Table 3.
Summary of the Toxicities Associated With Vandetanib After the First 6 Weeks of Therapy
| Toxicity | Dosage Level |
||||||||
|---|---|---|---|---|---|---|---|---|---|
| 1: 50 mg/m2(n = 3)Grades 1 and 2 | 2: 65 mg/m2 (n = 3) |
3: 85 mg/m2(n = 2)*Grades 1 and 2 | 4: 110 mg/m2(n = 14)* |
5: 145 mg/m2(n = 8)* |
|||||
| Grades 1 and 2 | Grade 3 | Grades 1 and 2 | Grade 3 | Grades 1 and 2 | Grade 3 | Grade 4 | |||
| Lymphopenia | 2 | 2 | 1 | 2 | 9 | 1 | 3 | 0 | 1 |
| Neutropenia | 0 | 0 | 0 | 0 | 3 | 0 | 1 | 0 | 0 |
| Proteinuria | 2 | 2 | 0 | 2 | 10 | 0 | 6 | 0 | 0 |
| Hypertension† | 0 | 0 | 0 | 1 | 6 | 0 | 2 | 1 | 0 |
| Hypokalemia | 1 | 1 | 0 | 0 | 0 | 0 | 3 | 1 | 0 |
| Hypophosphatemia | 0 | 1 | 0 | 0 | 1 | 0 | 2 | 0 | 0 |
| Prolonged QTc interval | 1 | 1 | 0 | 1 | 6 | 0 | 4 | 0 | 0 |
| Increase in aminotransferases | 0 | 1 | 0 | 1 | 6 | 0 | 3 | 0 | 0 |
| Fatigue | 0 | 1 | 0 | 0 | 6 | 0 | 2 | 0 | 0 |
| Skin rash | 2 | 2 | 0 | 1 | 5 | 0 | 2 | 0 | 0 |
| Photosensitivity | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Vomiting | 2 | 2 | 0 | 1 | 6 | 0 | 3 | 0 | 0 |
| Diarrhea | 0 | 2 | 0 | 0 | 5 | 0 | 2 | 1 | 0 |
| Mucositis | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Anorexia | 0 | 1 | 0 | 0 | 6 | 0 | 3 | 0 | 0 |
*
Five patients (one at dosage level 3, and two each at dosage levels 4 and 5) did not receive vandetanib after the dose-limiting toxicity evaluation period because of toxicity (n = 3), leptomeningeal disease progression (n = 1), and withdrawal of consent (n = 1).
†
Grade 1 hypertension was excluded.