Table 2.
Treatment-related adverse events (> 10% of patients) and laboratory abnormalities (hematological and biochemical) at the recommended dose for phase II studies, with or without BEV
|
Group A (Paclitaxel 80 mg/m2 / lurbinectedin 4.0 mg FD or 2.2 mg/m2) (n = 37) |
Group B (Paclitaxel 80 mg/m2 / lurbinectedin 2.2 mg/m2 / BEV 15 mg/kg) (n = 12) |
||||||||
|---|---|---|---|---|---|---|---|---|---|
| NCI-CTCAE grade | 1–2 | 3 | 4 | Total | 1–2 | 3 | 4 | Total | |
| Hematological laboratory abnormalities | |||||||||
| Anemia a | 72 | 22 | 94 | 83 | 17 | 100 | |||
| Neutropenia a | 14 | 31 | 28 | 72 | 42 | 25 | 67 | ||
| Thrombocytopenia a | 31 | 17 | 47 | 25 | 17 | 42 | |||
| Biochemical laboratory abnormalities | |||||||||
| ALT increased a | 47 | 11 | 3 | 61 | 75 | 75 | |||
| AP increased a | 36 | 6 | 42 | 42 | 42 | ||||
| AST increased a | 44 | 6 | 3 | 53 | 42 | 42 | |||
| Bilirubin increased a | 11 | 3 | 14 | ||||||
| CPK increased a | 11 | 11 | 17 | 17 | |||||
| Creatinine increased a | 81 | 81 | 75 | 75 | |||||
| Adverse events | |||||||||
| Abdominal abscess | 17 | 17 | |||||||
| Alopecia | 24 | 24 | 42 | 42 | |||||
| Constipation | 8 | 8 | 25 | 25 | |||||
| Decreased appetite | 16 | 16 | 25 | 25 | |||||
| Diarrhea | 22 | 3 | 24 | 33 | 33 | ||||
| Dysgeusia | 11 | 11 | |||||||
| Dyspepsia | 11 | 11 | 17 | 17 | |||||
| Epistaxis | 17 | 17 | |||||||
| Fatigue | 57 | 3 | 59 | 50 | 8 | 58 | |||
| Febrile neutropenia | 3 | 3 | 17 | 17 | |||||
| Hypertension | 25 | 25 | |||||||
| Nausea | 51 | 3 | 54 | 50 | 50 | ||||
| Peripheral sensory neuropathy | 27 | 27 | 17 | 17 | |||||
| Pulmonary embolism | 17 | 17 | |||||||
| Rash maculo-papular | 3 | 3 | 5 | 17 | 17 | ||||
| Vomiting | 43 | 3 | 46 | 8 | 8 | ||||
The percentage of patients with each adverse event is specified
Hematological and biochemical abnormalities are shown regardless of relationship to treatment
a Missing data for one patient in Group A
ALT alanine aminotransferase, AP alkaline phosphatase, AST aspartate aminotransferase, BEV bevacizumab, CPK creatine phosphokinase, FD flat dose, NCI-CTCAE National Cancer Institute Common Terminology Criteria for Adverse Events