Table 5 Nonhaematologic toxicities

From: A phase I/II trial of irinotecan–cisplatin combined with an anti-late-diarrhoeal programme to evaluate the safety and antitumour response of this combination therapy in patients with advanced non-small-cell lung cancer

 

Phase I

 

Dose level

60N

60P

65P

70P

75P

80P

Phase II

Number of patients (cycles)

7 (13)

5 (8)

5 (14)

4 (9)

6 (15)

2 (2)

48 (140)

Fatigue

 Grade 2

0

1 (1)

1 (1)

0

0

0

12 (16)

 Grade 3

0

0

0

0

0

2 (2)

2 (2)

 Grade 4

0

0

0

0

0

0

0

Nausea

 Grade 2

5 (8)

3 (3)

3 (6)

3 (5)

5 (10)

0

24 (40)

 Grade 3

0

1 (1)

0

1 (1)

0

2 (2)

7 (10)

 Grade 4

0

0

0

0

0

0

0

Infection

 Grade 2

1 (1)

0

1 (2)

2 (2)

1 (1)

0

9 (14)

 Grade 3

1 (1)

0

0

0

0

0

1 (1)

 Grade 4

0

0

0

0

0

0

0

 +NPGa 3

1 (1)

0

0

0

1 (1)

2 (2)

11 (13)

Early diarrhoea

 Grade 2

1 (1)

1 (2)

1 (1)

1 (1)

3 (4)

0

17 (23)

 Grade 3

0

0

0

0

0

1 (1)

1 (1)

 Grade 4

0

0

0

0

0

0

0

Late diarrhoea

 Grade 2

2 (2)

2 (2)

2 (3)

1 (1)

2 (3)

0

7 (9)

 Grade 3

0

0

0

0

0

0

3 (3)

 Grade 4

0

0

0

0

0

2 (2)

0

Total bilirubin

 Grade 2

1 (1)

0

1 (2)

1 (3)

1 (1)

2 (2)

7 (13)

 Grade 3

0

0

0

1 (1)

0

0

4 (4)

 Grade 4

0

0

0

0

0

0

0

Transaminases

 Grade 2

0

0

0

0

0

0

3 (5)

 Grade 3

0

0

0

0

1 (2)

0

3 (6)

 Grade 4

0

0

0

0

0

0

0

Hyponatremia

 Grade 2

2 (3)

0

0

0

2 (2)

0

11 (17)

 Grade 3

1 (1)

0

0

1 (1)

0

1 (1)

1 (1)

 Grade 4

0

0

0

0

0

0

0

  1. aNeutropenia grade.