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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 1d. Details of Included Studies—Part 4. Studies Included in the "Future Directions" Only

Additional articles included in Future Directions but not on other tables—Other factor

  First Author, Year Trial Phase Imatinib dose per day (mg) Comparator Quality Comments
Mechanism of action Kvasnicka, 2004111 Retro 400-600 Patients treated with IFN or hydroxy-urea 2/6 I is associated with reversal of bone marrow angiogenesis—suggesting an anti-angiogenic capacity not seen with IFN
*Soverini, 2004
[Soverini, 2004 #858]
II 400   * ABL mutations may be predictive of poor response
*Jabbour, 2004112 Obs Not stated   * Mutations in the p-loop and I binding pocket don't correlate with outcome
*Branford, 2004113 Unclear Not stated   * Frequency of BCR-ABL mutations persists even with continued CCR >24 mos
*Corm, 2004114 II 400-600   * Mutations in the p-loop and I binding pocket lead to poorer prognosis
*Deininger, 2004115 Obs Not stated   * Kinase domain mutations are correlated with phase of disease and clonal evolution
*Hochhaus, 2004116 Obs Not stated   * Kinase domain mutations are correlated with disease progression, especially p-loop
Approach to treatment Shimoni, 2003117 II 400-600   3/5 Use of I to induce remission in Ph+ leukemias prior to allogeneic SCT
*Lange, 2004118 II   Molecular response durability between allogeneic SCT and I * Responses after allogeneic SCT may be more durable
*Palandri, 2004119 Retro 400-600   * Evidence of response with I in the setting of relapsed CML after allogeneic SCT
*Pautas, 2004120 Unclear Not stated   * Evidence of response with I in the setting of relapsed CML after allogeneic SCT
*Conneally, 2004121 Unclear 300-600   * Evidence of response with I in the setting of relapsed CML after allogeneic SCT
*Laurence, 2004122 Obs Not stated   * BC can still occur even with CCR on I
*George, 2004123 Retro Not stated   * May be differential response to I by race and ethnicity
*Bassi, 2004124 II 400   * I is well tolerated in patients >65 years
*Martino, 2004125 Retro 400-600   * I well tolerated and efficacious in pts >70years
Diagnostic tests Soverini, 2004126 Retro 400   3/5 Denaturing-HPLC method to screen for ABL point mutations
*Issa, 2004127 Obs Not stated   * Peripheral blood FISH for Ph+ possible, although inferior to bone marrow samples and RT-PCR
*Thomazy, 2004128 Obs Not stated   * Plasma samples can be used for Q-RT-PCR monitoring
*Kagami, 2004129 Obs Not stated   * cDNA microarrays may be a useful strategy to predict response to I
*Vallespi, 2004130 Obs 400   * Further confirmation that BCR-ABL transcript ratios decrease with response to I
*Paschka, 2004131 Obs Not stated   * Methods of quantitating molecular response
*Albitar, 2005132 II 800   *  
Upcoming clinical trials *Berger, 2004133;
*Hehlmann, 2005134
III 400 (with IFN, AraC, or after IFN) All 4 arms contain I * *Berger, 2004133;*Hehlmann, 2005134
*Monroy, 2004135 III 400 vs 400 mg + AraC Both arms contain I * *Monroy, 2004135
*Fruehauf, 2004136 I/II 600 with mitoxantrone, etoposide, and AraC   * *Fruehauf, 2004136
*Cornelissen, 2004137 I/II 200-800 with Ara-C at 200-1000 mg/m2/24hs   * *Cornelissen, 2004137
*Rousselot, 2004138 I/II 600 mg AraC and daunorubicin   * *Rousselot, 2004138
*Ceglarek, 2004139 II 300-800   * *Ceglarek, 2004139
*Cortes, 2005140 II 800   * *Cortes, 2005140

Note:
* Presented as peer-reviewed abstract only.

Abbreviations: AP = accelerated phase; Ara-C = cytarabine; BC = blast crisis; BP = blastic phase; CP = chronic phase; CCR = complete cytogenetic response; HPLC = high performance liquid chromatography; I = imatinib; IFN = interferon; Obs = observational study; pts = patients; Ph = Philadelphia chromosome; Q-RT-PCR = quantitative reverse transcriptase polymerase chain reaction; QOL = quality of life; Retro = retrospective; SCT = stem cell transplant

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