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 1d

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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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