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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 1a. Details of Included Studies—Part 1 Imatinib Efficacy Studies

Phase Study # First Author, Year Trial Phase Imatinib dose per day (mg) Comparator Quality Comments
Chronic phase—newly diagnosed 1 O'Brien, Guilhot, et al., 200359 III 400 IFN + Ara-C 5/5 Main results from the IRIS phase III trial
1 Branford, 200333       5/6 IRIS sub-study—molecular responses
1 Hughes, 200311       6/6 IRIS sub-study—molecular responses
1 Hahn, 200360,61       5/5 IRIS sub-study-QOL (on a separate efficacy—QOL table)
1 *Guilhot, 200462       * Followup data
1 *Branford, 200432       * Followup data
2 Karntarjian, Cortes, et al., 200363 II 400 Historical controls 6/6 Main results of phase II trial
3 Karntarjian, Talpaz, et al., 200412 II 800 Historical controls 5/5 Main results of phase II trial
2&3 Kantarjian, O'Brien,
200444
II 400-800 Historical controls 3/6 Includes patients from another both studies above
2&3 *Cortes, Talpaz, O'Brien, Giles, et al., 200464 II 400-800   * Compares 400 & 800 mg doses
4 *Hughes, 200465 II 600-800 Compared to IRIS experience *  
Chronic phase—interferon resistant or refractory 5 Druker, Talpaz, et al., 200166 I/II 25-1000   4/5 Main results of initial STI571 phase I/II
5 Braziel, 200267       3/6 Druker sub-study—response predictors
6 Kantarjian, Sawyers, 20022 II 400-800   6/6 Main results of phase II trial
6 Marin, Marktel, Szydlo, et al., 200368     Historical controls 5/5 Survival followup
7 Cortes, Giles, et al, 200369 II 800   3/5  
6&8 Karntarjian, Talpaz, et al., 200270 II 400-800   5/5 Some patients from the phase II trial plus expanded access
6,8,&9 Karntarjian, Talpaz, et al., 200371 II 400-800   3/6 Some patients from the phase II trial plus expanded access-evaluation of higher dose I for pts resistant to 400 mg
6,8,&9 Kantarjian, O'Brien,
200444
II 400-800 Historical controls 5/6 Includes patients presented in two studies
6&8 Karntarjian, Cortes,
et al., 200472
II 400-800 Historical controls 5/6 Includes patients presented in two studies; survival followup
10 Le Coutre, 200373 II 400   4/5 Part of expanded access program population
11 Marin, Goldman, et al., 200374 II 600-1000   1/5 Evaluation of higher dose I for pts resistant to 400 mg
12 Marin, Marktel, Bua, et al., 200375 II 200-800   2/5  
13 Rosti, 20048 II 400   4/5  
14 *Pasquini, 200476 Unclear 400-600   * QOL on I (see QOL table)
Chronic phase—previous stem cell transplant/heavily pretreated 15 Cervantes, 200337 II 400 Prior auto
SCT vs. IFN
resistant/intolerant
3/6 Autologous SCT
16 Fischer, 200277 II 400   1/6 Autologous SCT
17 Kantarjian, O'Brien, et al., 200278 II 400-1000   3/6 Allogeneic SCT
18 O'Brien, Giles, et al., 200379 II Not stated   3/5 Prior IFN, Ara C, and homoharringtonine +/- allogeneic SCT
19 *Hess, 200480 II 400   * Allogeneic SCT
20 *Corsetti, 200481 II 400-400   * Autologous SCT
Mixed phases FDA Approval Cohen, 200282 I
II
25-1000
400-600
  5/6 FDA Approval summary
21 *Silver, 200483 II 400-600   * 4 yr followup on three studies
22 Olavarria, 200384 II 400-600   4/6 All relapsed after allogeneic SCT; all phases
23 Lahaye, 200585 II 400-600   5/6 4.5 yr followup
24 *Deshmukh, 200486 II Not stated   * All phases, conducted in India
Accelerated phase 25 Talpaz, 200287 II 400-800   5/6  
25 * Cortes, Talpaz, O'Brien, Gracia-Manero, et al., 200488       * Followup abstract
Blastic phase/blast crisis 26 Druker, Sawyers, et al., 200189 I/II 300-1000   5/6  
27 Kantarjian, Cortes, 200290 I/II 300-1000   5/6  
28 Sawyers, 20023 II 400-800   5/6  
29 Sureda, 20034 II 600   4/5  
Imatinib efficacy/other 30 Gardembas, 200338 II 400 (w/ Ara-C SQ 20 mg/m2/d on d15-28) 5/5 Combination=safe
31 Baccarani, 200491 II 400 (w/ Peg-IFN at 50-150 mcg/wk) 4/5 Combination=safe

Note:
* Presented as peer-reviewed abstract only.

Abbreviations: Ara-C=cytarabine; I=imatinib; IFN=interferon; pts=patients; QOL=quality of life; Retro=retrospective; SCT=stem cell transplant

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Proceed to Table 1b

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