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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 8. Summary of Efficacy of Imatinib for CML—Other Types of Studies

  Study ID Imatinib dose [median length of followup] No. of patients, age, sex, additional CML characteristics N Major
CR
Complete
CR
Partial
CR
Minor
CR
Minimal
CR
CHR Survival/
Other
Phase I/II Gardembas, 200338 400 mg (with Ara-C SQ 20 mg/m2/d on d15-28)
[12 mo]

median 6 cycles of Ara-C
30 pts
48 yrs [22-81]
67% M

Newly diagnosed CML-CP
I+AraC= 30              
3 mo 70% 23% 47% 6%   100% No CCR @ 3 mos = 6%
6 mo 73% 57% 17% 10%   100% No CCR @ 6 mos. = 6%
9 mo 77% 53% 23% 6%   100% No CCR @ 9 mos. = 3%
12 mo 83% 70% 13% 6%   97% No CCR @ 12 mos. = 3 %
Baccarani, 200491 400 mg (with pegylated IFN at 50 mcg/d, 100 mcg/d, or 150 mcg/d)
[min 6 mo]
76 pts
47 yrs [18-68]
58%M

Newly diagnosed CML-CP
I+PegIFN= 76 83% 70% 13%     97% CCR similar in all IFN cohorts

47% with BCR-ABL transcript reduction by >3 log

Abbreviations: * = abstract; CML = Chronic myelogenous leukemia; CP = chronic phase; CR = cytogenetic response; CHR = complete hematological response; I = Imatinib; IFN = Interferon; M = Male; N = Number; OS = Overall Survival; pt(s) = patient(s)

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