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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, 200360,61 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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