Table 2.
Patient demographics and characteristics of liso-cel administration by AE (N = 127)
| AE stratification | CRS only (n = 47)* | NE only (n = 14)* | Nonconcurrent CRS and NE (n = 21)* | Concurrent CRS and NE (n = 45)* | Any CRS and/or NE (n = 127) | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade ≥3 | Grade 1 | Grade 2 | Grade ≥3 | Grade ≤2 CRS and NE | Grade ≥3 CRS or NE | Grade ≤2 CRS and NE | Grade ≥3 CRS or NE | Grade ≥3 CRS and NE | ||
| Total, n (%)† | 33 (26.0) | 13 (10.2) | 1 (0.8) | 4 (3.1) | 3 (2.4) | 7 (5.5) | 16 (12.6) | 5 (3.9) | 29 (22.8) | 12 (9.4) | 4 (3.1) | 127 (100.0) |
| Age, y | ||||||||||||
| Mean (SD) | 56.3 (14.2) | 58.8 (13.6) | 47 (NA) | 60.8 (10.2) | 63.3 (8.1) | 62.3 (21.0) | 57.4 (11.2) | 57.6 (15.3) | 62.7 (14.3) | 60.4 (16.5) | 43.0 (23) | 58.8 (14.6) |
| Median | 58 | 63 | 47 | 64 | 62 | 66 | 58 | 58 | 64 | 64.5 | 45.5 | 62 |
| Range | 27-81 | 26-74 | NA | 46-69 | 56-72 | 19-82 | 33-74 | 33-73 | 29-86 | 37-79 | 18-63 | 18-86 |
| Male sex, n (%)‡ | 19 (57.6) | 10 (76.9) | 1 (100.0) | 3 (75.0) | 3 (100.0) | 5 (71.4) | 9 (56.3) | 4 (80.0) | 18 (62.1) | 7 (58.3) | 4 (100.0) | 83 (65.4) |
| White race, n (%)‡ | 27 (81.8) | 11 (84.6) | 1 (100.0) | 4 (100.0) | 3 (100.0) | 4 (57.1) | 15 (93.8) | 5 (100.0) | 28 (96.6) | 9 (75.0) | 4 (100.0) | 111 (87.4) |
| Non-Hispanic/non-Latino ethnicity, n (%)‡ | 29 (87.9) | 11 (84.6) | 1 (100.0) | 3 (75.0) | 3 (100.0) | 7 (100.0) | 14 (87.5) | 5 (100.0) | 25 (86.2) | 11 (91.7) | 2 (50.0) | 111 (87.4) |
| Site of administration, n (%)†‡ | ||||||||||||
| Inpatient | 30 (90.9) | 12 (92.3) | 1 (100.0) | 2 (50.0) | 3 (100.0) | 6 (85.7) | 13 (81.3) | 5 (100.0) | 25 (86.2) | 12 (100.0) | 3 (75.0) | 112 (88.2) |
| Outpatient | 3 (9.1) | 1 (7.7) | 0 | 2 (50.0) | 0 | 1 (14.3) | 3 (18.8) | 0 | 4 (13.8) | 0 | 1 (25.0) | 15 (11.8) |
Table includes all patients who experienced ≥1 CRS or NE episode (n = 127).
NA, not applicable; SD, standard deviation.
*
Lee et al12 criteria were used to determine CRS toxicity grade, and National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.03)17 were used to determine NE toxicity grade.
†
Percentages based on patients who experienced a CRS and/or NE episode.
‡
Percentages calculated within each column as percentage of AE type and severity.