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 4

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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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