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Table 3 Summary of 3-month landmark analyses of selected clinical studies of first-line TKI therapy

From: Biomarkers for determining the prognosis in chronic myelogenous leukemia

TKI Study Parameter BCR-ABL1% (IS) at 3 months P value
Imatinib Hammersmith Hospital [51]   ≤9.84% (n = 211) >9.84% (n = 68)  
8-year OS 93.3% 56.9% <0.001
  ≤9.54% (n = 208) >9.54% (n = 71)  
8-year PFS 92.8% 57.0% <0.001
  ≤8.58% (n = 169) >8.58% (n = 79)  
8-year CCyR 99.4% 21.7% <0.001
  ≤2.81% (n = 141) >2.81% (n = 137)  
8-year MMR 82.5% 21.1% <0.001
German CML Study IV [50]   >1-10% (n = 281) >10% (n = 189)  
5-year OS 92% 87% 0.037
  >1-10% (n = 283) >10% (n = 191)  
5-year PFS 94% 87% 0.012
ENESTnda[52]   ≤10% (n = 176) >10% (n = 88)  
MMR by 2 years 58% 21% NR
PFS at 3 years 97.7% 83.8%
OS at 3 years 98.9% 84.8%
DASISIONa[9]   ≤10% (n = 154) >10% (n = 85)  
AP/BC by 3 years 2.6% 12.9% NR
PFS at 3 years 95.9% 75.3% <0.0001
OS at 3 years 96.0% 88.0% 0.0036
BELAa[53]   ≤10% (n = 146) >10% (n =77)  
MMR by 24 months 69% 17% <0.001
CCyR by 12 months 95% 65% <0.001
OS at 24 months 99% 95% NS
Nilotinib ENESTnd [52]   ≤10% (n = 234) >10% (n = 24)  
MMR by 2 years 80% 29% NR
PFS at 3 years 95.9% 82.9%
OS at 3 years 97.6% 86.7%
Dasatinib DASISION [9]   ≤10% (n = 198) >10% (n = 37)  
AP/BC by 3 years 3.0% 13.5% NR
PFS at 3 years 93.1% 68.2% 0.0003
OS at 3 years 95.9% 85.9% 0.0348
Bosutinib BELA [53]   ≤10% (n = 179) >10% (n =29)  
MMR by 24 months 74% 21% <0.001
CCyR by 12 months 96% 48% <0.001
OS at 24 months 99% 88% 0.004
  1. aData for the imatinib arm of the study.
  2. AP/BC accelerated phase/blast crisis, CCyR complete cytogenetic response, MMR major molecular reponse, NR not reported, NS not significant, OS overall survival, PFS progression-free survival.