Baseline risk factors associated with outcomes for lymphoma patients treated with anti-CD19 CAR T-cell (on multivariate analysis)
| Risk factor . | Hazard ratio HR . |
|---|---|
| • ECOG ≥2 (baseline) | PFS: HR 1.7 (95% CI: 1.1-2.7; p = 0.010) OS: HR 1.8 (95% CI: 1.10-3.00; p = 0.020)9 PFS: HR 2.61 (1.90-3.60) OS: HR 3.27 (2.37-4.52)10 PFS: HR 5.446 (95% CI: 2.354-12.597; p < 0.001) OS: HR 4.306 (95% CI: 1.841-10.071; p = 0.001)11 OS: HR 1.63 (95% CI: 1.06-2.51; p = 0.03), ECOG considered as 1-unit increase8 |
| • Age ≥65 years old • Age >60 years old | ORR: OR 1.39 (95% CI: 1.05–1.83)10 PFS: HR 1.6 (95% CI: 1.1–2.3; p = 0.01)9 |
| • Chemo-resistant disease prior to infusion | PFS: HR 1.48 (95% CI: 1.21–1.79) OS: HR 1.44 (95% CI: 1.15–1.81)10 |
| • Disease status (PD vs other) | PFS: HR 1.804 (95% CI: 1.096-3.507; p = 0.018) OS: HR 2.561 (95% CI: 1.812-3.999; p = 0.018)11 |
| • CIRS ≥7 or CIRS-3+ (baseline) • “Severe4” score (baseline) | OS: HR 2.39 (95% CI: 1.10-5.20; p = 0.03) PFS: HR 2.15 (95% CI: 1.54-2.99; p < 0.001)8 OS: HR 1.94 (95% CI: 1.35-2.78; p < 0.001)13 |
| • aaIPI ≥2 at time of lymphodepletion | PFS: HR 6.76 (95% CI: 2.21–20.69; p = 0.001) OS: HR 7.91 (95% CI: 1.74–35.85; p = 0.007)17 |
| • High LDH at CAR T-cell election | Relapse: HR 2.04 (95% CI: 1.19-3.49; p = 0.009) Early relapse: 9.61 (95% CI: 1.23-75.41; p = 0.031)19 |
| • High LDH at apheresis | PFS: HR 2.181 (95% CI: 1.303-3.651; p = 0.003) OS: HR 1.809 (95% CI: 1.084-3.021; p = 0.023)11 |
| • High LDH before lymphodepletion | PFS: HR 1.9 (95% CI: 1.3-2.9; p = 0.001) OS: HR 3.0 (95% CI: 1.7-5.4; p = 0.0001)9 |
| • Extranodal sites ≥2 at infusion | Relapse: HR 2.50 (95% CI: 1.44-4.35; p = 0.00111) Early relapse: HR 4.67 (95% CI: 1.55-14.11; p = 0.0063) Death: HR 3.61 (95% CI: 1.55-8.38; p = 0.0028319 |
| • High MTV pre-lymphodepletion • Low MTV (baseline) • High MTV (baseline) | Relapse: HR 2.18 (95% CI: 1.23-3.89; p = 0.00794) Early relapse: HR 4.35 (95% CI: 1.32-14.37; p = 0.016) Death: HR 3.41 (95% CI: 1.41-8.26; p = 0.0651)19 PFS: HR 0.40; (95% CI: 0.18-0.89). OS: HR 0.25; (95% CI: 0.10-0.66)18 PFS: HR 3.44 (95% CI: 1.18-10.1; p = 0.02)42 |
| • Use of bridging therapy • Refractory to bridging therapy | OS: HR 1.7 (95% CI: .04–2.70, 0.0300)9 PFS: HR 2.273 (95% CI: 1.484-3.481; p = 0.001) OS: HR 2.273 (95% CI: 1.324-3.901; p = 0.003)21 |
| • Increased CRP at infusion | Relapse: HR 1.12 (95% CI: 1.07-1.17; p = 0.0001) Early relapse: HR 1.15 (95% CI: 1.03-1.29; p = 0.016) Death: HR 1.12 (95% CI: 1.06-1.17; p = .0001)19 |
| • Presence of TP53 gene alterations | CR: OR 3.61 (95% CI: 1.31-10.7; p = 0.016) OS: HR 2.03 (95% CI: 1.02-4.03; p = 0.044)43 |
| • High focal copy number alterations before infusion | PFS: HR 2.11 (95% CI: 1.36-3.275; p = 0.0007) OS: HR 2.10 (95% CI: 1.28-3.43; p = 0.0026)24 |
| • CAR T-cell type Tisa-cel vs axi-cel Axi-cel vs tisa-cel | PFS: HR 1.475 (95% CI: 1.122-1.942; p = 0.005)21 PFS: HR 0.61 (95% CI: 0.46-0.79; p = 0.0003) OS: HR 0.63 (95% CI: 0.45-0.88; p = 0.0072)28 |
| Risk factor . | Hazard ratio HR . |
|---|---|
| • ECOG ≥2 (baseline) | PFS: HR 1.7 (95% CI: 1.1-2.7; p = 0.010) OS: HR 1.8 (95% CI: 1.10-3.00; p = 0.020)9 PFS: HR 2.61 (1.90-3.60) OS: HR 3.27 (2.37-4.52)10 PFS: HR 5.446 (95% CI: 2.354-12.597; p < 0.001) OS: HR 4.306 (95% CI: 1.841-10.071; p = 0.001)11 OS: HR 1.63 (95% CI: 1.06-2.51; p = 0.03), ECOG considered as 1-unit increase8 |
| • Age ≥65 years old • Age >60 years old | ORR: OR 1.39 (95% CI: 1.05–1.83)10 PFS: HR 1.6 (95% CI: 1.1–2.3; p = 0.01)9 |
| • Chemo-resistant disease prior to infusion | PFS: HR 1.48 (95% CI: 1.21–1.79) OS: HR 1.44 (95% CI: 1.15–1.81)10 |
| • Disease status (PD vs other) | PFS: HR 1.804 (95% CI: 1.096-3.507; p = 0.018) OS: HR 2.561 (95% CI: 1.812-3.999; p = 0.018)11 |
| • CIRS ≥7 or CIRS-3+ (baseline) • “Severe4” score (baseline) | OS: HR 2.39 (95% CI: 1.10-5.20; p = 0.03) PFS: HR 2.15 (95% CI: 1.54-2.99; p < 0.001)8 OS: HR 1.94 (95% CI: 1.35-2.78; p < 0.001)13 |
| • aaIPI ≥2 at time of lymphodepletion | PFS: HR 6.76 (95% CI: 2.21–20.69; p = 0.001) OS: HR 7.91 (95% CI: 1.74–35.85; p = 0.007)17 |
| • High LDH at CAR T-cell election | Relapse: HR 2.04 (95% CI: 1.19-3.49; p = 0.009) Early relapse: 9.61 (95% CI: 1.23-75.41; p = 0.031)19 |
| • High LDH at apheresis | PFS: HR 2.181 (95% CI: 1.303-3.651; p = 0.003) OS: HR 1.809 (95% CI: 1.084-3.021; p = 0.023)11 |
| • High LDH before lymphodepletion | PFS: HR 1.9 (95% CI: 1.3-2.9; p = 0.001) OS: HR 3.0 (95% CI: 1.7-5.4; p = 0.0001)9 |
| • Extranodal sites ≥2 at infusion | Relapse: HR 2.50 (95% CI: 1.44-4.35; p = 0.00111) Early relapse: HR 4.67 (95% CI: 1.55-14.11; p = 0.0063) Death: HR 3.61 (95% CI: 1.55-8.38; p = 0.0028319 |
| • High MTV pre-lymphodepletion • Low MTV (baseline) • High MTV (baseline) | Relapse: HR 2.18 (95% CI: 1.23-3.89; p = 0.00794) Early relapse: HR 4.35 (95% CI: 1.32-14.37; p = 0.016) Death: HR 3.41 (95% CI: 1.41-8.26; p = 0.0651)19 PFS: HR 0.40; (95% CI: 0.18-0.89). OS: HR 0.25; (95% CI: 0.10-0.66)18 PFS: HR 3.44 (95% CI: 1.18-10.1; p = 0.02)42 |
| • Use of bridging therapy • Refractory to bridging therapy | OS: HR 1.7 (95% CI: .04–2.70, 0.0300)9 PFS: HR 2.273 (95% CI: 1.484-3.481; p = 0.001) OS: HR 2.273 (95% CI: 1.324-3.901; p = 0.003)21 |
| • Increased CRP at infusion | Relapse: HR 1.12 (95% CI: 1.07-1.17; p = 0.0001) Early relapse: HR 1.15 (95% CI: 1.03-1.29; p = 0.016) Death: HR 1.12 (95% CI: 1.06-1.17; p = .0001)19 |
| • Presence of TP53 gene alterations | CR: OR 3.61 (95% CI: 1.31-10.7; p = 0.016) OS: HR 2.03 (95% CI: 1.02-4.03; p = 0.044)43 |
| • High focal copy number alterations before infusion | PFS: HR 2.11 (95% CI: 1.36-3.275; p = 0.0007) OS: HR 2.10 (95% CI: 1.28-3.43; p = 0.0026)24 |
| • CAR T-cell type Tisa-cel vs axi-cel Axi-cel vs tisa-cel | PFS: HR 1.475 (95% CI: 1.122-1.942; p = 0.005)21 PFS: HR 0.61 (95% CI: 0.46-0.79; p = 0.0003) OS: HR 0.63 (95% CI: 0.45-0.88; p = 0.0072)28 |
aaIPI, age-adjusted International Prognostic Index; CIRS, Cumulative Illness Rating Scale; CRP, C-reactive protein; ECOG, Eastern Cooperative Oncology Group; HR, hazard ratio; HR, hazard ration; LDH, lactate dehydrogenase; MTV, metabolic tumor volume; OS, overall survival; PD, progression of disease; PFS, progression-free survival.