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Why is it important to think about monitoring and mutation testing when treating patients with cml and what is important to consider?

Think Test Treat

WHY?

  • Identifying patients at risk of failing, or who have failed, TKI treatment allows physicians to change therapy earlier in the treatment course to improve long-term outcomes1,2

WHAT?

  • Molecular monitoring by RQ-PCR is recommended at baseline and at least every 3 months throughout treatment1

  • Monitoring schedule has to be adapted for patients who cease therapy (TFR patients)1

Think Test Treat

WHY?

  • BCR-ABL1 kinase domain mutations are found in:

    • Up to 63% of patients with imatinib resistance7

    • 14–33% of patients with resistance to second-line 2G TKI5

  • Timely detection of mutations known to confer TKI resistance can facilitate appropriate clinical decisions1,3,4

WHAT?

  • Mutation testing should be performed:1

    • At diagnosis: only in CML patients who present in de-novo accelerated- or blast phase

    • During therapy: in all CML patients with failure/resistance and always when switching TKI

  • Conventional Sanger (direct) sequencing is the currently recommended method for mutation testing, but cannot detect mutations present in less than 20% of BCR-ABL1 transcripts (low-level mutations)8

  • There are several methods with varying sensitivities that are able to detect low-level mutations8-11

  • Sensitive methods of mutation detection, such as NGS, provide a more accurate picture of BCR-ABL1 mutation status in CML patients with failure or warning12

Mutation testing methods and associated sensitivities

Conventional Sanger sequencing
15–25%
Denaturing HPLC
0.1–10%
NGS
0.5–1%
Mass spectrometry
0.05–0.5%
ASO-PCR
0.001–0.01%

Think Test Treat

WHY?

  • Based on mutation testing results, the most appropriate TKI should be selected – different TKls are effective against different mutations1,3-5

  • Choosing an inappropriate TKI leads to a high risk of subsequent treatment failure with clonal expansion of the resistant mutant and a greater likelihood of developing additional mutations, including compound mutations8,12,13

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WHAT?

  • Mutation testing results should inform clinical decisions1,3,4

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