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Successful tyrosine kinase inhibitor discontinuation outside clinical trials — data from the population‐based Swedish chronic myeloid leukaemia registry
Author(s) -
Flygt Hjalmar,
Sandin Fredrik,
Dahlén Torsten,
Dremaine Arta,
Lübking Anna,
Markevärn Berit,
MyhrEriksson Kristina,
Olsson Karin,
OlssonStrömberg Ulla,
Själander Anders,
Söderlund Stina,
Wennström Lovisa,
Wadenvik Hans,
Stenke Leif,
Höglund Martin,
Richter Johan
Publication year - 2021
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/bjh.17392
Subject(s) - discontinuation , medicine , clinical trial , tyrosine kinase inhibitor , adverse effect , population , pediatrics , cancer , environmental health
Summary 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.