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 9

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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 9. Summary of Efficacy of Imatinib for CML—Quality of Life

Study ID	QOL scales used/measurements obtained	Imatinib dose [length of followup]	No. of patients, age, sex, additional CML characteristics	QOL outcomes
Hahn, 2003^60,61	FACT-BRM Within the FACT-BRM, the primary outcome was the TOI; (27 items, score range 0-108) Secondary endpoints included SFWB (7 items range 0-28) and EWB (six items, range from 0-24). Higher scores are better. baseline monthly for 6 mo, and then at 9, 12, and 18 mo	400 mg (increased to 800mg for no CHR at 3 months or at least a Minor CR at 12 months) [19 mo] [30 mo for first line therapy; 17 mo for crossovers]	CP newly diagnosed 1049 pts Imatinib: 530 50 [18-70] 62% M IFN+AraC: 519 51 [18-70] 56% M	TOI (mean across trial) Imatinib 84.4 IFN+AraC 67.7 (p<.001) SFWB (mean across trial) Imatinib 22.8 IFN+AraC 21.6 (p<.001) EWB (mean at 18 mo timepoint) Imatinib 19.5 IFN+AraC 17.7 (p<.001) Based upon 1,3,6,9, and 12 mo data: % of participants with clinically meaningful decrease in TOI by 5 or more points (goal = increased TOI) Imatinib 22-29% across timepoints IFN+AraC 52-73% across timepoints p<0.001 % of participants with clinically meaningful increase in TOI by 5 or more points Imatinib 29-43% across timepoints IFN+AraC 9-25% across timepoints p not stated
*Pasquini, 2004⁷⁶ Abstract only	FACT-BRM Primary outcome = TOI Baseline monthly for 6 mos, and then at mos 9,12,and 18	00-600 mg	CP - IFN refractory 230 pts All received imatinib 46 [18-76] 56%M	% of participants with clinically meaningful increase in TOI by 5 or more points All received I: 1 mo - increase by 5.4 (p<0.0001) 6 mo - increase by 7.4 (p<0.0001) 12 mo - increase by 9.8 (p<0.0051)

Abbreviations: * = abstract; AraC = Cytarabine; CML = chronic myelogenous leukemia; CP = chronic phase; emotional well being (EWB); FACT-BRM = Functional Assessment of Cancer Therapies - Biologic Response Modifiers; I = Imatinib; IFN = Interferon; M = Male; N = Number; pt(s) = patient(s); QOL = Quality of life; social/family well-being (SFWB); Trial Outcome Index (TOI)

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