Criteria and outcome in studies on treatment-free remission (TFR) in adults
| Study . | N . | Eligibility for discontinuation . | Prior treatment . | Criteria for reinitiation of therapy . | TFR . |
|---|---|---|---|---|---|
| Stop Imatinib72 | 100 | Undetectable transcript ≥2 y | Imatinib ≥3 y* | Loss of MR3 or ≥1 log fold increase in transcript | 43% (95% CI, 33-52) at 6 mo |
| 38% (95% CI, 29-47) at 60 mo | |||||
| TWISTER73 | 40 | Undetectable transcript ≥2 y | Imatinib ≥3 y† | Loss of MR3 or MR4.5 | 47.1% (95% CI, 31.5-62.7) at 2 y |
| A-STIM74 | 80 | CMR (undetectable transcript) ≥2 y‡ | Imatinib ≥3 y§ | Loss of MR3 | 64% (95% CI, 54-75) at 12 and 24 mo |
| 61% (95% CI, 51-73) at 36 mo | |||||
| ENEST freedom75 | 190 | MR4.5 ≥1 y | Nilotinib frontline ≥3 y | Loss of MR3 | 51.6% (95% CI, 44.2-8.9) at 48 wk |
| STOP 2G-TKI97 | 60 | MR4.5 ≥2 y | Nilotinib or dasatinib ≥3 y first or second line | Loss of MR3 | 63.33% (95% CI, 51.14-75.53) at 12 mo |
| 53.57% (95% CI, 40.49-66.65) at 48 mo | |||||
| EURO-SKI24 | 755 | MR4 or undetectable transcript ≥1 y | Any TKI ≥3 y | Loss of MR3 | 61% (95% CI, 57-64) at 6 mo |
| 50% (95% CI, 46-54) at 24 mo |
| Study . | N . | Eligibility for discontinuation . | Prior treatment . | Criteria for reinitiation of therapy . | TFR . |
|---|---|---|---|---|---|
| Stop Imatinib72 | 100 | Undetectable transcript ≥2 y | Imatinib ≥3 y* | Loss of MR3 or ≥1 log fold increase in transcript | 43% (95% CI, 33-52) at 6 mo |
| 38% (95% CI, 29-47) at 60 mo | |||||
| TWISTER73 | 40 | Undetectable transcript ≥2 y | Imatinib ≥3 y† | Loss of MR3 or MR4.5 | 47.1% (95% CI, 31.5-62.7) at 2 y |
| A-STIM74 | 80 | CMR (undetectable transcript) ≥2 y‡ | Imatinib ≥3 y§ | Loss of MR3 | 64% (95% CI, 54-75) at 12 and 24 mo |
| 61% (95% CI, 51-73) at 36 mo | |||||
| ENEST freedom75 | 190 | MR4.5 ≥1 y | Nilotinib frontline ≥3 y | Loss of MR3 | 51.6% (95% CI, 44.2-8.9) at 48 wk |
| STOP 2G-TKI97 | 60 | MR4.5 ≥2 y | Nilotinib or dasatinib ≥3 y first or second line | Loss of MR3 | 63.33% (95% CI, 51.14-75.53) at 12 mo |
| 53.57% (95% CI, 40.49-66.65) at 48 mo | |||||
| EURO-SKI24 | 755 | MR4 or undetectable transcript ≥1 y | Any TKI ≥3 y | Loss of MR3 | 61% (95% CI, 57-64) at 6 mo |
| 50% (95% CI, 46-54) at 24 mo |
A-STIM, According to Stop Imatinib; CMR, complete molecular response; ENEST freedom, Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients; EURO-SKI, European Stop Tyrosine Kinase Inhibitor Study; MR3, BCR-ABL1 ≤0.1% IS; MR4, BCR-ABL1 ≤0.01% IS; MR4, BCR-ABL1 ≤0.0032% IS; STOP 2G-TKI, STOP second generation-tyrosine kinase inhibitor study; TWISTER, a phase II study to determine relapse-free interval after withdrawal of imatinib therapy in adult patients with chronic phase chronic myeloid leukaemia in stable complete molecular remission.
Patients who had previous stem cell transplantation or who had been treated with immunomodulatory agents other than interferon-α were excluded.
Prior treatment was permitted, except for allogeneic stem cell transplantation or other kinase inhibitors.
Patients with confirmed CMR with occasional weekly positive samples before study entry were also considered eligible.
Prior treatment was permitted, except for allogeneic stem cell transplantation.