Table 1.
Patients treated with ICIs | Patients not treated with ICIs | P value | |
Demographics | |||
Number of patients | 2842 | 2699 | |
Male | 1632/2842 (57.4%) | 1429/2699 (52.9%) | 0.001 |
Age (years) | 64.4±13.1 | 64.0±13.2 | 0.33 |
Race or ethnic group | <0.001 | ||
White | 2475/2700 (91.7%) | 2443/2608 (93.7%) | |
Hispanic | 29/2700 (1.1%) | 39/2608 (1.5%) | |
Asian | 96/2700 (3.6%) | 43/2608 (1.7%) | |
Black or African American | 57/2700 (2.1%) | 64/2608 (2.5%) | |
Other | 43/2700 (1.6%) | 19/2608 (0.7%) | |
Clinical variables | |||
Body mass index (kg/m2) | 27.0±6.4 | 27.6±5.7 | 0.004 |
Systolic blood pressure (mm Hg) | 127.6±18.6 | 127.4±16.9 | 0.72 |
Diastolic blood pressure (mm Hg) | 75.7±9.7 | 74.7±10.3 | <0.001 |
Baseline comorbidities | |||
Hypertension | 1354/2752 (49.2%) | 1469/2695 (54.5%) | <0.001 |
Diabetes mellitus | 432/2752 (16.4%) | 502/2695 (18.6%) | 0.005 |
Smoking current or prior | 429/2753 (15.6%) | 398/2695 (14.8%) | 0.41 |
History of any cardiovascular event | 320/2842 (11.3%) | 352/2699 (13.0%) | 0.04 |
History of myocardial infarction | 134/1842 (4.7%) | 165/2699 (6.1%) | 0.02 |
History of coronary revascularization | 121/2842 (4.3%) | 135/2699 (5.0%) | 0.20 |
History of ischemic stroke | 83/2842 (2.9%) | 100/2699 (3.7%) | 0.11 |
History of pericarditis or pericardial effusion | 36/2842 (1.3%) | 13/2699 (0.5%) | 0.02 |
Chronic kidney disease | 325/2752 (11.8%) | 322/2695 (11.9%) | 0.90 |
Cardiovascular medications | |||
ACE inhibitor or angiotensin II receptor blocker | 612/2700 (22.7%) | 632/2340 (27.0%) | <0.001 |
Beta blockers | 627/2700 (23.2%) | 775/2340 (33.1%) | <0.001 |
Calcium channel blockers | 395/2700 (14.6%) | 355/2340 (15.2%) | 0.61 |
Diuretics | 670/2700 (24.8%) | 699/2340 (29.9%) | <0.001 |
Aspirin | 578/2700 (21.4%) | 589/2340 (25.2%) | 0.002 |
Other anti-platelet therapies | 66/2700 (2.4%) | 97/2340 (4.2%) | <0.001 |
Pre-ICI corticosteroid | 417/2338 (17.8%) | 67/1331 (5.0%) | <0.001 |
Cancer types | |||
Lung | 817/2842 (28.8%) | 815/2699 (30.2%) | 0.33 |
Melanoma | 798/2842 (28.1%) | 654/2699 (24.2%) | |
Head and neck | 343/2842 (12.1%) | 342/2699 (12.7%) | |
Renal and genitourinary | 182/2842 (6.4%) | 182/2699 (6.7%) | |
Breast | 118/2842 (4.2%) | 119/2699 (4.4%) | |
Gastrointestinal | 116/2842 (4.1%) | 116/2699 (4.3%) | |
Gynecologic | 110/2842 (3.9%) | 110/2699 (4.1%) | |
Hepatobiliary | 101/2842 (3.6%) | 101/2699 (3.7%) | |
Lymphoma | 82/2842 (2.9%) | 81/2699 (3.0%) | |
Other | 99/2842 (3.5%) | 99/2699 (3.7%) | |
Prior cancer treatment | |||
Radiation therapy | 570/2752 (20.7%) | 285/2695 (10.6%) | <0.001 |
5-fluorouracil | 282/2719 (10.4%) | 148/2615 (5.7%) | <0.001 |
Anthracyclines | 151/2719 (5.6%) | 153/2615 (5.9%) | 0.70 |
Tyrosine kinase inhibitors | 61/2719 (2.2%) | 59/2615 (2.3%) | 1.00 |
Platinum-based chemotherapy | 1019/2719 (37.5%) | 568/2615 (21.7%) | <0.001 |
ICI type | |||
Monotherapy | |||
PD-L1 | 2139/2842 (75.3%) | ||
CTLA-4 | 223/2842 (7.8%) | ||
PD-1 | 282/2842 (9.9%) | ||
CTLA-4 or PD-1 | 3/2842 (0.1%) | ||
Combination therapy | |||
CTLA-4 and PD-1 | 195/2842 (6.9%) | ||
Number of cycles of ICI, no (IQR) | 5 (2–11) | ||
Immune-mediated adverse events after ICI start | |||
Gastrointestinal | 500/2745 (18.2%) | ||
Skin | 429/2745 (15.6%) | ||
Pulmonary | 189/2745 (6.9%) | ||
Hepatic | 179/2745 (6.5%) | ||
Endocrine | 175/2745 (6.4%) | ||
Renal | 120/2745 (4.4%) | ||
Neuromuscular | 98/2745 (3.6%) | ||
Pancreas | 61/2745 (2.2%) | ||
Any of the above adverse events | 1179/2745 (43.0%) | ||
Immune-mediated adverse events treated with corticosteroid | |||
Among the entire cohort | 734/2745 (17.8%) | ||
Among those with immune-mediated adverse events | 734/1179 (62.3%) |
ACE, angiotensin-converting enzyme; CTLA-4, cytotoxic-T lymphocyte-associated protein 4; PD-1, programmed death protein 1; PD-L1, programmed death-ligand 1.