Successful tyrosine kinase inhibitor discontinuation outside clinical trials — data from the population-based Swedish chronic myeloid leukaemia registry

Hjalmar Flygt, Fredrik Sandin, Torsten Dahlén, Arta Dremaine, Anna Lübking, Berit Markevärn, Kristina Myhr-Eriksson, Karin Olsson, Ulla Olsson-Strömberg, Anders Själander, Stina Söderlund, Lovisa Wennström, Hans Wadenvik, Leif Stenke, Martin Höglund, Johan Richter

Research output: Contribution to journalArticlepeer-review

Abstract

Clinical trials show that tyrosine kinase inhibitor (TKI) treatment can be discontinued in selected patients with chronic myeloid leukaemia (CML). Although updated CML guidelines support such procedure in clinical routine, data on TKI stopping outside clinical trials are limited. In this retrospective study utilising the Swedish CML registry, we examined TKI discontinuation in a population-based setting. Out of 584 patients diagnosed with chronic-phase CML (CML-CP) in 2007–2012, 548 had evaluable information on TKI discontinuation. With a median follow-up of nine years from diagnosis, 128 (23%) discontinued TKI therapy (≥1 month) due to achieving a DMR (deep molecular response) and 107 (20%) due to other causes (adverse events, allogeneic stem cell transplant, pregnancy, etc). Among those stopping in DMR, 49% re-initiated TKI treatment (median time to restart 4·8 months). In all, 38 patients stopped TKI within a clinical study and 90 outside a study. After 24 months 41·1% of patients discontinuing outside a study had re-initiated TKI treatment. TKI treatment duration pre-stop was longer and proportion treated with second-generation TKI slightly higher outside studies, conceivably affecting the clinical outcome. In summary we show that TKI discontinuation in CML in clinical practice is common and feasible and may be just as successful as when performed within a clinical trial.

Original languageEnglish
Pages (from-to)915-921
JournalBritish Journal of Haematology
Volume193
Issue number5
Early online date2021
DOIs
Publication statusPublished - 2021
Externally publishedYes

Subject classification (UKÄ)

  • Hematology

Free keywords

  • BCR-ABL
  • chronic myeloid leukaemia
  • discontinuation
  • tyrosine kinase inhibitor

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