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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 6. Summary of Efficacy of Imatinib for CML—Blastic Phase/Blast Crisis

  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 Druker, Sawyers, et al., 200189 300-1000 mg dose escalation
[74 days (1-349 days)]
58 pts
48 yr [24-76]
60% M
I in Myeloid BC=38           11% TTP = 84 days [42-194]
BC or Ph+ ALL resistant or refractory to standard induction I in Lymphoid BC and Ph+ALL= 20           20% TTP = 58 days [42-123]
Kantarjian, Cortes, 200290 300-1000 mg
[11 mos]
75 pts
53 yr [27% >60 yr]
I = 75   6% 3% 3%   21% Median OS = non-lymphoid BC=6.5 mo

28% 1 yr survival for non-lymphoid BC

Lymphoid BC
=7.0 mos.

Compared to historical controls that received standard Ara-C based induction chemotherapy, I = 55% objective response rate vs 29% with Ara-C (p=0.001); 4-week mortality = 4% with I and 15% with Ara-C (p=0.07); median survival was 7 mo with I and 4 mo with Ara-C (p=0.04)
67% previously untreated I in Nonlymphoid BC = 65   5% 3% 3%   23%
33% previously treated I in Lymphoid BC = 10   10%        
Sawyers, 20023 400 mg

(later in study dose escalation for treatment resistance was allowed to max 800 mg)

[median duration of treatment 4 mos, f/u not stated]
260 pts
56 [19-81]
52%
I = 260 16% 7% 9% 2% 13% 52%
Sustained >4wks = 31%
Estimated PFS at 6 mos = 68% (CI 57-79%)

Estimated median response duration = 10ms (CI 7.2-12.6)

OS estimated from KM = median 6.9 mos (CI, 5.7-8.7) with 43% survival at 9 mos and 20% at 18 mos
57% previously untreated Previously untreated = 148 16% 8% 7% 2% 15% Sustained = 36%
43% previously treated Previously treated = 81 17% 6% 11% 1% 10% Sustained = 21%
Sureda, 20034 600 mg
[f/u not stated]
30 pts
50 [18-72]
53%M

All pretreated, 70% with multiple previous regimens
I = 30 3% 0% 3% 10%   30% Median response duration of CHR = 5 mos (range 4-18)

EFS at 1 yr = 29% (SD 8%)
OS at 1 yr = 36% (SD 13%)

Abbreviations:
* = abstract; ALL = Acute Lymphocytic Leukemia; Ara-C = Cytarabine; BC = Blastic crisis; BP = Blast phase; CI = 95% confidence interval; CML = Chronic myelogenous leukemia; CR = cytogenetic response; CHR = complete hematological response; EFS = event-free survival; f/u = followup; M = Male; N = Number; OS = Overall Survival; PFS = progression-free survival; Ph+ = Philadelphia chromosome positive; pt(s)=patient(s); TTP = time to progression

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