Table 3.
Summary of the Toxicities Associated With Vandetanib After the First 6 Weeks of Therapy
Toxicity | Dosage Level |
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---|---|---|---|---|---|---|---|---|---|
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)* |
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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.