Patient-Initiated Discontinuation of Tyrosine Kinase Inhibitor for Chronic Myeloid Leukemia

Table 1

Minimum criteria for tyrosine kinase inhibitor discontinuation outside of a clinical trial.

Criteria for TKI cessation	ESMO guidelines [18]	NCCN guidelines [19]
Consultation	CML speciality centre	CML speciality centre
Age	Not specified	≥18 years
Risk category or phase at diagnosis	Non-high Sokal score	Chronic phase
On TKI therapy	>5 years	>3 years
BCR-ABL1 transcript	e13a2, e14a2 or other transcript quantifiable over 4.5 log range	Evidence of quantifiable transcript
Molecular response achieved & duration	MR4.5 achieved/MR4.0 ≥ 2 years	MR4.0 ≥ 2 years
BCR-ABL1 test sensitivity/turnaround	At least MR4.5/4 weeks	At least MR4.5/2 weeks
Monitoring frequency	Monthly for 6 months/6 weekly for next 6 months/3 monthly thereafter	Monthly for one year/6 weekly for second year/3 monthly thereafter
TKI resumption	Not specified	Within 4 weeks of loss of MMR with monthly monitoring

TKI: tyrosine kinase inhibitor; ESMO: European Society for Medical Oncology; NCCN: National Comprehensive Cancer Network; CML: chronic myeloid leukemia; MR: molecular response; MMR: major molecular response.