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

Flygt, Hjalmar ; Sandin, Fredrik ; Dahlén, Torsten ; Dremaine, Arta ; Lübking, Anna LU ; Markevärn, Berit ; Myhr-Eriksson, Kristina ; Olsson, Karin ; Olsson-Strömberg, Ulla and Själander, Anders , et al. (2021) In British Journal of Haematology 193(5). p.915-921
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,... (More)

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.

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publishing date
type
Contribution to journal
publication status
published
subject
keywords
BCR-ABL, chronic myeloid leukaemia, discontinuation, tyrosine kinase inhibitor
in
British Journal of Haematology
volume
193
issue
5
pages
915 - 921
publisher
Wiley-Blackwell
external identifiers
  • scopus:85103418763
  • pmid:33782950
ISSN
0007-1048
DOI
10.1111/bjh.17392
language
English
LU publication?
no
id
a8873274-18dc-438f-8213-fe5524751370
date added to LUP
2021-04-15 09:57:28
date last changed
2023-09-12 18:23:23
@article{a8873274-18dc-438f-8213-fe5524751370,
  abstract     = {{<p>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.</p>}},
  author       = {{Flygt, Hjalmar and Sandin, Fredrik and Dahlén, Torsten and Dremaine, Arta and Lübking, Anna and Markevärn, Berit and Myhr-Eriksson, Kristina and Olsson, Karin and Olsson-Strömberg, Ulla and Själander, Anders and Söderlund, Stina and Wennström, Lovisa and Wadenvik, Hans and Stenke, Leif and Höglund, Martin and Richter, Johan}},
  issn         = {{0007-1048}},
  keywords     = {{BCR-ABL; chronic myeloid leukaemia; discontinuation; tyrosine kinase inhibitor}},
  language     = {{eng}},
  number       = {{5}},
  pages        = {{915--921}},
  publisher    = {{Wiley-Blackwell}},
  series       = {{British Journal of Haematology}},
  title        = {{Successful tyrosine kinase inhibitor discontinuation outside clinical trials — data from the population-based Swedish chronic myeloid leukaemia registry}},
  url          = {{http://dx.doi.org/10.1111/bjh.17392}},
  doi          = {{10.1111/bjh.17392}},
  volume       = {{193}},
  year         = {{2021}},
}