TABLE 2.
Toxicities for Reolysin in Combination With Paclitaxel and Carboplatin
| Toxicity | Reolysin Plus Paclitaxel With Carboplatin at 200mg/m2/AUC 6 (n = 2), % | Reolysin Plus Paclitaxel With Carboplatin at 175 mg/m2/AUC 5 (n = 36), % | ||||||
|---|---|---|---|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
| Hematologic | ||||||||
| Neutropenia | 0 | 0 | 0 | 50 | 0 | 14 | 19 | 0 |
| Anemia | 0 | 0 | 50 | 0 | 6 | 14 | 3 | 0 |
| Thrombocytopenia | 0 | 50 | 0 | 0 | 14 | 3 | 3 | 0 |
| Lymphocytopenia | 0 | 0 | 0 | 0 | 8 | 11 | 6 | 0 |
| Febrile neutropenia | 0 | 0 | 50 | 0 | 0 | 0 | 0 | 0 |
| Non hematologic | ||||||||
| Nausea | 50 | 50 | 0 | 0 | 64 | 8 | 3 | 0 |
| Vomiting | 0 | 0 | 0 | 0 | 22 | 8 | 8 | 0 |
| Anorexia | 0 | 50 | 0 | 0 | 17 | 11 | 0 | 0 |
| Diarrhea | 0 | 0 | 100 | 0 | 72 | 17 | 8 | 0 |
| Confusion | 0 | 0 | 0 | 0 | 6 | 3 | 3 | 0 |
| Headaches | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 |
| Transaminitis | 0 | 0 | 0 | 0 | 14 | 6 | 3 | 0 |
| Fatigue/asthenia | 0 | 50 | 50 | 0 | 83 | 33 | 19 | 3 |
| Arthralgia | 0 | 0 | 0 | 0 | 11 | 17 | 0 | 0 |
| Myalgia | 0 | 0 | 0 | 0 | 17 | 28 | 0 | 0 |
| Peripheral neuropathy | 50 | 0 | 0 | 0 | 14 | 3 | 0 | 0 |
| Hypotension | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 |
| Peripheral edema | 0 | 0 | 50 | 0 | 3 | 0 | 0 | 0 |
| Fever | 0 | 0 | 0 | 0 | 36 | 8 | 3 | 0 |
Abbreviation: AUC, area under the curve.