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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 7. Summary of Efficacy of Imatinib for CML—Mixed Phases

  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%

Abbreviations: * = abstract; AP = Accelerated phase; BC = Blast crisis; BP = Blastic phase; CI = 95% confidence interval; CML = Chronic myelogenous leukemia; CP = chronic phase; CR = cytogenetic response; CHR = complete hematological response; DFS = Disease free survival; I = Imatinib; IFN = Interferon; M = Male; MCR = major cytogenetic response; N = Number; OS = Overall Survival; PFS = progression-free survival; pt(s) = patient(s); QOL = Quality of life; RR = relative risk; SCT = Stem cell transplant

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