of them quickly regain DMR upon TKI resumption. Whether these patients can achieve a second treatment-free remission (TFR) remains unclear. DAstop2 (ClinicalTrials.gov ID: NCT03573596) is a prospective study including patients with a failed first TFR attempt re-treated with any TKI for ≥ one year. Upon entering the study, patients received the TKI dasatinib for additional two years. Patients with sustained DMR for ≥1 year qualified for a second TKI stop. Ninety-four patients were included between Oct 2017-Dec 2021. At the time of data analysis, 62 patients had attempted a 2nd stop. After a median follow-up of 27 months from 2nd stop, TFR rates were 61, 56 and 46% at 6, 12 and 24 months respectively. No progression to advanced stage disease was seen and 87% had re-achieved MR4 within a median of 3 months from TKI re-initiation. In summary, we show that a 2nd TFR attempt after dasatinib treatment is safe, feasible and TFR rates seem in the range of those reported in trials of a first TKI stop.
UR - http://www.scopus.com/inward/record.url?scp=85183379737&partnerID=8YFLogxK
U2 - 10.1038/s41375-024-02145-6
DO - 10.1038/s41375-024-02145-6
M3 - Article
C2 - 38278960
SN - 0887-6924
VL - 38
SP - 781
EP - 787
JO - Leukemia
JF - Leukemia
IS - 4
ER -