From: CD-19 CART therapy and orthostatic hypotension: a single center retrospective cohort study
Asymptomatic | Symptomatic | p-value | |
---|---|---|---|
n | 12 | 21 | |
Symptoms | |||
Lightheadedness only (%) | 3 (14.3) | ||
Fatigue only (%) | 5 (23.8) | ||
Lightheadedness and Fatigue (%) | 13 (61.9) | ||
Patient Characteristics | |||
Age (mean (SD)) | 63.00 (14.47) | 69.38 (8.03) | 0.112 |
Sex (%) | 0.866 | ||
Male | 8 (66.7) | 12 (57.1) | |
Female | 4 (33.3) | 9 (42.9) | |
Race (%) | 1 | ||
White | 12 (100.0) | 20 (95.2) | |
Black | 0 (0.0) | 1 (4.8) | |
BMI (mean (SD)) | 26.80 (5.40) | 28.53 (5.18) | 0.371 |
Past Medical History | |||
Hypertension (%) | 2 (16.7) | 15 (71.4) | 0.008 |
Hyperlipidemia (%) | 5 (41.7) | 13 (61.9) | 0.447 |
Type 2 Diabetes Mellitus (%) | 1 (8.3) | 2 (9.5) | 1 |
Coronary artery disease (%) | 0 (0.0) | 1 (4.8) | 1 |
Chronic kidney disease (%) | 3 (25.0) | 5 (23.8) | 1 |
Myocardial infarction (%) | 0 (0.0) | 1 (4.8) | 1 |
Atrial Fibrillation (%) | 0 (0.0) | 2 (9.5) | 0.73 |
Tobacco Use (%) | 8 (66.7) | 12 (57.1) | 0.866 |
Orthostatic hypotension (%) | 3 (25.0) | 4 (19.0) | 1 |
Neuropathy (%) | 7 (58.3) | 14 (66.7) | 0.716 |
Oncologic Treatment | |||
CAR-T Product (%) | |||
YESCARTA | 12 (100.0) | 21 (100.0) | |
KYMRIAH | 0 (0.0) | 0 (0.0) | |
Chest/axillary radiation (%) | 4 (33.3) | 5 (23.8) | 0.853 |
Neck radiation (%) | 1 (8.3) | 4 (19.0) | 0.63 |
Stem cell transplant (%) | 2 (16.7) | 5 (23.8) | 0.968 |
R-CHOP (%) | 9 (75.0) | 15 (71.4) | 1 |
R-ICE (%) | 5 (41.7) | 10 (47.6) | 1 |
GEM-OX (%) | 5 (41.7) | 6 (28.6) | 0.701 |
R-EPOCH (%) | 2 (16.7) | 3 (14.3) | 1 |
Pre-CART vital signs | |||
Ambulatory mean SBP (mean (SD)) | 114.83 (14.80) | 120.54 (12.42) | 0.245 |
Ambulatory mean DBP (mean (SD)) | 71.78 (9.80) | 71.67 (6.45) | 0.969 |
Ambulatory mean HR (mean (SD)) | 82.19 (14.91) | 83.68 (12.95) | 0.766 |
Pre-CART orthostatic vital signs assessed (%) | 4 (33.3) | 7 (33.3) | 1 |
Pre-CART orthostatic vital signs positive (%)a | 3 (75.0) | 3 (42.9) | 0.689 |
CART Hospitalization | |||
C ART hospitalization time (mean (SD)) | 21.83 (12.07) | 15.10 (5.48) | 0.035 |
Time from CART infusion to discharge (mean (SD)) | 15.67 (9.01) | 13.29 (5.17) | 0.34 |
Orthostatic vitals assessed (%) | 10 (83.3) | 18 (85.7) | 1 |
Orthostatic vital signs positive (%)a | 10 (100.0) | 16 (88.9) | 0.743 |
Post-CART vital signs | |||
Discharge orthostatic vital signs assessed (%) | 9 (75.0) | 16 (76.2) | 1 |
Discharge orthostatic vital signs positive (%)a | 5 (55.6) | 10 (62.5) | 1 |
1 month orthostatic vital signs assessed (%) | 11 (91.7) | 17 (81.0) | 0.748 |
1 month orthostatic vital signs positive (%)a | 3 (27.3) | 10 (58.8) | 0.212 |
3 months orthostatic vital signs assessed (%) | 5 (41.7) | 6 (28.6) | 0.701 |
3 months orthostatic vital signs positive (%)a | 2 (40.0) | 1 (16.7) | 0.853 |
Discharge HR (mean (SD)) | 79.25 (12.71) | 88.33 (16.91) | 0.117 |
1 month HR (mean (SD)) | 83.45 (16.46) | 84.68 (15.53) | 0.839 |
3 months HR (mean (SD)) | 83.36 (12.96) | 84.80 (15.36) | 0.804 |
Difference between supine/sitting and standing SBP (median [IQR]) | 23.50 [17.50, 32.75] | 25.00 [19.00, 31.50] | 0.792 |
Difference between supine/sitting and standing DBP (median [IQR]) | 10.00 [2.50, 17.25] | 10.00 [4.50, 14.00] | 0.745 |
Medications | |||
Pre-CART midodrine (%) | 0 (0.0) | 0 (0.0) | 1 |
CART discharge midodrine (%) | 1 (8.3) | 1 (4.8) | 1 |
1 month post CART-midodrine (%) | 2 (16.7) | 4 (19.0) | 1 |
3 months post-CART midodrine (%) | 1 (8.3) | 3 (14.3) | 1 |
Pre-CART fludrocortisone (%) | 1 (8.3) | 0 (0.0) | 0.364 |
CART discharge fludrocortisone (%) | 2 (16.7) | 0 (0.0) | 0.125 |
1 month post-CART fludrocortisone (%) | 3 (25.0) | 2 (9.5) | 0.328 |
3 months post-CART fludrocortisone (%) | 3 (25.0) | 4 (19.0) | 0.686 |
CART side effects | |||
CRS (%) | 12 (100.0) | 18 (85.7) | 0.457 |
CRS Grade (%) | 0.229 | ||
1 | 2 (16.7) | 6 (28.6) | |
2 | 10 (83.3) | 12 (57.1) | |
Tocilizumab (%) | 12 (100.0) | 17 (81.0) | 0.29 |
Neurotoxicity (%) | 9 (75.0) | 12 (57.1) | 0.516 |
Neurotoxicity grade (%) | 0.322 | ||
1 | 1 (8.3) | 3 (14.3) | |
2 | 6 (50.0) | 4 (19.0) | |
3 | 2 (16.7) | 5 (23.8) | |
Steroids (%) | 10 (83.3) | 12 (57.1) | 0.25 |
Echo parameters | |||
Pre-CART ejection fraction (mean (SD)) n = 28 | 52.27 (4.67) | 57.06 (5.62) | 0.027 |
Post-CART ejection fraction (mean (SD)) n = 15 | 49.29 (8.38) | 55.90 (4.43) | 0.051 |
Labs | |||
Positive troponin (%) | 1 (8.3) | 0 (0.0) | 0.077 |
Negative troponin (%) | 4 (33.3) | 2 (9.5) | |
No troponin measured (%) | 7 (58.3) | 19 (90.5) | |
Pre-CART creatinine (mean (SD)) | 0.97 (0.57) | 1.01 (0.58) | 0.838 |
Peak creatinine (mean (SD)) | 1.30 (0.83) | 1.18 (0.50) | 0.596 |
Pre-CART HsCRP (mean (SD)) | 9.08 (8.16) | 6.70 (6.28) | 0.355 |
Peak HsCRP (mean (SD)) | 15.96 (9.51) | 13.44 (7.99) | 0.422 |
Pre-conditioning hemoglobin (mean (SD)) | 9.85 (1.12) | 9.98 (1.25) | 0.766 |
CART discharge hemoglobin (mean (SD)) | 9.78 (1.36) | 9.46 (0.91) | 0.428 |