Univariate and multivariate analysis of risk factors for infection in patients treated with CAR19 T cells
| Characteristics/univariate analysis . | Total (N = 23), n (%) . | Infection (n = 14), n (%) . | No infection (n = 9), n (%) . | OR (95% CI) . | P value . |
|---|---|---|---|---|---|
| Age, median (range), y | 54 (18-77) | 47.5 (18-77) | 59 (24-74) | 0.9 (0.9-1.0) | .30 |
| Male sex | 15 (65.2) | 10 (71.4) | 5 (55.5) | 0.5 (0.08-2.8) | .43 |
| Hematologic diagnosis | |||||
| DLBCL | 18 (78.3) | 11 (78.5) | 7 (77.7) | — | — |
| ALL | 3 (13) | 2 (14.2) | 1 (11.1) | 0.7 (0.05-10.3) | .85 |
| FL | 2 (8.7) | 1 (7.1) | 1 (11.1) | 1.5 (0.08-29.4) | .76 |
| Advanced staging, Ann Arbor III or IV (DLBCL/FL), n (%) | 17/19 (89.5) | 11/12 (91.6) | 6/7 (85.7) | 1.8 (0.09-34.8) | .68 |
| Tumor burden >6 cm (DLBCL/FL) | 6/17 (35.3) | 4/11 (36.3) | 2/6 (33.3) | 1.1 (0.1-9.2) | .90 |
| Response before LD (DLBCL/FL) | |||||
| PD or ED vs CR or PR | 12/20 (60) | 10/12 (83.3) | 2/8 (25) | 15.0 (1.6-136.1) | .01 |
| ECOG ≥2 | 4 (17.4) | 3 (21.4) | 1 (11.1) | 2.1 (0.1-25.0) | .53 |
| Prior treatment, ≥3 lines | 23 (100) | - | - | - | - |
| Prior autologous or allogeneic BMT | 10 (43.5) | 7 (50) | 3 (33.3) | 2.0 (0.3-11.3) | .43 |
| CAR19 T cell | |||||
| Tisagenlecleucel | 14 (60.9) | 9 (64.2) | 5 (55.5) | - | - |
| Axicabtagene ciloleucel | 9 (39.1) | 5 (35.7) | 4 (44.4) | 0.6 (0.1-3.8) | .67 |
| LDH ≥250 U/L before LD | 13 (56.5) | 10 (71.4) | 3 (33.3) | 5.0 (0.8-30.4) | .08 |
| CRP ≥1 mg/dL before LD | 14/22 (63.6) | 11/13 (84.6) | 3/9 (33.3) | 11 (1.4-85.2) | .02 |
| Ferritin ≥500 ng/mL before LD | 16/18 (88.9) | 11/11 (100) | 5/7 (71.4) | - | - |
| Immunological evaluation before LD | |||||
| IgG <400 mg/dL | 8/17 (47.1) | 6/10 (60) | 2/7 (28.5) | 3.7 (0.4-29.7) | .21 |
| IgM <40 mg/dL | 15/17 (88.2) | 9/10 (90) | 6/7 (85.7) | 1.5 (0.07-28.8) | .78 |
| IgA <70 mg/dL | 12/17 (70.6) | 8/10 (80) | 4/7 (57.1) | 3.0 (0.3-25.8) | .31 |
| CD4 count <200 cells per mm3 | 14/14 (100) | - | - | - | - |
| CRS grade 3-4 | 4 (17.4) | 3 (21.4) | 1 (11.1) | 2.1 (0.1-25.0) | .53 |
| ICANS | 14 (60.9) | 9 (64.2) | 5 (55.5) | 1.4 (0.2-7.9) | .67 |
| Use of steroids | 16 (69.6) | 10 (71.4) | 6 (66.6) | 1.2 (0.2-7.6) | .80 |
| Use of tocilizumab | 19 (82.6) | 12 (85.7) | 7 (77.7) | 1.7 (0.1-15.0) | .62 |
| Use of anakinra | 8/22 (36.4) | 7/13 (53.8) | 1/9 (11.1) | 9.3 (0.8-97.6) | .06 |
| CAR-HEMATOTOX | |||||
| High risk, ≥2 | 17/21 (81) | 11/13 (84.6) | 6/8 (75) | 1.8 (0.2-16.5) | .58 |
| ICU admission | 12/22 (54.5) | 10/14 (71.4) | 2/8 (25) | 7.5 (1.0-54.1) | .04 |
| Multivariate analysis | |||||
| Use of anakinra | 48.1 (1.0-2191) | .04 | |||
| LDH ≥250 U/L before LD | 7.9 (0.3-161.0) | .17 | |||
| Response before LD (DLBCL/FL), PD or ED vs CR or PR | 15.4 (0.9-265.4) | .05 |
| Characteristics/univariate analysis . | Total (N = 23), n (%) . | Infection (n = 14), n (%) . | No infection (n = 9), n (%) . | OR (95% CI) . | P value . |
|---|---|---|---|---|---|
| Age, median (range), y | 54 (18-77) | 47.5 (18-77) | 59 (24-74) | 0.9 (0.9-1.0) | .30 |
| Male sex | 15 (65.2) | 10 (71.4) | 5 (55.5) | 0.5 (0.08-2.8) | .43 |
| Hematologic diagnosis | |||||
| DLBCL | 18 (78.3) | 11 (78.5) | 7 (77.7) | — | — |
| ALL | 3 (13) | 2 (14.2) | 1 (11.1) | 0.7 (0.05-10.3) | .85 |
| FL | 2 (8.7) | 1 (7.1) | 1 (11.1) | 1.5 (0.08-29.4) | .76 |
| Advanced staging, Ann Arbor III or IV (DLBCL/FL), n (%) | 17/19 (89.5) | 11/12 (91.6) | 6/7 (85.7) | 1.8 (0.09-34.8) | .68 |
| Tumor burden >6 cm (DLBCL/FL) | 6/17 (35.3) | 4/11 (36.3) | 2/6 (33.3) | 1.1 (0.1-9.2) | .90 |
| Response before LD (DLBCL/FL) | |||||
| PD or ED vs CR or PR | 12/20 (60) | 10/12 (83.3) | 2/8 (25) | 15.0 (1.6-136.1) | .01 |
| ECOG ≥2 | 4 (17.4) | 3 (21.4) | 1 (11.1) | 2.1 (0.1-25.0) | .53 |
| Prior treatment, ≥3 lines | 23 (100) | - | - | - | - |
| Prior autologous or allogeneic BMT | 10 (43.5) | 7 (50) | 3 (33.3) | 2.0 (0.3-11.3) | .43 |
| CAR19 T cell | |||||
| Tisagenlecleucel | 14 (60.9) | 9 (64.2) | 5 (55.5) | - | - |
| Axicabtagene ciloleucel | 9 (39.1) | 5 (35.7) | 4 (44.4) | 0.6 (0.1-3.8) | .67 |
| LDH ≥250 U/L before LD | 13 (56.5) | 10 (71.4) | 3 (33.3) | 5.0 (0.8-30.4) | .08 |
| CRP ≥1 mg/dL before LD | 14/22 (63.6) | 11/13 (84.6) | 3/9 (33.3) | 11 (1.4-85.2) | .02 |
| Ferritin ≥500 ng/mL before LD | 16/18 (88.9) | 11/11 (100) | 5/7 (71.4) | - | - |
| Immunological evaluation before LD | |||||
| IgG <400 mg/dL | 8/17 (47.1) | 6/10 (60) | 2/7 (28.5) | 3.7 (0.4-29.7) | .21 |
| IgM <40 mg/dL | 15/17 (88.2) | 9/10 (90) | 6/7 (85.7) | 1.5 (0.07-28.8) | .78 |
| IgA <70 mg/dL | 12/17 (70.6) | 8/10 (80) | 4/7 (57.1) | 3.0 (0.3-25.8) | .31 |
| CD4 count <200 cells per mm3 | 14/14 (100) | - | - | - | - |
| CRS grade 3-4 | 4 (17.4) | 3 (21.4) | 1 (11.1) | 2.1 (0.1-25.0) | .53 |
| ICANS | 14 (60.9) | 9 (64.2) | 5 (55.5) | 1.4 (0.2-7.9) | .67 |
| Use of steroids | 16 (69.6) | 10 (71.4) | 6 (66.6) | 1.2 (0.2-7.6) | .80 |
| Use of tocilizumab | 19 (82.6) | 12 (85.7) | 7 (77.7) | 1.7 (0.1-15.0) | .62 |
| Use of anakinra | 8/22 (36.4) | 7/13 (53.8) | 1/9 (11.1) | 9.3 (0.8-97.6) | .06 |
| CAR-HEMATOTOX | |||||
| High risk, ≥2 | 17/21 (81) | 11/13 (84.6) | 6/8 (75) | 1.8 (0.2-16.5) | .58 |
| ICU admission | 12/22 (54.5) | 10/14 (71.4) | 2/8 (25) | 7.5 (1.0-54.1) | .04 |
| Multivariate analysis | |||||
| Use of anakinra | 48.1 (1.0-2191) | .04 | |||
| LDH ≥250 U/L before LD | 7.9 (0.3-161.0) | .17 | |||
| Response before LD (DLBCL/FL), PD or ED vs CR or PR | 15.4 (0.9-265.4) | .05 |
BMT, bone marrow transplantation; CR, complete response; ECOG, Eastern Cooperative Oncology Group; ED, estable disease; CAR-HEMATOTOX, CAR-T–related hematologic toxicity; IgG, immunoglobulin G; LD, lymphodepletion; LDH, lactate dehydrogenase; PD, progressive disease; PR, partial response.
The bold values in Table 1 indicate statistical significance P < 0.05.