. 2015 Oct 26;27(1):62–68. doi: 10.1093/annonc/mdv488

Table 1.

Short-term outcomes with LEN treatment

Outcome	MDS-003 study [17]	MDS-004 study [18]
Outcome	10 mg^a (N = 148)	LEN 10 mg^b (N = 41)	LEN 5 mg^c (N = 47)	Placebo^c (N = 51)
RBC-TI ≥8 weeks (IWG 2000 [23]), n (%)	99 (67)	25 (61)^d	24 (51)^d	4 (8)
Median peak Hb increase, g/dl (range)	5.4 (1.1–11.4)	6.3 (1.8–10.0)	5.2 (1.5–8.5)	NA
RBC-TI ≥26 weeks, n (%)	NA	23 (56)^d	20 (43)^d	3 (6)
Cytogenetic response, %	73^e	50^d	25^d	0
Complete cytogenetic response	45^e	29^d	16^d	0

^aThe first 46 patients were treated on days 1–21 of 28-day cycles, and following a protocol amendment, 102 patients received continuous daily dosing.

^bDays 1–21 of 28-day cycles.

^cContinuous daily dosing.

^dP < 0.001 versus placebo.

^eOf 85 patients evaluable.

Hb, hemoglobin; IWG, International Working Group; LEN, lenalidomide; NA, not available; RBC-TI, red blood cell transfusion independence.