Table 2.
Treatment-Related Toxicities
| Dose Cixutumumab, Temsirolimus | 6 mg/kg, 25mg N=17 |
6 mg/kg, 37.5mg N=3 |
||
|---|---|---|---|---|
| NCI CTCAE Grade | 1–2 | 3–4 | 1–2 | 3–4 |
|
| ||||
| Endocrine | N/(%) | |||
|
| ||||
| Hypercholesterolemia | 12 (71%) | __ | 3 (100%) | __ |
| Hypertriglyceridemia | 10 (59%) | 2 (12%) | 1 (33%) | 1 (33%) |
| Hyperglycemia | 10 (59%) | 1 (6%) | 2 (67%) | __ |
|
| ||||
| Hematologic | ||||
|
| ||||
| Thrombocytopenia | 8 (47%) | 6 (35%) | 2 (67%) | 1 (33%)* |
| Neutropenia | 4 (24%) | 6 (35%) | 2 (67%) | 1 (33%)* |
| Anemia | 2 (12%) | __ | __ | __ |
|
| ||||
| Non-hematologic | ||||
|
| ||||
| Mucositis | 10 (59%) | 3 (18%) | 3 (100%) | __ |
| Fatigue | 9 (53%) | __ | 2 (67%) | __ |
| Rash/itching | 9 (53%) | __ | 2 (67%) | __ |
| Elevated AST/ALT | 8 (47%) | __ | __ | __ |
| Elevated Creatinine | 6 (35%) | __ | __ | __ |
| Diarrhea | 3 (18%) | __ | 2 (67%) | __ |
| Anorexia/Weight loss | 3 (18%) | __ | 1 (33%) | __ |
| Nausea/Vomiting | 2 (12%) | __ | 1 (33%) | __ |
*
febrile neutropenia;
NCI, National Cancer Institute; ALT= alanine aminotransferase; AST= aspartate aminotransferase