Chronic Myeloid Leukemia Clinical Practice Guidelines (2018)

National Comprehensive Cancer Network

Reviewed and summarized by Medscape editors

September 27, 2018

The guidelines on chronic myeloid leukemia were released in September 2018 by the NCCN.[1]

Initial evaluation should consist of a history and a physical exam, including palpation of the spleen, a CBC with differential, a chemistry profile, and a hepatitis panel.

Bone marrow aspirate and biopsy for morphologic and cytogenetic evaluation and quantitative reverse transcriptase polymerase chain reaction (qPCR) to establish the presence of quantifiable BCR-ABL1 mRNA transcripts at baseline are recommended to confirm the diagnosis of chronic myeloid leukemia (CML).

If bone marrow evaluation is not feasible, fluorescence in situ hybridization (FISH) on a peripheral blood specimen with dual probes for BCR and ABL1 genes is acceptable.

Imatinib (400 mg daily) and second-generation tyrosine kinase inhibitors (TKIs) dasatinib (100 mg once daily), nilotinib (300 mg twice daily), and bosutinib (400 mg daily) are all appropriate options for first-line TKI therapy for patients with chronic phase CML (CP-CML) across all risk scores.

The preferred method for monitoring response to TKI therapy is measurement of the decrease in the amount of BCR-ABL1 chimeric mRNA using qPCR standardized by international scale (IS).

Patients with ≤10% BCR-ABL1 IS at 3 and 6 months and ≤1% BCR-ABL1 IS at 12 and 15 months after first-line TKI therapy are considered to have TKI-sensitive disease and can be continued on the same dose of TKI with assessment of BCR-ABL1 transcripts with qPCR (IS) every 3 months.

Patients with >10% BCR-ABL1 IS at ≥6 months and those with BCR-ABL1 IS >1% at 15 months are considered to have TKI-resistant disease and should be evaluated for allogeneic hematopoietic cell transplantation (HCT).

BCR-ABL kinase domain mutation analysis and assessment of possible drug interactions and compliance with therapy are recommended before the start of second-line TKI therapy.

Switching to an alternate TKI is recommended for patients with disease that is resistant to imatinib 400 mg daily.

Switching to an alternate TKI (other than imatinib) in the second-line setting could be considered for patients with disease that is resistant to dasatinib, nilotinib, or bosutinib. However, there is no clear evidence that this improves long-term clinical outcome.

Ponatinib is an option for patients with T315I mutation and for those with disease that has not responded to several TKIs.

Discontinuation of TKI therapy (with close monitoring) is feasible in carefully selected patients with early CP-CML who have achieved and maintained a deep molecular response (≥MR4.0) for ≥2 years.


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