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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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