Baseline characteristics for all randomized patients
| Characteristic . | BSC group (n = 229) . | Tipifarnib group (n = 228) . | Total (n = 457) . |
|---|---|---|---|
| Sex, n (%) | |||
| Male | 128 (56) | 120 (53) | 248 (54) |
| Female | 101 (44) | 108 (47) | 209 (46) |
| Race, n (%)* | |||
| White | 217 (95) | 215 (95) | 432 (95) |
| Black | 0 | 1 (<1) | 1 (<1) |
| Asian | 5 (2) | 7 (3) | 12 (3) |
| Other | 6 (3) | 4 (2) | 10 (2) |
| Age, y, n (%) | |||
| ≤ 69 | 1 (< 1) | 2 (1) | 3 (1) |
| 70-74 | 92 (40) | 90 (39) | 182 (40) |
| 75-79 | 77 (34) | 87 (38) | 164 (36) |
| 80-84 | 53 (23) | 38 (17) | 91 (20) |
| ≥ 85 | 6 (3) | 11 (5) | 17 (4) |
| Mean age (SD) | 76.2 (4.43) | 76.2 (4.37) | 76.2 (4.39) |
| Median age | 76.0 | 76.0 | 76.0 |
| Range | 69-89 | 69-90 | 69-90 |
| Weight, kg† | |||
| Mean (SD) | 70.89 (12.858) | 70.59 (13.572) | 70.74 (13.202) |
| Median | 70.00 | 70.00 | 70.00 |
| Range | 44.0-113.1 | 39.0-106.0 | 39.0-113.1 |
| ECOG performance status, n (%) | |||
| 0 | 47 (21) | 46 (20) | 93 (20) |
| 1 | 118 (52) | 119 (52) | 237 (52) |
| 2 | 64 (28) | 63 (28) | 127 (28) |
| AML diagnosis to randomization, days, n (%) | |||
| ≤ 14 days | 161 (70) | 163 (71) | 324 (71) |
| 15-21 | 53 (23) | 50 (22) | 103 (23) |
| > 21 | 15 (7) | 15 (7) | 30 (7) |
| Mean (SD) | 11.13 (6.408) | 11.30 (11.786) | 11.21 (9.470) |
| Median | 10.00 | 9.00 | 9.00 |
| Range | 1.0-32.0 | 1.0-157.0 | 1.0-157.0 |
| Unfavorable cytogenetics, n (%) | |||
| Yes | 76 (33) | 68 (30) | 144 (32) |
| No | 116 (51) | 123 (54) | 239 (52) |
| Not done/not available | 37 (16) | 37 (16) | 74 (16) |
| WHO classification, n (%) | |||
| Recurrent cytogenetic translocations | 12 (5) | 6 (3) | 18 (4) |
| AML with t(8;21)(q22;q22) AML1/CBFalpha/ETO | 2 (1) | 3 (1) | 5 (1) |
| AML with abnormal bone marrow eosinophils Inv(16) (p13;q22) or t(16;16)(p13;q22) CBFbeta/MYH11 | 1 (< 1) | 1 (< 1) | 2 (< 1) |
| AML with 11q23 MLL abnormalities | 9 (4) | 2 (1) | 11 (2) |
| Multilineage dysplasia, n (%) | 80 (35) | 85 (37) | 165 (36) |
| With prior MDS | 45 (20) | 45 (20) | 90 (20) |
| Without prior MDS | 35 (15) | 40 (18) | 75 (16) |
| MDS, therapy-related, n (%) | 3 (1) | 4 (2) | 7 (2) |
| Alkylating agent | 2 (1) | 1 (< 1) | 3 (1) |
| Other types | 1 (< 1) | 3 (1) | 4 (1) |
| Baseline blasts in marrow, n (%) | |||
| 0%-20% | 3 (1) | 0 | 3 (1) |
| 20%-30% | 47 (21) | 63 (28) | 110 (24) |
| 30%-100% | 179 (78) | 165 (72) | 344 (75) |
| Mean (SD) percentage | 49.96 (22.247) | 48.51 (23.383) | 49.24 (22.807) |
| Median percentage | 44.80 | 41.00 | 43.50 |
| Baseline ANC grade, n (%)‡ | |||
| Less than grade 3 | 103 (45) | 98 (44) | 201 (45) |
| Grade 3 | 36 (16) | 47 (21) | 83 (18) |
| Grade 4 | 89 (39) | 78 (35) | 167 (37) |
| Baseline platelet count grade, n (%) | |||
| Less than grade 3 | 129 (56) | 108 (47) | 237 (52) |
| Grade 3 | 96 (42) | 109 (48) | 205 (45) |
| Grade 4 | 4 (2) | 11 (5) | 15 (3) |
| Characteristic . | BSC group (n = 229) . | Tipifarnib group (n = 228) . | Total (n = 457) . |
|---|---|---|---|
| Sex, n (%) | |||
| Male | 128 (56) | 120 (53) | 248 (54) |
| Female | 101 (44) | 108 (47) | 209 (46) |
| Race, n (%)* | |||
| White | 217 (95) | 215 (95) | 432 (95) |
| Black | 0 | 1 (<1) | 1 (<1) |
| Asian | 5 (2) | 7 (3) | 12 (3) |
| Other | 6 (3) | 4 (2) | 10 (2) |
| Age, y, n (%) | |||
| ≤ 69 | 1 (< 1) | 2 (1) | 3 (1) |
| 70-74 | 92 (40) | 90 (39) | 182 (40) |
| 75-79 | 77 (34) | 87 (38) | 164 (36) |
| 80-84 | 53 (23) | 38 (17) | 91 (20) |
| ≥ 85 | 6 (3) | 11 (5) | 17 (4) |
| Mean age (SD) | 76.2 (4.43) | 76.2 (4.37) | 76.2 (4.39) |
| Median age | 76.0 | 76.0 | 76.0 |
| Range | 69-89 | 69-90 | 69-90 |
| Weight, kg† | |||
| Mean (SD) | 70.89 (12.858) | 70.59 (13.572) | 70.74 (13.202) |
| Median | 70.00 | 70.00 | 70.00 |
| Range | 44.0-113.1 | 39.0-106.0 | 39.0-113.1 |
| ECOG performance status, n (%) | |||
| 0 | 47 (21) | 46 (20) | 93 (20) |
| 1 | 118 (52) | 119 (52) | 237 (52) |
| 2 | 64 (28) | 63 (28) | 127 (28) |
| AML diagnosis to randomization, days, n (%) | |||
| ≤ 14 days | 161 (70) | 163 (71) | 324 (71) |
| 15-21 | 53 (23) | 50 (22) | 103 (23) |
| > 21 | 15 (7) | 15 (7) | 30 (7) |
| Mean (SD) | 11.13 (6.408) | 11.30 (11.786) | 11.21 (9.470) |
| Median | 10.00 | 9.00 | 9.00 |
| Range | 1.0-32.0 | 1.0-157.0 | 1.0-157.0 |
| Unfavorable cytogenetics, n (%) | |||
| Yes | 76 (33) | 68 (30) | 144 (32) |
| No | 116 (51) | 123 (54) | 239 (52) |
| Not done/not available | 37 (16) | 37 (16) | 74 (16) |
| WHO classification, n (%) | |||
| Recurrent cytogenetic translocations | 12 (5) | 6 (3) | 18 (4) |
| AML with t(8;21)(q22;q22) AML1/CBFalpha/ETO | 2 (1) | 3 (1) | 5 (1) |
| AML with abnormal bone marrow eosinophils Inv(16) (p13;q22) or t(16;16)(p13;q22) CBFbeta/MYH11 | 1 (< 1) | 1 (< 1) | 2 (< 1) |
| AML with 11q23 MLL abnormalities | 9 (4) | 2 (1) | 11 (2) |
| Multilineage dysplasia, n (%) | 80 (35) | 85 (37) | 165 (36) |
| With prior MDS | 45 (20) | 45 (20) | 90 (20) |
| Without prior MDS | 35 (15) | 40 (18) | 75 (16) |
| MDS, therapy-related, n (%) | 3 (1) | 4 (2) | 7 (2) |
| Alkylating agent | 2 (1) | 1 (< 1) | 3 (1) |
| Other types | 1 (< 1) | 3 (1) | 4 (1) |
| Baseline blasts in marrow, n (%) | |||
| 0%-20% | 3 (1) | 0 | 3 (1) |
| 20%-30% | 47 (21) | 63 (28) | 110 (24) |
| 30%-100% | 179 (78) | 165 (72) | 344 (75) |
| Mean (SD) percentage | 49.96 (22.247) | 48.51 (23.383) | 49.24 (22.807) |
| Median percentage | 44.80 | 41.00 | 43.50 |
| Baseline ANC grade, n (%)‡ | |||
| Less than grade 3 | 103 (45) | 98 (44) | 201 (45) |
| Grade 3 | 36 (16) | 47 (21) | 83 (18) |
| Grade 4 | 89 (39) | 78 (35) | 167 (37) |
| Baseline platelet count grade, n (%) | |||
| Less than grade 3 | 129 (56) | 108 (47) | 237 (52) |
| Grade 3 | 96 (42) | 109 (48) | 205 (45) |
| Grade 4 | 4 (2) | 11 (5) | 15 (3) |
Percentages were calculated with the number of subjects in each group as denominator. Except where noted, numbers equaled the numbers in each of the 2 trial groups and in the entire cohort. AML indicates acute myeloid leukemia; ANC, absolute neutrophil count; ECOG, Eastern Cooperative Oncology Group; and MDS, myelodysplastic syndrome .
Race data were available for 228 in the BSC group and 227 in the tipifarnib group (total, 455).
Weight data were available for 229 in the BSC group and 224 in the tipifarnib group (total, 453).
Baseline ANC grade data were available for 228 in the BSC group and 223 in the tipifarnib group (total, 451).