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| |
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 |
Cohen, 200282
This is the FDA Approval Summary—most of these patients are presented
elsewhere predominantly as the 3 large phase II Novartis trials—see individual
tables |
Phase I = 25-1000 mg
Phase II = 400-600 mg |
IFN refractory CP: 83 pts |
I in IFN refractory CP = 83 |
31% |
13% |
|
|
|
98% [when dose > 300 mg] |
Median time to hematologic progression for CML-AP = >6 mo
Median time to hematologic progression for CML-BC = 5.6 mo |
CP:
532 pts
57 yr. [18-90]
59% M |
I in CP = 532 |
49% |
30% |
|
|
|
88% |
AP:
235 pts
56 yr [22-86]
50% M |
I in AP = 235 |
21% |
14% |
|
|
|
63% |
BC:
260 pts
56 yr [19-81]
52% M |
I in BC = 260 |
13.5% |
5% |
|
|
|
26% |
Silver, 200483
Followup data presented in abstract form only |
CP—400 mg |
CP—532 pts
(all late CP) |
I - CP = 532 |
65% |
52% |
13% |
|
|
|
CP:
64% still on I
82% of those with MCR continue @ 3 yr
3 yr OS = 88%
3 yr PFS = 80% |
| AP/ BP—400-600 mg |
AP—235 pts |
I - AP = 235 |
|
|
|
|
|
|
AP:
25% still on I
When at 600mg dose, 55% 3yr PFS |
| BP—260 pts |
I - BP = 260 |
|
|
|
|
|
|
BP:
5% still on I
When at 600mg dose, 14% 3yr PFS |
Dose escalation to 800 mg allowed in later parts of the studies
[40 mos for CP participants] |
Unclear how many are IFN refractory |
|
|
|
|
|
|
|
|
| Olavarria, 200384 |
400-600 mg
[9 mos] |
128 pts
45 yr [17-65]
62% M
All with previous allogeneic SCT; 40% received donor lymphocyte infusion;
heavily pretreated |
I = 123 |
54% |
42% |
12% |
|
|
71% |
Estimated 2-yr OS:
All = 65%
AP = 86%
BP = 12%
(p for AP vs BP <0.0001) |
| I in CP after alloSCT = 50 |
71% |
58% |
13% |
|
|
98% |
| I in AP after alloSCT = 29 |
67% |
48% |
19% |
|
|
83% |
| I in BP after alloSCT = 44 |
44% |
22% |
22% |
|
|
32% |
| Lahaye, 200585 |
400-600 mg. |
300 pts
56.2 yr [14.6-79.6]
57% M |
300 pts |
|
|
|
|
|
|
|
CP
[33 mo, 6-49] |
CP = 139 pts
55.9 yr [18.5-76.6]
56% M |
CP: I = 139
[median duration = 34 mo (19-49) |
|
49% |
12% |
4% |
27% |
97% |
@ 30 mo, estimated DFS = 83%;
CHR @ 30 mo = 79%
MCR after 3 mo =longer DFS (p=0.009)
MCR after 6 mo = longer DFS (p=0.004)
MCR after 12 mo= longer DFS (p=.0001)
&improved OS J16(p=0.021) |
AP
[28 mo, 0.4-50] |
AP = 80 pts
60.9 yr [30.9-81.8]
66% M |
AP: I= 80
[median duration = 28 mo(0.4-50) |
|
26% |
5% |
9% |
36% |
61% |
AP: DFS & OS were not predictive |
BC
[6 mo, 0.1-52] |
BC = 76 pts |
BC: I = 76 |
|
8% |
4% |
3% |
34% |
18% |
BC: Estimated survival
@ 12 mo =32%
@ 24 mo = 18%
OS = 6 mo (0.9-52) |
Deshmukh, 200486
Abstract only |
"Recommended doses"
[Not stated] |
174 pts
Participant profile not described |
|
|
|
|
|
|
|
|
| CP = 97 pts (of which 24 = early CP) |
CP, I = 97 |
50% |
31% |
|
|
|
92% |
| CP (early CP subset), I =24 |
63% |
21% |
|
|
|
100% |
| AP = 47 pts |
AP, I = 47 |
21% |
6% |
|
|
|
55% |
| BP = 30 pts |
BP, I = 30 |
23% |
13% |
|
|
|
37% |
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