Discontinuation of tyrosine kinase inhibitor (TKI) therapy appears to be safe among adult patients with chronic myeloid leukemia (CML) in the chronic phase who have achieved and maintained a deep molecular response (DMR), according to the updated NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for CML.
According to Neil P. Shah, MD, PhD, Professor of Medicine, Division of Hematology and Oncology, UCSF Helen Diller Family Comprehensive Cancer Center, who discussed the updated NCCN Guidelines for CML at the NCCN 2019 Annual Conference, no major updates were introduced this year in regard to discontinuing TKI therapy in CML. However, when combined with careful molecular monitoring, the current guidelines reinforce the safety of discontinuation in appropriate patients. “Based on data presented a couple years ago, [the NCCN panel] decided to modify the guidelines to incorporate TKI discontinuation as a reasonable option in select patients,” said Dr. Shah. “These recommendations in the guidelines have only been around for about 2.5 years, so in the last year nothing has really changed. But some clinicians, still to this day, are not aware that stopping is an option.”
According to the guidelines, achievement and maintenance of a DMR characterized by ≥4 log reduction in BCR-ABL1 transcripts (MR4.0) for ≥2 years is required before considering TKI discontinuation outside the context of a clinical trial. Loss of MMR (MR3.0; BCR-ABL1 >0.1%) should trigger immediate resumption of TKIs, with monthly monitoring, until MMR is regained. Approximately 50% of patients who attempt to discontinue TKI therapy after achieving a stable deep molecular remission remain in a treatment-free remission (TFR) after 5 years.
Disclosures: Dr. Shah has disclosed that he receives grant/research support from Bristol-Myers Squibb Company.
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)| false , Sauselle S , Richter J , Guilhot J Discontinuation of tyrosine kinase inhibitor therapy in chronic myeloid leukaemia (EURO-SKI): a prespecified interim analysis of a prospective, multicentre, non-randomised, trial. 2018; 19: 747– 757. 10.1016/S1470-2045(18)30192-X
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