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. Author manuscript; available in PMC: 2016 Dec 7.
Published in final edited form as: Clin Lymphoma Myeloma Leuk. 2015 Mar 24;15(6):323–334. doi: 10.1016/j.clml.2015.03.006

Table 4.

Predictive Models for Outcome With TKI Therapy in Patients With CP-CML Post–Imatinib Failure

Reference Patient
Population		 TKI
Therapy		 Factors Included in
Scoring		 Risk Groups Discrimination of Outcomes Using Prognostic Models
EFS PFS OS CyR
Jabbour et al 201150 CP-CML (N=123) Nilotinib (n=45) or dasatinib (n=78)

  • Lack of any cytogenetic response to imatinib

  • ECOG PS ≥1 at start of second-generation TKI therapy post–imatinib failure

  • Low risk = 0 risk factors (n=59)

  • Intermediate risk = 1 risk factor (n=48)

  • High risk = 2 risk factors (n=5)

 2-Year:

  • Low risk, 78%

  • Intermediate risk, 49%

  • High risk, 20%


P<0.001		 NR 2-Year:

  • Low risk, 95%

  • Intermediate risk, 85%

  • High risk, 40%


P=0.002		 1-Year MCyR:

  • Low risk, 64%

  • Intermediate risk, 36%

  • High risk, 20%


P=0.007
Milojkovic et al 201052 CP-CML (N=80) Nilotinib (n=13) or dasatinib (n=67)

  • Best cytogenetic response to imatinib (CCyR, 0 points; 1%–94% Ph+ metaphases, 1 point; ≥95% Ph+ metaphases, 3 points)

  • Sokal risk score (low, 0 points; intermediate or high, 0.5 points)

  • Neutropenia on imatinib (none, 0 points; recurrent grade 3/4 neutropenia requiring dose reduction to <400 mg/d, 1 point)

  • Low risk = total score <1.5 (n=24)

  • Intermediate risk = total score 1.5–2.5 (n=27)

  • High risk = total score >2.5 (n=29)

 2.5-Year:

  • Low risk, NR

  • Intermediate risk, 72.1%

  • High risk, NR

 2.5-Year:

  • Low risk, 100%

  • Intermediate risk, 89.3%

  • High risk, 77.6%


P=0.02 for low vs high risk		 2.5-Year:

  • Low risk, 100%

  • Intermediate risk, 90.7%

  • High risk, 89.9%


P=0.02 for low vs high risk		 2.5-Year cumulative incidence of CCyR

  • Low risk, 100%

  • Intermediate risk, 52.2%

  • High risk, 13.8%


P<0.0001
Jabbour et al 201353 CP-CML (N=321) Nilotinib Overall score

  • Baseline mutations with low sensitivity to nilotinib

  • Baseline Hb <120 g/L

  • Baseline basophils ≥4%

  • Lack of MCyR by 12 mo

 Score 0 = 0 risk factors (n=77)
Score 1 = 1 risk factor (n=116)
Score 2 = 2 risk factors (n=82)
Score 3 = 3 risk factors (n=31)
Score 4 = 4 risk factors (n=9)		 2-Year:

  • 0, 81%

  • 1, 50%

  • 2, 29%

  • 3, 8%

  • 4, 0%


P<0.001		 2-Year:

  • 0, 89%

  • 1, 67%

  • 2, 50%

  • 3, 19%

  • 4, 0%

 2-Year:

  • 0, 99%

  • 1, 88%

  • 2, 76%

  • 3, 82%

  • 4, 87%


P <0.001 for score 0 vs scores 1, 2, 3, or 4		 NR
Baseline score

  • Baseline mutations with low sensitivity to nilotinib

  • Baseline Hb <120 g/L

  • Baseline basophils ≥4%

 Score 0 = 0 risk factors (n=109)
Score 1 = 1 risk factor (n=153)
Score 2 = 2 risk factors (n=41)
Score 3 = 3 risk factors (n=12)		 NR 2-Year:

  • 0, 79%

  • 1, 65%

  • 2, 39%

  • 3, 0%

 2-Year:

  • 0, 93%

  • 1, 84%

  • 2, 81%

  • 3, 90%


P =0.06 for score 0 vs scores 1, 2, or 3		 1-Year MCyR:

  • 0, 71%

  • 1, 55%

  • 2, 32%

  • 3, 25%


P <0.001

Abbreviations: CCyR = complete cytogenetic response; CP-CML = chronic myeloid leukemia in chronic phase; CyR = cytogenetic response; ECOG PS = Eastern Cooperative Oncology Group performance status; EFS = event-free survival; Hb = hemoglobin; MCyR = major cytogenetic response; NR = not reported; OS = overall survival; PFS = progression-free survival; Ph+ = Philadelphia chromosome–positive; TKI = tyrosine kinase inhibitor.