Table 1 Cardiovascular exclusion and safety assessment reporting among various agents
From: How do breast cancer clinical trials approach cardiovascular safety: targeted or generalized?
Cardiovascular exclusion criteria, n (%) | Safety assessment, n (%) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
Any CV exclusion | Heart failure/Low EF | Coronary artery disease | Hypertension | Arrhythmia | Pericardial disease | Valvular disease | Any CV safety assessment | Electrocardiogram | Cardiac imaging | |
Anthracycline included in regimen | ||||||||||
Yes | 14 (100.0) | 13 (92.9) | 11 (78.6) | 10 (71.4)* | 10 (71.4) | 0 (0.0) | 4 (28.6) | 8 (57.1) | 8 (57.1) | 8 (57.1) |
No | 28 (77.8) | 24 (66.7) | 20 (55.6) | 11 (30.6) | 19 (52.8) | 5 (13.9) | 4 (11.1) | 19 (52.8) | 15 (41.7) | 12 (33.3) |
Microtubule inhibitor included in regimen | ||||||||||
Yes | 29 (93.5)* | 26 (83.9) | 24 (77.4)† | 18 (58.1)† | 22 (71.0)* | 3 (9.7) | 7 (22.6) | 16 (51.6) | 13 (41.9) | 13 (41.9) |
No | 13 (68.4) | 11 (57.9) | 7 (36.8) | 3 (15.8) | 7 (36.8) | 2 (10.5) | 1 (5.3) | 11 (57.9) | 10 (52.6) | 7 (36.8) |
Alkylating agent included in regimen | ||||||||||
Yes | 20 (95.2) | 17 (81.0) | 15 (71.4) | 11 (52.4) | 14 (66.7) | 0 (0.0) | 6 (28.6) | 11 (52.4) | 10 (47.6) | 10 (47.6) |
No | 22 (75.9) | 20 (69.0) | 16 (55.2) | 10 (34.5) | 15 (51.7) | 5 (17.2) | 2 (6.9) | 16 (55.2) | 13 (44.8) | 10 (34.5) |
Kinase inhibitor included in regimen | ||||||||||
Yes | 9 (81.8) | 9 (81.8) | 6 (54.5) | 4 (36.4) | 6 (54.5) | 0 (0.0) | 2 (18.2) | 8 (72.7) | 7 (63.6) | 6 (54.5) |
No | 33 (84.6) | 28 (71.8) | 25 (64.1) | 17 (43.6) | 23 (59.0) | 5 (12.8) | 6 (15.4) | 19 (48.7) | 16 (41.0) | 14 (35.9) |
Antibody to HER-2 included in regimen | ||||||||||
Yes | 15 (100.0) | 15 (100.0)† | 10 (66.7) | 7 (46.7) | 9 (60.0) | 1 (6.7) | 5 (33.3)* | 12 (80.0)* | 10 (66.7) | 12 (80.0)‡ |
No | 27 (77.1) | 22 (62.9) | 21 (60.0) | 14 (40.0) | 20 (57.1) | 4 (11.4) | 3 (8.6) | 15 (42.9) | 13 (37.1) | 8 (22.9) |
Aromatase inhibitor included in regimen | ||||||||||
Yes | 8 (61.5) | 7 (53.8) | 4 (30.8) | 2 (15.4) | 4 (30.8) | 2 (15.4) | 0 (0.0) | 6 (46.2) | 5 (38.5) | 4 (30.8) |
No | 34 (91.9)* | 30 (81.1) | 27 (73.0)* | 19 (51.4)* | 25 (67.6)* | 3 (8.1) | 8 (21.6) | 21 (56.8) | 18 (48.6) | 16 (43.2) |
Estrogen receptor binder included in regimen | ||||||||||
Yes | 6 (85.7) | 5 (71.4) | 3 (42.9) | 2 (28.6) | 3 (42.9) | 3 (42.9)* | 0 (0.0) | 5 (71.4) | 3 (42.9) | 3 (42.9) |
No | 36 (83.7) | 32 (74.4) | 28 (65.1) | 19 (44.2) | 26 (60.5) | 2 (4.7) | 8 (18.6) | 22 (51.2) | 20 (46.5) | 17 (39.5) |
Antimetabolite included in regimen | ||||||||||
Yes | 10 (83.3) | 10 (83.3) | 7 (58.3) | 5 (41.7) | 6 (50.0) | 0 (0.0) | 2 (16.7) | 7 (58.3) | 7 (58.3) | 5 (41.7) |
No | 32 (84.2) | 27 (71.1) | 24 (63.2) | 16 (42.1) | 23 (60.5) | 5 (13.2) | 6 (15.8) | 20 (52.6) | 16 (42.1) | 15 (39.5) |
Platinum included in regimen | ||||||||||
Yes | 6 (85.7) | 5 (71.4) | 4 (57.1) | 4 (57.1) | 4 (57.1) | 0 (0.0) | 2 (28.6) | 4 (57.1) | 3 (42.9) | 4 (57.1) |
No | 36 (83.7) | 32 (74.4) | 27 (62.8) | 17 (39.5) | 25 (58.1) | 5 (11.6) | 6 (14.0) | 23 (53.5) | 20 (46.5) | 16 (37.2) |