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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.