Table 2.

Hypomethylating agents in MDS

Study	N	Treatment	Median # cycles	Response including HI*	Time to response (median unless otherwise stated)	Dose reduction or delay?	Clinical endpoint
CALGB studies(2)	309	AZA 7-day	NA	10–17% CR 40–47% OR	3 cycles to first response; 2 additional cycles to best response; 90% of responses by cycle 6	NA	Response and clinical improvement (quality of life)
AZA-001(4)	179	AZA 7-day	9	17% CR 49% OR	2 cycles to first response; 90% of responses by cycle 6	86% with no reduction; 80% of cycles on time	Overall survival benefit
D-007(6)	89	Decitabine 3-day	3	9% CR 30% OR	2 cycles to first response	NA	Response and clinical improvement (quality of life)
ADOPT(10)	99	Decitabine 5-day	5	17% CR 51% OR	First response within 2 cycles in 82%; Best response at same time usually	68% of cycles on time	Response and clinical improvement (quality of life)
ID03-180(9)	95	Decitabine 5-day	7	34% CR 69% OR	3 cycles for CR; 5 cycles for PR	Cycles typically given every 4 weeks	Response and clinical improvement (quality of life)
EORTC 06011(7)	119	Decitabine 3-day	4	13% CR 34% OR	3–4 months to response	NA	No overall survival benefit

Table modified from Steensma and Stone, 2009.⁵⁰

N, Number of patients treated with drug.

^*Response by IWG 2000 criteria.

NA, data not available.

AZA 7-day; 75mg/m2 SC for 7 days, every 4 weeks; Decitabine 3-day; 15mg/m2 IV over 3–4 hours every 8 hours, every 6 weeks; Decitabine 5-day; 20mg/m2 IV over 1 hour for 5 days (and variants with total dose of 100mg/m2/cycle in ID03–180).