4CPS-081 Discontinuation of tyrosine kinase inhibitor therapy in chronic myeloid leukaemia in first or second-line
Year: 2025
Type: conference-paper
Study design: Observational Study
Abstract: Background and Importance Data on treatment discontinuation of Tyrosine Kinase Inhibitors (TKIs) in Chronic Myeloid Leukaemia (CML) in routine clinical practice are limited, and it would be interesting to develop treatment discontinuation studies in this situation to demonstrate that it is safe and effective in real-life. Aim and Objectives To analyse the Rates of Molecular Relapse-Free Survival (MRFS) and Treatment Free Remission (TFR) during discontinuation of TKIs in first or second-line CML. Material and Methods Observational multicentre prospective follow-up study of discontinuation of TKIs treatment in patients with chronic phase CML who have been on treatment with Imatinib, Nilotinib or Dasatinib at any dose, first or second-line, and who have achieved and maintained Molecular Response (MR) ≥ 4.5 log for at least 36 months. Authorisation was obtained from the Andalusian Biomedical Research Ethics Coordinating Committee (CCEIBA). Inclusion criteria: minimum TKI treatment time of 5 years, no resistance to any previous TKI, no diagnosis of accelerated phase or blast crisis, and maintenance of a MR ≥ 4.5 log for at least 36 months prior to discontinuation. Molecular monitoring of BCR-ABL levels by PCR-RT with the GeneXpert on a monthly basis in the first year, every 2 months in the second year and every 3 months after the third year. Molecular relapse was considered to be the confirmed loss of Major Molecular Response (MMR). Results Treatment was discontinued in 90 patients with a median age at diagnosis of 48 and 59 years at discontinuation. 60 discontinued Imatinib, 10 dasatinib and 20 Nilotinib. The median time to discontinuation was 30 months. The MRFS rate 74% and the TFR rate 62%. The 25 patients who lost MMR achieved MMR after reintroduction of the same TKI treatment, with a median of 3 months. There was no progression to advanced stages of the disease. A 15% of patients suffered withdrawal syndrome. Conclusion and Relevance The MRFS and RFT of our study is concordant with those reported in several real-life series. In selected patients, with a considerable exposure time to TKI treatment, and in deep and maintained MR, a successful RFT can be expected, which translates into effective and safe discontinuation of TKIs in clinical practice. References and/or Acknowledgements Conflict of Interest No conflict of interest
Institution: Hospital Universitario Virgen de las Nieves
Language: English
Subfield: Hematology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
OpenAlex ID: W4408376188