Table 3.
Clinical study | Patient no. | TKI at time of cessation | Depth of DMR | Duration of DMR | TKI restart criteria | TFR success (follow-up) |
---|---|---|---|---|---|---|
STIM140 | 100 | Imatinib | UMRD | ≥2 yr | Loss of MMR or ≥1-log increase in BCR-ABL1 | 38% (60 mo) |
TWISTER41 | 40 | Imatinib | UMRD | ≥2 yr | Loss of MMR or rising BCR-ABL1 on 2 consecutive tests | 47.1% (24 mo) |
KID49 | 90 | Imatinib | UMRD | ≥2 yr | Loss of UMRD on 2 consecutive tests of MMR loss | 58.5% (24 mo) |
STOP 2G-TKI44 | 60 | Dasatinib or nilotinib | UMRD | ≥2 yr | Loss of MMR | 53.57% (48 mo) |
A-STIM42 | 80 | Imatinib | UMRD (occasional weakly positive samples also eligible) | ≥2 yr | Loss of MMR | 61% (36 mo) |
ENESTFreedom43 | 190 | First-line nilotinib | MR4.5 | ≥1 yr | Loss of MMR | 51.6% (48 wk) |
ENESTop47 | 126 | Second-line nilotinib after imatinib | MR4.5 | ≥1 yr | Loss of MMR or confirmed loss of MR4 | 53% (96 wk) |
ISAV3 | 112 | Imatinib | MR4-MR4.5 | ≥18 mo | Loss of MMR | 48.1% (21.6 mo) |
DADI38 | 63 | Second-line dasatinib | MR4 or 0.0069% (IS) | ≥1 yr | Loss of DMR | 44% (36 mo) |
D-STOP50 | 54 | Dasatinib | MR4 | ≥1 yr | BCR-ABL1 > 0.0069% on 2 consecutive results | 57% (24 mo) |
EURO-SKI39 | 755 | Imatinib > nilotinib/dasatinib | MR4 | ≥1 yr | Loss of MMR | 50% (24 mo) |
Interim results | ||||||
STIM2 (interim)53 | 124 | Imatinib | UMRD | ≥2 yr | Loss of MMR or ≥1-log increase in BCR-ABL1 | 59% (12 mo) |
DASFREE (interim)54 | 84 | Dasatinib (first or second line) | MR4.5 | ≥1 yr | Loss of MMR | 49% (12 mo) |
DESTINY55 | 117 | Imatinib > dasatinib/nilotinib | MR4 | ≥1 yr | Loss of MMR | 77% (24 mo) |
UMRD, undetectable molecular residual disease.