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Table 1 Summary of discontinuation studies published as full papers or in abstract form, with MR levels required for inclusion and for the definition of relapse

From: Treatment and monitoring of Philadelphia chromosome-positive leukemia patients: recent advances and remaining challenges

Study (ref) No. of patients Treatment before discontinuation Requirements to stop therapy Definition of relapse TFR rate
STIM 1 [5] 100 Imatinib (1st line or after IFN) for 3 years CMR (undetectable transcript) for ≥ 2 years Loss of CMR or ≥ 1-log increase in BCR-ABL 39% @ 77 months
STIM 2 [6] 124 Imatinib (1st line or after IFN) for ≥ 3 years As for STIM As for STIM 61% @ 12 months
TWISTER [7] 40 Imatinib (1st line or after IFN) for ≥ 3 years Undetectable transcript for ≥ 2 years Loss of MMR or confirmed loss of MR4.5 42.7% @ 24 months
A-STIM [8] 80 Imatinib (1st line) for ≥ 3 years As for STIM; occasional positive samples eligible Loss of MMR 61% @ 36 months
KIDS [9] 48 Imatinib (1st line or after IFN) Undetectable transcript for ≥ 2 years Loss of MMR 58.5% @ 24 months
JALSG-STIM213 [10] 77 Imatinib (1st line or after IFN) MR4 for ≥ 24 months (4 PCR) Loss of MMR 67.6% @ 12 months
ISAV [11] 112 Imatinib (1st line or after IFN) Undetectable transcript for ≥ 18 months (3 PCRs) Loss of MMR 52% @ 22 months
EUROSKI [12] 758 Imatinib (1st line or after IFN), dasatinib, nilotinib MR4 for ≥ 1 year; TKI for ≥ 3 years Loss of MMR 50% @ 24 months
STOP 2G-TKI [13] 60 Nilotinib or dasatinib (2nd line) Undetectable transcript for ≥ 2 years Loss of MMR 63.3% @ 12 months
DADI [14] 63 Dasatinib (2nd line) MR4 for ≥ 1 year (4 PCR) Loss of MR4 44.4% @ 36 months
ENEST freedom [15, 16] 190 Nilotinib (1st line) MR4.5 for ≥ 2 years Loss of MMR 48.9% @ 96 weeks
ENESTop [17] 126 Nilotinib (2nd line, after imatinib) MR4.5 for ≥ 2 years Confirmed loss of MR4.0or any loss of MMR 53.2% @ 96 weeks
DESTINY [18] 174 Imatinib, dasatinib, nilotinib (50% de-escalation for 12 months, then stop) At least stable MMR for 12 months (3 PCR) and stable response under half standard dose for 12 months Loss of MMR 73% in pts. with stable MR4; 41% in pts with stable MMR
D-STOP [19] 65 Dasatinib as consolidation for 2 years MR4 for ≥ 2 years Loss of confirmed MR4 62.9% @ 12 months
DASFREE [20] 84 Dasatinib (1st or subsequent line) MR4.5 for ≥ 1 year Loss of MMR 48% @ 18 months
TRAD [21] 131 Dasatinib rechallenge and discontinuation after imatinib discontinuation (second-stop) MR4.5 for ≥ 2 years Loss of MR4 on 2 consecutive occasions or loss of MMR on 1 occasion 21.5% @ 6 months
NILSt [22] 112 Nilotinib (1st line or after imatinib) MR4.5 for 2 years Loss of MR4.5 61% @ 12 months
LAST [23] 173 Imatinib, dasatinib, nilotinib, or bosutinib MR4 for ≥ 2 years Loss of MMR 60% @ 12 months
STAT2 [24] 96 Nilotinib as consolidation for 2 years MR4.5 for 2 years Confirmed loss of MR4.5 67.9% @ 12 months
ENESTpath [25] 619 Nilotinib (2nd line, after imatinib) Randomized MR4.5 for ≥ 1 year vs ≥ 2 year Confirmed loss of MR4 or any loss of MMR In progress
ENESTGoal [26] 59 Nilotinib (2nd line, after imatinib) MR4.5 for ≥ 1 year Confirmed loss of MR4 or any loss of MMR In progress
CML V [27] (TIGER) 717 Randomized nilotinib vs nilotinib + pegIFN (1st line) MR4 for ≥ 1 year Loss of MMR In progress
  1. Abbreviations: IFN interferon, pegIFN pegylated IFN, PCR polymerase chain reaction, CMR complete molecular response, MMR major molecular response
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Journal of Hematology & Oncology

ISSN: 1756-8722

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