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. 2022 Aug 10;40(6):1263–1273. doi: 10.1007/s10637-022-01281-z

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