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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 5. Summary of Efficacy of Imatinib for CML—Accelerated phase

  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
Accelerated Phase: Phase I/II Talpaz, 200287 400-800 mg
[median treatment duration 10-11 months; median f/u not stated]

(initially at 400 mg daily, later increased to 600 mg, and subsequently 800 mg allowed for inadequate response)
235 pts (235 pts enrolled but only 181 pts with confirmed diagnosis presented)
58 [22-86]
50%M

34% previously untreated
66% previously treated
I = 181 24% 17% 7% 7% 17%   TTP estimated K-M >1-yr:
All doses = 59% (CI 52-66%)
400mg I = 44% (CI 31-56%)
600mg I = 67% (CI 59-76%)
(p=0.002)

1 yr OS estimated K-M:
All doses = 74% (CI 68-81%)
400mg I = 65% (CI 53-77%)
600mg I = 78% (CI 70-87%)

Median survival not reached at med of 38 mo f/u (21 mo for historical controls)—estimated at 53% at 3 yr
I @ 400mg = 62 16% 11% 5% 8% 15%  
I @ 600mg = 119 28% 19% 8% 6% 18%  
Followup data in abstract: *Cortes, Talpaz, O'Brien, Gracia-Manero, et al., 200488 [38 mos]   I = 171 48%          

Abbreviations: * = abstract; AP = Accelerated phase; CHR = complete hematologic response; CI = 95% confidence interval; CML = Chronic myelogenous leukemia; CP = chronic phase; CR = cytogenetic response; I = Imatinib; K-M = Kaplan-Meier; M = Male; N = Number; OS = Overall Survival; PFS = progression-free survival; pt(s)=patient(s); TTP = time to progression

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