Table 3 Drug related adverse effects seen in phase 1 trials of liposomal irinotecan.
From: Cancer nanomedicine: a review of recent success in drug delivery
| Â | 60Â mg/m2 NÂ =Â 1 | 120Â mg/m2 NÂ =Â 6 | 180Â mg/m2 NÂ =Â 4 | |||
|---|---|---|---|---|---|---|
All grade | G 3/4 | All grade | G 3/4 | All grade | G 3/4 | |
N (%) | N (%) | N (%) | N (%) | N (%) | N (%) | |
A | ||||||
 Diarrhoea | 1 (100) | 0 (0) | 6 (100) | 2 (33.3) | 4 (100) | 1 (25) |
 Vomiting | 1 (100) | 0 (0) | 5 (83.3) | 4 (66.7) | 2 (50) | 2 (50) |
 Nausea | 1 (100) | 0 (0) | 4 (66.7) | 2 (33.3) | 2 (50) | 1 (25) |
 Alopecia | 0 (0) | NA | 3 (50) | NA | 3 (75) | NA |
 Fatigue | 1 (100) | 0 (0) | 3 (50) | 1 (16.7) | 1 (25) | 0 (0) |
 Leukopenia | 0 (0) | 0 (0) | 2 (33.3) | 1 (16.7) | 2 (50) | 2 (50) |
 Neutropenia | 0 (0) | 0 (0) | 2 (33.3) | 1 (16.7) | 2 (50) | 2 (50) |
 Weight decreased | 1 (100) | 0 (0) | 2 (33.3) | 0 (0) | 1 (25) | 0 (0) |
 Dizziness | 0 (0) | 0 (0) | 2 (33.3) | 0 (0) | 0 (0) | 0 (0) |
 Anaemia | 0 (0) | 0 (0) | 1 (16.7) | 0 (0) | 1 (25) | 0 (0) |
 Anorexia | 0 (0) | 0 (0) | 1 (16.7) | 0 (0) | 1 (25) | 0 (0) |
 Electrolyte imbalance | 0 (0) | 0 (0) | 1 (16.7) | 0 (0) | 1 (25) | 0 (0) |
AE | Total (NÂ =Â 16) | 60Â mg/m2 NÂ =Â 3 | 80Â mg/m2 NÂ =Â 6 | 100Â mg/m2 NÂ =Â 5 | 120Â mg/m2 NÂ =Â 2 |
|---|---|---|---|---|---|
All grade | Grade 3–4 | ||||
B | |||||
 Anemia | 7 (43.8%) | 0 | 0 | 2 (40%) | 0 |
 Leukopenia | 6 (37.5%) | 0 | 0 | 2 (40%) | 1 (50%) |
 Neutropenia | 6 (37.5%) | 1 (33.3%) | 1 (16.7%) | 2 (40%) | 1 (50%) |
 Abdominal path | 7 (43.8%) | 0 | 0 | 1 (20%) | 1 (50%) |
 Diarrhea | 12 (75.0%) | 0 | 1 (16.7%) | 2 (40%) | 2 (100%) |
 Nausea | 13 (81.3%) | 0 | 1 (16.7%) | 0 | 0 |
 Vomiting | 12 (75.0%) | 0 | 1 (16.7%) | 0 | 0 |
 Fatigue | 8 (50.0%) | 0 | 0 | 1 (20%) | 0 |
 Infection | 6 (37.5%) | 0 | 0 | 2 (40%) | 1 (50%) |
 Anorexia | 4 (25.0%) | 0 | 0 | 1 (20%) | 0 |
 Hypoalbuminemia | 4 (25.0%) | 0 | 1 (16.7%) | 0 | 0 |
 Hypokalemia | 8 (50.0%) | 1 (33.3%) | 2 (33.3%) | 2 (40%) | 1 (50%) |
 Hyponatremia | 4 (25.0%) | 0 | 0 | 1 (20%) | 1 (50%) |
 Cough | 5 (31.3%) | 1 (33.3%) | 0 | 0 | 0 |