Technology Assessment: Report on the Relative Efficacy of Oral Cancer Therapy for Medicare Beneficiaries Versus Currently Covered Therapy, Part 3. Imatinib for Chronic Myeloid Leukemia (CML). Table 5

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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	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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