From: CD-19 CART therapy and orthostatic hypotension: a single center retrospective cohort study
Cohort | No orthostatic hypotension | Orthostatic hypotension | p-value | |
---|---|---|---|---|
n | 42 | 9 | 33 | |
Patient Characteristics | ||||
Age (mean (SD)) | 63.26 (14.99) | 49.33 (19.64) | 67.06 (11.05) | 0.001 |
Sex (%) | 0.575 | |||
Male | 27 (64.3) | 7 (77.8) | 20 (60.6) | |
Female | 15 (35.7) | 2 (22.2) | 13 (39.4) | |
Race (%) | 1 | |||
White | 41 (97.6) | 9 (100.0) | 32 (97.0) | |
Black | 1 (2.4) | 0 (0.0) | 1 (3.0) | |
BMI (mean (SD)) | 28.83 (5.80) | 32.24 (6.76) | 27.90 (5.25) | 0.045 |
Past Medical History | ||||
Hypertension (%) | 21 (50.0) | 4 (44.4) | 17 (51.5) | 1 |
Hyperlipidemia (%) | 19 (45.2) | 1 (11.1) | 18 (54.5) | 0.052 |
Type 2 Diabetes Mellitus (%) | 5 (11.9) | 2 (22.2) | 3 (9.1) | 0.619 |
Coronary artery disease (%) | 2 (4.8) | 1 (11.1) | 1 (3.0) | 0.9 |
Chronic kidney disease (%) | 8 (19.0) | 0 (0.0) | 8 (24.2) | 0.245 |
Myocardial infarction (%) | 1 (2.4) | 0 (0.0) | 1 (3.0) | 1 |
Atrial Fibrillation (%) | 2 (4.8) | 0 (0.0) | 2 (6.1) | 1 |
Tobacco Use (%) | 24 (57.1) | 4 (44.4) | 20 (60.6) | 0.625 |
Orthostatic hypotension (%) | 9 (21.4) | 2 (22.2) | 7 (21.2) | 1 |
Neuropathy (%) | 26 (61.9) | 5 (55.6) | 21 (63.6) | 0.711 |
Oncologic History | ||||
Cancer type (%) | ||||
ALL | 2 (4.8) | 2 (22.2) | 0 (0.0) | |
DLBCL | 39 (92.9) | 6 (66.7) | 33 (100.0) | |
DLBCL/CHL | 1 (2.4) | 1 (11.1) | 0 (0.0) | |
CAR-T Product (%) | 0.058 | |||
YESCARTA | 40 (95.2) | 7 (77.8) | 33 (100.0) | |
KYMRIAH | 2 (4.8) | 2 (22.2) | 0 (0.0) | |
Chest/axillary radiation (%) | 10 (23.8) | 1 (11.1) | 9 (27.3) | 0.57 |
Neck radiation (%) | 6 (14.3) | 1 (11.1) | 5 (15.2) | 1 |
Stem cell transplant (%) | 9 (21.4) | 2 (22.2) | 7 (21.2) | 1 |
R-CHOP (%) | 27 (64.3) | 3 (33.3) | 24 (72.7) | 0.073 |
R-ICE (%) | 18 (42.9) | 3 (33.3) | 15 (45.5) | 0.786 |
GEM-OX (%) | 13 (31.0) | 2 (22.2) | 11 (33.3) | 0.816 |
R-EPOCH (%) | 9 (21.4) | 4 (44.4) | 5 (15.2) | 0.15 |
Pre-CART vital signs | ||||
Ambulatory mean SBP (mean (SD)) | 119.93 (12.31) | 125.30 (4.18) | 118.46 (13.39) | 0.142 |
Ambulatory mean DBP (mean (SD)) | 73.21 (7.45) | 78.70 (2.27) | 71.71 (7.68) | 0.011 |
Ambulatory mean HR (mean (SD)) | 84.18 (13.23) | 88.00 (12.24) | 83.14 (13.48) | 0.335 |
Pre-CART orthostatic vital signs assessed (%) | 16 (38.1) | 5 (55.6) | 11 (33.3) | 0.407 |
Pre-CART orthostatic vital signs positive (%)a | 8 (50.0) | 2 (40.0) | 6 (54.5) | 1 |
CART Hospitalization | ||||
CART hospitalization time (mean (SD)) | 18.86 (13.71) | 23.67 (24.72) | 17.55 (8.93) | 0.24 |
Time from CART infusion to discharge (mean (SD)) | 15.38 (9.80) | 19.89 (16.72) | 14.15 (6.78) | 0.121 |
Orthostatic vitals assessed (%) | 36 (85.7) | 8 (88.9) | 28 (84.8) | 1 |
Orthostatic vital signs positive (%)a | 33 (91.7) | 7 (87.5) | 26 (92.9) | 1 |
Post-CART vital signs | ||||
Discharge orthostatic vital signs assessed (%) | 33 (78.6) | 8 (88.9) | 25 (75.8) | 0.694 |
Discharge orthostatic vital signs positive (%)a | 18 (54.5) | 3 (37.5) | 15 (60.0) | 0.481 |
1 month orthostatic vital signs assessed (%) | 36 (85.7) | 8 (88.9) | 28 (84.8) | 1 |
1 month orthostatic vital signs positive (%)a | 13 (36.1) | 0 (0.0) | 13 (46.4) | 0.046 |
3 months orthostatic vital signs assessed (%) | 13 (31.0) | 2 (22.2) | 11 (33.3) | 0.816 |
3 months orthostatic vital signs positive (%)a | 3 (23.1) | 0 (0.0) | 3 (27.3) | 1 |
Discharge HR (mean (SD)) | 85.69 (15.43) | 88.11 (14.01) | 85.03 (15.93) | 0.602 |
1 month HR (mean (SD)) | 84.50 (14.55) | 85.50 (10.39) | 84.23 (15.61) | 0.83 |
3 months HR (mean (SD)) | 83.12 (13.47) | 79.62 (11.10) | 84.19 (14.13) | 0.41 |
CART side effects | ||||
CRS (%) | 38 (90.5) | 8 (88.9) | 30 (90.9) | 1 |
CRS Grade (%) | 0.043 | |||
1 | 14 (33.3) | 6 (66.7) | 8 (24.2) | |
2 | 24 (57.1) | 2 (22.2) | 22 (66.7) | |
Tocilizumab (%) | 36 (85.7) | 7 (77.8) | 29 (87.9) | 0.818 |
Neurotoxicity (%) | 24 (57.1) | 3 (33.3) | 21 (63.6) | 0.212 |
Neurotoxicity grade (%) | 0.177 | |||
1 | 6 (14.3) | 2 (22.2) | 4 (12.1) | |
2 | 11 (26.2) | 1 (11.1) | 10 (30.3) | |
3 | 7 (16.7) | 0 (0.0) | 7 (21.2) | |
Steroids (%) | 25 (59.5) | 3 (33.3) | 22 (66.7) | 0.155 |
Echo parameters | ||||
Pre-CART ejection fraction (mean (SD)) n = 37 | 54.68 (5.51) | 53.11 (4.83) | 55.18 (5.70) | 0.334 |
Pre-CART global longitudinal strain (mean (SD)) n = 18 | 17.21 (3.10) | -14.60 (2.69) | -17.73 (2.98) | 0.112 |
Post-CART ejection fraction (mean (SD)) n = 25 | 53.44 (6.51) | 54.00 (5.81) | 53.18 (6.98) | 0.775 |
Post-CART global longitudinal strain (mean (SD)) n = 14 | 16.52 (3.25) | -16.37 (0.59) | -16.56 (3.69) | 0.93 |
Labs | ||||
Positive troponin (%) | 1 (2.4) | 0 (0.0) | 1 (3.0) | 0.558 |
Negative troponin (%) | 9 (21.4) | 3 (33.3) | 6 (18.2) | |
Troponin not measured (%) | 32 (76.2) | 6 (66.7) | 26 (78.8) | |
Pre-CART creatinine (mean (SD)) | 0.97 (0.52) | 0.90 (0.32) | 0.99 (0.57) | 0.637 |
Peak creatinine (mean (SD)) | 1.24 (0.62) | 1.31 (0.58) | 1.22 (0.63) | 0.703 |
Pre-CART HsCRP (mean (SD)) | 7.02 (6.59) | 5.01 (4.57) | 7.56 (7.00) | 0.309 |
Peak HsCRP (mean (SD)) | 13.96 (8.50) | 12.53 (8.80) | 14.36 (8.51) | 0.574 |
Pre-conditioning hemoglobin (mean (SD)) | 10.10 (1.58) | 10.72 (2.56) | 9.93 (1.19) | 0.187 |
CART discharge hemoglobin (mean (SD)) | 9.60 (1.09) | 9.72 (1.16) | 9.57 (1.09) | 0.72 |