Toxicities of glofitamab therapy in patients of this study
Parameters . | All patients, n = 70 . | Patients without prior CAR-Ts, n = 20 . | Patients with prior CAR-Ts, n = 50 . | P value . |
---|---|---|---|---|
Median number of glofitamab cycles administered, n (range) | 4 (1-12) | 2 (1-12) | 5 (1-12) | .013 |
CRS after glofitamab, n (%) | ||||
CRS (grade 1-4) | 28 (40%) | 9 (45%) | 19 (38%) | 1.000 |
Grade 0 | 42 (60%) | 11 (55%) | 31 (62%) | 1.000 |
Grade 1 | 17 (25%) | 5 (25%) | 12 (24%) | 1.000 |
Grade 2 | 9 (13%) | 3 (15%) | 6 (12%) | .708 |
Grade 3 | 1 (1%) | 1 (5%) | - | - |
Grade 4 | 1 (1%) | - | 1 (2%) | - |
ICANS after glofitamab, n (%) | ||||
ICANS (grade 1-3) | 8 (11%) | 3 (15%) | 5 (10%) | .708 |
Grade 0 | 62 (89%) | 17 (85%) | 45 (90%) | .708 |
Grade 1 | 4 (6%) | 1 (5%) | 3 (6%) | 1.000 |
Grade 2 | 3 (4%) | 2 (10%) | 1 (2%) | .194 |
Grade 3 | 1 (1%) | - | 1 (2%) | - |
Treatment of CRS (available for 24/28 cases) | ||||
Symptomatic (eg, antipyretics, volume), n (%) | 10 (36%) | 3 (33%) | 7 (47%) | - |
Steroids, n (%) | 1 (4%) | 1 (11%) | - | - |
Steroids/tocilizumab, n (%) | 11 (39%) | 4 (44%) | 7 (47%) | - |
Steroids/tocilizumab/vasopressor, n (%) | 2 (7%) | 1 (11%) | 1 (7%) | - |
Treatment of ICANS (available for 6/8 cases) | ||||
Supportive measures only, n (%) | 2 (33%) | 1 (33%) | 1 (33%) | - |
Steroids, n (%) | 2 (33%) | 1 (33%) | 1 (33%) | - |
Steroids/tocilizumab, n (%) | 1 (17%) | 1 (33%) | - | - |
Steroids/tocilizumab/vasopressor, n (%) | 1 (17%) | - | 1 (33%) | |
Admission to IMC/ICU because of CRS and/or ICANS, n (%) | 7 (10%) | 4 (20%) | 3 (2%) | .135 |
Infection incidence under glofitamab, n (%) | 22 (31%) | 8 (40%) | 14 (28%) | .397 |
Infection type under glofitamab, n (%) | ||||
Bacterial | 9 (13%) | 6 (30%) | 3 (6%) | .013 |
Fungal | 2 (3%) | - | 2 (4%) | 1.000 |
Viral non-SARS-CoV-2 | 7 (10%) | 1 (5%) | 6 (12%) | .664 |
SARS-CoV-2 | 4 (6%) | 2 (10%) | 2 (4%) | .572 |
Infection grade (CTCAE) under glofitamab, n (%) (n = 21) | ||||
Grade 1 | 8 (11%) | 2 (10%) | 6 (12%) | 1.000 |
Grade 2 | 5 (7%) | 1 (5%) | 4 (8%) | 1.000 |
Grade 3 | 6 (9%) | 3 (15%) | 3 (6%) | .097 |
Grade 5 | 2 (3%) | 1 (5%) | 1 (2%) | .493 |
Tumor lysis syndrome under glofitamab, n (%) | 2 (3%) | 1 (5%) | 1 (2%) | .493 |
Parameters . | All patients, n = 70 . | Patients without prior CAR-Ts, n = 20 . | Patients with prior CAR-Ts, n = 50 . | P value . |
---|---|---|---|---|
Median number of glofitamab cycles administered, n (range) | 4 (1-12) | 2 (1-12) | 5 (1-12) | .013 |
CRS after glofitamab, n (%) | ||||
CRS (grade 1-4) | 28 (40%) | 9 (45%) | 19 (38%) | 1.000 |
Grade 0 | 42 (60%) | 11 (55%) | 31 (62%) | 1.000 |
Grade 1 | 17 (25%) | 5 (25%) | 12 (24%) | 1.000 |
Grade 2 | 9 (13%) | 3 (15%) | 6 (12%) | .708 |
Grade 3 | 1 (1%) | 1 (5%) | - | - |
Grade 4 | 1 (1%) | - | 1 (2%) | - |
ICANS after glofitamab, n (%) | ||||
ICANS (grade 1-3) | 8 (11%) | 3 (15%) | 5 (10%) | .708 |
Grade 0 | 62 (89%) | 17 (85%) | 45 (90%) | .708 |
Grade 1 | 4 (6%) | 1 (5%) | 3 (6%) | 1.000 |
Grade 2 | 3 (4%) | 2 (10%) | 1 (2%) | .194 |
Grade 3 | 1 (1%) | - | 1 (2%) | - |
Treatment of CRS (available for 24/28 cases) | ||||
Symptomatic (eg, antipyretics, volume), n (%) | 10 (36%) | 3 (33%) | 7 (47%) | - |
Steroids, n (%) | 1 (4%) | 1 (11%) | - | - |
Steroids/tocilizumab, n (%) | 11 (39%) | 4 (44%) | 7 (47%) | - |
Steroids/tocilizumab/vasopressor, n (%) | 2 (7%) | 1 (11%) | 1 (7%) | - |
Treatment of ICANS (available for 6/8 cases) | ||||
Supportive measures only, n (%) | 2 (33%) | 1 (33%) | 1 (33%) | - |
Steroids, n (%) | 2 (33%) | 1 (33%) | 1 (33%) | - |
Steroids/tocilizumab, n (%) | 1 (17%) | 1 (33%) | - | - |
Steroids/tocilizumab/vasopressor, n (%) | 1 (17%) | - | 1 (33%) | |
Admission to IMC/ICU because of CRS and/or ICANS, n (%) | 7 (10%) | 4 (20%) | 3 (2%) | .135 |
Infection incidence under glofitamab, n (%) | 22 (31%) | 8 (40%) | 14 (28%) | .397 |
Infection type under glofitamab, n (%) | ||||
Bacterial | 9 (13%) | 6 (30%) | 3 (6%) | .013 |
Fungal | 2 (3%) | - | 2 (4%) | 1.000 |
Viral non-SARS-CoV-2 | 7 (10%) | 1 (5%) | 6 (12%) | .664 |
SARS-CoV-2 | 4 (6%) | 2 (10%) | 2 (4%) | .572 |
Infection grade (CTCAE) under glofitamab, n (%) (n = 21) | ||||
Grade 1 | 8 (11%) | 2 (10%) | 6 (12%) | 1.000 |
Grade 2 | 5 (7%) | 1 (5%) | 4 (8%) | 1.000 |
Grade 3 | 6 (9%) | 3 (15%) | 3 (6%) | .097 |
Grade 5 | 2 (3%) | 1 (5%) | 1 (2%) | .493 |
Tumor lysis syndrome under glofitamab, n (%) | 2 (3%) | 1 (5%) | 1 (2%) | .493 |
Significant P values are set in bold.
CTCAE, common terminology criteria for adverse events; ICU, intensive care unit; IMC, intermediate care.