Table 2.
Baseline characteristics in the CheckMate 238 and real-world cohorts
| Characteristic | CheckMate 238 (n = 369) |
Real-world (n = 452) |
P valuea |
|---|---|---|---|
| Age at index date, years, median (range) | 56.0 (19–83) | 63.0 (18.0–85.0) | < 0.001 |
| Female – no. (%) | 153 (41) | 169 (37) | 0.264 |
| Race – no. (%) | |||
| White | 345 (93) | 342 (76) | < 0.001 |
| Asian | 22 (6) | 1 (< 1) | |
| Black or African American | 0 | 2 (< 1) | |
| Otherb | 2 (1) | 55 (12) | |
| Missing/no. (%) | 0/369 (0) | 52/452 (12) | |
| Body weight, kg, median (range) | 80.0 (39.0–183.4) | 89.1 (38.8–191.9) | < 0.001 |
| Disease stage at initial diagnosis (per AJCC-8) – no. (%) | < 0.01 | ||
| IIIA | 3 (1) | 21 (5) | |
| IIIB | 117 (32) | 136 (30) | |
| IIIC | 232 (63) | 276 (61) | |
| IIID | 17 (5) | 19 (4) | |
| Dosing – no. (%) | < 0.001 | ||
| 3 mg/kg Q2W | 369 (100) | 5 (1) | |
| 240 mg Q2W | 0 | 194 (43) | |
| 480 mg Q4W | 0 | 253 (56) | |
| Year of index date – no. (%) | < 0.001 | ||
| 2015 | 369 (100) | 0 | |
| 2017 | 0 | 3 (1) | |
| 2018 | 0 | 126 (28) | |
| 2019 | 0 | 104 (23) | |
| 2020 | 0 | 101 (22) | |
| 2021 | 0 | 86 (19) | |
| 2022 | 0 | 32 (7) | |
| Time from surgical resection to index date, months, mean ± SD | 2.2 ± 0.6 | 1.4 ± 0.5 | < 0.001 |
| ECOG PS – no. (%) | < 0.001 | ||
| 0 | 333 (90) | 271 (60) | |
| 1 | 36 (10) | 73 (16) | |
| Missing/no. (%) | 0/369 (0) | 108/452 (24) | |
| Comorbiditiesc – no. (%) | |||
| Diabetes | 21 (6) | 33 (7) | 0.428 |
| Chronic pulmonary disease | 19 (5) | 17 (4) | 0.431 |
| Atrial fibrillation | 4 (1) | 16 (4) | < 0.05 |
| BRAF mutation status – no. (%) | < 0.05 | ||
| Negative | 157 (43) | 178 (39) | |
| Positive | 149 (40) | 113 (25) | |
| Missing/no. (%) | 63/369 (17) | 161/452 (36) |
aContinuous variables were compared using the Wald test; categorical variables were compared using Chi-square tests (Fisher’s exact tests for variables with small frequency counts)
bIncludes American Indian or Alaska Native, Hawaiian or Pacific Islander, or multiple races
cThose with a prevalence rate of > 2% in the real-world cohort
AJCC-8 American Joint Committee on Cancer, Cancer Staging Manual, eighth edition, ECOG PS Eastern Cooperative Oncology Group performance status, Q2W every 2 weeks, Q4W every 4 weeks, SD Standard deviation