Table 3 Drug-related adverse events occurring in ⩾10% of patients across all dose levels
50 mg m − 2 paclitaxel+400 mg pazopanib+1000 mg lapatinib ( n =7) | 50 mg m − 2 paclitaxel+800 mg pazopanib+1000 mg lapatinib ( n =3) | 80 mg m − 2 paclitaxel+800 mg pazopanib+1000 mg lapatinib ( n =3) | 80 mg m − 2 paclitaxel+400 mg pazopanib+1000 mg lapatinib ( n =13) | All dose levels ( N =26) | |||||
---|---|---|---|---|---|---|---|---|---|
Maximum CTCAE grade, n (%) | |||||||||
1 or 2 | 3 or 4 | 1 or 2 | 3 or 4 | 1 or 2 | 3 or 4 | 1 or 2 | 3 or 4 | Any grade, n (%) | |
Haematologic | |||||||||
Neutropenia | 2 (29) | 1 (14) | 0 | 1 (33) | 0 | 2 (67) | 1 (8) | 6 (46) | 13 (50) |
Anaemia | 0 | 1 (14) | 1 (33) | 0 | 0 | 1 (33) | 4 (31) | 0a | 7 (27) |
Thrombocytopenia | 1 (14) | 0 | 1 (33) | 0 | 0 | 1 (33) | 2 (15) | 0 | 5 (19) |
Lymphopenia | 0 | 1 (14) | 0 | 1 (33) | 0 | 0 | 0 | 2 (15) | 4 (15) |
Leucopenia | 1 (14) | 0 | 0 | 0 | 0 | 0 | 1 (8) | 1 (8) | 3 (12) |
Nonhematologic | |||||||||
Diarrhoea | 4 (57) | 0 | 0 | 1 (33) | 0 | 0 | 7 (54) | 2 (15) | 14 (54) |
Fatigue | 2 (29) | 0 | 2 (67) | 0 | 2 (67) | 1 (33) | 6 (46) | 0 | 13 (50) |
Nausea | 2 (29) | 0 | 2 (67) | 0 | 2 (67) | 0 | 4 (31) | 0 | 10 (38) |
Decreased appetite | 1 (14) | 0 | 2 (67) | 0 | 2 (67) | 0 | 3 (23) | 1 (8) | 9 (35) |
Alopecia | 3 (43) | 0 | 1 (33) | 0 | 0 | 0 | 3 (23) | 0 | 7 (27) |
Dysgeusia | 1 (14) | 0 | 1 (33) | 0 | 1 (33) | 0 | 3 (23) | 0 | 6 (23) |
Hypertension | 0 | 0 | 1 (33) | 0 | 3 (100) | 0 | 1 (8) | 1 (8) | 6 (23) |
Mucosal inflammation | 1 (14) | 0 | 1 (33) | 0 | 1 (33) | 0 | 3 (23) | 0 | 6 (23) |
Vomiting | 2 (29) | 0 | 2 (67) | 0 | 0 | 0 | 2 (15) | 0 | 6 (23) |
ALT increased | 0 | 1 (14) | 1 (33) | 1 (33) | 0 | 0 | 1 (8) | 1 (8) | 5 (19) |
AST increased | 0 | 1 (14) | 1 (33) | 1 (33) | 0 | 0 | 1 (8) | 1 (8) | 5 (19) |
Peripheral neuropathy | 0 | 1 (14) | 1 (33) | 0 | 2 (67) | 0 | 1 (8) | 0 | 5 (19) |
Rash | 0 | 0 | 1 (33) | 0 | 2 (67) | 0 | 2 (15) | 0 | 5 (19) |
Confusional state | 1 (14) | 0 | 0 | 0 | 0 | 0 | 1 (8) | 1 (8) | 3 (12) |
Dizziness | 1 (14) | 0 | 1 (33) | 0 | 1 (33) | 0 | 0 | 0 | 3 (12) |
Dyspepsia | 1 (14) | 0 | 0 | 0 | 1 (33) | 0 | 1 (8) | 0 | 3 (12) |
Epistaxis | 2 (29) | 0 | 1 (33) | 0 | 0 | 0 | 0 | 0 | 3 (12) |
Hypoalbuminemia | 0 | 0 | 1 (33) | 0 | 0 | 0 | 2 (15) | 0 | 3 (12) |