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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 4. Summary of Efficacy of Imatinib for CML—Chronic Phase, Interferon Resistant or Refractory

  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 Cervantes, 200337 400 mg
[f/u not stated; at least 12 mo.]
Prior autoSCT:
33 pt
53 yr [24-70]
61% M

No autoSCT/IFN refractory:
65 pt
53 yr [17-80]
54% M

Both groups received I
Prior autoSCT:
I = 33
             
3 mo 42% 21% 21% 14%     PFS = 93.7%
6 mo 45% 24% 21% 10%    
12 mo 55% 33% 22% 11%    
No autoSCT IFN refractory:
I = 65
             
3 mo 47% 20% 27% 20%     PFS= 96.7%
(p NS)
6 mo 52% 35% 17% 19%    
12 mo 66% 38% 28% 8%    
Fischer, 200277 400 mg
[28 wk]
24 pt—disease relapse after autologous transplant
56 yr. [25-64]
58% M
(only 15 CML-CP pt reported here; f/u period for AP and BP not long enough for endpoints)
I for CP relapse after autoSCT = 15 61% 46% 15% 8% 8% 100%  
Kantarjian, O'Brien, et al., 200278 400-1000 mg
[16 mo]
28 pt
43 yr [25-64]
57% M

(All with prior allogeneic SCT; 1 CP in CHR, 4 CP active, 3 AP in CHR, 12 AP active, 8 BP; 23 evaluable)
I = 28 (23 evaluable) 58% 35% 23%     74% OS 1-yr 74% for all, and 100% treated in CP
O'Brien, Giles, et al., 200379 Not stated
[46 mo]
90 pt
46 [25-64] (age >60yr 4%)
51% M
I = 90 (given after relapse from IFN, Ara C, and homoharringtonine +/- allogeneic SCT) 78% 65% 13% 5%     Estimated 5-yr OS = 88%
Hess, 200480 400 mg
[381 day]
37 pt I = 37 (given for CP relapse after allogeneic SCT)   85% of 11/13 with cytogenetic relapse only         25/27 (67%) achieved CMR

1 mild reactivation of GVHD

OS at 1.7 yr = 100%
*Corsetti, 200481

Abstract only
400 mg for CP
600 mg for AP
[36 mo]
50 pt
Age & gender not specified

CML-CP & AP relapsed after autoSCT & IFN
I =   CCR 61% Major 70%       At median f/u of 36 mo:
PFS 78%
OS 87%

Abbreviations: * = abstract; AP = Accelerated phase; Ara-C = Cytarabine; BP = Blastic phase; CML = Chronic myelogenous leukemia; CP = chronic phase; CR = cytogenetic response; CCR = complete cytogenetic response; CHR = complete hematological response; CMR = complete molecular response; f/u = followup; GVHD = graft versus host disease; I = Imatinib; IFN = Interferon; M = Male; N = Number; OS = Overall Survival; PFS = progression-free survival; pt(s)=patient(s); SCT = Stem cell transplant

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