open access publication

Article, 2024

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

Leukemia, ISSN 1476-5551, 0887-6924, Volume 38, 4, Pages 781-787, 10.1038/s41375-024-02145-6

Contributors

Flygt, Hjalmar 0000-0002-8912-2324 (Corresponding author) [1] Söderlund, Stina [1] Richter, Johan 0000-0002-0374-6823 [2] Saussele, Susanne 0000-0003-0357-5785 [3] Koskenvesa, Perttu 0000-0002-7121-321X [4] Stenke, Leif Å L [5] Mustjoki, Satu Maarit 0000-0002-0816-8241 [4] [6] [7] Dimitrijevic, Andreja [8] Stentoft, Jesper 0009-0003-4969-1201 [9] Majeed, Waleed [10] Roy, Lydia [11] Wolf, Dominik Georg Friedrich 0000-0002-4761-075X [12] [13] Dreimane, Arta [14] Gjertsen, Bjørn Tore 0000-0001-9358-9704 [15] Gedde-Dahl, Tobias J 0000-0002-3037-5378 [16] Ahlstrand, Erik 0000-0003-1928-7518 [17] Markevärn, Berit [18] Hjorth-Hansen, Henrik [19] Janssen, Jeroen J W M Jwm 0000-0001-9567-1955 [20] Olsson-Strömberg, Ulla [1]

Affiliations

  1. [1] Uppsala University Hospital
    2. [NORA names: Sweden; Europe, EU; Nordic; OECD];
  2. [2] Skåne University Hospital
    3. [NORA names: Sweden; Europe, EU; Nordic; OECD];
  3. [3] Heidelberg University
    4. [NORA names: Germany; Europe, EU; OECD];
  4. [4] Helsinki University Hospital
    5. [NORA names: Finland; Europe, EU; Nordic; OECD];
  5. [5] Karolinska Institutet
    6. [NORA names: Sweden; Europe, EU; Nordic; OECD];

Abstract

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.

Keywords

MR4, TKI discontinuation attempt, TKI resumption, advanced stage disease, analysis, attempt, care, chronic myeloid leukemia, dasatinib, dasatinib treatment, data analysis, deep molecular response, discontinuation, discontinuation attempt, disease, follow-up, inhibitors, interim results, kinase inhibitors, leukemia, median, median follow-up, molecular response, months, myeloid leukemia, patients, progression, progression to advanced stage disease, prospective study, range, rate, re-initiation, re-treatment, remission, response, results, resumption, routine care, stage disease, stop, study, sustained deep molecular response, time, time of data analysis, treatment, treatment-free remission, treatment-free remission attempt, treatment-free remission rates, trials, tyrosine, tyrosine kinase inhibitor dasatinib, tyrosine kinase inhibitors, years

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