Table 2 Summary of TRAE (≥15%) after HE072 treatment

From: Intravenous liposomal irinotecan in metastatic triple-negative breast cancer after ≥ 2 prior lines of chemotherapy: a phase Ib study

 

50 mg/m2 (n = 12)

70 mg/m2 (n = 107)

Total (n = 119)

TEAE

11 (91.7)

104 (97.2)

115 (96.6)

Serious TEAEs

2 (16.7)

25 (23.4)

27 (22.7)

Serious TRAEs

2 (16.7)

20 (18.7)

22 (18.5)

TRAEs

11 (91.7)

103 (96.3)

114 (95.8)

Hematological

   

Leukopenia

7 (58.3)

64 (59.8)

71 (59.7)

Anemia

8 (66.7)

59 (55.1)

67 (56.3)

Neutropenia

6 (50.0)

57 (53.3)

63 (52.9)

Lymphocytopenia

3 (25.0)

27 (25.2)

30 (25.2)

Thrombocytopenia

2 (16.7)

18 (16.8)

20 (16.8)

Non-hematological

   

Diarrhea

3 (25.0)

72 (67.3)

75 (63.0)

Nausea

6 (50.0)

61 (57.0)

67 (56.3)

Vomiting

4 (33.3)

54 (50.5)

58 (48.7)

Fatigue

5 (41.7)

35 (32.7)

40 (33.6)

Weight loss

2 (16.7)

30 (28.0)

32 (26.9)

Decreased appetite

1 (8.3)

25 (23.4)

26 (21.8)

Abdominal pain

0

22 (20.6)

22 (18.5)

Abnormality in laboratory examination

   

Hypokalemia

3 (25.0)

37 (34.6)

40 (33.6)

γ-GGT elevation

6 (50.0)

26 (24.3)

32 (26.9)

Increased ALT

5 (41.7)

22 (20.6)

27 (22.7)

Hyponatremia

3 (25.0)

23 (21.5)

26 (21.8)

Increased AST

5 (41.7)

19 (17.8)

24 (20.2)

Hypoproteinemia

2 (16.7)

20 (18.7)

22 (18.5)

Hyperuricemia

1 (8.3)

20 (18.7)

21 (17.6)

Hypocalcemia

3 (25.0)

17 (15.9)

20 (16.8)

Albuminuria

1 (8.3)

19 (17.8)

20 (16.8)

Increased ALP

2 (16.7)

16 (15.0)

18 (15.1)

  1. ALP alkaline phosphatase, ALT alanine aminotransferase, AST aspartate aminotransferase, GGT glutamyl transpeptidase, TEAE treatment emergent adverse event, TRAE treatment related adverse event.