Clinicals studies show that stopping TKI treatment is safe and effective in a limited group of patients. This is known as treatment-free remission (TFR).
Haematologists consider TFR as the ultimate goal for patients with CML. TFR can improve quality of life by avoiding TKI side effects. In addition, TFR can allow lowering the TKI dose or enhance supportive care.
Currently, clinical trial data do not fully establish which patients can stop treatment safely. Nevertheless, advice is that patients who would potentially be good candidates for TFR are those who:
Are in chronic phase CML
- Have received a TKI for a minimum of three years
- Have had a DMR (MR4.0 or MR4.5 for at least two years
So far, nilotinib is the only TKI approved by the EMA for TFR.
Nevertheless, if patients achieve and maintain a sustained molecular response with any TKI, treatment discontinuation is a possibility.