Table III.
Adverse events associated with eribulin in patients with soft tissue sarcoma.
| Comparison by histological subtypes | Comparison by treatment line | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| All patients (n=41) | L-sarcoma (n=26) | Non-L-sarcoma (n=15) | Second line (n=14) | Later lines (n=27) | ||||||||
| Variable | All grades, n (%) | Grade 3-4, n (%) | All grades, n (%) | Grade 3-4, n (%) | All grades, n (%) | Grade 3-4, n (%) | P-value (Two-tailed χ2)a | All grades, n (%) | Grade 3-4, n (%) | All grades, n (%) | Grade 3-4, n (%) | P-value (Two-tailed χ2)b |
| Hematologic adverse events | ||||||||||||
| Leukocytopenia | 29 (70.7) | 13 (31.7) | 21 (80.8) | 10 (38.5) | 8 (53.3) | 3 (20.0) | 0.083 | 11 (78.6) | 4 (28.6) | 18 (66.7) | 9 (33.3) | 0.494 |
| Neutropenia | 31 (75.6) | 24 (58.5) | 22 (84.6) | 18 (69.2) | 9 (60.0) | 6 (40.0) | 0.130 | 13 (92.9) | 10 (71.4) | 18 (66.7) | 14 (51.9) | 0.123 |
| Anemia | 25 (61.0) | 3 (7.3) | 16 (61.5) | 3 (11.5) | 9 (60.0) | 0 (0.0) | >0.999 | 6 (42.9) | 1 (7.1) | 19 (70.4) | 2 (7.4) | 0.105 |
| Thrombopcytopenia | 13 (31.7) | 1 (2.4) | 11 (42.3) | 1 (3.8) | 2 (13.3) | 0 (0.0) | 0.084 | 6 (42.9) | 1 (7.1) | 7 (25.9) | 0 (0.0) | 0.307 |
| Non-hematologic adverse events | ||||||||||||
| Increased total bilirubin | 3 (7.3) | 0 (0.0) | 3 (11.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0.287 | 1 (7.1) | 0 (0.0) | 1 (3.7) | 0 (0.0) | 0.265 |
| Increased AST | 25 (61.0) | 0 (0.0) | 13 (50.0) | 0 (0.0) | 9 (60.0) | 0 (0.0) | >0.999 | 7 (50.0) | 0 (0.0) | 18 (66.7) | 0 (0.0) | 0.332 |
| Increased ALT | 19 (46.3) | 0 (0.0) | 11 (42.3) | 0 (0.0) | 8 (53.3) | 0 (0.0) | 0.533 | 7 (50.0) | 0 (0.0) | 12 (44.4) | 0 (0.0) | 0.754 |
| Increased serum creatinine | 10 (24.3) | 0 (0.0) | 8 (30.8) | 0 (0.0) | 2 (13.3) | 0 (0.0) | 0.277 | 3 (21.4) | 0 (0.0) | 7 (25.9) | 0 (0.0) | >0.999 |
| Elevated QTc | 2 (4.8) | 0 (0.0) | 2 (7.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0.524 | 1 (7.1) | 0 (0.0) | 1 (3.7) | 0 (0.0) | >0.999 |
| Fatigue | 22 (53.7) | 0 (0.0) | 14 (53.8) | 0 (0.0) | 8 (53.3) | 0 (0.0) | >0.999 | 8 (57.1) | 0 (0.0) | 14 (51.9) | 0 (0.0) | >0.999 |
| Nausea | 13 (31.7) | 0 (0.0) | 8 (30.8) | 0 (0.0) | 5 (33.3) | 0 (0.0) | >0.999 | 2 (14.3) | 0 (0.0) | 11 (40.7) | 0 (0.0) | 0.156 |
| Anorexia | 15 (36.6) | 0 (0.0) | 11 (42.3) | 0 (0.0) | 4 (26.7) | 0 (0.0) | 0.502 | 5 (35.7) | 0 (0.0) | 10 (37.0) | 0 (0.0) | >0.999 |
| Diarrhea | 4 (9.8) | 0 (0.0) | 4 (15.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0.278 | 1 (7.1) | 0 (0.0) | 3 (11.1) | 0 (0.0) | >0.999 |
| Constipation | 8 (19.5) | 0 (0.0) | 8 (30.8) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0.018 | 3 (21.4) | 0 (0.0) | 5 (18.5) | 0 (0.0) | >0.999 |
| Neuropathy | 14 (34.1) | 0 (0.0) | 13 (50.0) | 0 (0.0) | 1 (6.7) | 0 (0.0) | 0.006 | 7 (50.0) | 0 (0.0) | 7 (25.9) | 0 (0.0) | 0.170 |
| Infection | 5 (12.2) | 4 (9.8) | 4 (15.4) | 4 (15.4) | 1 (6.7) | 0 (0.0) | 0.434 | 1 (7.1) | 1 (7.1) | 4 (14.8) | 3 (11.1) | 0.227 |
| Non-infectious fever | 8 (19.5) | 0 (0.0) | 4 (15.4) | 0 (0.0) | 4 (26.7) | 0 (0.0) | 0.636 | 1 (7.1) | 0 (0.0) | 7 (25.9) | 0 (0.0) | 0.645 |
aAll patients were compared with patients with L-sarcoma at all grades.
bSecond line patients were compared with those receiving later line therapy at all grades.