NCCN Updates Chronic Myeloid Leukemia Guidelines


The National Comprehensive Cancer Network (NCCN) revised their criteria for discontinuation of tyrosine kinase inhibitor (TKI) therapy in chronic myeloid leukemia (CML).

Due to the recent US Food and Drug Administration (FDA) updates regarding nilotinib discontinuation in CML, the NCCN criteria for discontinuation of TKI therapy and recommendations for post-discontinuation monitoring were amended.

Multiple modifications were made to the criteria for discontinuation section. “No history of resistance to any TKI” was removed. Bullet six now reads, “Access to a reliable qPCR test with a sensitivity of detection at least MR4.5 (BCR-ABL1 ≤ 0.0032% IS) and provides results within 2 weeks.”

For patients who remain in MMR (MR3; BCR-ABL1 ≤0.1% IS) after discontinuation of TKI therapy, monthly molecular monitoring for one year, then every 6 weeks for the second year, and every 12 weeks thereafter is recommended.

In the bullet addressing prompt resumption of TKI therapy, the revision now reads, “Prompt resumption within 4 weeks of a loss of MMR with a monthly molecular monitoring every 4 weeks until MMR is re-established, then every 12 weeks thereafter is recommended indefinitely for patients who have reinitiated TKI therapy after a loss of MMR.” Furthermore, the guidelines state that for those who fail to achieve MMR after 3 months of TKI resumption, BCR-ABL1 kinase domain mutation testing should be performed, and monthly monitoring should be continued for another 6 months.


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The guidelines note that the discussion section has been updated to reflect these changes.—Zachary Bessette