Table 1. Patient Characteristics Overall and by FACT-BRM TOI Baseline and Week 13 Score Availability.
| Characteristic | No. (%) | |||||||
|---|---|---|---|---|---|---|---|---|
| All eligible | Baseline FACT-BRM TOI score available | By whether the cycle 3 FACT-BRM TOI score was available | By arm for patients with baseline and cycle 3 FACT-BRM TOI scores available | |||||
| Not available | Available | P value | Ipilimumab/HDI | Pembrolizumab | P valuea | |||
| No. | 1303 | 1188 | 356 | 832 | NA | 267 | 565 | NA |
| Age, median (range), y | 56.7 (18.3-86.0) | 56.6 (18.3-86.0) | 56.2 (18.7-84.5) | 56.7 (18.3-86.0) | NA | 56.8 (18.3-86.0) | 56.3 (20.0-82.6) | NA |
| <65 | 970 (74.4) | 881 (74.2) | 258 (72.5) | 623 (74.9) | .39 | 190 (71.2) | 433 (76.6) | .09 |
| >65 | 333 (25.6) | 307 (25.8) | 98 (27.5) | 209 (25.1) | NA | 77 (28.8) | 132 (23.4) | NA |
| Sex | ||||||||
| Female | 524 (40.2) | 481 (40.5) | 139 (39.0) | 342 (41.1) | .51 | 113 (42.3) | 229 (40.5) | .62 |
| Male | 779 (59.8) | 707 (59.5) | 217 (61.0) | 490 (58.9) | NA | 154 (57.7) | 336 (59.5) | |
| Raceb | ||||||||
| Asian | 10 (0.8) | 6 (0.5) | 2 (0.6) | 4 (0.5) | NA | 1 (0.4) | 3 (0.5) | .34 |
| Black | 7 (0.5) | 5 (0.4) | 0 | 5 (0.6) | .10 | 3 (1.1) | 2 (0.4) | |
| White | 1243 (95.4) | 1139 (95.9) | 337 (94.7) | 802 (96.4) | NA | 255 (95.5) | 547 (96.8) | |
| Other/unknown | 43 (3.3) | 38 (3.2) | 17 (4.8) | 21 (2.5) | NA | 8 (3.0) | 13 (2.3) | |
| Ethnicityc | ||||||||
| Hispanic | 44 (3.4) | 33 (2.8) | 10 (2.8) | 23 (2.8) | >.99 | 8 (3.0) | 15 (2.7) | .33 |
| Not Hispanic | 1223 (93.9) | 1121 (94.4) | 336 (94.4) | 785 (94.4) | NA | 248 (92.9) | 537 (95.0) | |
| Unknown | 36 (2.8) | 34 (2.9) | 10 (2.8) | 24 (2.9) | NA | 11 (4.1) | 13 (2.3) | |
| Performance status | ||||||||
| 0 | 1091 (83.7) | 1005 (84.6) | 297 (83.4) | 708 (85.1) | .47 | 233 (87.3) | 475 (84.1) | .23 |
| 1 | 212 (16.3) | 183 (15.4) | 59 (16.6) | 124 (14.9) | NA | 34 (12.7) | 90 (15.9) | |
| Staged | ||||||||
| IIIA | 144 (11.1) | 132 (11.1) | 41 (11.5) | 91 (10.9) | .29 | 27 (10.1) | 64 (11.3) | .45 |
| IIIB | 637 (48.9) | 585 (49.2) | 400 (48.1) | NA | 126 (47.2) | 274 (48.5) | ||
| IIIC | 443 (34.0) | 400 (33.7) | 115 (32.3) | 285 (34.3) | NA | 95 (35.6) | 190 (33.6) | |
| IV | 79 (6.1) | 71 (6.0) | 15 (4.2) | 56 (6.7) | NA | 19 (7.1) | 37 (6.5) | |
| PD-L1 statusc | ||||||||
| Positive | 1070 (82.1) | 979 (82.4) | 290 (81.5) | 689 (82.8) | .79 | 218 (81.6) | 471 (83.4) | .63 |
| Negative | 188 (14.4) | 171 (14.4) | 53 (14.9) | 118 (14.2) | NA | 42 (15.7) | 76 (13.5) | |
| Indeterminate | 45 (3.5) | 38 (3.2) | 13 (3.7) | 25 (3.0) | NA | 7 (2.6) | 18 (3.2) | |
Abbreviation: FACT-BRM, Functional Assessment of Cancer Therapy Biological Response Modifiers; HDI, high-dose interferon α 2b; NA, not applicable; PD-L1, programmed cell death ligand 1; TOI, trial outcome index.
a
Differences between groups tested using χ2 test, unless otherwise specified.
b
Represents a test of White vs racial and ethnic minority groups. Race was categorized by self-report.
c
Statistical significance of χ2 statistics indicates heterogeneity by availability of baseline FACT-BRM TOI across nonordered categories. Ethnicity was categorized by self-report.
d
Used Mantel-Haenszel test for trend to test group differences based on linear ordering (ie, ordinal categorical variable) of stage groups.