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Can TKIs be discontinued?
Source: Chronic Myeloid Leukemia Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: March 13, 2025 · Captured 2026-09-09.
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For patients who obtain a DMR, it is unclear if TKI therapy can be discontinued. Several nonrandomized reports are summarized as follows:[20-24][Level of evidence C3]
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Patients who have taken a TKI for more than 3 to 5 years and attained a DMR (molecular remission, 4.5; BCR::ABL1 ≤ 0.0032%) are the best candidates to consider stopping therapy.
50% of patients will experience a relapse of their disease if they discontinue TKI therapy. However, a retrospective analysis with a median follow-up of 3 years found that patients who were in DMR (4 to 4.5 logs) for 5 or more years had a relapse rate of approximately 10%.[25][Level of evidence C3] Another retrospective report with a median of 3 years of follow-up found three measurable factors predictive of MMR maintenance: increased duration of TKI treatment, increased duration of DMR on TKI treatment, and the absence of any peripheral blood blast cells at diagnosis.[20]
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Almost all patients who relapse based on BCR::ABL1 quantitative reverse transcription–polymerase chain reaction (RT-PCR) testing can be successfully reinduced with the previous TKI.
However, after the reinduction of a previous TKI, the duration of remissions or the depth of responses are not known. Data to recommend universal discontinuation of TKIs are insufficient, even in patients with a DMR or CMR. Follow-up (i.e., at least every 3 months initially, although the precise interval is not well-defined) is required after stopping therapy because relapses have been noted even after 2 to 3 years. A withdrawal syndrome of muscle and joint pain has been reported after discontinuing TKI therapy.[26] Quality-of-life assessments suggest improved social function, diarrhea, and fatigue after stopping TKI therapy.[27][Level of evidence C1]
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