Table 2.
Toxicities by Treatment Arm
| Sorafenib + Temsirolimus (n=63) | Sorafenib + Tipifarnib (n=39) | ||||
|---|---|---|---|---|---|
| Grade 1–2 N (%) |
Grade 3–4 N (%) |
Grade 1–2 N (%) |
Grade 3–4 N (%) |
||
|
| |||||
| Blood/Bone Marrow | Hemoglobin | 26 (41) | 2 (3) | 3 (8) | - |
| Leukocytes | 15 (24) | - | 1 (3) | - | |
| Neutrophils | 6 (10) | - | - | - | |
| Platelets | 19 (30) | 1 (2) | 3 (8) | - | |
| Cardiac General | Hypertension | 10 (16) | 1 (2) | 6 (15) | 2 (5) |
| Left ventricular systolic dysfunction | - | 1 (2) | - | - | |
| Constitutional symptoms | Fatigue | 35 (56) | 8 (13) | 20 (51) | 2 (5) |
| Dermatology/Skin | Acne | 18 (29) | 3 (5) | 8 (21) | 5 (13) |
| Erythema multiforme | 2 (3) | 1 (2) | 1 (3) | - | |
| Hand-foot | 3 (5) | 2 (3) | 3 (8) | 4 (10) | |
| Pruritus | 7 (11) | 2 (3) | 8 (21) | 1 (3) | |
| Rash | 14 (22) | 4 (6) | 9 (23) | 2 (5) | |
| Gastrointestinal | Anorexia | - | 1 (2) | - | - |
| Dehydration | 3 (5) | 3 (5) | 1 (3) | - | |
| Diarrhea | 14 (22) | 4 (6) | 16 (41) | 1 (3) | |
| Mucositis | 12 (19) | 2 (3) | 5 (13) | - | |
| Nausea | 19 (30) | 3 (5) | 7 (18) | - | |
| Vomiting | 7 (11) | 3 (5) | 2 (5) | - | |
| Hemorrhage/Bleeding | GI Hemorrhage: stomach | - | 1 (2) | - | - |
| Metabolic/Laboratory | ALT | 14 (22) | - | 1 (3) | 1 (3) |
| AST | 15 (24) | - | 1 (3) | 1 (3) | |
| Amylase | - | - | - | 1 (3) | |
| Cholesterol | 25 (40) | - | 7 (18) | - | |
| Hyperglycemia | 14 (22) | 1 (2) | 4 (10) | - | |
| Hypokalemia | - | 1 (2) | - | - | |
| Lipase | - | - | - | 1 (3) | |
| Hypophosphatemia | - | 1 (2) | - | - | |
| Musculoskeletal | Muscle weakness: whole body | - | 1(2) | - | - |
| Neurology | Neurology-other | - | 1 (2) | - | - |
| Pulmonary | Pulmonary-other | - | 1 (2) | - | - |
| Renal/Genitourinary | Renal failure | - | 1 (2) | - | - |