Table 3 Profile of major toxicities during the DLT period (cycle 1)
From: A phase I dose-escalation study of eribulin and S-1 for metastatic breast cancer
Level 1 ( n =3) | Level 2 ( n =3) | Level 3 ( n =6) | Total ( n =12) (%) | |||||
|---|---|---|---|---|---|---|---|---|
Grade 1/2 | Grade⩾3 | Grade 1/2 | Grade⩾3 | Grade ½ | Grade⩾3 | Grade 1/2 | Grade⩾3 | |
Neutropenia | 1 | 2 | 0 | 3 | 1 | 5 | 2 (16.6) | 10 (83.3) |
Febrile neutropenia | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 3 (25) |
Oedema | 1 | 0 | 0 | 0 | 0 | 0 | 1 (8.3) | 0 |
Conjunctivitis | 0 | 0 | 1 | 0 | 0 | 0 | 1 (8.3) | 0 |
Blurred vision | 0 | 0 | 1 | 0 | 0 | 0 | 1 (8.3) | 0 |
Hypotension | 1 | 0 | 0 | 0 | 0 | 0 | 1 (8.3) | 0 |
Dysgeusia | 0 | 0 | 1 | 0 | 0 | 0 | 1 (8.3) | 0 |
Fatigue | 0 | 0 | 2 | 0 | 2 | 0 | 4 (33.3) | 0 |
Diarrhoea | 0 | 0 | 0 | 0 | 2 | 0 | 2 (16.6) | 0 |
Constipation | 1 | 0 | 0 | 0 | 0 | 0 | 1 (8.3) | 0 |
Peripheral neuropathy | 0 | 0 | 0 | 0 | 2 | 0 | 2 (16.6) | 0 |
Vomiting | 0 | 0 | 0 | 0 | 1 | 0 | 1 (8.3) | 0 |
Nausea | 0 | 0 | 0 | 0 | 1 | 0 | 1 (8.3) | 0 |
Mucositis oral | 0 | 0 | 0 | 0 | 2 | 0 | 2 (16.6) | 0 |
Fever | 0 | 0 | 0 | 0 | 2 | 0 | 2 (16.6) | 0 |
Anorexia | 0 | 0 | 0 | 0 | 1 | 0 | 1 (8.3) | 0 |
Rash acneiform | 0 | 0 | 0 | 0 | 1 | 0 | 1 (8.3) | 0 |
Hypokalaemia | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 (8.3) |
AST | 0 | 0 | 0 | 0 | 1 | 0 | 1 (8.3) | 0 |
ALT | 0 | 0 | 0 | 0 | 1 | 0 | 1 (8.3) | 0 |
Bilirubin increased | 0 | 0 | 1 | 0 | 0 | 0 | 1 (8.3) | 0 |
