Table 2.
Selected demographic and disease characteristics of patients participating in the OPTIC trial overall and by treatment cohort and in PACE.
| Trial | OPTIC | PACE | ||||
|---|---|---|---|---|---|---|
| Demographic parameters | Cohort A 45 mg → 15 mg (N = 94) |
Cohort B 30 mg → 15 mg (N = 94) |
Cohort C 15 mg (N = 94) |
Total (N = 282) |
CP-CML (N = 270) |
Total (N = 449) |
| Sex | ||||||
| Male | 50 (53%) | 38 (40%) | 53 (56%) | 141 (50%) | 144 (53%) | 238 (53%) |
| Female | 44 (47%) | 56 (60%) | 41 (44%) | 141 (50%) | 126 (47%) | 211 (47%) |
| Age | ||||||
| Median (years) | 46 | 50.5 | 49.0 | 48.0 | 60.0 | 59.0 |
| Min, max (years) | 19, 81 | 21, 77 | 18, 81 | 18, 81 | 18, 94 | 18, 94 |
| Race | ||||||
| White | 73 (78%) | 77 (82%) | 72 (77%) | 222 (79%) | 218 (81%) | 352 (78%) |
| Black or African American | 1 (1%) | 2 (2%) | 3 (3%) | 6 (2%) | 11 (4%) | 25 (6%) |
| Asian | 16 (17%) | 12 (13%) | 15 (16%) | 43 (15%) | 32 (12%) | 59 (13%) |
| Other | 2 (2%) | 1 (1%) | 0 (0%) | 3 (1%) | 3 (1%) | 5 (1%) |
| Unknown/Missing | 2 (2%) | 2 (2%) | 4 (4%) | 8 (3%) | 6 (2%) | 8 (2%) |
| Ethnicity | ||||||
| Hispanic or Latino | 22 (23%) | 26 (28%) | 20 (21%) | 68 (24%) | 21 (8%) | 42 (9%) |
| Not Hispanic or Latino | 70 (75%) | 67 (71%) | 72 (77%) | 209 (74%) | 249 (92%) | 407 (91%) |
| Missing | 2 (2%) | 1 (1%) | 2 (2%) | 4 (1%) | 0 | 0 |
| Region | ||||||
| North America | 10 (11%) | 9 (10%) | 7 (7%) | 26 (9%) | 111 (41%) | 206 (46%) |
| South America | 22 (23%) | 25 (27%) | 16 (17%) | 63 (22%) | 0 | 0 |
| Europe excluding Russia | 10 (11%) | 17 (18%) | 19 (20%) | 46 (16%) | NA | NA |
| Russia | 38 (40%) | 31 (33%) | 38 (40%) | 107 (38%) | NA | NA |
| Asia | 14 (15%) | 12 (13%) | 14 (15%) | 40 (14%) | 27 (10%) | 44 (10%) |
| Europe (all regions)/Australia | NA | NA | NA | NA | 132 (49%) | 199 (44%) |
| Smoker? | ||||||
| Current | 9 (10%) | 14 (15%) | 16 (17%) | 39 (14%) | 21 (8%)a | 23 (5%)a |
| Former | 20 (21%) | 23 (24%) | 17 (18%) | 60 (21%) | NA | NA |
| Never | 65 (69%) | 55 (59%) | 59 (63%) | 179 (63%) | 10 (4%) | 11 (2%)a |
| Unknown | 0 | 2 (2%) | 2 (2%) | 4 (1%) | 239 (89%) | 415 (92%) |
| Prior treatment | ||||||
| Single TKI | 1 (1%) | 1 (1%) | 4 (4%) | 6 (2%) | 18 (7%) | 31 (7%) |
| Imatinib + 2nd+ gen TKI | 37 (39%) | 28 (30%) | 34 (36%) | 99 (35%) | 89 (33%) | 155 (35%) |
| Any 2 2nd gen TKIs | 6 (6%) | 9 (9%) | 8 (9%) | 23 (8%) | 3 (1%) | 6 (1%) |
| At least 3 TKIs | 50 (53%) | 56 (60%) | 48 (51%) | 154 (55%) | 159 (59%) | 38256 (57%) |
| No prior approved TKIs | 0 | 0 | 0 | 0 | 1 (<1%) | 1 (<1%) |
| T315I status | ||||||
| Yes | 25 (27%) | 21 (22%) | 20 (21%) | 66 (23%) | 60 (22%) | 190 (43%) |
| No | 67 (71%) | 73 (77%) | 74 (79%) | 216 (77%) | 188 (70%) | 216 (48%) |
| Missing | 2 | 0 | 0 | 0 | 22 (8%) | 43 (10%) |
| History of ischemic disease | ||||||
| Yes | 3 (3%) | 1 (1%) | 0 | 4 (1%) | 48 (18%) | 67 (15%) |
| No | 91 (97%) | 93 (99%) | 94 (100%) | 278 (99%) | 222 (82%) | 382 (85%) |
| History of hypertension | ||||||
| Yes | 29 (31%) | 27 (29%) | 24 (26%) | 81 (29%) | 102 (38%) | 159 (35%) |
| No | 65 (79%) | 67 (71%) | 70 (74%) | 201 (71%) | 168 (62%) | 290 (65%) |
| History of diabetes | ||||||
| Yes | 5 (5%) | 3 (3%) | 7 (7%) | 15 (5%) | 35 (13%) | 57 (13%) |
| No | 89 (95%) | 91 (97%) | 87 (93%) | 267 (95%) | 235 (87%) | 392 (87%) |
| History of hypercholesterolemia | ||||||
| Yes | 3 (3%) | 4 (4%) | 6 (6%) | 13 (5%) | 65 (24%) | 100 (22%) |
| No | 91 (97%) | 90 (96%) | 88 (94%) | 269 (95%) | 205 (76%) | 349 (78%) |
| History of obesity | ||||||
| Yes | 8 (9%) | 10 (11%) | 4 (4%) | 22 (8%) | 15 (6%) | 19 (4%) |
| No | 86 (91%) | 84 (89%) | 90 (96%) | 260 (92%) | 255 (94%) | 430 (96%) |
Smoking status was described as “yes” or “no” only in the PACE trial.
Abbreviation: TKI, tyrosine kinase inhibitors.