Table 13.1.

Selected clinical trials with azacitidine (aza) or decitabine (dac) in MDS

Trial	CALGB 9221	D-0007	ICD03-180	AZA-001	US Oncology	ADOPT	EORTC 06011
Author (publication year)	Silverman (2002) [27]	Kantarjian (2006) [10]	Kantarjian (2007) [55]	Fenaux (2009) [7]	Lyons (2009) [36]	Steensma (2009) [56]	Lubbert (2011) [13]
Number enrolled	191	170	95	358	151	99	233
Number treated with study drug	150 (99 upfront, 51) crossovers	89	95	179	151	99	119
Phase	III	III	II	III	II	II	III
Study regimen	Aza SQ 75 mg/m2 × 7 days	Dac IV 15 mg/m2 q8h × 3 days	Dac IV 10 mg/m2 × 10 days IV 20 mg/m2 × 5 days SQ 20 mg/m2 × 5 days	Aza SQ 75 mg/m2 × 7 days	Aza SQ 75 mg/m2 × 5days–2 days off-2days × 5 days–2days off-5 days × 5 days	Dac IV 20 mg/m2 × 5 days	Dac IV 15 mg/m2 q8h × 3days
Int-2 or high IPSS (%)	46	70	66	87	Not reported	46	93
Median cycles administered	4	3	7	9	6	5	4
CR % (by IWG 2000)	9	9	37	17	Not reported	15	13
CR + PR + HI% (by IWG 2000)	48	30	73	49	48	43	34