What are the NCCN criteria for discontinuing TKI therapy in the treatment of chronic myelogenous leukemia (CML)?

Updated: Oct 23, 2019
  • Author: Rossa Khalaf, MD; Chief Editor: Emmanuel C Besa, MD  more...
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The National Comprehensive Cancer Network (NCCN) lists the following criteria for discontinuing TKI therapy:

  • Age ≥18 years
  • CP- CML
  • No prior history of AP-CML or BP-CML
  • On approved TKI therapy (imatinib, dasatinib, nilotinib, bosutinib, or ponatinib) for at least 3 years
  • Prior evidence of quantifiable BCR-ABL1 transcript
  • Stable molecular response (MR4; ≤0.01% International Scale [IS]) for ≥2 years, as documented on at least four tests, performed at least 3 months apart
  • No history of resistance to any TKI
  • Access to a reliable qPCR test with a sensitivity of detection of ≥4.5 logs that reports results on the IS and provides results within 2 weeks.
  • Monthly molecular monitoring for the first 6 months following discontinuation, bimonthly during months 7–24, and quarterly thereafter (indefinitely) for patients who remain in MMR (MR3; ≤0.1% IS).
  • Consultation with a CML Specialty Center to review the appropriateness for TKI discontinuation and potential risks and benefits of treatment discontinuation, including TKI withdrawal syndrome.

For patients who lose MMR, the NCCN recommends prompt resumption of TKI therapy, with monthly molecular monitoring for the first 6 months and every 3 months thereafter, indefinitely. For those who fail to achieve MMR after 6 months of TKI resumption, BCR-ABL1 kinase domain mutation testing should be performed, and monthly molecular monitoring should be continued for another 6 months. [19]

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