Response rates by patient stratum
| . | Complete response . | Complete response with inadequate platelet recovery . | Total complete response*† . | |||
|---|---|---|---|---|---|---|
| Laromustine/HDAC, no. (%) . | HDAC/placebo, no. (%) . | Laromustine/HDAC, no. (%) . | HDAC/placebo, no. (%) . | Laromustine/HDAC, no. (%) . | HDAC/placebo, no. (%) . | |
| All patients. Laromustine/HDAC, n = 179; HDAC/placebo, n = 86 | 36 (20) | 14 (16) | 26 (15) | 2 (2) | 62 (35)* | 16 (19) |
| Stratum 1: Younger than 60 y, CR less than 12 mo. Laromustine/HDAC, n = 61; HDAC/placebo, n = 26 | 7 (11) | 4 (15) | 9 (15) | 0 | 16 (26) | 4 (15) |
| Stratum 2: Younger than 60 y, CR 12 or more mo. Laromustine/HDAC, n = 31; HDAC/placebo, n = 16 | 7 (22) | 7 (44) | 3 (10) | 0 | 10 (32) | 7 (44) |
| Stratum 3: 60 y or older, CR less than 12 mo. Laromustine/HDAC, n = 51; HDAC/placebo, n = 26 | 14 (28) | 1 (4) | 4 (8) | 0 | 18 (35) | 1 (4) |
| Stratum 4: 60 y or older, CR 12 or more mo. Laromustine/HDAC, n = 34; HDAC/placebo, n = 18 | 8 (24) | 2 (11) | 10 (29) | 2 (11) | 18 (53) | 4 (22) |
| . | Complete response . | Complete response with inadequate platelet recovery . | Total complete response*† . | |||
|---|---|---|---|---|---|---|
| Laromustine/HDAC, no. (%) . | HDAC/placebo, no. (%) . | Laromustine/HDAC, no. (%) . | HDAC/placebo, no. (%) . | Laromustine/HDAC, no. (%) . | HDAC/placebo, no. (%) . | |
| All patients. Laromustine/HDAC, n = 179; HDAC/placebo, n = 86 | 36 (20) | 14 (16) | 26 (15) | 2 (2) | 62 (35)* | 16 (19) |
| Stratum 1: Younger than 60 y, CR less than 12 mo. Laromustine/HDAC, n = 61; HDAC/placebo, n = 26 | 7 (11) | 4 (15) | 9 (15) | 0 | 16 (26) | 4 (15) |
| Stratum 2: Younger than 60 y, CR 12 or more mo. Laromustine/HDAC, n = 31; HDAC/placebo, n = 16 | 7 (22) | 7 (44) | 3 (10) | 0 | 10 (32) | 7 (44) |
| Stratum 3: 60 y or older, CR less than 12 mo. Laromustine/HDAC, n = 51; HDAC/placebo, n = 26 | 14 (28) | 1 (4) | 4 (8) | 0 | 18 (35) | 1 (4) |
| Stratum 4: 60 y or older, CR 12 or more mo. Laromustine/HDAC, n = 34; HDAC/placebo, n = 18 | 8 (24) | 2 (11) | 10 (29) | 2 (11) | 18 (53) | 4 (22) |
Complete response plus complete response with inadequate platelet recovery.
P = .005 comparing the overall response rate between treatment arms using the Chochran-Mantel-Haenszal test stratified by age group and duration of first CR/CRp. Difference (95% confidence interval) between all strata of each treatment group (laromustine/HDAC–HDAC/placebo) was 16% (56%-27%).