Table 3.
Risk factors for overall NRM by univariate analysis
| All NRM N = 48 |
Comparative group n = 191 |
P value | ||
|---|---|---|---|---|
| Patient characteristics | Age, median, y | 67 | 63 | .003 |
| Diabetes, n (%) | 11 (23.4) | 19 (10.1) | .025 | |
| At lymphodepletion | ECOG PS, (%) | <.001 | ||
| 0-1 | 34 (77.3) | 176 (95.1) | ||
| ≥2 | 10 (22.7) | 9 (4.9) | ||
| Hemoglobin level (g/dL), median | 9.6 | 10.7 | .002 | |
| Platelet count (G/L), median | 156 | 185 | .034 | |
| C-reactive protein level (mg/L), median | 17 | 5 | <.001 | |
| Ferritin level (μg/L), median | 732 | 393 | .002 | |
| Hypogammaglobulinemia, n (%) | 17 (54.8) | 72 (48) | .556 | |
| CAR-HEMATOTOX, n (%) | <.001 | |||
| Low | 20 (41.7) | 136 (71.2) | ||
| High | 28 (58.3) | 55 (28.8) | ||
| EASIX score, median | 17.1 | 10.0 | <.001 | |
| At infusion | CAR T-cell product, n (%) | .287 | ||
| Axi-cel | 31 (64.6) | 139 (72.8) | ||
| Tisacel | 17 (35.4) | 52 (27.2) | ||
| Hemoglobin level (g/dL), median | 9.3 | 10.0 | .002 | |
| Platelet count (G/L), median | 117 | 153 | .007 | |
| C-reactive protein level (mg/L), median | 21 | 8 | .001 | |
| LDH level (IU/L), median | 354 | 221 | .021 | |
| Ferritin level (μg/L), median | 897 | 539 | <.001 | |
| Postinfusion | CRSgrade ≥3, n (%) | 13 (27.1) | 10 (5.2) | <.001 |
| ICANSgrade ≥3, n (%) | 15 (31.3) | 20 (10.5) | <.001 | |
| Grade 4 neutropenia at month 1, n (%) | 8 (23.5) | 19 (10.5) | .047 | |
| Grade 4 thrombocytopenia at month 1, n (%) | 11 (28.2) | 23 (12.3) | .024 | |
| Hemoglobin level (g/dL) at month 1, median | 9.7 | 10.8 | .001 | |
| Grade 4 neutropenia at month 3, n (%) | 2 (7.7) | 5 (2.7) | .213 | |
| Grade 4 thrombocytopenia at month 3, n (%) | 3 (12) | 4 (2.2) | .039 | |
| Hemoglobin level (g/dL) at month 3, median | 11.1 | 11.6 | .139 | |
| Grade 4 neutropenia at month 6, n (%) | 2 (11.1) | 5 (2.9) | .135 | |
| Grade 4 thrombocytopenia at month 6, n (%) | 2 (11.1) | 3 (1.8) | .072 | |
| Hemoglobin level (g/dL) at month 6, median | 11.3 | 12.3 | .105 | |
| Grade 4 neutropenia at month 12, n (%) | 1 (9.1) | 3 (1.8) | .225 | |
| Hemoglobin level (g/dL) at month 12, median | 12.7 | 12.9 | .571 |
Risk factors for overall NRM were identified by comparing the characteristics of the overall NRM population with those of patients alive at 1 year after CAR T-cell infusion.