Table 1.
Summary of the findings of the included studies
| Follow-up, mo*,† | Year/ref. | Journal/full paper or abstract | Outcome evaluated |
|---|---|---|---|
| RCT: DASISION (D); 519 patients | |||
| Imatinib: 49 (18-78) y; Male: 163 (63%) Dasatinib: 46 (18-84) y; Male: 144 (56%) |
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| 12 | 2010/7 | N Engl J Med/Full paper | PFS 12 mo; OS 12 mo; CCyR by 3 mo, by 12 mo; cCCyR by 12 mo; MMR by 3 mo, by 12 mo; AP/BP; DIS |
| 18 | 2010/29 | Blood/Abstract | PFS 18 mo; OS 18 mo; AP/BP |
| 24 | 2011/30 | J Clin Oncol/Abstract | PFS 18 mo; OS 18 mo; MR4.5; AP/BP |
| 24 | 2011/31 | Blood/Abstract | EMR at 3 mo; MMR by 3 mo, by 24 mo; MR4; MR4.5 |
| 24 | 2012/32 | J Clin Oncol/Abstract | MR4 |
| 24 | 2012/33 | Blood/Full paper | PFS 24 mo; OS 24 mo; CCyR at 12 mo, by 12 mo, at 24 mo, by 24 mo; cCCyR by 24 mo; MMR at 12 mo, by 12 mo, at 24 mo, by 24 mo; MR4.5; AP/BP; DIS |
| 36 | 2014/34 | Blood/Full paper | PFS 36 mo; OS 36 mo; CCyR at 3 mo, at 12 mo, by 36 mo; cCCyR by 36 mo; EMR at 3 mo; MMR at 12 mo, by 36; MR4; MR4.5; AP/BP; DIS |
| 48 | 2013/35 | Blood/Abstract | PFS 48 mo; OS 48 mo; EMR at 3 mo; MMR at 12 mo, by 48 mo; MR4; MR4.5, AP/BP |
| 60 | 2014/36 | Blood/Abstract | PFS 60 mo; OS 60 mo; cCCyR by 60 mo; EMR at 3 mo; MMR by 60 mo; MR4.5; AP/BP |
| 60 | 2016/37 | J Clin Oncol/Full paper | PFS 60 mo; OS 60 mo; cCCyR at 60 mo; EMR at 3 mo; MMR by 12 mo, by 24 mo, by 36 mo, by 48 mo, by 60 mo, at 60 mo; MR4; MR4.5; DIS |
| Quasi-RCT: NCT00070499 (D); 253 patients | |||
| Imatinib: 50 (19-89) y; Male: 72 (59%) Dasatinib: 47 (18-90) y; Male: 74 (60%) |
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| 12 (36 mo for PFS, OS) | 2012/6 | Blood/Full paper | PFS 36 mo; OS 36 mo; CCyR by 12 mo; MMR at 12 mo; MR4; MR4.5; AP/BP; DIS |
| RCT: NordCML006 (D); 46 patients | |||
| Imatinib: 60 (38-77) y; Male: 15 (63%) Dasatinib: 54 (29-71) y; Male: 7 (32%) |
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| 18 | 2013/38 | Leukemia/Full paper | CCyr at 12 mo |
| 24 | 2013/39 | Blood/Abstract | MMR at 3 mo, by 12 mo, by 24 mo; MR4; MR4.5; AP/BP; DIS |
| 36 | 2015/8 | Eur J Haematol/Full paper | CCyR at 3 mo, at 12 mo; EMR at 3mo; MR4; AP/BP; DIS |
| RCT: ENEST (N); 846 patients | |||
| Imatinib: 46 (18-80) y; Male: 158 (56%) Nilotinib 300 mg: 47 (18-85) y; Male: 158 (56%) Nilotinib 400 mg: 47 (18-81) y; Male: 175 (62%) |
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| 12 | 2010/40 | J Clin Oncol/Abstract | CCyR by 12 mo; MMR at 12 mo; MR4; MR4.5 |
| 12 | 2010/9 | N Engl J Med/Full paper | CCyR at 12 mo, by 12 mo; MMR at 3 mo, at 12 mo, by 12 mo; MR4; MR4.5; AP/BP; DIS |
| 18 | 2010/41 | Blood/Abstract | OS 18 mo; MR4.5; AP/BP |
| 24 | 2011/42 | Lancet Oncol/Full paper | PFS 24 mo; OS 24 mo; CCyR by 12 mo, by 24 mo; MMR by 12 mo, by 24 mo; MR4; MR4.5; AP/BP; DIS |
| 36 | 2012/43 | Blood/Abstract | PFS 36 mo; OS 36 mo; MMR by 36 mo; MR4; MR4.5 |
| 36 | 2012/44 | Leukemia/Full paper | PFS 36 mo; OS 36 mo; MMR at 36 mo, by 36 mo; MR4; MR4.5; AP/BP; DIS |
| 36 | 2013/45 | Blood/Full paper | AP/BP |
| 48 | 2014/46 | Blood/Full paper | PFS 48 mo; OS 48 mo; EMR at 3 mo; MMR by 48 mo; MR4; MR4.5; AP/BP |
| 60 | 2016/47 | Leukemia/Full paper | PFS 60 mo; OS 60 mo; EMR at 3 mo; MMR by 12 mo, by 24 mo, by 36 mo, by 48 mo, by 60 mo; MR4; MR4.5; AP/BP; DIS |
| 72 | 2015/48 | Blood/Abstract | MR4; MR4.5 |
| 72 | 2015/49 | Haematologica/Abstract | OS 72 mo; MMR by 72 mo; MR4.5 |
| Quasi-RCT: BELA (B); 502 patients | |||
| Imatinib: 47 (18-89) y; Male: 135 (54%) Bosutinib: 48 (19-91) y; Male: 149 (60%) |
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| 12 | 2012/13 | J Clin Oncol/Full paper | OS 12 mo; CCyR at 3 mo, at 12 mo, by 12 mo; MMR at 3 mo, at 12 mo, by 12 mo; AP/BP; DIS |
| 18 | 2011/50 | J Clin Oncol/Abstract | CCyR at 12 mo, by 12 mo; MMR at 12 mo, by 12 mo; AP/BP |
| 24 | 2014/51 | Br J Haematol/Full paper | OS 24 mo; CCyR at 24 mo, by 24; EMR at 3 mo; MMR at 24 mo, by 24 mo; MR4; AP/BP; DIS |
| 30 | 2012/52 | Haematologica/Abstract | OS 24 mo; CCyR by 24 mo; MMR by 24 mo; AP/BP |
| 30 | 2014/53 | Am J Hematol/Full paper | — |
| 48 | 2016/54 | Am J Hematol/Full paper | Only safety |
| RCT: BFORE (B); 536 patients | |||
| Imatinib: 53 (19-84) y; Male: 135 (56%) Bosutinib: 52 (18-84) y; Male: 142 (58%) |
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| 12 | 2018/14 | J Clin Oncol/Full paper | OS 12 mo; CCyR by 12 mo; MMR at 3 mo, at 12 mo; MR4; MR4.5; AP/BP; DIS |
| 18 | 2017/55 | Blood/Abstract | OS 18 mo; AP/BP |
| Quasi-RCT: EPIC (P); 307 patients | |||
| Imatinib: 52 (18-86) y; Male: 92 (61%) Ponatinib: 55 (18-89) y; Male: 97 (63%) |
|||
| 12 | 2016/16 | Lancet Oncol/Full paper | CCyR at 12 mo; EMR at 3 mo; MMR at 3 mo, at 12 mo; MR4; MR4.5; DIS |
—, no data available; B, bosutinib; D, dasatinib; DIS, discontinued treatment; I, imatinib; N, nilotinib; P, ponatinib.
*In the row headings in column 1, RCTs and Quasi-RCTs included are: B, BEFORE (NCT02130557); B, BELA (NCT00574873); D, DASISION (NCT00481247); D (NCT00070499); D, NordCML006 (NCT00852566); N, ENEST (NCT00471497); P, EPIC (NCT01650805).
†
In the row subheadings in column 1, data are presented as: median age (range), y; male patients, number (percentage).