Table 4. Observed Toxicities by Treatment Arm (Randomized Population) and in the Crossover Treatment Population.
Observed Toxicities by Treatment Arm (Randomized Population) | Docetaxel (N=64) Grade | Docetaxel + Vandetanib (N=61) Grade | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
1 | 2 | 3 | 4 | 5 | 1 | 2 | 3 | 4 | 5 | ||
Hematologic | |||||||||||
Anemia | 29 | 16 | 1 | 0 | 0 | 17 | 9 | 2 | 0 | 0 | |
Febrile neutropenia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | |
Leukocytosis | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | |
Neutrophil count decreased | 0 | 3 | 17 | 15 | 0 | 0 | 3 | 8 | 20 | 0 | |
Platelet count decreased | 6 | 0 | 0 | 0 | 0 | 5 | 2 | 1 | 0 | 0 | |
White blood cell decreased | 4 | 10 | 17 | 3 | 0 | 2 | 4 | 17 | 3 | 0 | |
Non-Hematologic | |||||||||||
Allergic reaction | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | |
Alopecia | 12 | 31 | 0 | 0 | 0 | 5 | 27 | 0 | 0 | 0 | |
Anorexia | 5 | 10 | 1 | 0 | 0 | 10 | 5 | 2 | 0 | 0 | |
Constipation | 15 | 7 | 0 | 0 | 0 | 10 | 4 | 1 | 0 | 0 | |
ECG QT corrected interval prolonged | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | |
Edema | 9 | 2 | 1 | 0 | 0 | 2 | 3 | 0 | 0 | 0 | |
Elevated Liver Function Tests | 8 | 0 | 0 | 0 | 0 | 13 | 0 | 0 | 0 | 0 | |
Fatigue/Malaise | 25 | 17 | 6 | 0 | 0 | 12 | 19 | 5 | 0 | 0 | |
Hand-Foot syndrome | 4 | 4 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | |
Hypertension | 0 | 0 | 0 | 0 | 0 | 1 | 7 | 0 | 0 | 0 | |
Hypocalcemia | 4 | 1 | 2 | 0 | 0 | 6 | 3 | 0 | 1 | 0 | |
Hypokalemia | 8 | 0 | 1 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | |
Hypomagnesemia | 11 | 3 | 0 | 1 | 0 | 19 | 2 | 1 | 1 | 0 | |
Mucositis oral | 15 | 5 | 0 | 1 | 0 | 8 | 9 | 1 | 0 | 0 | |
Myalgia | 3 | 7 | 0 | 0 | 0 | 10 | 4 | 0 | 0 | 0 | |
Nail disorders | 14 | 4 | 0 | 0 | 0 | 9 | 1 | 1 | 0 | 0 | |
Nausea/Vomiting | 22 | 7 | 5 | 0 | 0 | 19 | 8 | 3 | 0 | 0 | |
Neuropathy | 25 | 5 | 3 | 0 | 0 | 19 | 0 | 0 | 0 | 0 | |
Proteinuria | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Rash | 8 | 3 | 0 | 0 | 0 | 13 | 11 | 6 | 0 | 0 | |
Thromboembolic event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | |
Treatment-related secondary malignancy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Observed Toxicities during Crossover Treatment with Vandetanib | Vandetanib (N=33) Grade | ||||
---|---|---|---|---|---|
1 | 2 | 3 | 4 | 5 | |
Hematologic | |||||
Anemia | 9 | 2 | 0 | 0 | 0 |
Neutrophil count decreased | 1 | 0 | 0 | 0 | 0 |
White blood cell decreased | 2 | 0 | 0 | 0 | 0 |
Non-Hematologic | |||||
Alopecia | 2 | 6 | 0 | 0 | 0 |
Anorexia | 2 | 1 | 1 | 0 | 0 |
Constipation | 5 | 4 | 0 | 0 | 0 |
Elevated Liver Function Tests | 5 | 1 | 0 | 0 | 0 |
Fatigue/Malaise | 11 | 5 | 1 | 0 | 0 |
Hand-Foot syndrome | 1 | 1 | 0 | 0 | 0 |
Hypertension | 1 | 0 | 2 | 0 | 0 |
Hypokalemia | 1 | 0 | 0 | 1 | 0 |
Hypomagnesemia | 5 | 1 | 0 | 0 | 0 |
Mucositis oral | 0 | 1 | 0 | 0 | 0 |
Myalgia | 4 | 1 | 1 | 0 | 0 |
Nail disorders | 2 | 0 | 0 | 0 | 0 |
Nausea/Vomiting | 5 | 1 | 1 | 0 | 0 |
Neuropathy | 8 | 0 | 0 | 0 | 0 |
Proteinuria | 1 | 0 | 0 | 0 | 0 |
Rash | 0 | 1 | 0 | 0 | 0 |