Table 4. Toxicities in the phase II (n=34).
|
Grade
|
Grade 3/4 | ||||
|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | (Total) | |
| Leucopenia | 5 | 3 | 3 | 1 | 11.4% (35.2%) |
| Neutropenia | 3 | 1 | 7 | 3 | 28.5% (41.1%) |
| Anaemia | 5 | 3 | 0 | 0 | 0% (23.5%) |
| Thrombocytopenia | 2 | 2 | 0 | 1 | 2.9% (14.7%) |
| Febrile neutropenia | 0 | 0 | 1 | 0 | 2.9% (2.9%) |
| Nausea | 9 | 0 | 0 | 0 | 0% (26.4%) |
| Vomiting | 1 | 0 | 0 | 0 | 0% (2.9%) |
| Anorexia | 13 | 1 | 0 | 0 | 0% (41.1%) |
| Diarrhoea | 2 | 0 | 0 | 0 | 0% (5.8%) |
| Constipation | 7 | 0 | 0 | 0 | 0% (20.5%) |
| Malaise (fatigue) | 9 | 1 | 0 | 0 | 0% (29.4%) |
| GI haemorrhage | 0 | 1 | 0 | 0 | 0% (2.9%) |
| Stomatitis | 1 | 0 | 0 | 0 | 0% (2.9%) |
| Hiccups | 1 | 2 | 0 | 0 | 0% (8.8%) |
| Epistaxis | 2 | 0 | 0 | 0 | 0% (5.8%) |
| Tracheitis | 1 | 0 | 0 | 0 | 0% (2.9%) |
| Pneumonitis | 1 | 4 | 0 | 0 | 0% (14.7%) |
| Skin hyperpigmentation | 5 | 0 | 0 | 0 | 0% (14.7%) |
| Oral mucositis | 4 | 3 | 0 | 0 | 0% (20.5%) |
| Rush | 4 | 2 | 0 | 0 | 0% (17.6%) |
| Palmar plantar eythrodysesthesia syndrome | 1 | 0 | 0 | 0 | 0% (2.9%) |
| Paronychia | 0 | 2 | 0 | 0 | 0% (5.8%) |
| Nail loss | 0 | 1 | 0 | 0 | 0% (2.9%) |
| Nail ridging | 1 | 0 | 0 | 0 | 0% (2.9%) |
| Nail discoloration | 5 | 0 | 0 | 0 | 0% (14.7%) |
| Alopecia | 9 | 1 | 0 | 0 | 0% (29.4%) |
| Arthralgia | 1 | 0 | 0 | 0 | 0% (2.9%) |
| Dysgeusia | 7 | 1 | 0 | 0 | 0% (23.5%) |
| Neuropathy (sensory) | 6 | 1 | 0 | 0 | 0% (20.5%) |
| AST/ALT increased | 4 | 1 | 0 | 0 | 0% (14.7%) |
| CR increased | 3 | 0 | 0 | 0 | 0% (8.8%) |
| Bil increased | 2 | 0 | 0 | 0 | 0% (5.8%) |
| ALP increased | 1 | 0 | 0 | 0 | 0% (2.9%) |
| LDH increased | 1 | 0 | 0 | 0 | 0% (2.9%) |
Abbreviations: ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; Bil=bilirubin; CR=complete response; GI=gastrointestinal; LDH=lactate dehydrogenase.