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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 every 3 months during TKI therapy until stable MMR is achieved followed by 3- to 6-month testing thereafter1,2

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 for patients at risk of failing (ELN warning response) or who have failed (ELN failure response) treatment with their current TKI, and always when switching TKI1,3

  • Sensitive methods of mutation detection permit earlier identification of clinically relevant mutations that can expand and lead to TKI resistance8-11

  • 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)12

  • There are several methods with varying sensitivities that are able to detect low-level mutations12-15

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 can 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 mutations12,16

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WHAT?

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

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For further information, please contact Incyte Medical Information: eumedinfo@incyte.com