Table 3.
Commonly reported treatment-related toxicities (>10%) in patients receiving temsirolimus and erlotinib (N=41)
| Level 1 (N=15) | 1A (N=1) | 2 (n=5) | 3 (n=4) | Expansion (n=16) | All patients (N=41) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Any grade, N | G3 or worse, N | Any grade, N | G3 or worse, N | Any grade, N | G3 or worse, N | Any grade, N | G3 or worse, N | Any grade, N | G3 or worse, N | Any grade, N (%) | G3 or worse, N (%) | |||
| Non-Hematologic | ||||||||||||||
| Acneiform rash | 12 | 0 | 1 | 0 | 4 | 0 | 2 | 0 | 7 | 0 | 26 | 63.4% | 0 | 0.0% |
| Stomatitis | 7 | 1 | 1 | 0 | 3 | 0 | 3 | 0 | 11 | 1 | 25 | 61.0% | 2 | 4.9% |
| Hyperglycemia | 8 | 1 | 1 | 0 | 4 | 2 | 1 | 1 | 7 | 3 | 21 | 51.2% | 7 | 17.1% |
| Diarrhea | 8 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 10 | 0 | 21 | 51.2% | 0 | 0.0% |
| Nausea | 6 | 1 | 1 | 0 | 1 | 0 | 1 | 0 | 9 | 0 | 18 | 43.9% | 1 | 2.4% |
| Hypercholesterolemia | 6 | 0 | 0 | 0 | 3 | 0 | 1 | 0 | 7 | 0 | 17 | 41.5% | 0 | 0.0% |
| Fatigue | 3 | 1 | 1 | 0 | 2 | 0 | 3 | 0 | 8 | 0 | 17 | 41.5% | 1 | 2.4% |
| Anorexia | 4 | 1 | 1 | 0 | 2 | 0 | 2 | 0 | 6 | 0 | 15 | 36.6% | 1 | 2.4% |
| Dysgeusia | 2 | 0 | 0 | 0 | 3 | 0 | 3 | 0 | 6 | 0 | 14 | 34.1% | 0 | 0.0% |
| Hypertriglyceridemia | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 10 | 1 | 11 | 26.8% | 1 | 2.4% |
| Hypoalbuminemia | 4 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 5 | 0 | 10 | 24.4% | 0 | 0.0% |
| Rash, not otherwise specified | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 7 | 1 | 8 | 19.5% | 1 | 2.4% |
| Weight loss | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 4 | 0 | 7 | 17.1% | 0 | 0.0% |
| Hand-foot syndrome | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 6 | 0 | 7 | 17.1% | 0 | 0.0% |
| Dry skin | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 5 | 0 | 7 | 17.1% | 0 | 0.0% |
| Vomiting | 4 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 6 | 14.6% | 1 | 2.4% |
| Hypokalemia | 2 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 2 | 1 | 6 | 14.6% | 2 | 4.9% |
| Fever | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 5 | 12.2% | 0 | 0.0% |
| Alopecia | 4 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 5 | 12.2% | 1 | 2.4% |
| Nail changes | 1 | 0 | 1 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 5 | 12.2% | 0 | 0.0% |
| Elevated ALT | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 5 | 12.2% | 0 | 0.0% |
| Hematologic | 0 | 0.0% | ||||||||||||
| Anemia | 3 | 0 | 0 | 0 | 1 | 0 | 2 | 2 | 8 | 2 | 14 | 34.1% | 4 | 9.8% |
| Lymphopenia | 3 | 1 | 1 | 0 | 1 | 0 | 1 | 0 | 8 | 2 | 14 | 34.1% | 3 | 7.3% |
| Thrombocytopenia | 5 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 5 | 0 | 12 | 29.3% | 0 | 0.0% |
| Leukopenia | 3 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 6 | 14.6% | 0 | 0.0% |
| Neutropenia | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 5 | 12.2% | 0 | 0.0% |