Technology Assessment: Report on the Relative Efficacy of Oral Cancer Therapy for Medicare Beneficiaries Versus Currently Covered Therapy, Part 3. Imatinib for Chronic Myeloid Leukemia (CML). Table 14

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Report on the Relative Efficacy of Oral Cancer Therapy for Medicare Beneficiaries Versus Currently Covered Therapy

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Table 14. Tumor Characteristics Predictive of Disease Response or Survival: Group 3—Interaction Between the Tyrosine Kinase Protein and Imatinib

Prognostic factor

Studies indicating an association and quality

Strength of association with tumor response

Mutations in tyrosine kinase domain (may lead to I resistance)

Hochhaus, 2002⁵⁵
(Quality = 3/6)
CP, AP & BC

Median time to relapse:
   Mutation present (35%)=237 days
   Mutation not present (65%)=251 days
   p=NS

Shah, 2002¹⁰⁸
(Quality 1/6)
CP & AP

3/4 pt with CP CML with CHR on I and with kinase domain mutations progressed, whereas 1/9 without mutations progressed

Adapter protein phosphorylation

*White, 2004¹⁴⁵
(Quality*)
CML-unclear phase-
newly diagnosed

In vitro assay to predict imatinib inhibition of adaptor protein Crkl phosphorylation (measured by IC50).
Relationship between IC50, Sokal score and Probability of achieving a MMR at 12 mos:

All (N=57 newly diagnosed CP CML patients prior to I):
Low IC50: MMR = 47%
High IC50: MMR = 23%
p=0.034

Low Sokal (N=19):
Low IC50: MMR = 67%
High IC50: MMR = 20%
p=0.037

Intermed Sokal (N=15):
Low IC50: MMR = 50%
High IC50: MMR = 22%
p=NS

Intermed Sokal (N=16):
Low IC50: MMR = 17%
High IC50: MMR = 0%
p=NS

Abbreviations: *= abstract; AP = Accelerated phase; BC = Blast crisis; CML = Chronic myelogenous leukemia; CP = chronic phase; CHR = complete hematological response; I = Imatinib; MMR = major molecular response; minor = minor response; NS = not significant

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