Table 2.
Pooled relative risk of second- and third-generation TKIs in comparison with imatinib by efficacy
| Study | TKIs ENEST RCT: 300 mg | TKIs ENEST RCT: 400 mg | TKIs ENEST RCT: mean values of 300 mg and 400 mg | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Outcome efficacy* | No. of RCTs | No. of pts | RR† | 95% CI† | No. of RCTs | No. of pts | RR† | 95% CI† | No. of RCTs | No. of pts | RR† | 95% CI† |
| EMR at 3 mo | 6 | 2182 | 1.34 | 1.27-1.41 | 6 | 2184 | 1.33 | 1.27-1.40 | 6 | 2183 | 1.34 | 1.27-1.40 |
| MMR at 12 mo | 6 | 2208 | 1.52 | 1.32-1.75 | 6 | 2207 | 1.50 | 1.32-1.70 | 6 | 2208 | 1.51 | 1.32-1.73 |
| MR4 at any time | 7 | 2331 | 1.67 | 1.32-2.11 | 7 | 2330 | 1.60 | 1.31-1.96 | 7 | 2331 | 1.64 | 1.31-2.04 |
| CCyR at 12 mo | 5 | 1553 | 1.13 | 1.04-1.22 | 5 | 1552 | 1.13 | 1.04-1.22 | 5 | 1553 | 1.13 | 1.04-1.22 |
| CCyR by 12 mo | 5 | 2204 | 1.15 | 1.09-1.22 | 5 | 2203 | 1.15 | 1.09-1.20 | 5 | 2204 | 1.15 | 1.09-1.21 |
| MMR at 3 mo | 5 | 1823 | 4.50 | 2.23-9.09 | 5 | 1822 | 3.97 | 2.11-7.47 | 5 | 1823 | 4.28 | 2.20-8.32 |
| MR4.5 at any time | 6 | 1930 | 2.65 | 1.44-4.88 | 6 | 1929 | 2.58 | 1.42-4.70 | 6 | 1930 | 2.63 | 1.43-4.82 |
| AP/BP during study treatment | 6 | 2411 | 0.43 | 0.25-0.73 | 6 | 2410 | 0.44 | 0.26-0.74 | 6 | 2411 | 0.44 | 0.26-0.74 |
| Discontinued any time | 7 | 2715 | 1.00 | 0.81-1.24 | 7 | 2714 | 1.00 | 0.80-1.25 | 7 | 2715 | 1.00 | 0.80-1.24 |
Sensitivity analysis of different nilotinib doses (ENEST RCT: 300 mg, 400 mg, and mean values of 300 mg and 400 mg) (bosutinib BEFORE [NCT02130557], bosutinib BELA [NCT00574873], dasatinib DASISION [NCT00481247], dasatinib [NCT00070499], dasatinib NordCML006 [NCT00852566], nilotinib ENEST [NCT00471497; 300-mg and 400-mg doses], and ponatinib EPIC [NCT01650805]). In ENEST RCT, the patients (pts) were randomly assigned to receive 300 mg of nilotinib (n = 282), 400 mg of nilotinib (n = 281), 400 mg of imatinib (n = 283); the number of events is presented for the 3 groups (300 mg of nilotinib, 400 mg of nilotinib, 400 mg of imatinib). The sensitivity analysis was made by introducing into the meta-analysis: first, the results of 300 mg of nilotinib; second, the results of 400 mg of nilotinib; and third, the arithmetic mean of the results of the 2 nilotinib doses.
M-H method, random-effects method.
Bold values in these columns are statistically significant.